Top Regulatory News Stories – Week Ending November 3, 2017

This week saw the approval of two new molecular entities by the FDA along with a strong advisory panel recommendation.   Here is my recap of the top regulatory news stories to follow:

Valeant Pharmaceuticals has won U.S. FDA approval for its glaucoma drug Vyzulta ending a more than two-year effort to bring the drug to the market.

The FDA granted the accelerated approval to AstraZeneca’s Calquence, a BTK inhibitor for the treatment of cancer patients with mantle cell lymphoma

Indivior’s experimental drug to help fight America’s growing opioid addiction crisis has been recommended for approval by an FDA advisory panel

Merck announced that it would withdraw an application for European approval of Keytruda in combination with chemotherapy as a first-line treatment of non-small cell lung cancer (NSCLC).

GlaxoSmithKline received a boost for its oncology research on Thursday when an experimental drug for blood cancer received a breakthrough designation from U.S. regulators.

China is overhauling its drug-approval system to let companies bring their treatments to market quicker and more easily.

The US FDA announced that the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements.

According to a new report, OPDP enforcement letters have reached a record low with only two letters issued so far in 2017:

So far in 2017 the FDA has approved 37 new molecular entities through CDER and 13 biologic programs through CBER.  There are six drugs facing FDA decisions in November as follows:

In other news…

Novartis announced plans to buy nuclear medicine company Advanced Accelerator Applications for $3.9 billion in cash. Under the deal, Novartis will gain Advanced Accelerator’s radiopharmaceutical treatment for neuroendocrine tumours Lutathera (177Lu-Dotatate).

Sumitomo Dainippon acquired rights to a PhIII diabetes drug from Poxel in $300M deal

Sarepta announced that it is teaming up with Duke University to explore new CRISPR-based methods in the hunt for an effective Duchenne muscular dystrophy therapy.

Sanofi Genzyme has retreated from its Parkinson’s deal with Voyager Therapeutics:

Cancer biotech firm Apellis Pharmaceuticals set terms for their upcoming $150 million IPO

Amgen and Kirin Holdings have decided to dissolve their joint venture, Kirin-Amgen. It will become a wholly-owned subsidiary of Amgen.

AvidBiotics has decided that the company will split in two, creating one company called Xyphos to focus on cell-based therapies for cancer and another—Pylum Biosciences—taking forward its Avidocin antimicrobial protein portfolio for resistant infections.

Mallinckrodt snapped up another microcap biotech, picking up Ocera’s failed drug in $117M buyout

As part of a strategic restructuring, Proteostasis Therapeutics is laying off 13 members of its research-and-development workforce.

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