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Zacks News
Bristol-Myers' Injectable Opdivo Gets FDA Approval for mUC
by Zacks Equity Research
Bristol-Myers Squibb Company (BMY) announced that the FDA has approved an injectable form of immuno-oncology drug Opdivo
Roche (RHHBY) Beats on Earnings in 2016, Misses on Sales
by Zacks Equity Research
Roche beat on earnings but missed on sales in 2016 due to decline in sales of Lucentis, Pegasys, Avastin and Tarceva.
SanofiRegeneron Sarilumab Approved in Canada for Arthritis
by Zacks Equity Research
Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced that their pipeline candidate, sarilumab, has been approved in Canada for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA).
Pfizer (PFE) Gets Positive CHMP Opinion for Arthritis Drug
by Zacks Equity Research
Pfizer Inc. (PFE) announced that Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for the company's marketing authorisation application (MAA) for its rheumatoid arthritis (RA) drug, Xeljanz.
Roche (RHHBY) Arthritis Drug Actemra sBLA Accepted by FDA
by Zacks Equity Research
Roche's (RHHBY) supplemental Biologics License Application (sBLA) for arthritis drug, Actemra, accepted for review by the FDA for giant cell arteritis (GCA).
BioLineRx (BLRX) Starts Cancer Study on BL-8040+Keytruda
by Zacks Equity Research
BioLineRx (BLRX) announced the initiation of a second phase IIa study on BL-8040 in combination with Keytruda for the treatment of pancreatic cancer.
Merck KGaA Expands Distribution Deal with Roche (revised)
by Zacks Equity Research
Germany-based Merck KGaA announced that it has expanded the distribution alliance with Roche Holding AG (RHHBY).
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.