Top Regulatory News Stories – Week Ending January 26, 2018

Here is my regulatory news blog for this week…

Advanced Accelerator Applications received US FDA Approval for LUTATHERA® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

The FDA’s Center for Biologics Evaluation and Research (CBER) unveiled the draft guidance documents it plans to publish in 2018, which will include as many as six documents on gene therapy.

The FDA has approved the very first algorithm that monitors a patient’s vitals to help predict sudden death from heart attacks or respiratory failure. The algorithm called “Wave Clinical Platform” was developed by medical technology company ExcelMedical

Synergy Pharmaceuticals announced that the FDA has approved TRULANCE®(plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This is the second indication for TRULANCE, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC).

Just days before its PDUFA date, Braeburn Pharmaceuticals got a complete response letter from the FDA in lieu of an approval.

Puma Biotechnology announced that the EMA’a Committee for Medicinal Products for Human Use has communicated a negative trend vote after meeting with the company to discuss the MAA for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

 Seattle Genetics and collaborator Takeda Pharmaceuticals announced that the European Commission has extended the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

In other news…

Sanofi has agreed to buy Bioverativ for $11.6 billion, in a deal which will strengthen its presence in the field of treatment for rare diseases.

In a related story, Sanofi has announced major restructuring, which will involve layoffs. About 400 jobs cut will be in the U.S.

Celgene has struck a deal to buy Juno Therapeutics for $87 a share, or about $9 billion, instantly vaulting into the front ranks of the CAR-T companies.

Idera and Biocryst to merge, rebrand and focus in rare disease programs

In the latest setback to the Vical/Astellas partnership, their lead CMV vaccine fails a pivotal PhIII study

Biogen is paying $10 million upfront to buy the XPO1 inhibitor KPT-350 from Karyopharm

Menlo Therapeutics a low-profile biotech with a single asset just pulled off an upsized IPO raising $119 million.

Solid Biosciences’ failure to disclose some negative issues related to its work on a treatment for Duchenne muscular dystrophy (DMD) not only complicated its upcoming initial public offering (IPO), but is casting some shade on DMD research in general.

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