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Zacks News
North Chicago, IL-based AbbVie has become one of the top-most pharma companies after it acquired Botox maker Allergan in a cash-and-stock deal for $63 billion in May 2020. The deal is expected to transform AbbVie’s portfolio and lower its dependence on Humira, its flagship product, which has already lost patent protection in Europe and is due to face biosimilar competition in the United States in 2023. AbbVie has one of the most popular cancer drugs in its portfolio, Imbruvica and its newest drugs Skyrizi (risankizumab) and Rinvoq (upadacitinib) position it well for long-term growth.
Repros' Proellex Continues to be Under Partial Clinical Hold
by Zacks Equity Research
Repros Therapeutics (RPRX) announced that the FDA will continue to maintain partial clinical hold on its pipeline candidate Proellex for uterine fibroids indication as the agency internally reviews data related to the effect of the same on the liver
Gilead (GILD) HCV Drugs Gets FDA Nod for Label Expansion
by Zacks Equity Research
Gilead Sciences, Inc. (GILD) announced that the FDA approved additional indications for Harvoni tablets and Sovaldi tablets.
AbbVie's Elagolix Meets Primary Endpoint in Phase II Study
by Zacks Equity Research
AbbVie Inc. (ABBV) along with Neurocrine Biosciences, Inc. (NBIX) announced positive results from a phase IIb study evaluating its pipeline candidate elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids.
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.
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
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.
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 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
Infinity (INFI) Reports Narrower-than-Expected Loss in Q4
by Zacks Equity Research
Infinity Pharmaceuticals, Inc. (INFI) reported a loss of 46 cents per share in fourth-quarter 2016, much narrower than the Zacks Consensus Estimate loss of 63 cents.
Novartis (NVS) Reports Positive Data on Biosimilar Humira
by Zacks Equity Research
Novartis AG (NVS) announced encouraging data for its proposed biosimilar verison of AbbVie's (ABBV) Humira.
Inovio (INO): What's in the Cards this Earnings Season?
by Zacks Equity Research
Inovio Pharmaceuticals, Inc. (INO) is expected to report fourth-quarter 2016 results this month. The company incurred wider-than-expected loss in the last quarter.
BioDelivery (BDSI): What's in Store this Earnings Season?
by Zacks Equity Research
BioDelivery Sciences International, Inc. (BDSI) is expected to report fourth-quarter 2016 results on Mar 17, before the opening bell. Last quarter, the company???s loss was wider than expected.
J&J Presents Positive Phase III Data on Psoriasis Candidate
by Zacks Equity Research
Johnson & Johnson (JNJ) announced positive data from two phase III studies evaluating its pipeline candidate, guselkumab for the treatment of moderate-to-severe plaque psoriasis.
Pricing to Remain Pharma Headline Risk in 2017
by Arpita Dutt
Drug pricing is an issue that has been weighing on pharma and biotech stocks for more than a year now.
Pfizer's Xeljanz Combo Comparable to AbbVie's Humira
by Zacks Equity Research
Pfizer, Inc. (PFE) announced top-line results from a head-to-head study comparing its rheumatoid arthritis (RA) drug Xeljanz with AbbVie, Inc.'s (ABBV) Humira.
Gilead (GILD) Announces Data on Combination Therapy for HIV
by Zacks Equity Research
Gilead Sciences, Inc. (GILD) recently announced positive data from a phase II study on HIV cocktail therapy.
Gilead (GILD) Beats Q4 Earnings & Sales, View Disappoints
by Zacks Equity Research
Gilead Sciences' (GILD) fourth quarter results beat on both earnings and sales but the guidance for 2017 was quite disappointing.
The Zacks Analyst Blog Highlights: Apple, Visa and AbbVie
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Apple, Visa and AbbVie
Roche (RHHBY) Beats on Earnings in 2016, Misses on Sales
by Zacks Equity Research
Roche beat on earnings but missed on sales in 2016 due to decline in sales of Lucentis, Pegasys, Avastin and Tarceva.
AbbVie (ABBV) HCV Regimen Gets Priority Review in Canada
by Zacks Equity Research
AbbVie Inc. (ABBV) announced that its New Drug Submission (NDS) for an investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) received priority review in Canada for treatment of HCV.
Key Takeaways from AbbVie's Q4 Call: Humira and the Pipeline
by Arpita Dutt
2017 will be a year of significant R&D investment for AbbVie (ABBV) as well as several late-stage readouts which will give an insight into the company's long term growth prospects.
Pfizer (PFE) Gets Positive CHMP Opinion for Arthritis Drug
by Zacks Equity Research
Pfizer Inc. (PFE) announced that Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for the company's marketing authorisation application (MAA) for its rheumatoid arthritis (RA) drug, Xeljanz.
Amgen Wins Favorable CHMP Opinion for Humira Biosimilar
by Zacks Equity Research
Amgen (AMGN) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the company's marketing authorization application (MAA) for ABP 501.
AbbVie (ABBV) Q4 Earnings Meet Estimates, Revenues Lag
by Zacks Equity Research
AbbVie (ABBV) reported earnings of $1.20 in the fourth-quarter of 2016, with revenues coming in at $6.80 billion.
AbbVie (ABBV) Reports In-Line Q4 Earnings, Revenues Miss
by Zacks Equity Research
AbbVie (ABBV) reported earnings of $1.20 in the fourth-quarter of 2016, with revenues coming in at $6.80 billion.