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  • COMPANY NEWS: AcelRx plummets on Zalviso complete response

    AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) fell $4.44 (41%) to $6.39 on Monday after receiving a complete response letter from FDA for an NDA for Zalviso sufentanil sublingual tablet system to treat moderate to severe …

    Published on 7/28/2014
  • COMPANY NEWS: AZ partners with Qiagen, Roche to develop plasma-based EGFR mutation tests

    AstraZeneca plc (LSE:AZN; NYSE:AZN) announced a pair of deals on Monday to develop companion diagnostics that can detect non-small cell lung cancer (NSCLC) EGFR mutations directly from circulating tumor DNA in plasma …

    Published on 7/28/2014
  • COMPANY NEWS: Boehringer, Zealand enter cardio-metabolic deal

    Boehringer Ingelheim GmbH (Ingelheim, Germany) and Zealand Pharma A/S (CSE:ZEAL) partnered to discover and develop therapeutic peptide candidates against an undisclosed cardio-metabolic target from Zealand's preclinical…

    Published on 7/28/2014
  • COMPANY NEWS: EC approves Veloxis' Envarsus

    The European Commission approved Envarsus tacrolimus from Veloxis Pharmaceuticals A/S (CSE:VELO) to prevent organ rejection in adult kidney and liver transplant patients. Veloxis said partner Chiesi Farmaceutici S.p.A.…

    Published on 7/28/2014
  • COMPANY NEWS: Horizon falls on Duexis, Vimovo coverage concerns

    Horizon Pharma Inc. (NASDAQ:HZNP) dropped $4.69 (34%) to $9.20 on Monday after disclosing that pharmacy benefit managers CVS Caremark Corp. (NYSE:CVS) and Express Scripts Holding Co. (NASDAQ:ESRX) notified the company …

    Published on 7/28/2014
  • COMPANY NEWS: Hospira said to be mulling bid for Danone unit

    Hospira Inc. (NYSE:HSP) declined to comment on media reports that the company is in talks to acquire the medical nutrition unit of food product conglomerate Danone (Euronext:BN) in a deal valued at about $5 billion. The…

    Published on 7/28/2014
  • COMPANY NEWS: Reckitt Benckiser to spin out pharma business

    Reckitt Benckiser Group plc (LSE:RB) disclosed in its 2Q14 earnings that it plans to spin out Reckitt Benckiser Pharmaceuticals Inc. -- its pharmaceutical business -- with a separate listing on the London Stock Exchange…

    Published on 7/28/2014
  • COMPANY NEWS: Bristol-Myers, Ono ink Asia immunotherapy deal

    Bristol-Myers Squibb Co. (NYSE:BMY) and Ono Pharmaceutical Co. Ltd. (Tokyo:4528) partnered to jointly develop and commercialize multiple products, including Opdivo nivolumab and Yervoy ipilimumab, in Japan, South Korea …

    Published on 7/24/2014
  • COMPANY NEWS: EMA to review GSK's malaria vaccine

    EMA accepted for review an MAA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for its RTS,S malaria vaccine -- moving the product closer to being the first vaccine approved to prevent malaria infection in infants and …

    Published on 7/24/2014
  • COMPANY NEWS: Gilead exec suggests lower cost for ledipasvir than Sovaldi

    Comments by a Gilead Sciences Inc. (NASDAQ:GILD) executive during the company's 2Q14 earnings call suggest the company may not price HCV therapeutic ledipasvir (GS-5885) as high as Sovaldi sofosbuvir. EVP of Commercial …

    Published on 7/24/2014
  • COMPANY NEWS: Sarepta terminates CSO Krieg

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) disclosed in an SEC filing that Arthur Krieg was terminated as SVP and CSO on July 22. Krieg, co-founder and formerly CEO of RaNA Therapeutics Inc. (Cambridge, Mass.), joined …

    Published on 7/24/2014
  • COMPANY NEWS: ArmaGen licenses AGT-182 to Shire

    ArmaGen Technologies Inc. (Calabasas, Calif.) granted Shire plc (LSE:SHP; NASDAQ:SHPG) exclusive, worldwide rights to develop and commercialize AGT-182, which is in development to treat mucopolysaccharidosis type II (…

    Published on 7/23/2014
  • COMPANY NEWS: FDA approves Eagle's Ryanodex for malignant hyperthermia

    FDA approved an NDA from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) for Ryanodex dantrolene to treat malignant hyperthermia. The company said it plans to launch the drug next month at a wholesale acquisition cost of $2,…

    Published on 7/23/2014
  • COMPANY NEWS: FDA approves Gilead's idelalisib

    FDA approved Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) on Wednesday for three blood cancers. The agency granted full approval to Zydelig in combination with rituximab to treat relapsed chronic …

    Published on 7/23/2014
  • COMPANY NEWS: FDA approves Purdue's abuse-deterrent oxycodone/naloxone

    FDA approved an NDA for Targiniq ER oxycodone/naloxone from Purdue Pharma L.P. (Stamford, Conn.) to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative …

    Published on 7/23/2014
  • COMPANY NEWS: Advaxis, AZ in immunotherapy deal

    Advaxis Inc. (NASDAQ:ADXS) and the MedImmune Inc. unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) partnered in a non-exclusive deal to conduct a Phase I/II trial with Advaxis' ADXS-HPV in combination with MedImmune's …

    Published on 7/22/2014
  • COMPANY NEWS: FDA panel to discuss NPS's Natpara

    FDA's Endocrinologic and Metabolic Drug Products Advisory Committee will meet on Sept. 12 to discuss a BLA from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) for Natpara to treat hypoparathyroidism. The PDUFA date is Oct. 24. …

    Published on 7/21/2014
  • COMPANY NEWS: Basilea submits MAA for isavuconazole

    Basilea Pharmaceutica AG (SIX:BSLN) submitted an MAA to EMA for isavuconazole to treat invasive aspergillosis and invasive mucormycosis (zygomycosis). Partner Astellas Pharma Inc. (Tokyo:4503) submitted an NDA to FDA …

    Published on 7/17/2014
  • COMPANY NEWS: FDA approves Ruconest from Pharming, Salix

    Pharming Group N.V. (Euronext:PHARM) jumped EUR 0.08 (17%) to EUR 0.54 on Thursday after FDA approved a resubmitted BLA for Ruconest conestat alfa to treat acute angioedema attacks in adult and adolescent patients with …

    Published on 7/17/2014
  • COMPANY NEWS: GSK rumored to have fired staff in China in 2001

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) declined to confirm media reports that it fired staff in China for bribing officials in 2001. According to the Financial Times, about 30 employees in the pharma's vaccine business…

    Published on 7/17/2014
  • COMPANY NEWS: Immunocore, Lilly in cancer immunotherapy deal

    Immunocore Ltd. (Abingdon, U.K.) partnered with Eli Lilly and Co. (NYSE:LLY) to use Immunocure's ImmTAC technology to discover and develop ImmTACs against three undisclosed jointly selected targets for cancer. ImmTACs …

    Published on 7/16/2014
  • COMPANY NEWS: Pfizer to acquire sterile injectable company InnoPharma

    Pfizer Inc. (NYSE:PFE) will acquire InnoPharma Inc. (Piscataway, N.J.) for $225 million in cash up front. InnoPharma is also eligible for up to $135 million in milestones. InnoPharma develops sterile injectable …

    Published on 7/16/2014
  • COMPANY NEWS: Non-profit wants FTC to investigate Replagal saga

    Knowledge Ecology International sent a letter to the U.S. Federal Trade Commission requesting the agency investigate a March 2012 decision by Shire plc (LSE:SHP; NASDAQ:SHPG) to withdraw a BLA for Replagal agalsidase …

    Published on 7/15/2014
  • COMPANY NEWS: Novartis, Banner partner on Alzheimer's trial

    Novartis AG (NYSE:NVS; SIX:NOVN) partnered with not-for-profit Banner Alzheimer's Institute (BAI) (Phoenix, Ariz.) to evaluate two of the pharma's compounds in cognitively healthy adults at risk of developing symptoms …

    Published on 7/15/2014
  • COMPANY NEWS: Novartis, Google in smart lens deal

    The Alcon Inc. ophthalmic unit of Novartis AG (NYSE:NVS; SIX:NOVN) partnered with Google Inc. (NASDAQ:GOOG) to co-develop Google's smart lens for ocular conditions. The smart lens technology consists of non-invasive …

    Published on 7/15/2014

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