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Zacks News
Mylan's EpiPen Recall Expanded to U.S.
by Madeleine Johnson
On Monday, Mylan NV???s (MYL) manufacturing partner Meridian Medical Technologies announced that it will expand its voluntary recall of the EpiPen to the United States after discussing with the Food and Drug Administration (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.
Dow 30 Stock Roundup: Apple Buys Workflow, J&J Wins European Label Expansion
by Swarup Gupta
The Dow experienced a mixed week, with most of its gains coming from encouraging economic releases.
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
Pfizer's Arthritis Drug Xeljanz Gets Marketing Nod in Europe
by Zacks Equity Research
Pfizer, Inc.'s (PFE) rheumatoid arthritis (RA) drug, Xeljanz has received marketing approval in Europe.
The 'Fearless Girl' Statue Isn't a Symbol, It Is an Advertisement
by Eric Dutram
The Fearless Girl statue has taken New York City by storm. However, this statue, which is facing down the Charging Bull, is actually an ad.
Merck's Ketruda Gets Positive CHMP Opinion for Lymphoma
by Zacks Equity Research
Merck & Co., Inc. (MRK) recently announced that its anti-PD-1 therapy, Keytruda, has received positive opinion from CHMP for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (cHL).
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).
Pfizer's Immunotherapy for Skin Cancer Gets FDA Approval
by Zacks Equity Research
Pfizer, Inc. (PFE) and German partner Merck KGaA's investigational cancer treatment, avelumab, was approved by the FDA for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive form of skin cancer.
Pharma Stock Roundup: Is Sanofi Buying Flexion? Pfizer, Merck KGaA Drug Approved
by Arpita Dutt
This week's highlights include rumors regarding Sanofi (SNY) acquiring Flexion, accelerated FDA approval for a Pfizer/Merck KGaA drug and drug pricing.
Catalyst Pharma (CPRX) Focused on U.S. Approval for Firdapse
by Zacks Equity Research
We issued an updated research report on Catalyst Pharmaceuticals, Inc. (CPRX) on Mar 22.
Nektar's Pain Drug Positive in Phase III Study; Shares Gain
by Zacks Equity Research
Nektar Therapeutics??? (NKTR) shares surged 42.6% after the company announced positive results from a phase III efficacy study evaluating its investigational candidate, NKTR-181, in patients with moderate to severe chronic low back pain.
Is Pfizer (PFE) a Great Stock for Value Investors?
by Zacks Equity Research
Let's see if Pfizer Inc. (PFE) stock is a good choice for value-oriented investors right now from multiple angles.
Lilly's Breast Cancer Combo Drug Phase III Results Positive
by Zacks Equity Research
Eli Lilly and Company (LLY) recently announced that a phase III combination study evaluating its pipeline candidate abemaciclib in advanced breast cancer, met the primary endpoint of progression-free survival (PFS).
Trump, Biogen and Amgen Hammer Healthcare ETFs
by Sweta Killa
After making a strong comeback in February, the U.S. healthcare sector again witnessed some pain in the last couple of sessions.
Dow 30 Stock Roundup: Boeing Inks $3.3B U.S. Army Deal, Intel Buys Mobileye
by Swarup Gupta
The Dow endured a difficult week dominated by the Fed's two day policy meeting.
Pfizer's Arthritis Drug Xeljanz Gets Marketing Nod in China
by Zacks Equity Research
Pfizer, Inc.'s (PFE) rheumatoid arthritis (RA) drug, Xeljanz (5 mg taken twice daily) has received marketing approval in China to be used in combination with methotrexate
Glaxo Files for Label Expansion of Influenza Vaccine in US
by Kinjel Shah
GlaxoSmithKline plc (GSK) announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval to expand the label of Fluarix Quadrivalent ??? an influenza vaccine - for infants six months or older.
Merck's (MRK) Keytruda Gets FDA Nod for Lymphoma Indication
by Zacks Equity Research
Merck & Co., Inc (MRK) announced that it has received FDA approval for Keytruda for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who had relapsed after three or more prior lines of therapy.
Aerie Resubmits Rhopressa NDA, Roclatan Gains Traction
by Zacks Equity Research
Aerie Pharmaceuticals is a development-stage company focused on the development and commercialization of eye disease therapies, including glaucoma and other eye-diseases.
The Zacks Analyst Blog Highlights: Caterpillar, Apple and Pfizer
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Caterpillar, Apple and Pfizer
Aerie (AERI) Q4 Loss Widens, Rhopressa NDA Resubmitted
by Zacks Equity Research
Aerie Pharmaceuticals, Inc. (AERI) posted fourth-quarter 2016 loss of 87 cents per share (including stock-based compensation), wider than both the Zacks Consensus Estimate of a loss of 65 cents
Caterpillar Stock Slides After Report Accuses It of Tax Fraud
by Madeleine Johnson
On Wednesday, shares of manufacturing giant Caterpillar Inc. (CAT) are sliding, down about 1.5% in late-morning trading after a new report, commissioned by the government, accused the company of tax and accounting fraud, according to The New York Times.
Merck/Pfizer's Diabetes Drug Accepted for Review by FDA, EMA
by Zacks Equity Research
Merck & Co., Inc. (MRK) and partner Pfizer, Inc. (PFE) announced that the FDA has accepted its new drug applications (NDA) for ertugliflozin as a monotherapy as well as two fixed-dose combination tablets.
Trump Tweet on Drug Pricing Hits Biotech and Pharma ETFs
by Sweta Killa
President Donald Trump March 7 tweet on increasing competition and lowering drug prices sent fresh shockwaves across the industry.