Prescribed Reading: Quiet before the storm

A weekly guide to the goings-on in the biopharma industry.

Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

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Mergers & analysis

Dealmaking was incredibly slow in 2016 and the first week of 2017 has proven to be no different. There have been a handful of small licensing deals and research collaborations, including Novartis linking up with Ionis Pharmaceuticals for two early cardiovascular candidates. Novartis is paying $225 million in near-term cash and options in a deal that could be worth $1 billion when all is said and done.

AstraZeneca also inked a small cardiovascular deal with week with APT Therapeutics, signing on for an option to license its preclinical next-gen clotting drug.

But don't expect the drought of deals to last. Most of the industry is descending on San Francisco next week for the JP Morgan Healthcare Conference — including the editors from BioPharma Dive. Expect there to be plenty of deals announced next week, as well as early guidance announcements from a few companies.

Check back at BioPharma Dive or follow us on Twitter for real-time updates from the West Coast.  

In light of the conference, this column will not appear next week and will return Friday, Jan. 20.

Clinically relevant

Like M&A, data has been trickling in slowly this first week of the year. Some of the most widely talked about data came from Halozyme Therapeutics, which announced Phase 2 data for its pancreatic cancer drug PEGPH20. While the drug performed well on a progression-free survival endpoint in a certain population, it showed no improvement over placebo in other patients. 

Meanwhile, there were some new clinical developments in the ophthalmology space — an area of drug development that has been attracting attention in recent years. Ocular Therapeutix announced this week that its post-surgery inflammation treatment Dextenza hit secondary endpoints in a late-stage trial, following up on previously announced positive results.

Inotek Pharmaceuticals, on the other hand, notched a failure for its glaucoma drug in a Phase 3 study of 303 patients. The company claims an unexpectedly strong placebo response skewed the trial results.

Highly regulated

Not much has gone down on the regulatory front so far. 2016 was a disappointing year for drug approvals with only 22 new molecular entities getting the green light during the year. This is well off the mark of 45 new drugs approved by the Food and Drug Administration in 2015.

Departing head of the FDA's Center of Drug Evaluation and Research John Jenkins made headlines this week when he revealed some of the secrets behind the drug approval process. He chastised drug companies for manufacturing issues slowing down drug approvals. There was an inordinately high number of rejections this year that could have been avoided if companies following current Good Manufacturing Practice regulations.

He also suggested that companies fib about the communications that go on between the agency and pharma companies, including the content of Complete Response Letters. These drug rejections are not made public and companies often only reveal what they see fit. Jenkins claims those company revelations are often rosier than reality. 

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Filed Under: Clinical Trials Mergers and Acquisitions / Deals Regulatory / Compliance