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Zacks News
Abbott Labs to Close St. Jude Acquisition Later this Week
by Zacks Equity Research
Abbott Laboratories (ABT) announced to close the acquisition of St. Jude Medical, Inc., (STJ) on Jan 4, 2017.
Immunomedics Completes Enrollment In Cancer Drug Study
by Zacks Equity Research
Immunomedics (IMMU) achieved the planned enrollment in a phase II study on IMMU-132.
Cempra (CEMP) Gets CRL from FDA for Pneumonia Candidate
by Zacks Equity Research
Cempra (CEMP) announced that it received a CRL from the FDA relating to its new drug applications for oral and intravenous formulation of candidate solithromycin.
Prima (PBMD) Reports Favorable Initial Melanoma Study Data
by Zacks Equity Research
Prima (PBMD) announced interim data from the TACTI-mel program on IMP321 for the treatment of patients with unresectable or metastatic melanoma.
Innocoll (INNL) Down on FDA's Refusal to File Xaracoll NDA
by Zacks Equity Research
Innocoll (INNL) announced that it has received a Refusal to File letter from the FDA in connection with the NDA for Xaracoll for the treatment of postsurgical pain.
Abbott to Sell 2 Medical Device Businesses for St. Jude Buyout
by Zacks Equity Research
Abbott Laboratories (ABT) has agreed to divest two medical device businesses in order to settle Federal Trade Commission (FTC) charges in relation to its proposed acquisition of St. Jude Medical (STJ).
ImmunoGen: Phase I Data on Ovarian Cancer Drug Published
by Zacks Equity Research
ImmunoGen, Inc. (IMGN) announced that data from a 46-patient phase I expansion cohort study on its lead pipeline candidate, mirvetuximab soravtansine (IMGN853), were published in the Journal of Clinical Oncology.
BioMarin (BMRN) Raised to Buy: Should You Add the Stock?
by Zacks Equity Research
The Zacks Investment Research upgraded BioMarin (BMRN) to a Zacks #2 Rank (Buy).
Galena Biopharma Reveals Regulatory Pathway for GALE-401
by Zacks Equity Research
Galena (GALE) confirmed the regulatory pathway to advance GALE-401 (anagrelide CR) into a pivotal phase III study.
Amphastar Stock Down on CRL for Asthma Drug in the U.S.
by Zacks Equity Research
Amphastar Pharmaceuticals, Inc. (AMPH) announced that its subsidiary, Armstrong Pharmaceuticals, Inc., has received a Complete Response Letter (CRL) from the FDA for Primatene Mist (epinephrine inhalation aerosol).
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.