July 2, 2024

The need-to-know this morning

Cartesian Therapeutics announced results from a mid-stage study investigating an mRNA-based cell therapy for myasthenia gravis, a type of autoimmune disorder. The company also raised $130 million via a PIPE.

infectious disease

Moderna secures BARDA deal for flu vaccines

Moderna said this morning that it's been awarded $176 million by BARDA for the development of mRNA-based influenza vaccines.

The U.S. government already had stockpiles of H5 vaccines made using other platforms by other manufacturers, including CSL Seqirus and Sanofi, but BARDA has said for weeks that it's been talking with mRNA vaccine manufacturers with the aim of diversifying the U.S. flu response capacity.

Moderna last year conducted a Phase 1/2 clinical trial of its candidate for H5 and H7 avian influenza viruses, but it has not disclosed the size of the doses it tested and also has not yet released results of the study.

regulation

FTC deepens scrutiny of Teva's 'improper patents'

The FTC last year began warning Teva that it should remove "improperly or inaccurately" listed patents on asthma and COPD inhalers from a key federal registry. Now, after Teva refused to remove its patents, the FTC has formally launched an investigation into the pharma company.

This move by the FTC is part of a broader effort by the Biden administration to curb alleged patent abuses by the pharma industry. Industry critics say the tactic of listing improper patents makes it harder for generic drugmakers to sell lower-cost alternatives to Americans.

regulation

Lina Khan, Dick Durbin bash 'patent shenanigans'

Relatedly — FTC Chair Lina Khan and Illinois Sen. Dick Durbin published an opinion piece in STAT this morning blaming the pharma industry for certain patent tactics they say have been a major reason for high drug prices in the U.S.

Listing "improper" patents delays generic competition and stifles innovation, and it's a priority of the Biden administration to change that, they say. "Pharmaceutical companies have gotten away with tactics like these for far too long, boosting profits at the expense of people's lives and pocketbooks."

gene therapy

FDA dodges questions on Sarepta approval

A little over a week ago, top FDA official Peter Marks overruled his staff to approve Sarepta's Duchenne gene therapy for nearly all patients. The decision, already controversial when it first happened, looks even more surprising upon closer examination, my colleague Matt Herper writes.

The FDA has declined to answer questions about why it didn't convene a panel of outside advisers, what precedent exists for Marks taking such a dramatic action, and why his decision wasn't appealed.

biotech

The biggest biotech events to watch in Q3

We are somehow at the third quarter of the year already! I was not prepared, but my colleague Adam Feuerstein was, and he brings us his quarterly scorecard of the key events to watch out for in the next three months.

Among them: the full results of Alnylam's HELIOS-B trial trial of its RNAi therapy in the heart condition ATTR-CM. We're also expecting readouts of some obesity candidates that are not GLP-1 drugs, specifically a treatment that blocks CB1 receptors that's in development by Novo Nordisk and a treatment that blocks activin type 2 receptors that's being studied by Lilly.

See here for the other major updates this quarter.

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