New Alzheimer’s Drug Could Cost the Government as Much as It Spends on NASA

The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” for Medicare.

#aduhelm-drug, #biogen-inc, #drugs-pharmaceuticals, #federal-budget-us, #medicare

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Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited

Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.

#aduhelm-drug, #alzheimers-assn, #alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #labeling-and-labels-product, #your-feed-healthcare, #your-feed-science

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Desperate for Covid Care, Undocumented Immigrants Resort to Unproven Drugs

Shut out from mainstream medicine, some immigrants are buying expensive, unproven Covid therapies from “wellness” clinics or turning to the black market.

#alternative-and-complementary-medicine, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #health-insurance-and-managed-care, #illegal-immigration, #immigration-and-emigration, #migrant-labor-agriculture, #rumors-and-misinformation, #your-feed-healthcare

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High Hopes for Johnson & Johnson’s Covid Vaccine Have Fizzled in the U.S.

Production problems and a brief pause on its use kept the one-dose vaccine from becoming the game changer that health officials across the country believed it would be.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #factories-and-manufacturing, #gorsky-alex, #johnsonjohnson, #regulation-and-deregulation-of-industry, #rural-areas, #shutdowns-institutional, #states-us, #vaccination-and-immunization

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A Pill to Treat Covid-19? The U.S. Is Betting on It.

A new $3.2 billion program will support the development of antiviral pills, which could start arriving by the end of this year.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #national-institutes-of-health, #remdesivir-drug, #your-feed-healthcare

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The F.D.A.’s Approval of Biogen’s Alzheimer’s Drug Is a New Low

The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable. 

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #drugs-pharmaceuticals, #food-and-drug-administration

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F.D.A. Still Lacks a Permanent Commissioner

With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing without a permanent commissioner.

#aduhelm-drug, #biden-joseph-r-jr, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food, #food-and-drug-administration, #smoking-and-tobacco, #united-states-politics-and-government, #woodcock-janet, #your-feed-healthcare

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F.D.A. Tells Johnson & Johnson That60 Million Vaccine Doses Cannot Be Used

The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #food-and-drug-administration, #johnsonjohnson, #regulation-and-deregulation-of-industry, #united-states-politics-and-government, #vaccination-and-immunization

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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #elderly, #your-feed-science

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Wisconsin Pharmacist Who Tampered With Vaccine Gets 3-Year Sentence

The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.

#brandenburg-steven-1974, #conspiracy-theories, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #federal-bureau-of-investigation, #food-and-drug-administration, #grafton-wis, #united-states, #vaccination-and-immunization, #wisconsin

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A U.N. Declaration on Ending AIDS Should Have Been Easy. It Wasn’t.

Even with U.N.’s previous goals unmet, delegates tried to water down provisions regarding protections for vulnerable populations and patents for essential drugs.

#acquired-immune-deficiency-syndrome, #belarus, #china, #coronavirus-2019-ncov, #discrimination, #drugs-pharmaceuticals, #european-union, #homosexuality-and-bisexuality, #intellectual-property, #inventions-and-patents, #iran, #prostitution, #russia, #sex-education, #switzerland, #united-nations, #united-states, #vaccination-and-immunization, #your-feed-science

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Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.

#alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #health-insurance-and-managed-care

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Looking to Tackle Prescription Overload

Older adults often take more medications than they need, or than is safe. Increasingly, geriatric experts and their patients are exploring the benefits of “deprescribing.”

#drugs-pharmaceuticals, #elderly, #falls, #jama-internal-medicine-journal, #your-feed-health, #your-feed-science

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Alzheimer’s Drug Poses a Dilemma for the F.D.A.

If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.

#aducanumab-drug, #alzheimers-assn, #alzheimers-disease, #biogen-inc, #brain, #clinical-trials, #drugs-pharmaceuticals, #elderly, #food-and-drug-administration, #memory, #your-feed-healthcare, #your-feed-science

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F.D.A. Approves New Drug to Treat Vaginal Yeast Infections

Regulators allowed a new antifungal treatment, but critics say it is unneeded and costs too much.

#drugs-pharmaceuticals, #food-and-drug-administration, #scynexis-inc, #women-and-girls, #yeast-infections, #your-feed-science

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U.S. Covid Vaccine Donations Will Go to ‘Wide Range’ of Nations

Latin America, South and Southeast Asia and Africa will be among the recipients of an initial 25 million excess doses that the Biden administration is sharing this month.

#astrazeneca-plc, #biden-joseph-r-jr, #coronavirus-2019-ncov, #defense-production-act, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #shortages, #united-states, #vaccination-and-immunization, #walensky-rochelle

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Could Spilling Big Pharma’s Secrets Vaccinate the World?

We need more vaccines, fast. Is forcing pharmaceutical companies to share their intellectual property the answer?

#biden-joseph-r-jr, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #intellectual-property, #inventions-and-patents, #stockpiling, #vaccination-and-immunization

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Ketamine as a Depression Treatment Saved Me

I tried everything to treat my depression. Ketamine is the one thing that worked.

#depression-mental, #drugs-pharmaceuticals, #mental-health-and-disorders

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People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.

An F.D.A. sign-off for aducanumab would make finding a good treatment harder.

#alzheimers-disease, #brain, #clinical-trials, #drugs-pharmaceuticals, #placebos

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How Women Can Have a Feminist Menopause

Women often experience the hormonal transition of midlife in a shroud of misinformation and shame. We deserve better.

#drugs-pharmaceuticals, #estrogen, #hormones, #medicine-and-health, #menopause, #menstruation, #women-and-girls

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‘Delayed Prescribing’ May Help Cut Down on Antibiotic Use

Most respiratory illnesses don’t require antibiotics, which can have harmful side effects.

#antibiotics, #doctors, #drug-resistance-microbial, #drugs-pharmaceuticals, #infections, #otitis, #respiratory-diseases

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Pakistan’s Private Vaccinations Draw Criticism

An inoculation push, plagued with limited supplies and red tape, makes doses available to those who can pay for them. In a country with a struggling economy, most can’t.

#cansino-biologics, #china-national-pharmaceutical-group-corp-sinopharm, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #hospitals, #income-inequality, #international-trade-and-world-market, #pakistan, #politics-and-government, #prices-fares-fees-and-rates, #regulation-and-deregulation-of-industry, #vaccination-and-immunization

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Paul J. Hanly Jr., Top Litigator in Opioid Cases, Dies at 70

Mr. Hanly had been central to the current nationwide litigation against pharmaceutical companies, pharmacies and others in the opioid supply chain.

#deaths-obituaries, #drugs-pharmaceuticals, #hanly-paul-j-jr-1951-2021, #legal-profession, #liability-for-products, #opioids-and-opiates, #oxycontin-drug, #pain-relieving-drugs, #suits-and-litigation-civil

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In the Race for a Covid-19 Pill, a Little Lab Plays a Big Role

The Big Pharma drug model is inefficient and unsustainable. There is an alternative.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals

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Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations

Emergent BioSolutions faces scrutiny in Congress for ruining Covid-19 vaccines and securing lucrative federal contracts. Executives will appear before some lawmakers who benefited from the company’s spending.

#biomedical-advanced-research-and-development-authority, #campaign-finance, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #el-hibri-fuad, #elections-house-of-representatives, #emergent-biosolutions-inc, #factories-and-manufacturing, #government-contracts-and-procurement, #hoyer-steny-h, #johnsonjohnson, #kadlec-robert-p, #kramer-robert-g, #lobbying-and-lobbyists, #maryland, #political-action-committees, #scalise-steve, #united-states-politics-and-government, #vaccination-and-immunization

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Biden Dips Into U.S. Vaccine Supply to Send 20 Million Doses Abroad

President Biden’s pledge to ship out doses that could have been used domestically was a step toward a global campaign, but activists say much more is needed.

#astrazeneca-plc, #biden-joseph-r-jr, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #johnsonjohnson, #moderna-inc, #pfizer-inc, #united-states-politics-and-government, #vaccination-and-immunization

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New Drugs Could Help Treat Obesity. Could They End the Stigma, Too?

The hope is that new treatments will encourage people to think of obesity as a chronic disease, like high blood pressure or diabetes.

#bariatric-surgery, #chronic-condition-health, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #novo-nordisk-a-s, #obesity, #obesity-journal, #research, #weight

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FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15

The shots may allow millions of youngsters to get back to school, camps, sleepovers and hangouts with friends.

#biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #pediatric-inflammatory-multisystem-syndrome-pims, #pfizer-inc, #vaccination-and-immunization, #your-feed-science

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After a Decade Without Executions, South Carolina’s Solution: Bring Out the Firing Squad

State lawmakers have voted to add the firing squad as an alternative to the electric chair or lethal injection, with the drugs used for capital punishment in short supply.

#capital-punishment, #drugs-pharmaceuticals, #law-and-legislation, #mcmaster-henry, #south-carolina

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Baltimore Vaccine Plant’s Troubles Ripple Across 3 Continents

Millions of doses of Johnson & Johnson’s Covid-19 vaccine produced by Emergent BioSolutions have been held back in Europe, South Africa and Canada as a precaution.

#canada, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #europe, #factories-and-manufacturing, #government-contracts-and-procurement, #johnsonjohnson, #south-africa, #vaccination-and-immunization

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Biden Backs Suspending Patents on Covid Vaccines

The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.

#biden-joseph-r-jr, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #intellectual-property, #international-trade-and-world-market, #inventions-and-patents, #united-states-politics-and-government, #vaccination-and-immunization, #world-trade-organization

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Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine

The company said its vaccine generated $3.5 billion in revenue in the first three months of this year.

#biontech-se, #company-reports, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #international-trade-and-world-market, #inventions-and-patents, #pfizer-inc, #third-world-and-developing-countries, #vaccination-and-immunization

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FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.

#biden-joseph-r-jr, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #teenagers-and-adolescence, #united-states-politics-and-government, #vaccination-and-immunization

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Biden Confronts Coronavirus Vaccine Patents

President Biden and drugmakers are facing demands from liberal activists and global leaders to suspend intellectual property rights on the vaccines as the pandemic surges.

#barkan-ady, #biden-joseph-r-jr, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #humanitarian-aid, #intellectual-property, #inventions-and-patents, #moderna-inc, #pfizer-inc, #united-states-international-relations, #united-states-politics-and-government, #vaccination-and-immunization, #world-trade-organization

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Biden Can Help Make Covid-Vaccine Tech Available to Poor Countries

The West has hoarded vaccines and blocked developing nations from making their own. President Biden can put a stop to that.

#biden-joseph-r-jr, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #india, #international-trade-and-world-market, #inventions-and-patents, #third-world-and-developing-countries, #vaccination-and-immunization, #world-trade-organization

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Shake-Up at Covid Vaccine Manufacturer That Tossed Millions of Doses

Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.

#astrazeneca-plc, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #factories-and-manufacturing, #government-contracts-and-procurement, #johnsonjohnson, #regulation-and-deregulation-of-industry, #vaccination-and-immunization

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John C. Martin, 69, Dies; Led Drugmaker in Breakthroughs

A chemist by training, he turned Gilead Sciences into a leading, and lucrative, innovator with single-pill treatments for H.I.V. and hepatitis C.

#acquired-immune-deficiency-syndrome, #deaths-obituaries, #drugs-pharmaceuticals, #gilead-sciences-inc, #h-i-v, #hepatitis, #martin-john-c-1951-2021, #sovaldi-drug, #tamiflu-drug, #truvada-drug

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How Europe Sealed a Pfizer Vaccine Deal With Texts and Calls

The European Union is about to sign a deal for 1.8 billion doses of the Pfizer-BioNTech vaccine after a dispute with AstraZeneca derailed its vaccination campaign. Here’s how it came about.

#biontech-se, #bourla-albert, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #european-commission, #pfizer-inc, #vaccination-and-immunization, #von-der-leyen-ursula

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Inject the Vaccine Fan Fiction Directly Into My Veins

It feels very American to turn the vaccine rollout into a branding spectacle rooted in the worship of pharmaceutical companies.

#drugs-pharmaceuticals, #johnsonjohnson, #moderna-inc, #pfizer-inc, #quarantine-life-and-culture, #social-media, #tiktok-bytedance, #vaccination-and-immunization

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Biden to Send Coronavirus Vaccine Abroad

President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a four-alarm fire.”

#astrazeneca-plc, #biden-joseph-r-jr, #coronavirus-2019-ncov, #disease-rates, #drugs-pharmaceuticals, #food-and-drug-administration, #medicine-and-health, #modi-narendra, #united-states-politics-and-government, #vaccination-and-immunization, #world-health-organization

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Crohn’s Disease Is on the Rise

Many think the abdominal disorder starts in childhood, but it can occur at any age and is becoming more prevalent throughout the world.

#bowels, #colon, #crohns-disease, #digestive-tract, #drugs-pharmaceuticals

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Millions Are Skipping Their Second Doses of Covid Vaccines

Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #moderna-inc, #offit-paul-a, #pfizer-inc, #vaccination-and-immunization, #walgreen-co

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Vaccines Made at Troubled Baltimore Plant Were Shipped to Canada and Mexico

The Biden administration said it did not know of manufacturing problems at the Emergent factory when it approved shipping millions of doses of AstraZeneca’s vaccine. The company says the doses were safe.

#astrazeneca-plc, #baltimore-md, #biden-joseph-r-jr, #canada, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #factories-and-manufacturing, #government-contracts-and-procurement, #international-trade-and-world-market, #mexico, #united-states-international-relations, #united-states-politics-and-government, #vaccination-and-immunization

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Imagine, Surgery Without a Scar

A new study shows that a 20-year-old drug prevents scarring in mice. If it works on humans, it could change the lives of those with disfiguring wounds.

#burns, #drugs-pharmaceuticals, #gurtner-geoffrey, #longaker-michael, #research, #science-journal, #skin, #stanford-university, #surgery-and-surgeons

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Federal Inspectors Say More Vaccines at Troubled Plant May Be Contaminated

Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.

#astrazeneca-plc, #baltimore-md, #biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #food-and-drug-administration, #government-contracts-and-procurement, #house-of-representatives, #johnsonjohnson, #kadlec-robert-p, #trump-donald-j, #vaccination-and-immunization, #woodcock-janet

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Vaccines Won’t Protect Millions of Patients With Weakened Immune Systems

Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.

#antibodies, #autoimmune-diseases, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #immune-system, #leukemialymphoma-society, #regeneron-pharmaceuticals-inc, #rituxan, #vaccination-and-immunization, #your-feed-science

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Vaccines Won’t Protect Millions of Patients With Crippled Immune Systems

Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.

#antibodies, #autoimmune-diseases, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #immune-system, #leukemialymphoma-society, #regeneron-pharmaceuticals-inc, #rituxan, #vaccination-and-immunization, #your-feed-science

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Changing Strategy, the E.U. Bets Big on Pfizer to Battle Covid

After an early focus on AstraZeneca and months of turmoil, the European Union is pivoting away from the company’s vaccine. It has reached agreement for a faster rollout of the Pfizer-BioNTech shot.

#astrazeneca-plc, #blood-clots, #drugs-pharmaceuticals, #europe, #pfizer-inc, #vaccination-and-immunization, #von-der-leyen-ursula

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Worry Over 2 Covid Vaccines Deals Fresh Blow to Europe’s Inoculation Push

Confusion over AstraZeneca’s vaccine threatens to hurt the E.U. campaign just as it gathers momentum. And on Tuesday, Johnson & Johnson said it was pausing the rollout of its shot on the continent.

#astrazeneca-plc, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #europe, #european-union, #johnsonjohnson, #moderna-inc, #vaccination-and-immunization

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F.D.A. Will Allow Abortion Pills By Mail During the Pandemic

The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or hospital.

#abortion, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #supreme-court-us, #telemedicine, #women-and-girls, #your-feed-science

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