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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Bloody Tuesday for biotech

Biotech shares dropped in the wake of Monday's news of price wars for HCV drugs, with the BioCentury 100 index falling 5% and the NYSE Arca Biotechnology (BTK) dropping 4%. more >>

   COMPANY NEWS

Cytokinetics, Astellas expand in neuromuscular space

Cytokinetics Inc. (NASDAQ:CYTK) added $0.62 to (13%) $5.52 on news it will receive $55 million in payments from Astellas Pharma Inc. (Tokyo:4503) to expand their skeletal muscle activation collaboration into neuromuscular indications. more >>

Novo's Saxenda wins FDA approval

FDA approved Saxenda liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) for chronic weight management as an adjunct to diet and exercise in obese adults or in overweight adults with at least one co-morbidity. The approval comes well after Saxenda's Oct. 20 PDUFA date. more >>

Otsuka takes Asian rights to Ariad's Iclusig

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) licensed rights in 10 Asian territories to Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) to treat resistant and intolerant chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (ALL). more >>

Vanda climbs on Fanapt settlement

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) rose $1.67 (14%) to $13.58 on Tuesday after it reacquired exclusive U.S. and Canadian rights to Fanapt iloperidone from Novartis AG (NYSE:NVS; SIX:NOVN). The deal settled a licensing dispute between the two companies, in which Vanda had begun an arbitration proceeding in May seeking $539 million from Novartis. more >>

   FINANCIAL NEWS

Alder proposes $115M follow-on

After completing a downsized IPO in May, Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) is proposing to raise $115 million in a follow-on underwritten by Credit Suisse; Leerink; Wells Fargo; and Sanford Bernstein. more >>

CardioDx withdraws IPO

CardioDx Inc. (Palo Alto, Calif.) withdrew its IPO on NASDAQ, citing market conditions. In April, the company revived plans for an IPO it had postponed the previous fall, but it did not set terms (see BioCentury Extra, April 29). more >>

   POLITICS & POLICY

U.S.-China clear some air on clinical pathways

China has explicitly made clear that pharma companies can obtain waivers to avoid running domestic clinical trials after conducting multiregional clinical trials (MRCTs) that meet the government's technical requirements for use of Chinese data. more >>

Holiday notice

BioCentury Extra will not publish on Wednesday, Dec. 24, through Friday, Dec. 26, in observance of the Christmas holiday. BioCentury Extra will resume publishing on Monday, Dec. 29. more >>

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BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS

BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS
COVER STORY

Targeting access

How ASCO and the Palmetto-backed Molecular Evidence Development Consortium propose to use cancer genomics to choose and study off-label therapies.

PRODUCT DISCOVERY & DEVELOPMENT

A lasting impression

Naurex is planning a Phase III program that it expects will avoid the issues that tripped up its depression compound in Phase IIb.

EMERGING COMPANY PROFILE

Work horse gene therapy

GeneQuine is developing a gene therapy for sustained expression of an IL-1 antagonist for osteoarthritis.

The long and short of it

Cergentis aims to improve upon PCR with its TLA technology, which can amplify all variants of any gene.

REGULATION

Drug price changes loom in China

Price-setting reforms expected in China pose quandaries for multinationals that have enjoyed margin protections from domestic generics.

FINANCE

Out with a bang

Juno closes 2014 with biggest IPO for a clinical-stage, U.S.-listed biotech

Falling for HER

Immunogen sinks on prospects for Kadcyla in first-line breast cancer.

Annexon connections

Why Novartis Venture backed neurodegeneration play Annexon's $34M A-1 round

Unlocking autoimmune diseases

What autoimmune play Padlock plans to do with $23M A round

Flexible funding for CRT

CRT Pioneer Fund's plans for its latest cash influx

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