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Zacks News
AbbVie's Imbruvica Combo Gets FDA Nod in First-Line Setting
by Zacks Equity Research
AbbVie's (ABBV) key cancer drug, Imbruvica, in combination with Gazyva, gets FDA approval for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in first-line setting.
AbbVie (ABBV) Misses on Q4 Earnings & Revenues, Shares Down
by Zacks Equity Research
AbbVie (ABBV) misses estimates for both earnings and revenues in fourth quarter. Biosimilar competition impacts Humira sales in ex-U.S. markets. Imbruvica and Mavyret offset Humira decline.
Amgen/Allergan's Rituxan Biosimilar Meets Goal in Phase III
by Zacks Equity Research
Amgen (AMGN) along with partner Allergan reports upbeat top-line data from a phase I/III study on ABP 798, a biosimilar candidate of Roche???s Rituxan. The program achieves the primary endpoint.
Dow 30 Stock Roundup: UTX, TRV, PG, JNJ Earnings Impress, IBM Revenues Decline Y/Y
by Swarup Gupta
The index traversed an eventful, yet holiday-shortened week.
AbbVie's Imbruvica Fails in Phase III Pancreatic Cancer Study
by Zacks Equity Research
AbbVie's (ABBV) Imbruvica falls short of meeting the primary endpoint of PFS or OS benefit in a phase III study that probed its combo usage in first-line metastatic pancreatic cancer.
Merck's Partner Gets FDA Nod for Herceptin Biosimilar
by Zacks Equity Research
Merck's (MRK) partner, Samsung Bioepis Co. gets FDA approval for Ontruzant, a Herceptin Biosimilar.
Biogen (BIIB) Q4 Earnings Coming Up: What's in the Cards?
by Zacks Equity Research
While sales of Biogen's (BIIB) MS franchise are expected to be stable in the fourth quarter that of Spinraza are likely to increase.
Pharma Stock Roundup: Regulatory Updates in Focus at PFE, BMY, RHHBY, SNY
by Zacks Equity Research
Pfizer's (PFE) tafamidis application gets FDA's priority review. Regulatory updates for Roche's (RHHBY) and Bristol-Myers'(BMY) cancer combination drugs in focus.
Immunomedics Gets CRL From FDA for Breast Cancer Candidate
by Zacks Equity Research
Immunomedics (IMMU) receives a CRL from the FDA pertaining to the BLA for its lead breast cancer candidate, sacituzumab govitecan.
Roche's sBLA for Tecentriq-Abraxane Combo Accepted by FDA
by Zacks Equity Research
Roche's (RHHBY) sBLA for the label expansion of Tecentriq in combination with Abraxane for the initial treatment of NSCLC has been accepted by the FDA.
Exelixis' Cabometyx Tablets Receive FDA Nod for Liver Cancer
by Zacks Equity Research
Exelixis (EXEL) gets FDA approval for Cabometyx tablets for patients with hepatocellular carcinoma (liver cancer), who have been previously treated with Nexavar.
5 Reasons Why Investors Should Buy Exelixis (EXEL) in 2019
by Zacks Equity Research
Exelixis (EXEL) lead drug, Cabometyx continues to perform well.
ASLAN's Varlitinib Fails to Meet Endpoint in Phase II Study
by Zacks Equity Research
ASLAN's (ASLN) varlitinib is unable to show any statistical significance for the primary endpoint in a phase II study with regard to first-line treatment of advanced or metastatic gastric cancer.
NASH Space in Focus in 2019 as Firms Look to Diversify
by Zacks Equity Research
NASH is a highly lucrative market with blockbuster potential. Hence, we take a look at some of the companies in this space.
Puma Biotech (PBYI) Down More Than 40% in 90 Days: Here's Why
by Zacks Equity Research
Puma Biotech's (PBYI) only marketed drug, Nerlynx, is suffering low sales due to higher patient discontinuations.
Athenex Completes Enrollment Target for Breast Cancer Study
by Zacks Equity Research
Athenex (ATNX) has completed target enrollment in the Oraxol phase III study in metastatic breast cancer on schedule.
Epizyme to File NDA for Tazemetostat in Follicular Lymphoma
by Zacks Equity Research
Epizyme (EPZM) announces that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma.
Biogen Begins Improved Dosing Regimen on Tysabri in Phase III
by Zacks Equity Research
Biogen (BIIB) commences enrollment in late-stage study to evaluate an expanded interval dosing of its MS drug, Tysabri, in patients with relapsing MS.
AbbVie (ABBV) Inks Immunotherapy Deal with Private Biotech
by Zacks Equity Research
AbbVie (ABBV) inks deal with Tizona Therapeutics, to develop and commercialize CD39-targeted therapeutics, including TTX-030, which is a first-in-class antibody for the treatment of cancer.
Bristol-Myers to Acquire Leading Biotech Celgene for $74B
by Zacks Equity Research
Bristol-Myers (BMY) announces an agreement to acquire leading biotech player, Celgene, for a whopping $74 billion.
Bristol-Myers' (BMY) Sprycel Gets FDA Nod for Label Expansion
by Zacks.com
Bristol-Myers' (BMY) obtains FDA approval for the label expansion of leukemia drug Sprycel to include pediatric population.
Horizon Pharma (HZNP) Up 28% on Business Expansion Strategy
by Zacks Equity Research
Horizon Pharma's (HZNP) share price increases about 28% based on its business expansion plan and acquisitions.
Sanofi Wins FDA Nod for Pediatric Hexavalent Combo Vaccine
by Zacks Equity Research
Sanofi (SNY) gains an FDA approval for its pediatric hexavalent combination vaccine, Vaxelis.
AbbVie Partners Lupin to Boost Hematological Cancer Pipeline
by Zacks Equity Research
AbbVie (ABBV) enters into partnership with India-based Lupin, gaining exclusive rights to develop and commercialize the latter's investigational MALT1 inhibitors for hematological cancers.
Pfizer/Merck KGaA End Bavencio Ovarian Cancer Phase III Study
by Zacks Equity Research
Pfizer (PFE) and Merck KGaA terminate a late-stage study on Bavencio. This is the second ovarian cancer study failure in less than two months.