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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Sanofi ouster opens can of worms

Sanofi (Euronext:SAN; NYSE:SNY) shares touched a 52-week low of $44.50 in New York on Wednesday before its ADSs closed down $2.85 (6%) to $45.22, on the news that Christopher Viehbacher had been removed as CEO, a move that leaves several loose ends affecting the industry. more >>

   COMPANY NEWS

FDA approves Pfizer's meningitis B vaccine

FDA granted accelerated approval for Trumenba from Pfizer Inc. (NYSE:PFE) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25. The bivalent meningococcal B vaccine targeting LP2086 (factor H binding protein) had breakthrough therapy and Priority Review designations, and was approved ahead of its Feb. 14 PDUFA date. more >>

Xencor revises XmAb5871 deal with Amgen

Xencor Inc. (NASDAQ:XNCR) renegotiated its deal with Amgen Inc. (NASDAQ:AMGN) related to autoimmune candidate XmAb5871. Xencor terminated the companies' original deal in which the bellwether had an option to license exclusive, worldwide rights to XmAb5871 upon completion of a Phase II trial to treat rheumatoid arthritis (RA). more >>

   FINANCIAL NEWS

Regulus raises $75M in follow-on

Regulus Therapeutics Inc. (NASDAQ:RGLS) wasted little time cashing in on a recent stock surge, as the microRNA company raised $75 million through the sale of 4.4 million shares at $17 in a follow-on underwritten by Deutsche Bank; BMO; Needham; Wedbush; and FBR. more >>

Vanda raises $58M in follow-on

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) raised $58 million through the sale of 5 million shares at $11.60 in a follow-on underwritten by Jefferies; Piper Jaffray; JMP Securities; and Canaccord. The neurology company proposed the offering on Tuesday, when its share price was $12.03. more >>

Chimerix planning $105M follow-on

Chimerix Inc. (NASDAQ:CMRX) said it plans to raise about $105 million in a follow-on underwritten by Morgan Stanley; JP Morgan; Cowen; Piper Jaffray; and Stifel, Nicolaus. more >>

Synergy raises $175M in note deal

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) raised $175 million through the sale of senior unsecured convertible notes. The notes bear 7.5% interest, mature in 2019 and initially convert at $3.11. more >>

   POLITICS & POLICY

Rep. McCaul outlines compassionate access bill

Rep. Michael McCaul (R-Texas) plans to introduce compassionate access legislation that would impose new requirements on drug developers and establish rights for patients. McCaul summarized the legislation and his reasons for introducing it in a white paper submitted to the House Energy & Commerce Committee's 21st Century Cures initiative. more >>

EMA could allow extrapolation for biosimilars

EMA's final guidance outlining general principles for developing biosimilars in the EU suggests that regulators may allow extrapolation of evidence of biosimilarity from one indication to others. The detail is among a handful of changes from draft guidance issued in May 2013 (see BioCentury Extra, May 2, 2013). more >>

Senators seek to incentivize Ebola research

Sens. Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) plan to introduce a bill that would add Ebola to the list of eligible diseases under FDA's Priority Review voucher program for tropical diseases. 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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