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Zacks News
Shire Gets FDA Approval for Label Expansion of Adynovate
by Zacks Equity Research
Shire announced that the FDA has approved the use of hemophilia A drug, Adynovate,in pediatric patients under 12 years of age
Seattle Genetics' Acute Myeloid Leukemia Drug on FDA Hold
by Zacks Equity Research
Seattle (SGEN) announced that the FDA had placed a clinical hold or partial clinical hold on several early-stage studies on SGN-CD33A for the treatment of AML.
Synergy Reports Positive Top-Line Phase III Data on IBS Drug
by Zacks Equity Research
Synergy Pharmaceuticals announced positive top-line data from a pivotal phase III study evaluating the efficacy and safety of its investigational drug, plecanatide, for the treatment of adult patients suffering from irritable bowel syndrome.
Ionis/Biogen Spinraza Approved For Spinal Muscular Atrophy
by Zacks Equity Research
Ionis (IONS) and Biogen (BIIB) announced that FDA has approved Spinraza under Priority Review for the treatment of spinal muscular atrophy.
Aerie (AERI) Rhopressa Regulatory Application Delayed Again
by Zacks Equity Research
Aerie (AERI)'s NDA for lead candidate, Rhopressa, gets delayed again due to delay on the manufacturer's part.
Why Vanda Pharmaceuticals (VNDA) Might Be a Diamond in the Rough
by Zacks Equity Research
Solid estimate revisions and an impressive Zacks Rank suggest that better days may be ahead for Vanda Pharmaceuticals (VNDA) and that now might be an interesting buying opportunity.
Roche (RHHBY) Hemophilia A Drug Positive in Phase III
by Zacks Equity Research
Roche (RHHBY) announced that the phase III study, HAVEN 1, met its primary endpoint.
Teva Settles Foreign Bribery Charges with U.S. Government
by Zacks Equity Research
Teva (TEVA) announced that it has completed negotiations with the U.S. government over violations of the Foreign Corrupt Practices Act.
Exelixis, Ipsen Amend Exclusive Agreement for Cabometyx
by Zacks Equity Research
Exelixis, Inc. (EXEL) announced that it has amended the exclusive collaboration and licensing agreement with its European partner Ipsen.
Merrimack (MACK) Drops as Breast Cancer Drug Trial Stops
by Zacks Equity Research
Shares of Merrimack Pharmaceuticals, Inc. (MACK) tanked 18.4% after the company announced the discontinuation of a phase II trial on its breast cancer candidate, MM-302.
Incyte/Merus Ink Collaboration for Bispecific Antibodies
by Zacks Equity Research
Incyte (INCY) entered into an agreement with Merus (MRUS) to discover and develop bispecific antibodies using the latter's proprietary Biclonics technology platform.
Pfizer (PFE) Nimenrix Vaccine's Label Expanded in the EU
by Zacks Equity Research
Pfizer Inc. (PFE) announced that the European Commission has approved an expanded indication for its meningococcal vaccine, Nimenrix.
J&J Files for FDA Approval of Simponi Aria Label Expansion
by Zacks Equity Research
Johnson & Johnson's (JNJ), Janssen submitted two sBLAs in the U.S. seeking approval of Simponi Aria for the treatment of psoriatic arthritis and ankylosing spondylitis.
Biogen (BIIB) Board Okays Hemophilia Business Spin-off
by Zacks Equity Research
Biogen (BIIB) announced that its board of directors has approved the spin-off of its hemophilia business into a new company Bioverativ Inc.
Sarepta's (SRPT) Application for DMD Drug Accepted in the EU
by Zacks Equity Research
Sarepta Therapeutics, Inc. (SRPT) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization application (MAA) for Exondys 51.
Conatus Stock Up on Liver Drug Collaboration with Novartis
by Zacks Equity Research
Conatus (CNAT) inked an exclusive option, collaboration and license agreement with Novartis (NVS) for the worldwide development and commercialization of emricasan.
Agios Stops Development of PKR Activator AG-519, Stock Falls
by Zacks Equity Research
Shares of Agios (AGIO) tanked 19.4% after the company decided to discontinue the development of its PKR activator, AG-519.
Ionis (IONS) Receives Milestone Payment from AstraZeneca
by Zacks Equity Research
Ionis (IONS) received $28 million from AstraZeneca (AZN) following the completion of IND-supporting studies and licensing of IONIS-KRAS-2.5.
Incyte/Lilly Olumiant Wins CHMP Nod for Rheumatoid Arthritis
by Zacks Equity Research
Incyte (INCY) and Eli Lilly (LLY) announced that the EMA's CHMP has issued a positive opinion for the approval of Olumiant (baricitinib).
Roche (RHHBY) to Terminate Pacifica Bioscience Agreement
by Zacks Equity Research
Roche Holding AG (RHHBY) announced that it intends to terminate its agreement with Pacifica Bioscience.
Gilead to Pay Merck $2.5B in HCV Patent Dispute, Stock Falls
by Zacks Equity Research
Gilead (GILD) has been ordered to pay $2.5 billion in royalties to Merck (MRK) in the largest patent infringement dispute in the history of the U.S.
Intercept (ICPT) Ocaliva Gains Conditional Approval in EU
by Zacks Equity Research
Intercept (ICPT) Ocaliva, in combination with UDCA, was approved in the EU for the treatment of PBC.
Trovagene to Focus More on Liquid Biopsy Testing Market
by Zacks Equity Research
Trovagene, Inc. (TROV), recently announced that it will increase its focus on the global distribution of kits and systems to clinical research laboratories for the liquid biopsy oncology testing market.
athenahealth (ATHN) Reaffirms 2016 View, Guides for 2017
by Zacks Equity Research
athenahealth Inc. (ATHN) reaffirmed its full-year 2016 guidance and issued a stable guidance for 2017.
Intuitive Surgical (ISRG) Raises Share Buyback to $3 Billion
by Zacks Equity Research
Intuitive Surgical Inc. (ISRG) increased the authorized amount available under the company's share repurchase program to $3.0 billion.