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Zacks News
Novo Nordisk (NVO) Misses Q4 Earnings Estimates, Sales Beat
by Zacks Equity Research
Novo Nordisk's (NVO) top-line growth was backed by growth in new-generation insulin, Victoza, Saxenda, and haemophilia products.
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.
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.
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.
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.
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.
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.
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).
Acorda Therapeutics (ACOR) Jumps: Stock Rises 8.8%
by Zacks Equity Research
Acorda Therapeutics (ACOR) was a big mover last session, as the company saw its shares nearly 9% on the day amid huge volumes.
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.
3 Pharma and Biotech Stocks to Watch Out for in 2018
by Arpita Dutt
Here is a look at three pharma and biotech stocks including Alkermes (ALKS) that look well-positioned for 2018.
Aradigm's Bronchiectasis Candidate Has Negative FDA Vote
by Zacks Equity Research
The FDA panel votes against the approval of Aradigm's (ARDM) Linhaliq for treatment of non-cystic fibrosis bronchiectasis. A response from the regulatory agency is expected on Jan 26, 2018.
Perrigo (PRGO) Hits 52-Week High: What's Driving the Stock?
by Zacks Equity Research
We look at the factors that drive the share price of Perrigo to a 52-week high.
Vertex's Cystic Fibrosis Drug Ok'd for Pediatric Use in EU
by Zacks Equity Research
Vertex (VRTX) receives extension of the marketing application for Orkambi to include use in children with CF who have two copies of the F508del mutation from European Commission.
Why is Novo Nordisk Stock Up More Than 50% in Past Year?
by Zacks Equity Research
We take a look at the factors that led to the rise in Novo Nordisk's (NVO) share price in the past year.
Adamas (ADMS) Launches Dyskinesia Drug in the US, Stock Up
by Zacks Equity Research
Adamas (ADMS) shares climb on the commercial launch of Gocovri in the United States for treating dyskinesia in patients with Parkinson's disease. This is the first FDA approved drug for the ailment.
Acorda's Shares Down on Disappointing Ampyra View for 2018
by Zacks Equity Research
Acorda (ACOR) announces preliminary sales numbers of its key multiple sclerosis drug, Ampyra, for Q4. The company's net sales expectations are higher year over year.
Novo Nordisk Confirms Bid for Ablynx But Faces Rejection
by Zacks Equity Research
Novo Nordisk (NVO) confirmed its revised offer made on Dec 22, to acquire Ablynx NV for $3.1 billion.
Alnylam, Sanofi Announce Restructuring Deal for RNAi Products
by Zacks Equity Research
Alnylam (ALNY) and Sanofi entered into a strategic restructuring of their RNAi therapeutics rare genetic diseases alliance.
The Zacks Analyst Blog Highlights: XOMA, Exelixis, Emergent BioSolutions and Medicines
by Zacks Equity Research
The Zacks Analyst Blog Highlights: XOMA, Exelixis, Emergent BioSolutions and Medicines
4 Biotech Stocks to Watch in the New Year
by Zacks Equity Research
We take a look at four companies with a favorable Zacks Rank that performed well in 2017 and are likely to continue on the growth path in 2018 as well.
Emergent Starts Phase II Study on Anti-influenza Candidate
by Zacks Equity Research
Emergent (EBS) initiates a phase II dose-ranging trial to evaluate the safety, pharmacokinetics and clinical benefit of its investigational FLU-IGIV to treat influenza virus infection.