Today we talk about an advance in an experimental mRNA vaccine for HIV, dive deep on Vinay Prasad’s sudden FDA departure, and more.

The need-to-know this morning

• Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.
• Biogen, Argenx, Sanofi, and Bristol Myers Squibb reported second-quarter earnings. 
• AbbVie and Apellis Pharma reported earnings, too. 

Inside the undoing of Vinay Prasad at the FDA

Vinay Prasad’s short-lived but polarizing run as head of the FDA’s biologics division ended just 84 days in, after his aggressive push to tighten oversight on gene therapies and Covid-19 vaccines drew heat from all sides — Trump allies, RFK Jr. loyalists, Democrats, and Duchenne patient advocates.

His decision-making on Sarepta Therapeutics’ gene therapy— which he viewed as backed by staff and rooted in safety concerns — fueled political pressure that only mounted after far-right influencer Laura Loomer launched a campaign highlighting his progressive leanings and past anti-Trump comments. A powerful and extremely online regulator ran out of friends when it mattered most.

Continue to STAT+ to read the full story…

Please feel free to join us. Remember, no prescription is required. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams. …

Vinay Prasad had a problem. Several, actually, STAT tells us. His staff at the U.S. Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats  were unhappy with his Covid vaccine restrictions and anti-vaccine advocates were lambasting him for approving the shots at all. He sent off an email to his team on Saturday evening, attempting to control the backlash. The agency’s recent crackdown on the gene therapy product was driven by a scientific consensus, he said. Not just him. “The motivation is solely what we think is in the public interest— the accurate judgment of benefits and risks,” Prasad wrote. By Tuesday, he was out of a job. His tenure as director of the FDA Center for Biologics Evaluation and Research lasted just 84 days. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary opposed dismissing Prasad, but were overruled by President Trump, according to POLITICO. Meanwhile, George Tidmarsh, the FDA’s top drug regulator, was named acting director of the FDA’s Center for Biologics Evaluation and Research, STAT notes.

Eli Lilly’s blockbuster diabetes drug Mounjaro matched the ability of an older treatment to prevent major heart complications in a large trial, results that show the medication has cardiovascular benefits on top of helping lower blood sugar and weight, STAT says. Type 2 diabetes patients taking Mounjaro experienced an 8% lower risk of cardiovascular-related death, heart attack, or stroke compared to people taking Trulicity. The data mean the drug met the study goal of showing “non-inferiority” — that is, Mounjaro did not perform worse than Trulicity, but Mounjaro was not proven to be better than Trulicity. Some doctors had hoped Mounjaro would outperform Trulicity. In a survey conducted by TD Cowen analysts, doctors assigned Moujaro a 60% chance of superiority. The demonstration of non-inferiority confirms the widely held belief that Mounjaro does benefit the heart. Doctors are likely to continue prescribing the drug at the same rate, given it is already shown to be highly effective in lowering blood sugar and reducing weight.

Continue to STAT+ to read the full story…

To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is crème brulée, a tasty treat. Now, though, the time has come to get cracking. So here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. Feedback, tips, and suggestions are always welcome. …

President Trump said he was likely to impose tariffs on pharmaceuticals as soon as the end of the month, suggesting that those import taxes could hit alongside broad “reciprocal” rates set for implementation on Aug. 1, Bloomberg News informs us. “Probably at the end of the month, and we’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we’re going to make it a very high tariff,” he said. Still, any tariffs could immediately impact drugmakers like Eli Lilly, Merck, and Pfizer that produce drugs overseas and risk driving up costs for U.S. consumers. At a Cabinet meeting earlier this month, Trump said he expected pharmaceutical tariffs to grow as high as 200% after giving companies a year to bring manufacturing back to the U.S. Trump has already announced investigations under Section 232 of the Trade Expansion Act of 1962 on drugs, arguing a flood of foreign imports was threatening national security.

A divided U.S. appeals court panel upheld West Virginia’s ban on medication abortion, ruling that the law does not conflict with the ability of the U.S. Food and Drug Administration to regulate the drug, The Hill explains. The U.S. Court of Appeals for the 4th Circuit dismissed mifepristone manufacturer GenBioPro’s effort to strike down West Virginia’s near-total abortion ban in a 2-1 decision. The court ruled FDA approval of mifepristone did not preempt West Virginia’s law. GenBioPro produces a majority of the mifepristone sold in the United States and has held FDA approval for generic mifepristone since 2019. GenBioPro argued that FDA authority to impose regulations on the prescription and distribution of mifepristone superseded state efforts to restrict access to medications. A lower court ruled against the company, which then appealed the decision. The ruling marks the first time a federal appeals court has said states can restrict the use of mifepristone. Twenty-eight states restrict access to medication abortions, according to the reproductive health nonprofit Guttmacher Institute. 

Continue to STAT+ to read the full story…

AbbVie has acquired rights to a multispecific antibody that IGI Therapeutics designed to bind to three targets to treat multiple myeloma. Early Phase 1 results showed encouraging responses in a heavily pretreated patient population and a favorable safety profile.

The post AbbVie Pays $700M for Drug Engineered to Overcome Resistance in Multiple Myeloma appeared first on MedCity News.

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Hello! Today, we talk about a cool experimental enzyme therapy, observe more patent maneuvers over Eylea, and see an ‘underdog’ startup get a huge seed round to target a common kidney disease.

The need-to-know this morning

• Soleno Therapeutics pre-announced $31-33 million in Vykat XR sales for the second quarter — beating consensus expectations by a wide margin. The drug was approved in late March to treat Prader-Willi syndrome, a rare genetic disease that causes an insatiable desire to eat. Soleno is also raising $200 million in a follow-on stock sale.
• AbbVie is paying $700 million upfront to acquire licensing rights to a “trispecific antibody” treatment for cancer developed by Ichnos Global Innovation. The drug, called ISB 2001, targets CD38 and BCMA protein receptors on tumor cells and the CD3 receptor on T cells. A Phase 1 study in multiple myeloma is underway.

Brawl over Eylea gets biosimilar industry’s attention

A high-stakes legal fight between Regeneron and Amgen over the blockbuster eye drug Eylea is putting the U.S. patent system under a microscope — and is being closely watched by biosimilar makers.

Continue to STAT+ to read the full story…

So join us as we hoist the ever-present cup of stimulation — our choice today is maple bourbon — and attack the fast-growing to-do list. Have a grand day, everyone, and do stay in touch. …

A court battle between two of the nation’s largest biotechs — Regeneron Pharmaceuticals and Amgen — is testing the legal limits of how far drugmakers can go in using patents to thwart competition, STAT writes. The case is being closely watched by companies that sell biosimilar medicines amid concerns that the U.S. patent system is being gamed in ways that critics say can maintain high prices for medicines. The saga began early last year when Regeneron filed a lawsuit accusing Amgen of infringing a key patent on its best-selling Eylea injectable drug, which is used to combat such eye diseases as wet age-related macular degeneration, among other ailments. The treatment, with a list price of nearly $1,900 a shot, is at the heart of a multibillion-dollar product line. At the time, Amgen was one of several companies that hoped to sell a biosimilar version, but Amgen’s approach set it apart from the others — and paved its way to the marketplace earlier than Regeneron had hoped.

The U.S. Food and Drug Administration will start publishing the rejection letters that companies until now have mostly kept hidden from investors and the public, Bloomberg News reports. “We had a long set of meetings with our lawyers to determine that we can do this,” FDA Commissioner Marty Makary said in an interview with Bloomberg Television’s Wall Street Week. The agency has historically left it up to drugmakers to disclose when and why their medicines are not approved. But companies often give incomplete or misleading accounts of their interactions with regulators, and that can make an application’s deficiencies seem more minor than they really are, Makary said in the interview airing Friday. “There’s an opportunity for companies to spin the results,” he said. “Now, the decision letters will be public for shareholders and the public to see.” Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.

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Novartis’s Cosentyx failed to beat a placebo in a Phase 3 clinical trial in giant cell arteritis. The antibody drug was being developed as an alternative to Roche and AbbVie drugs whose approved uses include treating this autoimmune disorder affecting blood vessels.

The post Blockbuster Novartis Drug Fails Key Test Hoped to Expand Its Use to Rare Blood Vessel Disorder appeared first on MedCity News.

To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is strawberry creme, which occupies a prominent spot in our pantry. But now, the time has come to get cracking. Here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. Feedback, tips, and suggestions are always welcome. …

Spain is investigating Novo Nordisk over concerns it may be illegally advertising its weight loss drugs Ozempic and Wegovy, EuroNews tells us. It is the latest in a string of inquiries into the company, with authorities in at least two other European countries accusing Novo Nordisk of unlawfully promoting its medications in recent years. Health officials worry drugmakers are seeking to boost already sky-high demand, possibly in violation of a European Union ban on consumer advertising for drugs that can only be obtained via prescription. The latest kerfuffle involves a campaign Novo Nordisk launched in Spain this month to raise public awareness about the health risks of obesity. The company also launched a website — which has since been taken down — on obesity’s health risks that cited endorsements from key scientific societies, recommended questions for people to ask their doctors, and offered weight loss tips. The tips included a healthy diet, exercise and sleep, and did not explicitly mention any medicines, but the Spanish health ministry said the campaign could serve as “covert advertising” for Novo Nordisk drugs.

AstraZeneca chief executive officer Pascal Soriot would like to move the drugmaker’s stock market listing to the U.S., The Times of London reports. Soriot has spoken privately of his preference to move the listing on a number of occasions and has even discussed moving AstraZeneca’s domicile. But he is likely to face resistance from parts of the board should he push for such a move, as well as the U.K. government, which is not believed to have been informed. Soriot, who has led AstraZeneca since 2012, has spoken publicly of his concerns about how Europe has fallen behind the U.S. and China, the company’s two largest markets, in innovating new medicines. He is known to be deeply frustrated with the U.K.’s operating environment, particularly restrictions on the approval of new medicines by the National Institute for Health and Care Excellence and the pricing of medicines under a National Health Service sales rebate scheme. Any attempt to move the listing would be highly controversial and a significant blow to the London stock market and the U.K. life sciences sector, which the Labor government set as a priority in its industrial strategy.

Continue to STAT+ to read the full story…

After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. …

Novo Nordisk’s top executives ignored internal warnings that the company was not sufficiently prepared for the launch of its weight loss drug Wegovy, leaving the drugmaker in a more vulnerable position when rival Eli Lilly entered the market, Reuters reports. Novo has enjoyed $46 billion in net profits since 2021, when Wegovy became the first highly effective obesity treatment approved in the U.S. But Lilly’s Zepbound therapy outstripped Wegovy in weekly new prescriptions this year as Novo struggles to convince investors it can remain competitive amid the weight loss drug boom. Novo is reorganizing its leadership team following the surprise ouster of chief executive office Lars Fruergaard Jorgensen. Other key executives already stepped down, including U.S. chief Doug Langa, who had insisted on a commercial launch soon after Wegovy’s U.S. approval. In heated internal discussions, sales and marketing executives urged Langa to first secure more supply and health insurance coverage, without which many patients could not afford Wegovy’s monthly cost of up to $1,300. Lilly was not expected to enter the market for at least two years and Novo could have been better prepared, according to former employees.

The House Judiciary Committee has subpoenaed a former Pfizer executive who is considered central to its investigation into an allegation that clinical testing related to the development of the company’s Covid-19 vaccine was purposefully delayed until after the 2020 presidential election, CNN reports. The demand for documents and a deposition from Philip Dormitzer comes after the committee says he failed to comply with requests to appear voluntarily and turn over records. Dormitzer is a key figure in the legislative probe. The committee has alleged it had information that the former Pfizer executive, after he left for a job with GSK, told his colleagues that Pfizer had delayed announcing its Covid vaccine was effective until after the election. The Wall Street Journal had reported that GSK brought those claims to federal prosecutors in Manhattan. But Dormitzer disputed that there had been any delay in seeking approval for the vaccine.

Continue to STAT+ to read the full story…

AbbVie is acquiring Capstan Therapeutics, a startup with technology that enables in vivo engineering of immune cells. The University of Pennsylvania spinout’s lead program recently began a Phase 1 test as a potential treatment for B cell-mediated autoimmune disorders.

The post AbbVie’s $2.1B Acquisition Adds In Vivo Cell Therapy to Its Immunology & Inflammation Pipeline appeared first on MedCity News.