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Zacks News
ImmunoGen (IMGN) Q4 Loss Wider Than Expected, Revenues Grow
by Zacks Equity Research
ImmunoGen (IMGN) reports wider-than-expected loss in Q4. However, higher license and milestone fees drive substantial revenue rise year over year.
FDA Okays J&J's Prostate Cancer Drug in First-Line Setting
by Zacks Equity Research
The FDA lends a nod to the label expansion of Johnson & Johnson's (JNJ) Zytiga in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer.
Theravance, J&J Ink Deal for Inflammatory Intestinal Drug
by Zacks Equity Research
Theravance (TBPH) signs a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize TD-1473 for inflammatory intestinal diseases.
Alexion's (ALXN) Earnings and Sales Beat Estimates in Q4
by Zacks Equity Research
Alexion (ALXN) surpass earnings and sales estimates in the fourth quarter of 2017. The company received FDA approval for label expansion of Soliris in the United States.
Keryx (KERX) Loss Wider Than Expected in Q4, Stock Down
by Zacks Equity Research
Keryx (KERX) reports wider-than-expected loss in Q4. However, sales surpassed estimates.
Pfizer Files for Xtandi in Early Stage Prostate Cancer
by Zacks Equity Research
Pfizer (PFE) announces detailed results from a late-stage study which can expand the label of Xtandi to include early-stage patients. It also files for approval in U.S. and EU.
Allergan's Anti-Infective Drug Avycaz Receives Third FDA Nod
by Zacks Equity Research
The FDA's label expansion approval for Allergan's (AGN) Avycaz marks its third therapeutic indication nod for the anti-infective drug in the United States.
Puma, CANbridge Team Up to Commercialize Nerlynx in China
by Zacks Equity Research
Puma (PBYI) enters an exclusive agreement with CANbridge under which the latter will seek regulatory approval for Nerlynx in China and develop and commercialize it in the region.
Alnylam's (ALNY) RNAi Candidate's NDA Gets Priority Review
by Zacks Equity Research
Alnylam's NDA for lead candidate patisiran is accepted by the FDA and granted priority review. The FDA also set an action date of Aug 11, 2018.
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.