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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Third Point pushes for Amgen breakup

Activist investor Third Point on Tuesday outlined a plan for increasing the valuation of Amgen Inc. (NASDAQ:AMGN) by more than 80% in the next two years. The firm wants Amgen to split into two companies, one each for "cash-generative Mature Products and R&D-intensive Growth Products," although it didn't provide specifics. more >>

   COMPANY NEWS

FDA panel backs Kalydeco for R117H CF patients

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 13-2 that data support approval of Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to treat cystic fibrosis patients six and older with an R117H mutation in the CF transmembrane conductance regulator (CFTR) gene. The panel also voted 9-6 that efficacy data provide substantial evidence of a clinically meaningful benefit, and 14-1 that safety data for the overall Kalydeco CF program are sufficient for approval. The PDUFA date is Dec. 30. more >>

Enanta falls on revised AbbVie deal

Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) fell $4.76 (10%) to $41.83 on Tuesday after the company said it decided not to exercise its option to co-develop HCV candidate ABT-493 with AbbVie Inc. (NYSE:ABBV) in the U.S. Enanta and Abbott Laboratories (NYSE:ABT) discovered the next-generation HCV NS3/4A protease inhibitor under a 2006 deal. more >>

NICE backs GSK's Tafinlar for melanoma

NICE issued final guidance recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat unresectable metastatic melanoma with a BRAF V600 mutation, its approved indication. more >>

FDA approves expanded Xiaflex label

FDA approved an sBLA from Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) for Xiaflex collagenase clostridium to treat up to two Dupuytren's contracture joints in the same hand during a single treatment visit. The injectable form of collagenase previously was approved for one collagen cord. more >>

   CLINICAL NEWS

Omeros suspends Phase II Huntington's trial

Omeros Corp. (NASDAQ:OMER) was off $1.70 (12%) to $12.12 on Tuesday after suspending a Phase II trial of OMS824 to treat Huntington's disease (HD). more >>

   FINANCIAL NEWS

Illumina, Actelion boost guidance

Illumina Inc. (NASDAQ:ILMN) gained $2.1 billion in market cap on Tuesday in the wake of its earnings release after market on Monday. The shares added $15.08 to $179.55 after the sequencing company said revenue jumped 35% year over year to $480.6 million and raised its revenue guidance for the year. The company now anticipates revenue to grow about 30% over 2013, up from prior guidance of 25-26% growth. more >>

Unum launches with $12M series A

Oncology play Unum Therapeutics (Cambridge, Mass.) raised $12 million in a series A round led by Atlas Venture and Fidelity Biosciences. Sanofi-Genzyme BioVentures also participated. more >>

Viamet replaces IPO with $60M D round

One day after withdrawing a proposed IPO, Viamet Pharmaceuticals Inc. (Durham, N.C.) closed a $60 million series D round led by new investor Brandon Point Industries Ltd. working with Woodford Investment Management. more >>

Tobira amends IPO

Tobira Therapeutics Inc. (San Francisco, Calif.) amended the terms for its proposed IPO on NASDAQ underwritten by Oppenheimer & Co., removing the price range, the number of shares and several of the underwriters. The company on Aug. 7 said it would postpone the offering, but did not give a reason (see BioCentury Extra, Aug. 7). more >>

   POLITICS & POLICY

FDA backs further study of kidney biomarkers

FDA issued its first Letter of Support for two kidney biomarkers identified by the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute (C-Path). more >>

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BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS

BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS
COVER STORY

Walking the toll road

Better understanding of biology and new delivery approaches are refreshing interest in TLR modulators.

STRATEGY

Guest Commentary: Paying for cures

A Guest Commentary proposes a framework to help evaluate the value of drugs and define financing options to ensure access.

PRODUCT DISCOVERY & DEVELOPMENT

Beyond knockdown

Alnylam's Phase II patisiran data are the first to validate the company's siRNA platform on a clinically meaningful endpoint.

EMERGING COMPANY PROFILE

Kesios: Reactivating apoptosis

Kesios is targeting tumor-specific NF-kappa B signaling to develop a safer treatment for multiple myeloma.

Rogne: Penetrating peptides

Rogne's topical peptide to treat mild to moderate psoriasis could be safer than topical steroids or injectable biologics.

FINANCE

Sticking with big

Why Canaan is sticking with hybrid venture model for $675M tenth fund

Bicycle pedals on

Bicycle to use £20M to move two bicycle-drug conjugates into clinic for cancer

Raising for Raze

How Atlas built Raze to explore novel mitochondrial metabolism targets in cancer

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