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Zacks News
Pharma Stock Roundup: Merck Gets CRL for Label Expansion Effort, Roche Cancer Drug Tops
by Arpita Dutt
Key highlights this week include a complete response letter (CRL) for Merck (MRK) and some positive data from Roche.
Geron Stock Rises after Positive Interim Update on Imetelstat
by Zacks Equity Research
Shares of Geron Corporation (GERN) increased almost 20% on Monday after it provided a positive update on two late-stage studies for imetelstat, its lead pipeline candidate.
Louisiana-Pacific, Bed Bath & Beyond, Roche Holdings AG, Adidas AG and Deere highlighted as Zacks Bull and Bear of the Day
by Zacks Equity Research
Louisiana-Pacific, Bed Bath & Beyond, Roche Holdings AG, Adidas AG and Deere highlighted as Zacks Bull and Bear of the Day
Forget Novartis, Buy These Two Pharma Stocks Instead
by Arpita Dutt
With Novartis (NVS) being a Zacks Rank #4 (Sell) stock, here is a look at two European pharma stocks that sport a strong Zacks Rank.
Roche's Lung Cancer Drug Alecensa Meets Primary Endpoint
by Zacks Equity Research
Roche (RHHBY) announced that the global, randomized phase III study, ALEX, on lung cancer drug Alecensa met its primary endpoint as an initial (first-line) treatment.
Huh? Brazil Matters? Global Week Ahead
by John Blank
Peaking at +10.7% y/y in January 2016, Brazilian inflation now runs under +5% y/y. Risk markets in Brazil have also sharply pared down forward inflation expectations.
Allergan (AGN) Presents Mixed Depression Data on Botox
by Zacks Equity Research
Allergan plc (AGN) announced mixed top-line data from a mid-stage study evaluating its key drug Botox for the treatment of major depressive disorder (MDD).
Roche Announces Positive Data on Lung Cancer Drug Alecensa
by Zacks Equity Research
Roche Holdings AG (RHHBY) recently announced encouraging results from the phase III study, ALUR on lung cancer drug Alecensa.
AbbVie/J&J's Imbruvica Label Expansion Filing Accepted by FDA
by Zacks Equity Research
AbbVie Inc. (ABBV) and partner Janssen, Johnson & Johnson's (JNJ) pharmaceuticals subsidiary, announced that a supplemental new drug application (sNDA) for their cancer drug Imbruvica has been accepted for review by the FDA.
Bristol-Myers Announces Data on Immuno-oncology Drug Opdivo
by Zacks Equity Research
Bristol-Myers Squibb Company (BMY) recently announced encouraging data from various trials on Opdivo.
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.