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  • COMPANY NEWS: Raptor acquires Quinsair

    Raptor Pharmaceutical Corp. (NASDAQ:RPTP) acquired aerosolized levofloxacin (MP-376) from Tripex Pharmaceuticals LLC, a privately held shell company. The formulation, which Raptor intends to market as Quinsair, is …

    Published on 8/21/2015
  • COMPANY NEWS: Sarepta's eteplirsen gets rare pediatric disease designation

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) said FDA granted rare pediatric disease designation to eteplirsen (AVI-4658) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.In June, the company completed…

    Published on 8/21/2015
  • COMPANY NEWS: BeiGene expands into BioBay

    BeiGene Co. Ltd. (Beijing, China) said it is establishing a biomanufacturing facility in BioBay, an innovation hub located in the Suzhou Industrial Park of Suzhou, China. It expects the facility to be completed by 2017.…

    Published on 8/20/2015
  • COMPANY NEWS: IQWiG assesses Boehringer's Giotrif, Newron's Xadago

    Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment Gilotrif/Giotrif afatinib from Boehringer Ingelheim GmbH (Ingelheim, Germany) had a "major added benefit" in non-small …

    Published on 8/20/2015
  • COMPANY NEWS: Janssen terminates deal with Chi-Med

    Hutchison China MediTech Ltd. (AIM:HCM) said the Janssen Pharmaceutical Inc. unit of Johnson & Johnson (NYSE:JNJ) terminated an agreement with its Hutchison MediPharma Ltd. R&D unit to develop HMPL-507, a small molecule…

    Published on 8/20/2015
  • COMPANY NEWS: Lupin launches IPR challenge against Vimovo

    Lupin Ltd. (NSE:LUPIN; BSE:500257) filed three inter partes review (IPR) petitions with the U.S. Patent and Trademark Office challenging patents from Pozen Inc. (NASDAQ:POZN) covering Vimovo naproxen/esomeprazole. Lupin…

    Published on 8/20/2015
  • COMPANY NEWS: Macrocure plunges on Phase III futility analysis

    Macrocure Ltd. (NASDAQ:MCUR) lost $9.07 (75%) to $2.98 on Thursday following its disclosure after market on Wednesday that a futility analysis showed CureXcell was unlikely to meet the primary endpoint of the Phase III …

    Published on 8/20/2015
  • COMPANY NEWS: Management tracks

    Infectious disease company Achaogen Inc. (NASDAQ:AKAO) named Blake Wise COO, effective Oct. 1. Wise was VP of Cross BioOncology at the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).Antibody play Arsanis Inc. (…

    Published on 8/20/2015
  • COMPANY NEWS: Valeant to acquire Sprout

    Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said it will acquire Sprout Pharmaceuticals Inc. (Raleigh, N.C.) for $1 billion in cash. FDA approved Sprout's female sexual dysfunction treatment Addyi …

    Published on 8/20/2015
  • COMPANY NEWS: AbbVie buys United's Priority Review voucher

    United Therapeutics Corp. (NASDAQ:UTHR) said it sold a rare pediatric disease Priority Review voucher to AbbVie Inc. (NYSE:ABBV) for $350 million. AbbVie spokesperson Adelle Infante declined to disclose the company's …

    Published on 8/19/2015
  • COMPANY NEWS: Cempra's solithromycin gets Fast Track

    Cempra Inc. (NASDAQ:CEMP) gained $1.92 to $38.70 on Wednesday after FDA granted Fast Track designation to IV and oral solithromycin (CEM-101) to treat community acquired bacterial pneumonia (CABP). The company expects …

    Published on 8/19/2015
  • COMPANY NEWS: Lundbeck restructuring

    H. Lundbeck A/S (CSE:LUN) climbed DKK32.10 (19%) to DKK201 on Wednesday after unveiling restructuring plans designed to cut costs and regain profitability. The restructuring is Lundbeck's first major move since Kare …

    Published on 8/19/2015
  • COMPANY NEWS: CEO Zahnd returns to Molecular Partners

    Molecular Partners AG (SIX:MOLN) said CEO Christian Zahnd returned to his role after a medical absence. The company had said in March that Zahnd would take temporary leave (see BioCentury Extra, March 10).

    Published on 8/18/2015
  • COMPANY NEWS: FDA approves first drug for sexual desire disorder

    FDA approved Addyi flibanserin from Sprout Pharmaceuticals Inc. (Raleigh, N.C.) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The agency said Addyi is the first drug …

    Published on 8/18/2015
  • COMPANY NEWS: FDA committee to discuss AZ's gout treatment

    FDA's Arthritis Advisory Committee will meet on Oct. 23 to discuss an NDA for lesinurad in combination with a xanthine oxidase inhibitor to treat hyperuricemia associated with gout. Ardea Biosciences Inc. submitted the …

    Published on 8/18/2015
  • COMPANY NEWS: Management tracks

    Anemia and asthma play Pieris Pharmaceuticals Inc. (NASDAQ:PIRS) named Louis Matis SVP and chief development officer. Matis was executive director of strategic evaluation at Alexion Pharmaceuticals Inc. (NASDAQ:ALXN).…

    Published on 8/18/2015
  • COMPANY NEWS: Aveo gains on Novartis licensing deal

    Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) rose $0.53 (45%) to $1.70 after it granted Novartis AG (NYSE:NVS; SIX: NOVN) an exclusive, worldwide license to preclinical candidate AV-380, in development to treat cachexia. …

    Published on 8/17/2015
  • COMPANY NEWS: Celltrion files IPR against Genentech

    Celltrion Inc. (KOSDAQ:068270) filed an inter partes review (IPR) petition with the U.S. Patent and Trademark Office challenging a patent from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) that covers methods …

    Published on 8/17/2015
  • COMPANY NEWS: ContraFect's CF-301 gets Fast Track designation

    ContraFect Corp. (NASDAQ:CFRX) gained $0.83 (18%) to $5.39 on Monday after FDA granted Fast Track designation to CF-301, a lysin targeting Staphylococcus aureus. ContraFect began a Phase I study in April of CF-301 in …

    Published on 8/17/2015
  • COMPANY NEWS: Management tracks

    Molecular diagnostics play Veracyte Inc. (NASDAQ:VCYT) named Neil Barth CMO. Barth was CMO at Agendia N.V. (Amsterdam, the Netherlands).Infectious disease company Spring Bank Pharmaceuticals Inc. (Milford, Mass.) named …

    Published on 8/17/2015
  • COMPANY NEWS: Palmetto to cover Genomic Health's prostate cancer test

    Genomic Health Inc. (NASDAQ:GHDX) rose $1.94 to $26.79 after it said Medicare administrative contractor Palmetto GBA LLC issued a local coverage determination (LCD) that covers the company's Oncotype Dx prostate cancer …

    Published on 8/17/2015
  • COMPANY NEWS: Pfenex lands BARDA contract for anthrax vaccine

    Pfenex Inc. (NYSE-M:PFNX) said HHS's Biomedical Advanced Research and Development Authority awarded it a five-year contract with a total potential value of $143.5 million to develop Px563L, a recombinant protective …

    Published on 8/17/2015
  • COMPANY NEWS: Avalanche slides as AVA-101 hits dead end in AMD

    Avalanche Biotechnologies Inc. (NASDAQ:AAVL) fell $3.82 (28%) to $10.01 on Friday after it said it will not begin a Phase IIb study this half of gene therapy AVA-101 to treat wet age-related macular degeneration (AMD), …

    Published on 8/14/2015
  • COMPANY NEWS: Bass' latest IPR petition targets Eliquis

    Hedge fund manager Kyle Bass is challenging a patent on Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) with an inter partes review (IPR) petition.The Coalition for Affordable Drugs …

    Published on 8/14/2015
  • COMPANY NEWS: Kite files IPR against MSKCC

    Kite Pharma Inc. (NASDAQ:KITE) filed an inter partes review (IPR) petition with the U.S. Patent and Trademark Office challenging a patent from Memorial Sloan Kettering Cancer Center (MSKCC) covering chimeric antigen …

    Published on 8/14/2015

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