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October 17, 2016

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Today's Rundown

  1. Regeneron and Teva’s fasinumab hit with FDA clinical hold

  2. Clinton campaign questioned FDA commissioner’s Big Pharma ties: WikiLeaks

  3. Small cap PTC tumbles as FDA rejects it again in Duchenne

  4. Merck KGaA returns PhII multiple sclerosis drug to Apitope

  5. Sofinnova raises $650M in mid-to-late-stage fund

  6. Celgene’s big hope ozanimod lowers pMS score in long-term ulcerative colitis

  7. From FierceBiotechIT: Veeva expands into EDC, poaches VPs from Medidata

  8. From FiercePharma: Would Teva buy Korea's Celltrion to beef up in biosimilars? It wouldn't say no

Featured Story

Regeneron and Teva’s fasinumab hit with FDA clinical hold

Drug development partners Teva and Regeneron have seen a midstage study of their experimental pain med fasinumab put on a clinical hold by the U.S. regulator due to safety concerns.


Top Stories

Clinton campaign questioned FDA commissioner’s Big Pharma ties: WikiLeaks

Monday, October 17, 2016

New evidence has come to light from a series of emails released by the whistle-blowing website WikiLeaks that Hillary Clinton’s legal team worried about FDA commissioner Califf’s ties to the biopharma industry, and wanted someone “willing to stand up to Pharma.”

Small cap PTC tumbles as FDA rejects it again in Duchenne

Monday, October 17, 2016

The FDA has denied the New Jersey company’s appeal of a refuse-to-file letter that dates back to February.

Merck KGaA returns PhII multiple sclerosis drug to Apitope

Monday, October 17, 2016

Merck KGaA has returned a Phase II multiple sclerosis drug to Apitope. The German drugmaker picked up the rights to the peptide-based therapeutic in 2009 and advanced it to the cusp of a Phase IIa readout, but has now decided to relinquish its claim on the drug.

Sofinnova raises $650M in mid-to-late-stage fund

Monday, October 17, 2016

Sofinnova has closed its tenth venture fund at $650 million--a big step up from the $500 million the firm raised for its prior fund that dated back to the summer of 2014.

Celgene’s big hope ozanimod lowers pMS score in long-term ulcerative colitis

Monday, October 17, 2016

After its $7.2 billion buyout of Receptos, Celgene has posted some encouraging midstage data for its acquired asset ozanimod for certain forms of inflammatory bowel disease.

Veeva expands into EDC, poaches VPs from Medidata

Monday, October 17, 2016

Veeva Systems is wading into the fight between Medidata and Oracle for the EDC market. And the cloud software player has poached a pair of VPs from Medidata as part of a hiring spree intended to equip it to take on the incumbents in EDC.

Would Teva buy Korea's Celltrion to beef up in biosimilars? It wouldn't say no

Monday, October 17, 2016

Earlier this month, Teva agreed to pick up U.S. and Canadian rights on a pair of biosims from Korea’s Celltrion. But it might not stop with just two. The generics giant may consider purchasing the Korean drugmaker itself.

News of Note

Warp Drive Bio has appointed Decibel Therapeutics’ CEO and former Biogen exec Steven Holtzman as its latest board member. Statement

Celgene’s latest early-stage data for its Crohn’s pill is “unspectacular but perhaps good enough,” according to TheStreet. Story

Analysts at Kalorama Information have posted figures estimating that the embryonic global market for gene editing technologies saw revenues of $382.9 million in 2015. Release

Rare blood disorder biotech Ra Pharmaceuticals says it plans to raise $75 million via an IPO by offering 5.8 million shares at a price range of $12 to $14. Story

And upstart endocrine biotech Myovant Sciences has also priced its IPO at a meaty $176 million. Story

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Events

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