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Zacks News
Pharma Stock Roundup: Trump Targets Pharma Again, Merck Up on Keytruda News
by Arpita Dutt
The sector was once again slammed by president-elect Donald Trump's comments this week regarding drug pricing.
Mylan/Biocon's Herceptin Biosimilar under Review in the U.S.
by Zacks Equity Research
Mylan (MYL) and Biocon Ltd. announced that the FDA had accepted the BLA for their biosimilar version of Herceptin (trastuzumab), MYL-1401O.
by Zacks Equity Research
Roche Gets Priority Review for Immunotherapy Drug Tecentriq
by Zacks Equity Research
Roche Holding AG's (RHHBY) Genentech announced that the FDA has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for cancer immunotherapy, Tecentriq.
The FDA Approved Fewer Drugs in 2016: Here's Why
by Arpita Dutt
Was there any specific reason for the significantly lower number of drug approvals in 2016 compared to 2015?
Roche's (RHHBY) Lucentis Gets FDA Nod for Fifth Indication
by Zacks Equity Research
Roche Holding AG (RHHBY) announced today that the FDA has approved a label expansion of ophthalmology drug Lucentis- fifth indication.
Mylan/Biocon's Herceptin Biosimilar Phase III Data Published
by Zacks Equity Research
Mylan (MYL) and partner Biocon's biosimilar version of Herceptin phase III data published in JAMA.
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.
Pharma Stock Roundup: J&J Back in Talks with Actelion, Teva Settles Corruption Probe
by Arpita Dutt
J&J (JNJ) and Actelion are back in the limelight with the companies in exclusive talks regarding a possible deal.
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.
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.
Roche (RHHBY) MS Drug FDA Review Date Extended in U.S.
by Zacks Equity Research
Roche (RHHBY) announced that the FDA has extended the PDUFA date for the review of the company's Biologics License Application (BLA) for Ocrevus.
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.
Merck (MRK) Offers Update on Keytruda-Halaven Combination
by Zacks Equity Research
Merck (MRK) and Eisai (ESALY) announced new interim data from a phase Ib/II study on the Keytruda-Halaven combination for the treatment of metastatic TNBC.
Ophthotech Hits 52-Week Low on Unfavorable Fovista Data
by Zacks Equity Research
Ophthotech's (OPHT) shares tumbled 86.4% to a 52-week low after the company reported disappointing phase III data on its eye drug, Fovista, in wet AMD patients.
Roche/AbbVie's Leukemia Drug Venclyxto Gains EU Approval
by Zacks Equity Research
Roche (RHHBY) and AbbVie's (ABBV) Venclyxto has gained EU approval for the treatment of appropriate patients with hard-to-treat chronic lymphocytic leukemia.
Biogen Presents Positive Early Data from Alzheimer's Study
by Zacks Equity Research
Last week, Biogen Inc. (BIIB) presented positive data from a phase I study (PRIME) on its anti-amyloid treatments in development, aducanumab, at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in San Diego.
Novartis (NVS) Zykadia Positive in Phase III ASCEND-4 Study
by Zacks Equity Research
Novartis (NVS) announced results from the phase III ASCEND-4 study on Zykadia, for the treatment of patients with advanced ALK+ NSCLC.
Roche Presents Positive Follicular Lymphoma Data on Gazvya
by Zacks Equity Research
Roche Holding AG (RHHBY) announced encouraging data from the pivotal phase III study, GALLIUM.
Kite Pharma Begins Filing for KTE-C19, Presents Data at ASH
by Zacks Equity Research
Kite Pharma, Inc. (KITE) announced it has initiated a rolling submission of the Biologic License Application (BLA) for its lead pipeline candidate, KTE-C19, to the FDA.
Amgen/Allergan File for EU Approval of Avastin Biosimilar
by Zacks Equity Research
Amgen Inc. (AMGN), along with partner Allergan plc. (AGN), announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215.
Zacks Industry Outlook Highlights: Johnson & Johnson, Medtronic, Zimmer Biomet and Roche
by Zacks Equity Research
Zacks Industry Outlook Highlights: Johnson & Johnson, Medtronic, Zimmer Biomet and Roche
Merck KGaA (MKGAF) Expands Distribution Deal with Roche
by Zacks Equity Research
Merck (MKGAF) announced that it has expanded the distribution alliance with Roche (RHHBY) to include enzyme products ??? PCR and qPCR.
Pharma Stock Roundup: Nivalis Falls on Study Data, Priority Reviews for Merck's Keytruda
by Arpita Dutt
This week, companies like Merck (MRK) and Pfizer (PFE) provided updates on their pipelines.