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November 11, 2016

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Today's Rundown

  1. Trump’s brief medicines update sends tongues wagging at ‘FDA reform’ promise

  2. Witty warns of ‘tremendous disruption’ if EMA exits London

  3. Trump, Republican victory to boost biotech M&A: Reuters

  4. Bristol-Myers, Johns Hopkins pen I/O research pact

  5. From FiercePharma: Gilead snags FDA approval for improved hep B drug Vemlidy

  6. From FierceMedicalDevices: Intuity raises $40M to commercialize blood glucose monitor

  7. EuroBiotech Report: Opdivo combo data, Celyad CAR-T, Evotec-Oxford, Innocoll, Bone Therapeutics and more

  8. Chutes & Ladders: Teva appoints new CLO amid DOJ's price collusion investigation

Featured Story

Trump’s brief medicines update sends tongues wagging at ‘FDA reform’ promise

As the Trump bump for biotech continues to reverberate after he became president-elect on Wednesday, biotech may now have more to celebrate as a new, but lightly detailed, healthcare update is being seen by some as a positive read-through for the industry.


Top Stories

Witty warns of ‘tremendous disruption’ if EMA exits London

GlaxoSmithKline CEO Andrew Witty has said moving the European Medicines Agency from London will cause “tremendous disruption.” Witty is worried moving the EMA and its 900 staff from London to another European city post-Brexit will cause upheaval that affects the smooth running of the regulatory machinery.

Trump, Republican victory to boost biotech M&A: Reuters

A combination of lower corporate taxes, a sense that deregulation for meds is coming and pricing issues will be dropped, bumped-up stocks and an influx of foreign cash will combine to create a perfect storm for a major biotech M&A spree, according to analysis from Reuters.

Bristol-Myers, Johns Hopkins pen I/O research pact

Bristol-Myers Squibb has teamed up with Johns Hopkins University to research why patients respond and develop resistance to its PD-1 drug Opdivo. The five-year project will look at the tumor microenvironment, the microbiome and other factors in a bid to better understand what happens when a patient receives Opdivo in isolation or in combination with other immunotherapies.

Gilead snags FDA approval for improved hep B drug Vemlidy

Gilead Sciences, whose hepatitis C dynasty has been slipping, has won approval for its next-gen hepatitis B treatment.

Intuity raises $40M to commercialize blood glucose monitor

Intuity Medical has raised $40 million to commercialize its diabetes blood glucose monitoring system. The round marks the long-delayed start of the next phase of Intuity’s evolution, which spent years trying to secure FDA clearance for its device before belatedly getting the green light in April.

EuroBiotech Report: Opdivo combo data, Celyad CAR-T, Evotec-Oxford, Innocoll, Bone Therapeutics and more

Innate posts Opdivo combination data, Celyad shares a look at CAR-T results, Evotec inks a University of Oxford pact and more.

Chutes & Ladders: Teva appoints new CLO amid DOJ's price collusion investigation

Teva promotes David Stark to chief legal officer amid DOJ's investigation of price fixing, Terrance Coughlin was named EVP and COO of Endo, and Neon Therapeutics recruits former Eli Lilly vet Dr. Richard Gaynor as new CMO. Plus more hirings, firings and retirings throughout the industry.

News of Note

PTC Therapeutics was up nearly 90% premarket on the CHMP's decision to renew its marketing app for DMD med Translarna. Release

Meanwhile, Europe has also seen nine medicines recommended for approval by the CHMP, including three biosimilars. Statement

After a series of setbacks, nanocap Mirna Therapeutics says it will discontinue development of its cancer microRNA med MRX34 and suspend its pipeline R&D programs. Statement

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