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March 13, 2017

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Today's Rundown

  1. Trump picks industry favorite Gottlieb to run FDA

  2. Change in direction at Intrexon has Germano heading for the exit

  3. After an AML flop, Karyopharm hit with hold for selinexor tests

  4. Heptares adds Daiichi pain pact to string of R&D deals

  5. Reviving tired T cells when immuno-oncology drugs fail

  6. Biogen’s Spinraza sparks pricing concerns as Trump renews attack on pharma

Featured Story

Trump picks industry favorite Gottlieb to run FDA

President Donald Trump has chosen Scott Gottlieb to run the FDA. Gottlieb has a history of calling for faster approvals, greater regulatory transparency and a realignment of the balance of power between FDA and doctors, but as an industry insider is seen as a safer pair of hands than some of the other mooted candidates.

Top Stories

Change in direction at Intrexon has Germano heading for the exit

Last year, ex-Pfizer exec Geno Germano joined synthetic biology firm Intrexon as president and CEO-in-waiting, intent on helping the company push forward its cell and gene therapies. Fast-forward a few months, and Germano is leaving, prompted by a restructuring that has stripped those health-related programs from beneath him.

After an AML flop, Karyopharm hit with hold for selinexor tests

Karyopharm has seen studies for its big hope selinexor placed on a partial clinical hold, meaning it can no longer recruit new patients, over the FDA’s demands for more safety details, but the company insists this is all down to paperwork errors.

Heptares adds Daiichi pain pact to string of R&D deals

Heptares Therapeutics has struck a pain drug R&D pact with Daiichi Sankyo. The agreement will see Heptares apply the G protein-coupled receptor and structure-based drug design skills that have landed it deals with Allergan, AstraZeneca and Pfizer to the discovery of small molecules that hit a pain target.

Reviving tired T cells when immuno-oncology drugs fail

Checkpoint inhibitors like Merck’s Keytruda (pembrolizumab) are designed to stimulate the immune system’s T cells to recognize and attack cancer cells. Problem is, they don’t work for many patients, and no one has been able to pinpoint exactly why. Now, scientists at Emory say they’ve found a clue.

Biogen’s Spinraza sparks pricing concerns as Trump renews attack on pharma

Is Spinraza the next Sovaldi? That’s the question on the minds of health insurers, analysts and investors as Biogen launches Spinraza (nusinersen), its highly anticipated spinal muscular atrophy drug. The latest health industry player to raise a red flag about Spinraza’s price is Molina Healthcare, which warned in its recent annual report that it didn’t factor the drug into its expectations for this year and that it might affect earnings.

News of Note

Beset by problems, Cempra asked Morgan Stanley to help weigh up its corporate options but has kept mum on the details. Statement

Heat Biologics hit an efficacy endpoint in phase 1b test of its HS-110 candidate in combination with Bristol-Myers Squibb’s anti-PD-1 Opdivo in lung cancer, as it plans to move on to phase 2. Release

Agios gets $8 million upfront from partner Celgene for an MTAP pathway research program in certain cancers, with more biobucks lined up weighted to future development. Statement

Resources

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