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Zacks News
Amgen Gets CHMP Nod to Add ENDEAVOR Data on Kyprolis Label
by Zacks Equity Research
Amgen (AMGN) gains consent from the Committee for Medicinal Products for Human Use to add overall survival data from a phase III study on the label of its cancer drug, Kyprolis.
Puma & Medison Team Up to Commercialize Nerlynx in Israel
by Zacks Equity Research
Puma (PBYI) and Medison enters into a licensing deal to commercialize Puma's breast cancer treatment drug Nerlynx in Israel.
What's in the Cards for GW Pharma (GWPH) in Q1 Earnings?
by Zacks Equity Research
GW Pharma (GWPH) will report fiscal first-quarter results next week. Investors focus is expected to be on the Epidiolex commercialization plan.
Theravance's NDA for COPD Candidate Gets FDA Acceptance
by Debapriya Chakraborty
The FDA accepts the new drug application for Theravance (TBPH) and partner Mylan's COPD candidate, revefenacin. A response on the same is expected on Nov 13, 2018.
Roche Gets Breakthrough Therapy Designation For ASD Drug
by Zacks Equity Research
Roche obtains Breakthrough Therapy Designation for its experimental drug oral medicine balovaptan from the FDA which is likely to expedite the review and development of the drug.
Vertex (VRTX) to Report Q4 Earnings: What's in the Cards?
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) will report its Q4 results on Jan 31, 2018.
Glaxo's Shingles Vaccine Shingrix Gets Positive CHMP Opinion
by Zacks Equity Research
The Committee for Medicinal Products for Human Use passes a positive viewpoint on Glaxo's (GSK) shingles vaccine, Shingrix. A final decision from the EU is awaited in April 2018.
Quality Systems (QSII) Q3 Earnings in Line, Revenues Beat
by Zacks Equity Research
Quality Systems (QSII) benefits from solid bookings and acquisitions in Q3.
Vertex (VRTX) Stock Up 70% in a Year's Time: Here's Why
by Zacks Equity Research
Vertex Pharmaceuticals' (VRTX) stock rallies on consistent expansion in patient population through label expansions of Kalydeco and Orkambi and positive data readout from pivotal studies.
Dr. Reddy's (RDY) Q3 Earnings Fall, Revenues Improve Y/Y
by Zacks Equity Research
Dr. Reddy's (RDY) earnings per American Depositary Share were down 27.3% in third-quarter fiscal 2018 from the year-ago quarter while the top line beat the prior-year figure.
Shire Gets FDA Nod for Cinryze Tech Transfer to New Site
by Zacks Equity Research
Shire (SHPG) receives an FDA approval for transferring the product manufacturing technology of its hereditary angioedema drug, Cinryze, to its manufacturing site in Vienna, Austria.
EU Unlikely to Approve Puma's Nerlynx in 2018, Stock Down
by Zacks Equity Research
Puma's (PBYI) shares decline after CHMP conveyed the company that the former will probably vote against the approval of breast cancer drug Nerlynx at the CHMP meeting scheduled in February.
The Zacks Analyst Blog Highlights: Anthera Pharmaceuticals, Bio-Techne, Exelixis, Paratek and Bioverativ
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Anthera Pharmaceuticals, Bio-Techne, Exelixis, Paratek and Bioverativ
Novartis Announces Positive Results on Migraine Candidate
by Zacks Equity Research
Novartis announced positive results on migraine candidate, AMG334, from the phase IIIb study. The candidate is being developed in collaboration with Amgen,
Anthera's Sollpura Strong on Positive Futility in Phase III
by Zacks Equity Research
Anthera (ANTH) posts positive results from the second interim futility analysis of Sollpura for EPI. Top-line data from the study is expected in the first quarter of 2018.
Seattle Genetics' Adcetris Gets EU Nod for Label Expansion
by Zacks Equity Research
European Commission extend the current conditional marketing authorization for an expanded indication of Adectris of Seattle Genetics (SGEN) and partner Takeda.
Regeneron's Dupixent Receives MHLW Nod for Label Expansion
by Zacks Equity Research
Ministry of Health, Labor and Welfare (MHLW) in Japan has granted approval for the label expansion of Regeneron's (REGN) Dupixent.
BioCryst (BCRX) & Idera (IDRA) Announce Merger, Shares Fall
by Zacks Equity Research
Shares of BioCryst Pharmaceuticals (BCRX) and Idera Pharmaceuticals (IDRA) plunge following the announcement of their merger.
Fancy Biotech Stocks on Buyout Buzz? 5 Top Picks
by Tirthankar Chakraborty
More deals are expected to be signed in the biotech space, now that the tax reform bill allows companies to repatriate cash pilling up overseas.
Bristol-Myers (BMY) Reports Data from CheckMate-142 Study
by Zacks Equity Research
Bristol-Myers (BMY) announces new data from a cohort of the phase II CheckMate -142 study evaluating Opdivo (nivolumab) and Yervoy (ipilimumab).
Here's Why Agios (AGIO) Stock is Up More Than 50% in a Year
by Zacks Equity Research
Last year's FDA approval of Agios' (AGIO) only marketed drug Idhifa and its rapid progress on a robust pipeline during the period drive the share price consistently.
BeiGene (BGNE) Surges: Stock Moves 12.6% Higher
by Zacks Equity Research
BeiGene (BGNE) saw a big move last session, as its shares jumped nearly 13% on the day, amid huge volumes.
BioLineRx Cancer Drug Positive as Monotherapy in Phase IIa
by Zacks Equity Research
BioLineRx (BLRX) posts encouraging partial results from the monotherapy portion of a phase IIa COMBAT study, assessing its lead pipeline candidate, BL-8040, for pancreatic cancer patients.
Merck Strong on Confirmatory Phase III Lung Cancer Study
by Zacks Equity Research
Merck's (MRK) Keytruda in combination with Eli Lilly's Alimta and carboplatin meet dual primary endpoints in a confirmatory phase III study for the first-line treatment of lung cancer.
Novo Nordisk's (NVO) Hits 52-Week High: What's Driving It?
by Zacks Equity Research
Regulatory approvals of some key pipeline candidates along with the strong performance of products like Victoza have contributed to a rally in Novo Nordisk's (NVO) shares.