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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

BioMarin rises on takeout rumors

Rare disease company BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) jumped $13.23 (11%) to $128.78 on Friday, ending the day with a market cap of $20.5 billion, amid rumors that Shire plc (LSE:SHP; NASDAQ:SHPG) has approached it with a takeout bid. Both companies declined to comment. more >>

   COMPANY NEWS

FDA denies Amgen's biosimilar Citizen's Petition

FDA denied a Citizen's Petition from Amgen Inc. (NASDAQ:AMGN) asking the agency to require that biosimilar applications include a certification that the applicant will comply with the patent resolution protocol outlined in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen submitted the petition in October after it filed a lawsuit against the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to prevent the launch of Zarxio filgrastim-sndz, a biosimilar version of Amgen's Neupogen filgrastim G-CSF (see BioCentury Extra, Nov. 3, 2014). more >>

CHMP backs Eisai's Lenvima

EMA's CHMP recommended marketing authorization for Lenvima lenvatinib from Eisai Co. Ltd. (Tokyo:4523) to treat adults with progressive, radioiodine-refractory, locally advanced or metastatic differentiated thyroid carcinoma. EMA reviewed Lenvima under its accelerated assessment program; it has Orphan Drug designation in the EU and the U.S. more >>

Management tracks

Bionor Pharma ASA (OSE:BIONOR) announced a trio of hires. Soren Keller is joining as SVP, COO and interim CFO. Keller was director and general counsel to the management at Zealand Pharma A/S (CSE:ZEAL). Kamilla Rolsted is joining Bionor as SVP and chief strategy and business officer. Rolsted was director of strategy and planning at Zealand. Finally, Bionor hired Barbara Ruskin as SVP, general counsel and chief patent officer more >>

   CLINICAL NEWS

Genfit sinks on Phase II NASH data

Genfit S.A. (Euronext:GNFT) plunged EUR 22.54 (44%) to a six-month low of EUR 28.31 on Friday after its GFT505 missed the primary endpoint in the Phase IIb GOLDEN-505 trial to treat non-alcoholic steatohepatitis (NASH) (see BioCentury Extra, March 26). more >>

Northwest gains on GBM survival data

Northwest Biotherapeutics Inc. (NASDAQ:NWBO) reported data from glioblastoma multiforme (GBM) patients who were ineligible for enrollment in the company's ongoing Phase III trial of DCVax-Brain (DCVax-L), and instead were treated in a separate study arm. In that "informational arm," DCVax-Brain (DCVax-L) led to a median overall survival of 18.3 months in 51 GBM patients whose tumors showed evidence of regrowth following six weeks of radiation and chemotherapy. more >>

   FINANCIAL NEWS

Modest biotech rally ends bumpy week

Biotech stocks recovered some of the week's losses Friday, ending a turbulent week that included a three-day sell-off in which some investors feared companies in the sector were overvalued (see BioCentury Extra, March 25). more >>

PolyPid withdraws IPO

PolyPid Ltd. (Petach Tikva, Israel) withdrew its proposed IPO on NASDAQ. CBO Asaf Bar said the company is confident it could have gone public under current market conditions, but anticipates undisclosed milestones in the next few months that could boost its valuation. more >>

   POLITICS & POLICY

White House unveils antibiotics plan

The White House outlined its five-year National Action Plan for Combating Antibiotic Resistant Bacteria, which includes measures to slow the emergence and spread of antibiotic resistant bacteria and advance the development of antibiotic drugs, vaccines and diagnostics. NIH, the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense will allocate funding to projects aimed at developing rapid diagnostics and antibiotic drug candidates. more >>

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