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☆ FTC Poised to Block Amgen’s $27.8 Billion Deal for Horizon Therapeutics
▼ + stars: | 2023-05-16 | by ( Dave Michaels | Joseph Walker | ) www.wsj.com time to read: 1 min

Amgen said it isn’t aware of any decision by the Federal Trade Commission. Photo: Eric Thayer/Bloomberg NewsThe Federal Trade Commission is preparing to block Amgen ’s acquisition of Horizon Therapeutics , a person familiar with the matter said, marking a new effort by antitrust enforcers to prevent a merger of pharmaceutical companies. The FTC is preparing to seek an injunction in federal court that would prevent the deal from closing, according to the person familiar with the matter. A federal judge would need to approve the injunction. That is part of a two-step legal process the agency typically uses to prevent mergers it believes are illegal.

The rollout of long-awaited Alzheimer’s treatments looks set to start as a case of the haves and the have-nots. Clinics and academic hospitals in large cities are recruiting neurologists and buying screening equipment on a bet that Biogen and Eisai’s drug Leqembi will win full approval this summer and draw a flood of new patients. Eli Lilly’s treatment donanemab could also be up for approval this year or next and could draw even more patients seeking care.

It is getting tougher for people taking expensive medicines to get financial help from drugmakers. Johnson & Johnson , Pfizer and other pharmaceutical companies are scaling back programs that cover the copayments of patients or provide free drugs. The programs have been costing drugmakers billions of dollars a year and have been increasing as health plans seeking to control their own spending have tried to take advantage of the assistance.

☆ These Biotech Companies Were Told Their SVB Funds Were Available. It Wasn’t That Simple.
▼ + stars: | 2023-03-15 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

The sudden collapse of Silicon Valley Bank was supposed to have been fixed by Sunday afternoon when federal regulators said they would make depositors whole starting Monday. But early this week, some companies were still left hurrying to make sure they could make this week’s payroll. In biotech—a sector where many startups relied on SVB—some were still finalizing the opening of new checking accounts to pay their employees from; and many of those who tried to move their funds out of their SVB accounts were unable to do so because the bank’s website kept crashing.

☆ Veterans Affairs to Be First Major Insurer to Cover Alzheimer’s Drug Leqembi
▼ + stars: | 2023-03-10 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Leqembi is the first anti-amyloid drug shown to slow decline from Alzheimer’s. Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year. Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.

☆ Eli Lilly Drug Fails to Prevent Alzheimer’s in Study
▼ + stars: | 2023-03-09 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Eli Lilly’s solanezumab was tested in more than 1,100 people with no signs of cognitive problems but who had clumps of the amyloid protein in their brains. An experimental drug from Eli Lilly & Co. failed to prevent memory loss in a study of healthy older people with a high risk of developing clinical Alzheimer’s disease in one of the first studies aimed at stopping symptoms before they start. The drug was no better than a placebo over about 4½ years of treatment at slowing patients’ decline in areas including memory and the ability to plan and complete tasks, Lilly said Wednesday.

☆ Amyloid Gains Converts in Debate Over Alzheimer’s Treatments
▼ + stars: | 2023-02-27 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

The success of Eisai Co.’s new Alzheimer’s drug has helped quiet a decadeslong dispute over a leading theory of what causes the disease and how to treat it, with proponents declaring victory and some former skeptics switching sides. Since the early 1990s, many scientists have thought that removing clumps of a sticky protein called amyloid from the brains of Alzheimer’s patients could help slow the disease, if not stall or reverse it. The theory was an outgrowth of the “amyloid hypothesis,” which held that an abnormal accumulation of brain amyloid was the central trigger in a complex neurodegenerative process leading to Alzheimer’s.

☆ Layoffs and Shutdowns Hit Biotech Industry in U-Turn
▼ + stars: | 2023-02-10 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

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☆ U.S. Appeals Court Sides With Drugmakers on Discount Program
▼ + stars: | 2023-01-30 | by ( Anna Wilde Mathews | Joseph Walker | ) www.wsj.com time to read: 1 min

The ruling by a three-judge panel of the Philadelphia-based Third Circuit Court of Appeals can be appealed. A U.S. appeals court ruled that pharmaceutical companies can limit their shipments of federally-discounted drugs to pharmacies, in a major win for the drugmakers and a blow to hospitals and clinics that receive the low-priced medicines. The ruling on Monday, by a three-judge panel of the Philadelphia-based Third Circuit Court of Appeals, was in favor of drugmakers Sanofi SA, AstraZeneca PLC and Novo Nordisk A/S, and against the Health Resources and Services Administration, or HRSA, which oversees the federal drug-discount program known as 340B.

☆ New Alzheimer’s Drug Leqembi Will Be Out of Reach for Most Patients
▼ + stars: | 2023-01-07 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

A sweeping Medicare rule issued last year will keep the newly approved Alzheimer’s disease drug Leqembi out of reach of most U.S. patients for months to come. The Food and Drug Administration on Friday approved Eisai Co. and Biogen Inc.’s Leqembi, known generically as lecanemab, for the treatment of people with early-stage Alzheimer’s disease, the vast majority of whom are insured by Medicare. However, Medicare won’t pay for the drug unless patients are enrolled in government-sanctioned clinical trials, and no such studies are ongoing or planned.

☆ New Alzheimer’s Drug Approved by FDA, Promises to Slow Disease
▼ + stars: | 2023-01-06 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

The Food and Drug Administration gave conditional approval to the Alzheimer’s drug based on an early study. U.S. health regulators gave early approval to a new Alzheimer’s drug from Eisai Co. and Biogen Inc., the most promising to date in a new class of medicines that may help slow cognitive decline caused by the disease. The Food and Drug Administration granted conditional approval to the drug, called lecanemab, based on an early study finding it reduced levels of a sticky protein called amyloid from the brains of people with early-stage Alzheimer’s. The companies will sell it under the brand name Leqembi.

☆ Jan. 6 response would have been 'vastly different' if rioters were Black, House sergeant at arms told investigators
▼ + stars: | 2022-12-28 | by ( Ryan J. Reilly | Ryan J. Reilly Is A Justice Reporter For Nbc News. | ) www.nbcnews.com time to read: +4 min

WASHINGTON — The House sergeant at arms, who was head of the D.C. National Guard during the attack on the U.S. Capitol, told the Jan. 6 committee that the law enforcement response would have looked much different had the rioters been Black Americans. I think it would have been a vastly different response if those were African Americans trying to breach the Capitol,” William J. Walker told congressional investigators, in an interview transcript released Tuesday. Walker indicated he thought that more rioters would have died at the hands of law enforcement on Jan. 6 had the makeup of the crowd not been overwhelmingly white. “You know, as a law enforcement officer, there were — I saw enough to where I would have probably been using deadly force,” Walker said. Walker told investigators that it was clear to him beforehand that Jan. 6 was going to be a "big deal" just from being aware of what was happening in the world.

A decades-old federal program that offered big drug discounts to a small number of hospitals to help low-income patients now benefits some of the most successful nonprofit health systems in the U.S. Under the program, hospitals buy drugs at reduced prices and sell them to patients and their insurers for much more, often at facilities in affluent communities.

☆ Mark Cuban Has a New Job: Working at an Online Discount Pharmacy
▼ + stars: | 2022-12-09 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

DALLAS—When Mark Cuban got an email in 2018 from a stranger asking if he wanted to invest in a company dedicated to bringing down the cost of prescription drugs, he replied: “Tell me more.”Today, the Dallas Mavericks owner and entrepreneur is helping steer the fledgling startup as it takes aim at high prescription drug prices and the industry middlemen who he says keeps them that way.

☆ New Alzheimer’s Drug Shows Positive Results but Side Effects
▼ + stars: | 2022-11-30 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Researchers released new details from a study of a closely watched drug for Alzheimer’s disease on Tuesday, shedding more light on the drug’s risks and benefits as U.S. health regulators weigh approving it. Eisai Co. and Biogen Inc.’s drug, called lecanemab, slowed cognitive decline by 27% compared with a placebo over 18 months in a study of more than 1,700 people with early-stage Alzheimer’s, researchers reported in the New England Journal of Medicine on Tuesday.

☆ Newest Alzheimer’s Drugs Take Large but Fraught Step Toward Approval
▼ + stars: | 2022-11-30 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

After years of failures, drugmakers appear on the verge of rolling out two new Alzheimer’s therapies in the next several months. The drugs, one from Eisai Co. and partner Biogen Inc. and another from Eli Lilly & Co., promise patients some much-needed options for slowing Alzheimer’s memory-robbing advance.

☆ Newest Alzheimer’s Drugs Take Large But Fraught Step Toward Approval
▼ + stars: | 2022-11-30 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

☆ Biogen Names Christopher Viehbacher New CEO
▼ + stars: | 2022-11-10 | by ( Joseph Walker | Colin Kellaher | ) www.wsj.com time to read: 1 min

Biogen Inc. named veteran pharmaceutical executive Christopher Viehbacher president and chief executive on Thursday, capping a monthslong search for a new leader after the failed launch of its once-promising Alzheimer’s disease drug Aduhelm. Mr. Viehbacher, who will also join the board, succeeds Michel Vounatsos , who has led Biogen since 2017 and in May said he would resign.

☆ RSV Vaccine Protected Infants From Severe Cases, Pfizer Study Finds
▼ + stars: | 2022-11-01 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Respiratory syncytial virus results in 58,000 hospitalizations annually of children under five years, and 100 to 500 deaths each year. An experimental vaccine from Pfizer Inc. significantly reduced the risk of infants developing severe cases of a respiratory virus that kills hundreds of children each year, according to the company. Among mothers who received the vaccine for the respiratory syncytial virus, their infants had an 81.8% lower risk of developing severe lower respiratory tract infections requiring medical attention within three months of birth than infants whose mothers received a placebo, Pfizer said Tuesday.

☆ RSV Vaccine Protects Babies From Severe Infections, Pfizer Study Finds
▼ + stars: | 2022-11-01 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

☆ Alzheimer’s Drug Slows Disease Progression in Trial
▼ + stars: | 2022-09-28 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Eisai's headquarters in Nutley, N.J.; the company said it would present more detailed study results in November at an Alzheimer’s research conference. Eisai Co. and Biogen Inc. said their experimental Alzheimer’s disease drug significantly slowed progression of the memory-robbing disease in a large study, bolstering the drug’s prospects for approval. The pharmaceutical companies said their drug lecanemab reduced cognitive and functional decline by 27%, compared with a placebo, over 18 months in a Phase 3 study of 1,800 patients with early-stage Alzheimer’s. The drug was also linked to higher rates of brain swelling and small bleeds, though the company said they were rarely symptomatic.

☆ Biogen Agrees to Pay $900 Million Over Alleged Improper Physician Payments
▼ + stars: | 2022-09-26 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

Biogen Inc. agreed to pay $900 million to settle allegations that it paid kickbacks to doctors to induce them to prescribe the company’s drugs, the Justice Department said Monday. From 2009 to 2014, Biogen allegedly used speaking and consulting fees and other remuneration to persuade doctors to prescribe the company’s multiple sclerosis drugs such as Avonex and Tecfidera, which resulted in fraudulent payments by Medicare and Medicaid for the drugs, according to a federal whistleblower lawsuit filed in 2012 by former Biogen employee Michael Bawduniak—and unsealed in 2015

☆ FDA Clashes With Swedish Biotech Seeking to Resume Cancer Drug Sale
▼ + stars: | 2022-09-23 | by ( Joseph Walker | ) www.wsj.com time to read: 1 min

The Food and Drug Administration is in a standoff with the Swedish biotech Oncopeptides AB over whether the company should be able to sell its anti-cancer drug, after a clinical trial indicated the therapy might harm patients. Oncopeptides stopped selling the drug Pepaxto in the U.S., in October 2021, after the disappointing test results. The company said the FDA pressured it to pull the drug. Since then, the company has been at odds with the FDA over resuming sales, at least for a group of patients that a subsequent analysis found might benefit.

The Sinaloa and Jalisco organizations have taken over from Chinese sellers as a dominant source of the potent synthetic opioid, a leading cause of the U.S.’s record overdoses. Among the reasons, it is easier and less expensive to produce than heroin.

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