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☆ AstraZeneca Is Withdrawing Its Covid Vaccine Worldwide, Citing Low Demand
▼ + stars: | 2024-05-08 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

AstraZeneca has started to pull its Covid-19 vaccine from global markets because of low demand, the pharmaceutical giant said. The move was not related to any concerns about the shot’s side effects, the company said. Since the vaccine was approved in Britain in December 2020, over three billion doses have been supplied globally. The company said that it had decided to voluntarily withdraw all licenses to market its Covid vaccine. In March, AstraZeneca requested that the vaccine be withdrawn from most European countries.

Organizations: AstraZeneca, Oxford University, European Commission Locations: Britain

☆ Under Armour’s Founder Will Return as C.E.O.
▼ + stars: | 2024-03-13 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

Under Armour, the sports apparel company, said on Wednesday that its founder, Kevin Plank, would return as chief executive, in a leadership shake-up that will seek to revitalize the struggling brand. Mr. Plank, who founded Under Armour in 1996, had remained the company’s executive chair and controlling shareholder after exiting as chief executive at the end of 2019. He will take over on April 1 from Stephanie Linnartz, who led the company for just over a year. With sales slumping, the company’s stock has fallen by about 85 percent since reaching a record high in 2015. It rose slightly in after-hours trading after the news that Mr. Plank would be returning to lead the company after four years away from the job.

Persons: Armour, Kevin Plank, Plank, Stephanie Linnartz, Linnartz, Patrik Frisk, ” Organizations: Nike, LinkedIn

☆ Under Bernie Sanders’s Glare, Pharmaceutical Chiefs Will Testify on Drug Prices
▼ + stars: | 2024-02-08 | by ( Noah Weiland | Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The chief executives of three major pharmaceutical companies are set to appear in front of the Senate health committee on Thursday to defend how much they charge for drugs in the United States, drawing them further into a confrontation with lawmakers and the Biden administration over the cost of some of the most widely used prescription medications. The three executives scheduled to testify — Joaquin Duato of Johnson & Johnson, Robert M. Davis of Merck and Christopher Boerner of Bristol Myers Squibb — are expected to clash with the health committee’s chairman, Senator Bernie Sanders of Vermont, an independent who has made reining in drug prices a signature cause of his late-career years in Congress. Mr. Sanders plans to focus the hearing on why drug prices are higher in the United States than in other wealthy countries. His staff has singled out several widely used drugs, including Eliquis, a blood thinner made by Bristol Myers Squibb, and Januvia, a diabetes drug from Merck, that can be bought for much less in Canada and Europe than in the United States.

Persons: Biden, — Joaquin Duato, Johnson, Robert M, Davis, Christopher Boerner, Bernie Sanders of, Sanders Organizations: Merck, Bristol Myers Squibb Locations: United States, Bernie Sanders of Vermont, Canada, Europe

☆ Six Reasons Why It’s So Hard to Get Your Weight-Loss Drugs
▼ + stars: | 2024-02-02 | by ( Reed Abelson | Rebecca Robbins | ) www.nytimes.com time to read: 1 min

Talk to people who have tried to get one of the wildly popular weight-loss drugs, like Wegovy, and they’ll probably have a story about the hoops they had to jump through to get their medication — if they could get it at all. Emily Weaver, a nurse practitioner in Cary, N.C., said she told her patients that finding Wegovy was “like winning the lottery.”Here are six reasons why. Fueled in part by TikTok videos and celebrity testimonials, people are increasingly seeking prescriptions for appetite-suppressing medications. The drugs in this class have long been used to treat diabetes but more recently have been recognized for their extraordinary ability to help patients lose weight. The medications are injected weekly and have sticker prices as high as $16,000 a year.

Persons: they’ll, Emily Weaver, Wegovy Locations: Cary, N.C

☆ Biogen Abandons Its Controversial Alzheimer’s Drug Aduhelm
▼ + stars: | 2024-01-31 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The drug maker Biogen said on Wednesday it would abandon its ownership rights to Aduhelm, an Alzheimer’s drug that had provoked fierce criticism of the company and regulators after it was approved based on weak evidence that it would help patients. The company will also stop a clinical trial that the Food and Drug Administration had ordered to confirm whether the drug is effective in slowing the progression of Alzheimer’s disease. Biogen’s decision closes out a yearslong saga that generated outrage and eroded trust in the regulatory process for bringing new medicines to market. adviser called the approval of the drug perhaps “the worst approval decision that the F.D.A. has made that I can remember.” A congressional inquiry later found that the F.D.A.’s process for approving Aduhelm was “rife with irregularities” and involved “lapses in protocol,” including unusually close collaboration with Biogen.

Persons: Biogen, Aduhelm Organizations: and Drug Administration

☆ Buried in Wegovy Costs, North Carolina Will Stop Paying for Obesity Drugs
▼ + stars: | 2024-01-26 | by ( Rebecca Robbins | ) www.nytimes.com time to read: 1 min

In June 2021, the insurance plan for North Carolina state employees was paying for 2,800 people to take weight-loss drugs. Last year, it paid for nearly 25,000. Medications like Wegovy cost the North Carolina State Health Plan $100 million last year, rising seemingly out of nowhere to represent 10 percent of its spending on prescription drugs. “This is something we never anticipated,” said Dale Folwell, the state treasurer whose office runs the health plan.

Persons: ”, Dale Folwell Organizations: North Carolina, Health Locations: North Carolina

Here are six reasons drugs in the United States cost so much:1. In the United States, negotiations with drug makers are split among tens of thousands of health plans, resulting in far less bargaining muscle for the buyers. Other nations also conduct careful analyses of how much additional benefit a new drug presents over drugs already on the market — and at what cost. If the cost is too high and the benefit too small, those countries are more willing to say no to a new drug. Health policy analysts say that is a start, but much broader negotiating authority is needed to make a dent in drug prices overall.

Persons: ”, Stacie Dusetzina Organizations: Vanderbilt University School of Medicine, Pharmaceutical, Industry Locations: United States

☆ Common Patenting Tactic by Drug Companies May Be Illegal, F.T.C. Says
▼ + stars: | 2023-09-14 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The Federal Trade Commission on Thursday issued what amounted to a warning to pharmaceutical companies about the legality of a widespread patenting strategy that experts say has helped keep inhaler costs high for patients with asthma and lung problems. In a policy statement unanimously endorsed by the agency’s commissioners, the F.T.C. said it “intends to scrutinize” whether companies are illegally engaging in an unfair method of competition when they exploit a regulatory loophole that can delay rivals from entering the market. The policy statement did not single out any particular products. “This seems to be a real problem, and one that could really be contributing to unaffordable medicines and drug products,” Lina Khan, the F.T.C.

Persons: “, ” Lina Khan Organizations: Federal Trade Commission

☆ Kroger Agrees to Pay $1.2 Billion to Settle Opioid Claims
▼ + stars: | 2023-09-08 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +2 min

Background: Pharmacy chains have been settling opioid claims. Three large pharmacy chains that compete with Kroger — Walgreens, CVS Health and Walmart — reached similar settlements last year totaling about $13 billion. The claims against Kroger and its competitors have focused on the role of their pharmacies in flooding communities with legal painkillers. Why It Matters: Opioid settlement money is funding recovery efforts. Kroger said on Friday that the opioid settlement agreement would not impede the merger.

Persons: Kroger, Walmart —, overprescribing, Josh Stein, ”, Harris, Jan Hoffman Organizations: Kroger, Walgreens, CVS Health, Walmart, Rite, Albertsons Locations: Washington State, West Virginia, North Carolina

For decades, drugmakers have argued that patents are critical to bringing new drugs to the market. But in 2004, when a promising H.I.V. treatment emerged, Gilead Sciences decided to slow-walk its release to maximize profit on the company’s existing patents. Rebecca Robbins, who covers the pharmaceutical industry for The Times, discusses one man’s case and how patents can create perverse incentives to delay new and better drugs.

Persons: drugmakers, Rebecca Robbins Organizations: Gilead Sciences, The Times

A year ago, Congress overhauled how drugs for older Americans are paid for, giving Medicare the power to bargain with drug makers over prices. It’s the biggest change to health care for more than a decade, and this week, the Biden administration began to implement it. Sheryl Gay Stolberg, who covers health policy for The Times, discusses the decades of struggle behind the change and Rebecca Robbins, who covers the pharmaceutical industry, explains its potential to reshape the business of drugs in America.

Persons: Biden, Sheryl Gay Stolberg, Rebecca Robbins Organizations: The Times Locations: America

The medications on the list are taken by millions of older Americans and cost Medicare billions of dollars annually. The drugs were selected by the Centers for Medicare & Medicaid Services through a process that prioritized medications that account for the highest Medicare spending, have been on the market for years and do not yet face competition from rivals. Drugs Selected for Price Negotiations1. Eliquis, for preventing strokes and blood clots, from Bristol Myers Squibb and Pfizer2. Xarelto, for preventing strokes and blood clots, from Johnson & Johnson4.

Persons: Biden, Price, Boehringer Ingelheim, Eli Lilly, Johnson Organizations: Tuesday, Medicare, Centers, Services, Bristol Myers Squibb, Pfizer, Johnson, Merck, AstraZeneca, Novartis, Novo Nordisk Locations: AbbVie, Novo

☆ Opioid Maker’s Bankruptcy Plan Would Cut Payments to Victims by $1 Billion
▼ + stars: | 2023-08-23 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

A major opioid manufacturer that had promised to pay $1.7 billion as compensation over its role in the opioid crisis disclosed on Wednesday that it had reached an agreement with its creditors to reduce the settlement payments by $1 billion. The funds had been earmarked for addiction victims to rebuild their lives and for governments to pay for priorities like drugs to reverse opioid overdoses. In a regulatory filing on Wednesday, Mallinckrodt disclosed that it had reached a plan to file for bankruptcy for the second time in three years. The plan to cancel a majority of the outstanding payments was devised with backing from hedge funds that would control the company under a second bankruptcy. The funds had lent money to Mallinckrodt and were in a position to force the company to prioritize paying back its lenders over compensating victims.

Persons: Mallinckrodt Organizations: Mallinckrodt Pharmaceuticals

The legal push comes just weeks before the Centers for Medicare & Medicaid Services is scheduled to publish a long-awaited list of the first 10 drugs that will be subject to negotiations. Earlier this month, the chamber asked a federal judge in Ohio to issue an injunction that would block any negotiations while its case is being heard. Lawrence O. Gostin, an expert in public health law at Georgetown University, said the Supreme Court might be sympathetic to some of the industry’s arguments. The president and Democrats have long campaigned on reducing drug prices and plan to make it a central theme of their 2024 campaigns. The White House press secretary, Karine Jean-Pierre, said in a statement that Mr. Biden was confident the administration would win in court.

Persons: Lawrence O, “, Mr, Gostin, Biden, Karine Jean, Pierre Organizations: Medicare, Medicaid Services, Georgetown University, Supreme, White Locations: Ohio

The promising drug, then in the early stages of testing, was an updated version of tenofovir. The “patent extension strategy,” as the Gilead documents repeatedly called it, would allow the company to keep prices high for its tenofovir-based drugs. Gilead could switch patients to its new drug just before cheap generics hit the market. By putting tenofovir on a path to remain a moneymaking juggernaut for decades, the strategy was potentially worth billions of dollars. The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s older H.I.V.

Persons: Gilead

But Mr. Ramaswamy, now 37, made a fortune anyway. The core company Mr. Ramaswamy built has since had a hand in bringing five drugs to market, including treatments for uterine fibroids, prostate cancer and the rare genetic condition he mentioned on the stump in Iowa. Mr. Ramaswamy’s resilience was in part a result of the savvy way he structured his web of biotechnology companies. He’s a sort of a Music Man,” said Kathleen Sebelius, a Democrat and former health secretary during the Obama administration who advised two of Mr. Ramaswamy’s companies. For his part, Mr. Ramaswamy said that criticism that he overpromised was missing the point.

Persons: Ramaswamy, ”, Kathleen Sebelius, Obama, overpromised Organizations: Democrat Locations: Iowa

☆ Merck Sues Over Law Empowering Medicare to Negotiate With Drugmakers
▼ + stars: | 2023-06-06 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The pharmaceutical company Merck on Tuesday sued the government over a federal law that empowers Medicare for the first time to negotiate prices directly with drugmakers. Democrats pushed through the Medicare-negotiation program last summer as a provision of the Inflation Reduction Act, framing it as a way of lowering drug prices. Only some drugs will be subject to negotiation with Medicare and only after they have been on the market without competition for years. But Merck, which generated $14.5 billion in profit last year, claimed in a statement on Tuesday that the law would stifle its ability and that of its peers to make risky investments in new cures. Other drug companies have suggested that they will choose to cut certain drug development programs because of the projected dent to their revenue.

Organizations: Merck, Medicare Locations: Washington

☆ U.S. Sues to Block Amgen’s $27.8 Billion Takeover of Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The Federal Trade Commission on Tuesday sued to block the drug maker Amgen’s $27.8 billion acquisition of the pharmaceutical company Horizon Therapeutics, saying it would thwart competition in the drug industry. said the deal would allow Amgen to use its large portfolio of top-selling drugs to pressure insurers and others to favor two Horizon medications that lack competition. The commission’s move is its most aggressive yet after years of signaling that it would be tougher in scrutinizing pharmaceutical mergers. This case is unusual because Amgen and Horizon do not sell competing products. won’t hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”

☆ U.S. Loses Key Case on Rights to H.I.V.-Prevention Drugs
▼ + stars: | 2023-05-09 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

A federal jury in Delaware on Tuesday found that the federal government did not have an ownership claim to lucrative drugs to prevent H.I.V. The Trump administration brought the lawsuit in 2019 in part because of concern over the high price Gilead was charging. The two versions of the drug — Truvada and the newer Descovy — have generated huge profits for Gilead. Lawyers for the federal government had argued that Gilead had violated three government patents that protected the concept of using Truvada to prevent H.I.V. The patents were granted to researchers at the Centers for Disease Control and Prevention for inventions stemming from experiments they conducted on monkeys in the mid-2000s.

☆ F.D.A. Approves Drug for Rare Form of A.L.S.
▼ + stars: | 2023-04-25 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

Biogen will be required to provide confirmatory evidence, from ongoing clinical research, to keep the drug on the market. The decision is the first conditional approval granted for a medication for A.L.S., or amyotrophic lateral sclerosis, which generally causes paralysis and death within a few years. The approval is based on evidence that the drug can significantly reduce levels of a protein that has been linked to damage to nerve cells. Despite the uncertainty about its benefit, Qalsody’s approval is widely seen as more justifiable than that of Aduhelm, another drug from Biogen. unanimously recommended that the agency grant conditional approval of Qalsody, even though a majority of advisers concluded that there was not convincing evidence that it was effective.

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