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Zacks News
Sanofi's (SNY) Diabetes Drug Toujeo Lowers Hypoglycemia Risk
by Zacks Equity Research
A real-world observational study showed that when type 2 diabetes patients on basal insulin switched to Toujeo, it led to a significant reduction in risk of hypoglycemia without compromising blood sugar control
Bristol-Myers (BMY), Incyte to Advance Clinical Program
by Zacks Equity Research
Bristol-Myers Squibb Company (BMY) and Incyte Corporation (INCY) recently announced that the companies will advance their clinical development program.
AstraZeneca's (AZN) Lung Cancer Drug Gets Full FDA Approval
by Zacks Equity Research
AstraZeneca plc (AZN) announced that its lung cancer drug, Tagrisso has received full approval from the FDA.
Pfizer Gets Regular Approval for Breast Cancer Drug Ibrance
by Zacks Equity Research
Pfizer, Inc. (PFE) announced that its supplemental new drug application (sNDA) to convert accelerated approval for Ibrance to regular approval has been approved by the FDA.
4 FDA Decisions to Watch Out for in Apr 2017
by Arpita Dutt
Companies like BioMarin (BMRN), Roche and Takeda among others have regulatory decisions scheduled for this month.
Mylan Receives CRL for Generic Advair Diskus From the FDA
by Zacks Equity Research
Mylan N.V. (MYL) recently suffered a huge setback when it received a complete response letter from the FDA regarding its ANDA for the generic version of asthma drug Advair Diskus.
AbbVie's (ABBV) Humira Drug Label Update Approved by FDA
by Zacks Equity Research
AbbVie Inc.'s (ABBV) announced that the FDA has approved the inclusion of moderate to severe fingernail psoriasis data on the label of AbbVie???s multi-utility TNF blocker drug, Humira
Pharma Stock Roundup: FDA Nod for SNY, Roche Drugs, Generic Advair Relief for GSK?
by Arpita Dutt
Two drugs with blockbuster potential - Sanofi (SNY)/Regeneron's Dupixent and Roche's Ocrevus - gained FDA approval this week.
Roche's Rituxan Gets FDA Advisory Committee's Recommendation
by Zacks Equity Research
Roche Holding AG's (RHHBY) member, Genentech announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of subcutaneous Rituxan /hyaluronidase for the treatment of patients with certain blood cancers.
Roche's Ocrevus Wins FDA Approval for 2 Forms of Sclerosis
by Zacks Equity Research
Roche Holdings AG (RHHBY) announced that the FDA has approved Ocrevus (ocrelizumab) as the first and only drug for both relapsing and primary progressive forms of multiple sclerosis.
AstraZeneca's (AZN) Lynparza NDA Accepted for Review by FDA
by Zacks Equity Research
AstraZeneca plc (AZN) announced that the FDA has accepted the new drug application (NDA) for Lynparza (300mg twice daily) for the maintenance treatment of patients suffering from platinum sensitive relapsed ovarian cancer with the germline BRCA mutation
AstraZeneca's Lung Cancer Drug Tagrisso Approved in China
by Zacks Equity Research
AstraZeneca plc (AZN) announced that its lung cancer drug, Tagrisso has received approval in China.
Roche's Rituxan Gets 'Breakthrough Therapy' Designation by FDA
by Zacks Equity Research
Roche Holding AG's (RHHBY) member, Genentech announced that the FDA has granted Breakthrough Therapy Designation status to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
Amgen's (AMGN) Humira Biosimilar Receives Approval in EU
by Zacks Equity Research
Amgen, Inc. (AMGN) announced that its biosimilar version of AbbVie Inc.'s (ABBV) rheumatoid arthritis (RA) drug Humira has been approved by the European Commission (EC).
Should Value Investors Pick Roche Holding (RHHBY)?
by Zacks Equity Research
Roche Holding (RHHBY) is an inspired choice for value investors, as it is hard to beat its incredible lineup of statistics on this front.
Inovio (INO) Q4 Loss Wider than Expected; Shares Decline
by Zacks Equity Research
Inovio Pharmaceuticals, Inc. (INO) reported a loss of 36 cents for the fourth quarter of 2016.
Celldex (CLDX) Shares Up as Q4 Loss Narrows; Sales Beat
by Zacks Equity Research
Celldex Therapeutics, Inc. (CLDX) posted fourth-quarter 2016 loss of 30 cents per share, narrower than both the Zacks Consensus Estimate of a loss of 34 cents and the year-ago loss of 33 cents.
How Incyte Stock Became a Bull Market Star for Biotech Investors
by Arpita Dutt
Incyte (INCY) tops the list of stocks that enjoyed a stupendous run in the last 8 years.
Immune Design (IMDZ) Q4 Loss In Line; Sales Beat Estimates
by Zacks Equity Research
Immune Design Corp.(IMDZ) reported fourth-quarter 2016 loss of 57 cents per share, in line with Zacks Consensus Estimate but narrower than the year-ago loss of 60 cents.
Can Epizyme (EPZM) Spring a Surprise This Earnings Season?
by Zacks Equity Research
Epizyme, Inc. (EPZM) is scheduled to report fourth-quarter 2016 results on Mar 9, before the opening bell.
The Zacks Analyst Blog Highlights: Mylan, Roche, AstraZeneca, Merck and Sanofi
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Mylan, Roche, AstraZeneca, Merck and Sanofi
5 FDA Decisions to Watch Out for in Mar 2017
by Arpita Dutt
Companies like Merck (MRK) are awaiting key FDA decisions this month.
What's in Store for Immune Design (IMDZ) in Q4 Earnings?
by Zacks Equity Research
Immune Design Corp (IMDZ) is scheduled to report fourth-quarter 2016 results after the market closes on Mar 7.
Pharma Stock Roundup: Mylan, Endo Report 4Q Results, FDA Nod for AZN Diabetes Drug
by Arpita Dutt
Quite a few companies including AstraZeneca (AZN) provided pipeline/regulatory updates this week.
Mylan (MYL) Beats on Q4 Earnings, Stock Up on Strong View
by Zacks Equity Research
Shares of Mylan N.V.'s (MYL) were up 7.2% after the company beat expectations in the fourth-quarter 2016 and provided a strong outlook for 2017 amid challenging conditions.