Our choice today is salted caramel, which offers a whiff of the Jersey shore. Sounds appetizing, yes? As always, we invite you to join us. Meanwhile, here is the latest menu of tidbits to help you get started on your journey. We hope that your day is simply smashing and that you conquer the world. And of course, do keep in touch. We appreciate suggestions, criticism, and juicy tips. …

AbbVie agreed to pay up to $1.2 billion to buy Gilgamesh Pharmaceuticals’ investigational psychedelic drug to treat major depression, a sign that pharmaceutical companies are warming up to the burgeoning field, STAT writes. The move builds on AbbVie’s growing focus on neuroscience. Last year, it also acquired Cerevel Therapeutics for $9 billion, but after the deal closed, the schizophrenia drug at the center of the acquisition failed to show benefits in key trials. A growing number of biotech companies have emerged to study psychedelics for psychiatric disorders, but the field suffered a major setback last year when regulators rejected a Lykos Therapeutics MDMA candidate for post-traumatic stress disorder. Companies are now hoping the Trump administration will be supportive of psychedelics after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. vowed to end the “aggressive suppression of psychedelics.” 

The European Commission granted marketing authorization for Gilead Sciences’ twice-yearly injection for preventing HIV infection, Reuters notes. The drug, known as lenacapavir, will be sold in Europe under the brand name Yeytuo. It was approved in June by regulators in the U.S., where it is marketed as Yeztugo. The EC approval applies to the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein. Before the drug can be made available to patients, Gilead will need to establish pricing and reimbursement terms with health systems in each country. In the U.S., the list price is over $28,000 a year, prompting some insurers to postpone coverage. Meanwhile, Gilead said it also filed for regulatory review with authorities in Australia, Brazil, Canada, South Africa, and Switzerland and is preparing filings in Argentina, Mexico, and Peru. The company intends to pursue submissions to regulatory authorities in low- and middle-income countries, including priority registrations covering 18 countries that represent 70% of the HIV burden of 120 countries named in voluntary licensing agreements.

Continue to STAT+ to read the full story…

Gilead Sciences, whose Kite subsidiary was one of the pioneers of ex vivo cancer cell therapy, is joining the pursuit of in vivo therapies with the acquisition of startup Interius BioTherapeutics. The deal follows AstraZeneca and AbbVie acquisitions this year for in vivo cell therapy developers.

The post Gilead Sciences Gains In Vivo Cell Therapy Capability With $350M Interius Bio Acquisition appeared first on MedCity News.

Have a wonderful day and do drop us a line when you hear something juicy. …

Insmed received U.S. Food and Drug Administration clearance for the first treatment for a chronic lung disease, opening the biotech up to what could be a multibillion-dollar product, STAT writes. The company will sell the daily pill, brensocatib, under the brand name Brinsupri for bronchiectasis. The approval comes after the treatment succeeded in one of last year’s most closely watched Phase 3 trials. Insmed, which will sell the drug at an annual list price of $88,000, estimates the drug can deliver peak sales of $5 billion, making it a growth driver that could help propel it into becoming a major biotech. The company has also filed for the drug to be approved in Europe and the U.K. and plans to file in Japan. Bronchiectasis affects about 350,000 to 500,000 adults in the U.S., according to the American Lung Association. 

A clutch of Western drugmakers are looking to boost sales of their most innovative and expensive medicines in China, the world’s second-largest pharmaceuticals market, by trying to get their treatments included in Beijing’s new catalog for commercial health insurance, Bloomberg News explains. Eli Lilly, Pfizer, and Novo Nordisk are among those who have applied for a place in the catalog, according to documents released by the National Health Security Administration. The idea of the list, incorporating innovative drugs that are far too expensive to be covered by the state insurance program but recommended for reimbursement by private health insurers, was first touted this year. With state-backed insurance unable to afford their treatments, drugmakers until now had to choose between offering steep discounts in exchange for a spot on the national drug reimbursement list, or limit themselves to a much smaller private market. The commercial catalog, which could allow these drugs to be reimbursed at a smaller discount, will open a new door for multinational companies to expand sales.

Continue to STAT+ to read the full story…

We also plan to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? As always, summer is moving by quickly, so perhaps this is an opportunity to enjoy the great outdoors. Beaches, lakes, and mountain trails are perennials, yes? You could also tend to your garden, visit the local library (your tax dollars at work), or perhaps take time to experiment with a recipe or two. Or you could simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The Trump administration has been talking to drugmakers about ways to raise prices of medicines in Europe and elsewhere in order to cut drug costs in the United States, Reuters reports, citing a White House official and three pharmaceutical industry sources. U.S. officials told drug companies it would support their international negotiations with governments if they adopt “most favored nation” pricing under which U.S. drug costs match the lower rates offered to other wealthy countries. The Trump administration has asked some companies for ideas on raising prices abroad and has held multiple meetings over several months aimed at lowering U.S. prices without triggering cuts to research and development spending drugmakers insist would result. The previously unreported discussions reflect the challenges Trump faces to achieve that goal, and are the backdrop to the letters he sent last week to 17 major drugmakers, urging them to cut U.S. prices to match those paid overseas.

The U.S. Food and Drug Administration announced a program to make it easier for drug companies to set up manufacturing facilities in the U.S. and reduce the country’s reliance on imported medicines, Pharmaphorum notes. The regulator revealed FDA PreCheck, a two-phase approach to getting approval for new production sites. The first promises to provide quicker responses from the agency on start-up tasks like facility design, construction, and pre-production. The second phase is based on a pledge by the FDA to “streamline” the chemistry, manufacturing, and controls section of new facility applications with the help of “pre-application meetings and early feedback.” The move ties in with President Trump’s ongoing campaign to drive medicines manufacturing to the U.S. from overseas, a push that has already resulted in big investment commitments from a string of companies, including AstraZeneca, AbbVie, Roche, Novartis, Eli Lilly, and Johnson & Johnson. The FDA plans to hold a public meeting on September 30 to discuss the new program.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…