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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Sarepta silent on FDA's riposte

Sarepta Therapeutics Inc. (NASDAQ:SRPT) declined to comment on Friday after FDA vigorously defended itself in front of the Duchenne muscular dystrophy (DMD) community over the agency's advice and treatment of the company's eteplirsen (AVI-4658). In a rare statement on a compound still in development, FDA said it has been consistent in the advice it has provided to Sarepta on the development and regulatory pathway for the phosphorodiamidate morpholino oligomer (PMO) targeting exon 51. more >>

   COMPANY NEWS

AbbVie looking for specialty deals

With 3Q14 earnings that beat guidance, AbbVie Inc. (NYSE:ABBV) CEO Richard Gonzalez said the pharma still has an appetite for M&A, but declared it's unlikely to find more $50 billion opportunities like the attempted inversion deal with Shire plc (LSE:SHP; NASDAQ:SHPG). more >>

Aegerion trips on Juxtapid shortfall

Aegerion (NASDAQ:AEGR) plunged $14.02 (41%) to $20.19 on Friday as investors reponded to the company's FY14 guidance post-market on Thursday that fell short of expectations. more >>

   FINANCIAL NEWS

Chimerix rises with its bank account

Chimerix Inc. (NASDAQ:CMRX) gained $1.15 to $31.04 after completing its second big follow-on in 2014. The infectious disease company raised $105.9 million through the sale of 3.65 million shares at $29 in a deal underwritten by Morgan Stanley; JP Morgan; Cowen; Piper Jaffray; Stifel, Nicolaus; Cantor Fitzgerald; and Brean Capital. more >>

Imago raises $26.5M series A

Myeloid malignancy company Imago BioSciences Inc. (San Francisco, Calif.) raised $26.5 million in a series A round led by Clarus Ventures. Frazier Healthcare; Amgen Ventures; and Merck Research Labs Venture Fund also participated. CEO Hugh Rienhoff did not disclose if the round was tranched, but told BioCentury it was "fully committed." more >>

Virobay pulls IPO

Virobay Inc. (Menlo Park, Calif.) withdrew its proposed IPO on NASDAQ, citing market conditions. Earlier this month, the company amended its offering to sell 3.8 million shares at $12-$14. At $13, it would have raised $50 million and been valued at $169 million. Piper Jaffray; JMP Securities; Cantor Fitzgerald; and Summer Street Research Partners were underwriters. more >>

PolyPid sets IPO terms

PolyPid Ltd. (Petach Tikva, Israel) amended its proposed IPO on NASDAQ and now plans to sell 1.8 million shares at $10-$12. At $11, PolyPid would raise $20 million and be valued at $103 million. Aegis Capital; MLV; and Chardan are underwriters. more >>

Venture tracks

Clarus Ventures named Barry Gertz a venture partner. He also will become chief medical advisor for Clarus portfolio company Relay Pharmaceuticals Inc., which finances late-stage clinical studies of pharma assets. Gertz previously was SVP of global clinical development at Merck & Co. Inc. (NYSE:MRK). more >>

   POLITICS & POLICY

Veloxis respectfully begs to differ with FDA

Veloxis Pharmaceuticals A/S (CSE:VELO) plunged DKK0.63 (31%) to DKK1.40 on Friday after the company said FDA's tentative approval of immunosuppressant Envarsus XR tacrolimus will not become finalized until exclusivity expires for Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503) on July 19, 2016. more >>

Regulator tracks

Joseph Griffin joined regulatory consulting firm Greenleaf Health LLC as EVP of drug and biological drug products. He was associate director for policy development in the Office of Medical Policy at FDA's Center for Drug Evaluation and Research (CDER). more >>

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SCIBX: SCIENCE-BUSINESS EXCHANGE

SCIBX: SCIENCE-BUSINESS EXCHANGE
COVER STORY

Redistributing BRD4 in inflammation

A new link between inflammation and atherosclerosis centers on the BET bromodomain protein BRD4 and could provide new targets for intervention.

TOOLS

Sex matters at the NIH

The NIH is taking steps to make the inclusion of both sexes in preclinical studies a standard practice.

TRANSLATIONAL NOTES

The ALS bucket brigade

The ALS Association is allocating the first funds from its ice bucket challenge to create four new research alliances that focus on genetics and biomarkers for the disease.

Bayer's Bay Area formula

Bayer is emphasizing alliances rather than money to tap into Bay Area innovation.

THERAPEUTICS

This Week in Therapeutics

Preventing bone loss and consequent bone fractures with WNT16B therapy; enhancing brain levels of progranulin to treat AD; promoting repair of infection- or ischemia-induced tissue damage with compounds derived from human milk; and more...

TECHNIQUES

This Week in Techniques

Aptamer-mediated detection of monosaccharides and other low-epitope molecules to aid diagnostics development; transgenic Cas9 mice with CRIPSR-edited genomes as models of cancer; insulin-producing cells generated from human pluripotent cells to treat type 1 diabetes; and more...

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