Boston area's biotech slump is raising concerns

The Boston area biotech sector was for a while bullish that perhaps 2025 was the year everything would turn back around after a prolonged slump. Instead, it finds itself mired in uncertainty thanks to falling stock valuations, layoffs, and far too much open lab space.

A few companies, including Vertex Pharmaceuticals, are flying high despite broader challenges to the industry, The Boston Globe's Robert Weisman reports. But even industry stalwarts like Moderna and Biogen are under immense strain, and investors are acting cautiously amid broader economic and political instability. It’s unclear if a new expansion cycle will begin — and it’s unwise to try and predict when it might.

“Lots of companies are limping along,” Leerink analyst Mani Foroohar said, saying that the post-pandemic “hangover can last longer than the part.”

politics

Makary and Bhattacharya set for votes in full Senate

The Senate health committee has voted to advance the nomination of Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director — with a GOP majority expected to confirm them in the full chamber. Both nominees align with the MAHA agenda espoused by President Trump and health secretary Robert F. Kennedy Jr., with its focus on curbing food additives and reducing chronic disease.

“The American people's trust in public health institutions must be restored,” Senate health committee Chairman Bill Cassidy (R-La.) said in remarks before the votes. “Dr. Bhattacharya and Dr. Makary have demonstrated that they are ready to take on this responsibility.”

Meanwhile, the FDA and NIH are in turmoil after mass layoffs and policy shifts.

podcast

The sudden withdrawal of a CDC nominee

Why were some Republican senators concerned about Dave Weldon, the Trump administration's nominee to lead the Centers for Disease Control and Prevention? Why did U.S. officials respond the way they did to the Covid pandemic? And why was the pandemic a "stress test" for U.S. democracy?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We bring on our colleague Sarah Owermohle to discuss the White House's sudden move to withdraw the nomination of Dave Weldon as its pick to run the CDC just hours before his confirmation hearing.

It's also the five-year anniversary of the Covid-19 pandemic. We chat with Princeton political scientist Frances Lee about a new book she co-authored that offers an unflinching assessment of the U.S. policy responses to the pandemic and raises some provocative questions about what went wrong.

Listen here.

glp-1 drugs

Altimmune to study obesity drug in alcohol use disorder, following Eli Lilly

From STAT's Elaine Chen: Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.

Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.

The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.

Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.

Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease, but has not yet started any trials in addiction.

There hasn’t been much uptake of current treatments for alcohol use disorders, but Altimunne executives attribute that to the fact that the drugs aren’t very effective and are difficult to administer. They argue that once effective treatments are made available, the market will materialize, much like what happened with obesity drugs.“The drug creates the marketplace if it’s effective,” Altimmune’s chief medical officer, Scott Harris, said in an interview.

Opinion

Restrictions will weaken FDA advisory committees

The proposed “conflict-free” restrictions on FDA advisory committees will erode their efficacy, Peter J. Pitts, a former agency associate commissioner, opines for STAT. Setting such a high bar would exclude many top experts who have industry experience, in his view. Pitts argues that the existing advisory committee structure offers transparency and scientific rigor, which are now under threat.

Selectively scrutinizing conflicts of interest and limiting qualified voices in decision-making will harm regulatory decisions, he says.

“Independent-thinking advisory committee members will feel threatened and suffocated by the unspoken threat of federal investigators knocking at their clinic doors,” Pitts writes. “Such ill-considered policies amount to lettres de cachet for science deniers, posturing politicians, and the tort bar.”

Thanks for reading! Until next week,

@megkesh

industry