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Zacks News
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.
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.
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.
AbbVie (ABBV) Q4 Earnings Beat, 2018 View Raised, Shares Up
by Zacks Equity Research
AbbVie's (ABBV) Q4 earnings top estimates with revenues marginally beating the same. Sales of the company's lead marketed drug, Humira, also rise year over year.
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.
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.
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.
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.
Endo (ENDP) Loses 35% in a Year: Can It Turn Around in 2018?
by Zacks Equity Research
Endo International (ENDP) lost 35% in the past year mired by controversy related to Opana ER and weaknesses in both the businesses.
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.
Endo (ENDP) Gets Subpoena From Florida for Opioid Misuse
by Zacks Equity Research
Endo (ENDP) announced that it received a subpoena from the Florida authorities in connection with products related to opioid misuse.
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.
Mallinckrodt (MNK) to Sell Recothrom and Preveleak to Baxter
by Zacks Equity Research
Mallinckrodt's (MNK) strategy to streamline its business to evolve as a top-performing specialty pharmaceutical company has led the company to enter into an agreement to sell Recothrom and Preveleak to Baxter.
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.
Celsion's Phase I/II Cancer Study Initiation Gets FDA Nod
by Zacks Equity Research
Celsion's (CLSN) plan for phase I/II study to evaluate DNA-based immunotherapy, GEN-1, in ovarian cancer gets FDA approval and clearance for initiation.
Are Options Traders Betting on a Big Move in Sucampo (SCMP) Stock?
by Zacks Equity Research
Investors in Sucampo (SCMP) need to pay close attention to the stock based on moves in the options market lately.
United Therapeutics (UTHR) Collaborates With Corsair Pharma
by Zacks Equity Research
United Therapeutics (UTHR) entered into an exclusive license agreement with Corsair Pharma.