After ruining 75M J&J doses, Emergent gets FDA clearance for 25M doses

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

The US Food and Drug Administration is making progress in its efforts to sort out the fiasco at Emergent BioSolutions’ Baltimore facility, which, at this point, has ruined more than 75 million doses of COVID-19 vaccines stemming from what the regulator identified as significant quality control failures.

In March, news leaked that Emergent ruined 15 million doses of Johnson & Johnson’s vaccine as well as millions more doses of AstraZeneca’s vaccine. The spoilage happened when Emergent cross-contaminated batches of the two vaccines with ingredients from the other.

Last week, the FDA told Emergent to trash about 60 million more doses of Johnson & Johnson’s vaccine due to similar contamination concerns, The New York Times reported.

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Before ruining millions of vaccines, Emergent failed inspections, raked in cash

A flatscreen TV shows a serious man in a business suit.

Enlarge / Robert Kramer, President and Chief Executive Officer of Emergent BioSolutions, speaks via videoconference during a House Select Subcommittee on the Coronavirus Crisis hearing in the Rayburn House Office Building on Capitol Hill on May 19, 2021, in Washington, DC. (credit: Stefani Reynolds-Pool / Getty Images)

When contract-manufacturer Emergent BioSolutions contaminated at least 15 million doses of Johnson & Johnson’s COVID-19 vaccine and millions more doses of AstraZeneca’s vaccine at its Baltimore facility earlier this year, the company had been collecting monthly payments of $27 million from the US government—payments intended to help Emergent avoid just such a manufacturing disaster.

That’s according to a preliminary report from a Congressional investigation, conducted by two House committees—the Select Subcommittee on the Coronavirus Crisis and the Committee on Oversight and Reform. The report was released today and includes a number of troubling new details about the ongoing Emergent scandal.

The monthly “reservation fees” Emergent received were paid out of a questionable $628 million contract from May 2020. The money was intended to help Emergent maintain a state of “cleanliness and readiness” to produce vaccine under proper manufacturing standards and practices. But, as Ars previously reported, an inspection by the Food and Drug Administration in April found that to be far from the case.

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States won’t receive J&J doses next week amid ongoing production failures

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

States will not receive shipments of Johnson & Johnson’s one-shot COVID-19 vaccine next week, according to a report by Politico.

White House officials told governors in a call Tuesday that there are no new doses available for order. It’s unclear if the federal government will be able to distribute doses through other channels, such as those that provide vaccines directly to pharmacies and community health centers.

The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US.

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Ushopal looks to charm China’s beauty lovers with niche Western brands

What will China’s answer to Estée Lauder look like in the digital age?

According to Ushopal, it will provide a seamless online and offline shopping experience, where China’s savvy beauty shoppers get to discover niche, tasteful brands and learn their stories.

Ushopal was founded in 2017 by J&J veteran Lu Guo as an “omni-channel” partner for luxury beauty brands at a time when online and offline consumption were increasingly merging in China. Unlike traditional import distributors, which simply puts goods on the shelves, Ushopal offers a holistic solution that helps brands develop their digital and brick-and-mortar retail channels as well as marketing content through its network of 2,500 influencers.

Ushopal felt that patnerships weren’t enough, so in 2019, it took a step further by adding a strategic investment arm to seek deeper operational influence on brands. Check sizes range from $10 million to $100 million, and for the larger rounds, Ushopal says it can leverage its own investors such as Cathay Capital, a private equity firm focused on global companies.

For instance, Cathay Capital bought a minority stake in the Paris-based, high-end fragrance brand Juliette Has A Gun. As its investor and partner, Ushopal helped the brand, which was founded by the grandson of the legendary couturier Nina Ricci, grow its gross merchandise value in China from zero to over 70 million yuan within a year.

To boost its capital pool, Ushopal raised $100 million in March that lifted its total fundings to $200 million. Aside from Cathay Capital, its past investors also include FountainVest Partners, a Chinese private equity firm that recently acquired the Canadian premium outdoor clothing label Arc’teryx, and Chinaccelerator, SOSV’s China-based accelerator focused on cross-border businesses.

Chinese consumers are hooked to e-commerce today, but there is still much of the shopping experience that Alibaba’s marketplace and WeChat mini-stores can’t offer. As such, Ushopal opened its first multi-brand store in an upscale mall in Shanghai last year, carrying brands that are normally found in Neiman Marcus in the U.S. and Le Bon Marché in Paris. The goal is to showcase treasures from around the world, an idea that is captured by the chain’s name — Bonnie&Clyde — the names of a Depression-era crime couple who is often depicted as chic and rebellious in popular culture.

Customers don’t pay at B&C’s brick-and-mortar store; instead, they order through its app and can have the order delivered to their doorsteps within four hours if they live in Shanghai. The delivery time is much shorter than China’s standard e-commerce import practice, which normally takes three to seven days for goods to arrive from their overseas distribution centers.

B&C, on the other hand, stockpiles in its own warehouse in a free trade zone in Shanghai, which allows for much quicker delivery. And since it holds exclusive and selective distribution rights to the brands it works with, it has a good grasp over how much inventory to keep.

A promotional short video made by Ushopal for Juliette Has A Gun in China

At China’s beauty stores targeting the mass market, shoppers are often seen moving from one busily stocked shelf to another while their eyes are fixated on their phones, browsing product reviews on content commerce apps like Xiaohongshu. B&C wants full attention from its customers by limiting its in-store product number and statinoing a team of beauty advisors. The demographics it targets are also quite different.

“When they are traveling in the U.S., they are going to Barneys, Saxs Fifth Avenue and whey they are in the U.K., they are going to Harrods,” Lau, vice president of brands at Ushopal, told TechCrunch in an interview. “They are familiar with the experience, and they are not here to line up.”

Last year, B&C generated over $200 million in gross merchandise value through the products it bought from a dozen of brands and subsequently sold in China. The average ticket size of its sales was over 5,000 yuan ($770), with shoppers often spending over 10,000 yuan per order, according to Lau. Many of the customers were what he called “second-generation rich,” roughly China’s equivalent to trust fund kids, as well as “well-to-do wives.”

Ushopal doesn’t limit its portfolio to overseas products. It doesn’t distinguish the origin of a brand, said Lau, whether it’s Chinese, Japanese or European. Though the company mainly works with Western brands at the moment, Lau said Chinese brands are becoming more sophisticated and often understand the local market better.

“For us, it’s just about creating great brands. It’s like Estée Lauder, which has brands from all over the world. We are a China-based company but a global luxury business.”

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CDC, FDA lift pause of J&J vaccine after advisors vote in support of use [Updated]

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

Update 4/23/2021 7:00pm ET: The Centers for Disease Control and Prevention and the Food and Drug Administration announced late Friday that the pause on the use of Johnson & Johnson’s one-shot COVID-19 vaccine is now lifted.

The announcement comes just hours after a panel of CDC advisors voted largely in favor of resuming use, reaffirming its recommendation that it be used in all adults.

The two agencies paused use on April 13 after six women developed dangerous blood clots after receiving the vaccine. Though the CDC confirmed nine additional cases during the 11-day pause, the agencies and their advisors determined that the benefits of the vaccine greatly outweigh risks of the extremely rare condition.

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Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800%

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

Things are not looking good for Emergent BioSolutions, the contract manufacturer that ruined 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine and millions more doses of AstraZeneca’s COVID-19 vaccine at its production facility in Baltimore.

The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.

Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.

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Pause of J&J vaccine was the right call, say 88% of polled Americans

A large streetside sign for a Johnson and Johnson vaccine.

Enlarge / General exterior view of the head office of Janssen pharmaceutical company on April 15, 2021 in Leiden, Netherlands. (credit: Getty | BSR Agency)

About 88 percent of Americans support the pause of Johnson & Johnson’s COVID-19 vaccine, and the pause did not increase vaccine hesitancy, according to fresh data from the Axios-Ipsos Coronavirus poll.

The finding is likely to hearten public health experts, who have faced criticism and concern that the pause could erode confidence in vaccine safety and fortify already high-levels of vaccine hesitancy in the country.

The Centers for Disease Control and Prevention, along with the Food and Drug Administration, recommended a pause in the use of the Johnson & Johnson vaccine on April 13 after linking the one-dose vaccine to six cases of a rare blood-clotting condition, one of which was fatal. The six cases occurred among more than 6.8 million people given the vaccine, suggesting that if the blood clots are, in fact, a side effect of the vaccine, they are an extremely rare side effect.

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More J&J troubles: Vaccine manufacturing halted and more possible clot cases

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

The US Food and Drug Administration last week asked Emergent BioSolutions to stop making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to a regulatory filing Emergent released Monday.

The FDA had begun an inspection of the contract manufacturer’s facility on April 12 but requested on April 16 that production be halted “pending completion of the inspection and remediation of any resulting findings,” the filing reads. Any vaccine materials already made at the plant will be held in quarantine.

The production halt follows news last month that a mishap at the plant led to the ruin of 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine. The ruined doses had reportedly been contaminated with ingredients from AstraZeneca’s COVID-19 vaccine, which was also being manufactured at the plant at the time.

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CDC expert panel punts on deciding fate of J&J COVID vaccine

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

An advisory committee for the Centers for Disease Control and Prevention declined to vote on the fate of Johnson & Johnson’s COVID-19 vaccine Wednesday, likely leaving in place a pause on the vaccine’s use until the committee reconvenes in seven to 10 days.

The CDC’s Advisory Committee on Immunization Practices, or ACIP, expects that the coming week or so will provide additional data and analyses on the vaccine’s potential risks. Until it has more information, ACIP opted to provide no new recommendations on the use of the vaccine.

On the table, however, was everything from recommending against use of the vaccine altogether; recommending that only certain groups receive the vaccine, such as only men or only people over a certain age; or recommending that the pause be lifted and use continue in all adults as before.

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The very common vaccine ingredient at the center of J&J, AstraZeneca drama

Adenoviruses seen via transmission electron microscopy.

Enlarge / Adenoviruses seen via transmission electron microscopy. (credit: Getty | BSIP)

Out of an abundance of caution, US officials on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine. Officials linked the vaccine to six peculiar illnesses in which people developed life-threatening blood clots in combination with low levels of blood platelets, the cell fragments in blood that form clots. One person died from their condition and another is in critical condition.

It’s unclear if the vaccine caused the illnesses. Even if it did, the illnesses would represent an exceedingly rare side effect. The six cases occurred among more than 6.8 million people in the US who received the Johnson & Johnson vaccine. That would make it a side effect seen in fewer than one in a million. The risk of hospitalization and death from COVID-19, which the vaccine protects against, easily exceeds those odds. Without question, the benefits of the vaccine outweigh the potential risks.

Still, with robust supplies of vaccine from Moderna and Pfizer-BioNtech—neither of which have been linked to these unusual cases—US officials took the cautious route of pausing Johnson & Johnson’s vaccine while they investigate the cases further and inform clinicians about how to spot and treat any others that may arise. This latter point is critical because if doctors try to use standard blood clot treatments in these vaccine-linked cases, the outcomes can be fatal.

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J&J COVID vaccine use paused due to one-in-a-million complication

Image of a woman receiving a vaccine.

Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson. (credit: Tom Williams / Getty Images)

On Tuesday morning, the US Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.

Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.

This is not the first vaccine to create extremely rare clotting issues. They’ve also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.

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AstraZeneca vaccine linked to rare blood clots, EU regulators conclude

Extreme close-up photo of small, clear vials.

Enlarge / Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination center in Cyprus on March 22, 2021. (credit: Getty | Etienne Torbey)

European medical regulators on Wednesday concluded that there is a strong link between AstraZeneca’s COVID-19 vaccine and life-threatening conditions involving the unusual combination of blood clots and low levels of blood platelets.

As such, the conditions should be listed as a “very rare side effects” of the vaccine, according to the European Medicines Agency, a regulatory agency of the European Union.

The conclusion was based on the EMA’s in-depth review of 86 blood-clotting events among around 25 million people vaccinated with the AstraZeneca vaccine in Europe and the UK. Of the 86 blood-clotting events, 18 people died. Most—but not all—of the cases occurred in women under the age of 60.

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Factory mix-up spoils 15 million doses of J&J COVID vaccine

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine were ruined, and future vaccine shipments will be delayed. This all follows a mix-up at a manufacturing facility in Baltimore, according to multiple media reports.

Johnson & Johnson had partnered with Emergent BioSolutions to manufacture the active ingredient of its vaccine. But according to two US officials who spoke with Politico, workers at the West Baltimore facility mixed up the ingredients in Johnson &Johnson’s vaccine with those for a different coronavirus vaccine. Emergent BioSolutions is also a manufacturing partner of AstraZeneca, according to the New York Times, which first reported the problem.

The mishap with Johnson & Johnson’s vaccine began before the Food and Drug Administration had authorized the facility to produce the vaccine. Now, that authorization has been delayed and shipments are stalled.

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Merck/J&J deal may help US get enough vaccine for all adults by end of May

An older man in a suit speaks at a podium with a presidential seal.

Enlarge / US President Joe Biden delivers remarks on the government’s pandemic response, including the recently announced partnership between Johnson & Johnson and Merck to produce more Johnson & Johnson vaccine, as US Vice President Kamala Harris (L) looks on at the White House in Washington, DC on March 2, 2021. (credit: Getty | Jim Watson)

With a White House-brokered deal, vaccine giant Merck has agreed to help Johnson & Johnson boost its COVID-19 vaccine production, which is woefully behind on its manufacturing schedule.

President Joe Biden announced today that, with the new deal, the country is on track to have enough COVID-19 vaccine doses to vaccinate every adult in the country by the end of May—two months ahead of earlier plans.

“About three weeks ago, we were able to say that we’ll have enough vaccine supply for adults by the end of July,” the president said in an afternoon address. “And I’m pleased to announce today, as a consequence of the stepped-up process that I’ve ordered and just outlined, this country will have enough vaccine supply—I’ll say it again—for every adult in America by the end of May. By the end of May. That’s progress—important progress.”

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We’ll likely have a 3rd COVID vaccine soon; J&J vaccine clears last hurdle

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

After a day-long meeting Friday, an advisory panel for the US Food and Drug Administration voted 22 to 0 to recommend issuing an Emergency Use Authorization for Johnson & Johnson’s single-shot, refrigerator-stable COVID-19 vaccine.

If the FDA accepts the panel’s recommendation and grants the EUA—which it likely will—the country will have a third COVID-19 vaccine authorized for use. Earlier this week, FDA scientists released their review of the vaccine, endorsing authorization.

Agency watchers expect the FDA to move quickly on the decision, possibly granting the EUA as early as tomorrow, February 27. The FDA moved that fast in granting EUAs for the two previously authorized vaccines, the Moderna and Pfizer/BioNTech mRNA vaccines.

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Johnson & Johnson’s vaccine safe and effective, FDA review concludes

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

Johnson & Johnson’s single-shot COVID-19 vaccine is effective and has a “favorable safety profile,” according to scientists at the Food and Drug Administration.

The endorsement comes out of a review released by the regulatory agency Wednesday. The FDA has been looking over data on Johnson & Johnson’s vaccine since February 4, when the company applied for Emergency Use Authorization. The agency’s green light is a positive sign ahead of this Friday, February 26, when the FDA will convene an advisory committee to make a recommendation on whether the FDA should grant the EUA. The FDA isn’t obligated to follow the committee’s recommendation, but it usually does.

If Johnson & Johnson’s vaccine is granted an EUA, it will become the third COVID-19 vaccine available for use in the US. The other two vaccines are both two-dose, mRNA-based vaccines, one made by Pfizer and its German partner BioNTech and the other from Moderna, which developed its vaccine in collaboration with researchers at the US National Institutes of Health.

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FDA now reviewing a third COVID vaccine, made by Johnson & Johnson

The head office of Janssen pharmaceutical company on February 5, 2021 in Leiden, the Netherlands. The American mother company of Janssen, Johnson & Johnson, has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden.

Enlarge / The head office of Janssen pharmaceutical company on February 5, 2021 in Leiden, the Netherlands. The American mother company of Janssen, Johnson & Johnson, has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden. (credit: Getty | BSR Agency)

Johnson & Johnson on Thursday announced it has applied to the US Food and Drug Administration for an Emergency Use Authorization for its one-shot COVID-19 vaccine.

If the EUA is granted, the vaccine will be the third authorized for use in the US against the pandemic coronavirus, likely boosting the vaccine supply in the coming months and helping to hasten immunization country-wide.

J&J’s application to the FDA comes just a week after the company revealed top-line results of its Phase III clinical trial, which found the vaccine to be 66 percent effective overall at preventing moderate and severe COVID-19. J&J’s vaccine—made by its vaccine developer Janssen Pharmaceuticals—was 85 percent effective at preventing severe disease. In the trial, severe disease was defined as testing positive for the virus as well as having signs consistent with severe systemic illness, respiratory failure, shock, or organ failure, or being admitted to an intensive care unit, or dying. The company reported that no one who received the vaccine was hospitalized or died during the trial.

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COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%

COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%

Enlarge (credit: Getty | SOPA Images)

Johnson & Johnson’s experimental COVID-19 vaccine was 72 percent effective at preventing moderate and severe disease in the United States and 85 percent effective at preventing severe disease globally. But the one-shot vaccine struggled to fight off emerging virus variants in other countries, lowering its overall efficacy to 66 percent.

The topline results from Johnson & Johnson’s Phase III ENSEMBLE trial, announced Friday, suggest the vaccine will be yet another much-needed weapon against the pandemic virus, which has now infected over 100 million worldwide and killed nearly 2.2 million.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, global head of research and development at Janssen Pharmaceutical (owned by J&J). “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

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Johnson & Johnson’s COVID-19 vaccine is 85% effective against severe cases, and 66% effective overall per trial data

Another COVID-19 vaccine is almost ready to begin being distributed – a single-shot inoculation made by Johnson & Johnson’s Janssen pharmaceutical subsidiary. The company just released an efficacy report based on data from its Phase 3 trial, which found that the new vaccine is 66% effective overall in preventing moderate to severe incarnations of COVID-19 in those who received the jab, and 85% effective in preventing sever disease.

Those numbers aren’t as impressive as the reported figures for the Moderna and Pfizer/BioNTech vaccines that are already being distributed via emergency FDA approval, both of which reported 90+% efficacy. But Johnson & Johnson’s vaccine is a single shot rather than a two-course treatment, which should make it much easier to distribute much more quickly. The vaccine also showed 100% efficacy in preventing hospitalization or death among participants in the trial, 28 days after vaccination, which is a key measure when considering the broader impact of COVID-19 on healthcare resources, and efficacy varied by region, with the jab proving 72% effective in the U.S. across moderate and severe cases vs. 66% globally.

It’s also important to note that Johnson & Johnson’s Phase 3 trial is happening amid the emergence of new strains of the virus, including much more contagious versions like the UK and South African variants. At the time that both Moderna and BioNTech released their trial data, these variants hadn’t yet emerged or been confirmed by pandemic researchers.

Johnson & Johnson’s vaccine uses a modified version of a common cold virus to deliver DNA that provides a person’s body with instructions on building a replica of the spike protein that SARS-CoV-2 uses to attach to cells. The modified adenovirus can’t replicate in human cells, however, meaning it won’t lead to illness – only an immune response that can later be employed to combat contracting the virus that leads to COVID-19. This adenovirus method is much more proven in terms of use in human patients vs. the mRNA method that the other vaccines currently in use employ.

All of which is to say, despite headline numbers that appear to fall short relative to the data we’ve seen from Moderna and Pfizer, this Johnson & Johnson report is actually very encouraging. The company says it expects to file a request for an Emergency Use Approval (EUA) from the FDA in February, which could see it begin to be distributed next month, adding yet another weapon in the arsenal to combat the global pandemic.

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Resilience raises over $800 million to transform pharmaceutical manufacturing in response to COVID-19

Resilience, a new biopharmaceutical company backed by $800 million in financing from investors including ARCH Venture Partners and 8VC, has emerged from stealth to transform the way that drugs and therapies are manufactured in the U.S.

Founded by ARCH Venture Partners investor Robert Nelsen, National Resilience Inc., which does business as Resilience was born out of Nelsen’s frustrations with the inept American response to the COVID-19 pandemic.

According to a statement the company will invest heavily in developing new manufacturing technologies across cell and gene therapies, viral vectors, vaccines and proteins.

Resilience’s founders identified problems in the therapeutic manufacturing process as one of the key problems that the industry faces in bringing new treatments to market — and that hurdle is exactly what the company was founded to overcome.

“COVID-19 has exposed critical vulnerabilities in medical supply chains, and today’s manufacturing can’t keep up with scientific innovation, medical discovery, and the need to rapidly produce and distribute critically important drugs at scale. We are committed to tackling these huge problems with a whole new business model,” said Nelsen in a statement.

The company brings together some of the leading investment firms in healthcare and biosciences including operating partners from Flagship Pioneering like Rahul Singhvi, who will serve as the company’s chief executive’ former Food and Drug Administration commissioner Scott Gottlieb, a partner at New Enterprise Associates and director on the Resilience board; and Patrick Yang, the former executive vice president and global head of technical operations at Roche/Genentech .

“It is critical that we adopt solutions that will protect the manufacturing supply chain, and provide more certainty around drug development and the ability to scale up the manufacturing of safe, effective but also more complex products that science is making possible,” said Dr. Gottlieb, in a statement. “RESILIENCE will enable these solutions by combining cutting edge technology, an unrivaled pool of talent, and the industry’s first shared service business model. Similar to Amazon Web Services, RESILIENCE will empower drug developers with the tools to more fully align discovery, development, and manufacturing; while offering new opportunities to invest in downstream innovations in formulation and manufacturing earlier, while products are still being conceived and developed.”

Other heavy hitters in the world of medicine and biotechnology who are working with the company include Frances Arnold, the Nobel Prize-winning professor from the California Institute of Technology; George Barrett, the former chief executive of Cardinal Health; Susan Desmond-Hellmann, the former president of product development at Genentech; Kaye Foster, the former vice president of human resources at Johnson and Johnson; and Denice Torres, the former President of Johnson & Johnson Pharmaceutical and Consumer Companies.

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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

#astrazeneca, #covid-19, #jake-tapper, #jennifer-doudna, #johnson-johnson, #moderna-therapeutics, #pfizer, #pharmaceutical, #tc, #vaccine, #world-health-organization

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Thirty Madison raises $47 million for its direct to consumer treatments of hair loss, migraines, and indigestion

Thirty Madison, the New York-based startup developing a range of direct to consumer treatments for hair loss, migraines, and chronic indigestion, has raised $47 million in new financing.

After last week’s nearly $19 billion merger between Teladoc and Livongo, remote therapies and virtual care companies are all the rage among the healthcare industry and Thirty Madison’s business is no exception. 

An indicator of just how important these companies are to the future of the healthcare business can be seen in the presence of Johnson & Johnson Innovation – JJDC, Inc. (JJDC) in the latest round for Thirty Madison. 

Existing investors Maveron and Northzone also returned to back the company in a deal led by Polaris Partners. Thirty Madison has raised a total of $70 million so far. 

Founded just three years ago by Steven Gutentag and Demetir Karagas, Thirty Madison expanded from treating hair loss with its Keeps brand in 2018 to migraine treatments in early 2019 with Cove, and launched Evens (the company’s acid reflux treatment service) later that year. 

Thirty Madison has just begun offering urgent care consultations for users on a pay what you will model.

And the company’s founders differentiate Thirty Madison’s business from their better-funded competitors like Hims and Ro by emphasizing that their company provides continuing care after a diagnosis and offers a range of treatment options for the conditions that the company treats. That, coupled with the more narrow focus on a few specific conditions, distinguish Thirty Madison from its peers in the industry.

“Over 59% of Americans suffer from at least one chronic condition, but few resources exist to help them connect the dots of their care,” said Amy Schulman, a partner with Polaris Partners and new director on the Thirty Madison board. 

 

#articles, #healthcare, #healthcare-industry, #hims, #johnson-johnson, #keeps, #livongo, #maveron, #new-york, #partner, #polaris-partners, #ro, #tc, #teladoc-health, #telemedicine

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Moderna set to start final-stage trial of its coronavirus vaccine by July

Pharmaceutical company Moderna told Bloomberg on Thursday that it’s on pace to begin the final-stage clinical trial of its vaccine for the novel coronavirus that causes COVID-19 by July. Moderna was the first company to begin human clinical trials of its vaccine candidate in the U.S., and the last stage of its study will include 30,000 people and be conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the study will be to show definitive clinical proof that Moderna’s vaccine actually does prevent people from developing COVID-19, and, secondarily, that it prevents at least severe symptoms and cases that require hospitalization from materializing. Moderna’s second-stage clinical trial kicked off last month, and the company has previously said that it could potentially begin offering experimental doses available to healthcare workers in limited capacities as early as this fall.

The pace of development of a number of leading vaccine candidates is actually moving just as quickly, if not more quickly. Johnson & Johnson said early this week that it would start trials of its vaccine later in July, while AstraZeneca and its research and development partner the University of Oxford will be entering its own final-stage clinical trials as of this month.

Moderna’s vaccine candidate is an mRNA vaccine, which is a technology that essentially provides instructions to healthy cells to produce antibodies to the coronavirus, without having to actually introduce any of the active or inactive virus itself. mRNA vaccines, while used in veterinary medicines, are relatively new technology and have not yet been approved for use in human patients, but they represent a number of the early vaccine attempts, because of their advantages in terms of speed of development and the lessened theoretical health risk they pose to people, including early trial participants.

#astrazeneca, #coronavirus, #covid-19, #drugs, #health, #johnson-johnson, #medicine, #moderna, #tc, #united-states, #vaccines

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Cue Health raises $100 million to speed development of rapid, portable COVID-19 diagnostics

San Diego-based startup Cue Health has closed a $100 million Series C funding round, including participation from Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation, ACME Capital and others. The funding will be used to help Cue finish up development, validate and scale production of its Cue Health Monitoring System and test cartridges, including test kits designed to diagnose COVID-19, which are currently being reviewed by the U.S. Food and Drug Administration (FDA) for emergency use authorization.

Cue has been developing its connected, portable lab to provide on-site care including molecular diagnostic tests since its founding a decade ago. The company also secured a $13 million contract in March specifically targeted towards development of a portable point-of-care COVID-19 test. Cue co-founder and CEO Ayub Khattak says that this pandemic has only re-emphasized the need for its product, which is primarily aimed at providing rapid, simple-to-use diagnostics that can be implemented quickly by a wide range of frontline workers in a variety of settings.

Concurrently with its EUA process for the Cue COVID-19 test, the company is also finishing up validation of the results for its influenza A and B tests, which will be used to submit to the agency for final approval of those tests as well. Its tests would provide at-home molecular based testing, with a connected results platform that can immediately provide diagnostics to certified healthcare providers within 20 minutes, unlocking a new level of remote care.

In total, Cue has $30 million in contract from the U.S. HHS’ Biomedical Advanced Research and Development Authority (BARDA) across its efforts both for flu testing and for COVID-19 diagnostics.

#biomedical-advanced-research-and-development-authority, #coronavirus, #covid-19, #cue-health, #flu, #foresite-capital, #funding, #health, #johnson-johnson, #madrone-capital-partners, #san-diego, #science, #tc

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Locatee raises $4M Series A for its workplace analytics platform

Locatee, a Swiss startup that uses existing sensors and IT infrastructures to provide employers and commercial real estate owners with detailed data about how their spaces are utilized, today announced that it has raised a $4 million Series A funding round led by San Francisco-based FYRFLY Venture Partners and Zurich-based Tomahawk VC.

“We started the company based on the experience we had with the big banks,” Locatee CEO and co-founder Thomas Kessler told me. “As users, we were introduced to this new world of working. You can work from any place. You can work from Starbucks. You can work from any area. And in the office, I did not have my own desk anymore. I could choose between meeting rooms, focus areas and so on. But that also has some challenges for managing the space.”

Corporate real estate managers often don’t understand how their buildings are utilized these days because they simply don’t have the tools to gather this data. As a result, they overprovision their office spaces and large chunks of it remain empty — which organizations then unnecessarily pay for.

What makes Locatee stand out from similar players in this space is that it integrates with existing motion sensors inside a building and other data sources, like Wi-Fi networks. For Swiss Re’s Munich office, for example, Locatee was able to work with NetCloud and integrate with the existing Cisco network infrastructure. Thanks to the data it gathered, Swiss Re was able to reduce its local office space by 10%, which Locatee says allowed the company to save about €290,000 per year.

On top of the core data analytics, Locatee also offers a number of other tools, ranging from smart signage for meeting rooms and workstations, for example, to desk finders for workers who now (or at least once they return to their offices) are often not working from a single, pre-assigned cubicle every day but who roam around a building and work from a different spot every day.

As Keller stressed, Locatee approached its first customers by trying to understand their use cases, not by trying to sell them technology. One of Locatee’s first customers was Biogen, but today, it also calls Swiss Re, Johnson & Johnson and Zurich (the financial services company, not the city) among its users.

Locatee’s data is anonymized and Kessler argues that employees don’t tend to worry about being tracked. “[Employees] have a benefit,” he said. “They have an app, for instance, where they can see available meeting rooms and desks. And they can see where colleagues are — on an opt-in basis. So it’s more like a ‘share your location’ feature like in iOS Messenger or in WhatsApp .”

With that kind of momentum, Kessler told me, finding investors was relatively easy — though it surely helped that the company closed this raise before the coronavirus pandemic hit Europe.

“Locatee’s vision to transform how space is used will ultimately elevate the quality of life for employees and can also contribute significantly to sustainable development goals,” said Philipp Stauffer, co-founder and managing director at FYRFLY Venture Partners. “Office space is only one component and increasingly all ‘work points’ matter for productivity optimization. A quantitative approach to space optimization and productivity holds both significant top- and bottom-line potential for large global organizations. Furthermore, aggregated data can help predict larger market trends, which is exciting to us.”

The company says it wants to use the new funding to become the “Google Analytics of office buildings.” And while its technology could also be used in other environments, Kessler says he wants to focus on office space for now. “There is still a lot of wasted real estate that needs to be optimized,” he said.

#analytics, #economy, #europe, #fyrfly-venture-partners, #google, #johnson, #johnson-johnson, #locatee, #real-estate, #recent-funding, #san-francisco, #social-media, #startups, #swiss-re, #tc, #telecommuting, #tomahawk-vc, #whatsapp, #working-conditions, #zurich

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Desperate to exit, a $10B price tag for Magic Leap is crazy

Augmented reality headset maker Magic Leap has struggled with the laws of physics and failed to get to market. Now it’s seeking an acquirer, but talks with Facebook and medical goods giant Johnson & Johnson led nowhere according to a new report from Bloomberg’s Ed Hammond.

After raising over $2 billion and being valued between $6 billion and $8 billion back when it still had momentum, Hammond writes that “Magic Leap could fetch more than $10 billion if it pursues a sale” according to his sources. That price seems ridiculous. It’s the kind of number a prideful company might strategically leak in hopes of drumming up acquisition interest, even at a lower price.

Startups have been getting their valuations chopped when they go public. The whole economy is hurting due to coronavirus. Augmented Reality seems less interesting than virtual reality with people avoiding public places. Getting people to strap used AR hardware to their face for demos seems like a tough sell for the forseeable future.

No one has proven a killer consumer use case for augmented reality eyewear that warrants an expensive and awkward-to-wear gadget. Our phones can already deliver plenty of AR’s value while letting you take selfies and do video chat that headsets can’t. My experiences with Magic Leap at Sundance Film Festival last year were laughably disappointing, with its clunky hardware, ghostly projections, and narrow field of view.

Apple and Facebook are throwing the enduring profits of iPhones and the News Feed into building a better consumer headset. Snapchat has built intermediary glasses since CEO Evan Spiegel thinks it will be a decade before AR headsets see mainstream adoption. AR rivals like Microsoft have better enterprise experience, connections, and distribution. Enterprise AR startup Daqri crashed and burned.

Magic Leap’s CEO said he wanted to sell 1 million of its $2300 headset in its first year, then projected it would sell 100,000 headsets, but only moved 6,000 in the first six months, according to a daming report from The Information’s Alex Heath. Alphabet CEO Sundar Pichai left Magic Leap’s board despite Google leading a $514 million funding round for the startup in 2014. Business Insider’s Steven Tweedie and Kevin Webb revealed CFO Scott Henry and SVP of creative strategy John Gaeta bailed in November. The company suffered dozens of layoffs. It lost a $500 million contract to Microsoft last year. The CEOs of Apple, Google, and Facebook visited Magic Leap headquarters in 2016 to explore an acquisition deal, but no offers emerged.

Is AR eyewear part of the future? Almost surely. And is this startup valuable? Certainly somewhat. But Magic Leap may prove to be too little too early for a company burning cash by the hundreds of millions in a market newly fixated on efficiency. A $10 billion price tag would require one of the world’s biggest corporations to believe Magic Leap has irreplicable talent and technology that will earn them a fortune in the somewhat distant future.

The fact that Facebook, which does not shy from tall acquisition prices, didn’t want to buy Magic Leap is telling. This isn’t a product with hundreds of millions of users or fast-ramping revenue. It’s a gamble on vision and timing that looks to be coming up snake eyes. It’s unclear when the startup would ever be able to deliver on its renderings of flying whales and living room dinosaurs in a form factor people actually want to wear.

 

One of Magic Leap’s early renderings of what it could supposedly do

With all their money and plenty of time before widespread demand for AR headsets materializes, potential acquirers could likely hire away the talent and make up the development time in cheaper ways than buying Magic Leap. If someone acquires them for too much, it feels like a write-off waiting to happen.

#apple, #augmented-reality, #daqri, #facebook, #fundings-exits, #gadgets, #google, #hardware, #johnson-johnson, #magic-leap, #microsoft, #microsoft-hololens, #startups, #sundar-pichai, #tc, #wearables

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