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  • COMPANY NEWS: Amgen moves to stall Zarxio launch again

    Amgen Inc. (NASDAQ:AMGN) filed an emergency motion with the U.S. Court of Appeals for the Federal Circuit (CAFC) for an injunction to further delay the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis …

    Published on 8/27/2015
  • COMPANY NEWS: uniQure looks beyond Glybera

    uniQure N.V. (NASDAQ:QURE) has shifted its attention from Glybera alipogene tiparvovec to new gene therapy candidates in its pipeline. On Thursday, the company said FDA has required an additional trial of Glybera to …

    Published on 8/27/2015
  • COMPANY NEWS: PTAB institutes IPRs against Teva's thrice-weekly Copaxone

    The Patent Trials and Appeals Board of the U.S. Patent and Trademark Office instituted inter partes review (IPR) proceedings challenging two patents that cover the thrice-weekly formulation of multiple sclerosis drug …

    Published on 8/26/2015
  • COMPANY NEWS: Sucampo launches tender offer to acquire R-Tech Ueno

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP) launched a tender offer to acquire R-Tech Ueno Ltd. (JASDAQ:4573) for Y33 billion ($273.9 million).R-Tech manufactures constipation drug Amitiza lubiprostone for Sucampo and …

    Published on 8/26/2015
  • COMPANY NEWS: Amgen submits etelcalcetide NDA

    Amgen Inc. (NASDAQ:AMGN) submitted an NDA to FDA for etelcalcetide (AMG 416) to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. The IV peptide calcimimetic that …

    Published on 8/25/2015
  • COMPANY NEWS: Illumina, Burning Rock to develop cancer diagnostics kit

    Illumina Inc. (NASDAQ:ILMN) and Burning Rock Biotech (Guangzhou, China) will collaborate to develop an oncology molecular diagnostics kit for the Chinese market. The kit will include Illumina's next-generation …

    Published on 8/25/2015
  • COMPANY NEWS: Insys' Subsys becomes Bass' latest target

    Kyle Bass' Coalition for Affordable Drugs XI filed three new inter partes review (IPR) petitions with the Patent Trials and Appeals Board (PTAB) of the U.S. Patent and Trademark Office challenging three patents from …

    Published on 8/25/2015
  • COMPANY NEWS: Management tracks

    Oncology company Halozyme Therapeutics Inc. (NASDAQ:HALO) promoted Michael LaBarre to CSO from VP of product development and alliances. He replaces Michael Shepard, who will remain at Halozyme as a research fellow.Women…

    Published on 8/25/2015
  • COMPANY NEWS: MorphoSys, immatics enter immuno-oncology deal

    MorphoSys AG (Xetra:MOR; Pink:MPSYF) partnered with immatics biotechnologies GmbH (Tuebingen, Germany) to develop antibodies against undisclosed cancer targets recognized by T cells. MorphoSys will gain access to an …

    Published on 8/25/2015
  • COMPANY NEWS: Sarepta's eteplirsen gets Priority Review

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) said FDA accepted and granted Priority Review to NDA for eteplirsen (AVI-4658) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The PDUFA date is Feb. 26, …

    Published on 8/25/2015
  • COMPANY NEWS: AstraZeneca names Bohen CMO

    AstraZeneca plc (LSE:AZN; NYSE:AZN) hired Sean Bohen as CMO and EVP of global medicines development. Bohen, who joins AZ Sept. 15, was SVP of early development at the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).…

    Published on 8/24/2015
  • COMPANY NEWS: Constellation targets IPO after Genentech passes on takeout

    Constellation Pharmaceuticals Inc. (Cambridge, Mass.) plans to tap the public markets now that the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) has declined to exercise a one-time option to acquire the …

    Published on 8/24/2015
  • COMPANY NEWS: Epizyme gains as tazemetostat moves forward

    Epizyme Inc. (NASDAQ:EPZM) gained $1.53 (10%) to $17.46 on Monday after FDA accepted an IND for tazemetostat (E7438, EPZ-6438) to treat adults and pediatric patients with tumors deficient in SWI/SNF related matrix …

    Published on 8/24/2015
  • COMPANY NEWS: Exelixis' Cometriq gets breakthrough designation in RCC

    Exelixis Inc. (NASDAQ:EXEL) said FDA granted breakthrough therapy designation to Cometriq cabozantinib as second-line treatment for advanced renal cell carcinoma (RCC).The company also said Monday that data from the …

    Published on 8/24/2015
  • COMPANY NEWS: Medivation buys PARP inhibitor from BioMarin

    Medivation Inc. (NASDAQ:MDVN) acquired worldwide rights to talazoparib from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN). BioMarin will receive $410 million up front and is eligible for $160 million in milestones, plus …

    Published on 8/24/2015
  • COMPANY NEWS: PTAB denies Bass' IPR petitions against Acorda

    Acorda Therapeutics Inc. (NASDAQ:ACOR) climbed $8.03 (28%) to $36.99 in early after-hours trading after the U.S. Patent and Trademark Office denied two inter partes review (IPR) petitions from Kyle Bass' Coalition for …

    Published on 8/24/2015
  • COMPANY NEWS: IPR petitions target Oracea, Kerydin

    Rosacea drug Oracea doxycycline from Galderma S.A. (Lausanne, Switzerland) and onychomycosis drug Kerydin tavaborole from Anacor Pharmaceuticals Inc. (NASDAQ:ANAC) were the targets of several new inter partes review (…

    Published on 8/21/2015
  • 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

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