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With Phase II Win for Ankylosing Spondylitis, Gilead and Galapagos' Filgotinib Inches Toward Appr...
9/6/2018
Gilead Sciences and its partner Galapagos NV announced results from its Phase II TORTUGA clinical trial of filgotinib, a selective JAK1 inhibitor, in adults with moderately to severely active ankylosing spondylitis (AS). -
Although there is a general complaint about drug prices, which rocketed into the public domain during the 2016 U.S. presidential election, nothing particularly dramatic has been done about it.
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FDA Approves EYLEA® (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration
8/17/2018
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
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Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
8/16/2018
Data include final primary efficacy results and an interim safety analysis
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Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
8/16/2018
Data include final primary efficacy results and an interim safety analysis
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Branded Direct-to-Consumer Advertising Likely to Provide a Bump in Patient Requests for Sanofi/Regeneron's Dupixent, but Insurance Coverage and Out-of-Pocket Costs Continue to be Key Barriers for the Only Approved Atopic Dermatitis Biologic
8/15/2018
According to the latest update from Spherix Global Insights, while dermatologists continue to report high satisfaction with the first FDA approved biologic, there is still a large unmet need for new pharmacologic treatments for atopic dermatitis.
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Shares of Realm Therapeutics have plunged more than 50 percent this morning after the company announced its Phase II atopic dermatitis drug failed to distinguish itself from the control arm in the trial.
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Regeneron Provides Regulatory Update on EYLEA® (aflibercept) Injection sBLA in Wet Age-Related Macular Degeneration
8/13/2018
Regeneron Pharmaceuticals, Inc. announced that due to ongoing labeling discussions the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept)
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The last two weeks have marked the second-quarterly financial report by numerous biopharma companies. Here’s a quick look at some of the major ones.
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Regeneron Pharmaceuticals reported its second-quarter financial results, citing quarterly total revenues of $1.608 billion, up 9 percent from the same quarter in 2017 of $1.470 billion.
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Regeneron Reports Second Quarter 2018 Financial and Operating Results
8/2/2018
Second quarter 2018 GAAP net income per diluted share increased by 44% to $4.82 versus second quarter 2017 and second quarter 2018 non-GAAP net income per diluted share increased 31% to $5.45 versus second quarter 2017
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For its second-quarter financial report, Paris-based Sanofi reported a decrease in net sales for the quarter of 5.7 percent, down to 8.176 billion euros. Sanofi’s diabetes and cardiovascular franchises have struggled in the U.S.
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Q2 2018 Performance Positions Sanofi for New Growth Phase
7/31/2018
Q2 2018 Performance Positions Sanofi for New Growth Phase
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It’s pretty easy to complain about the price of drugs. Drug companies typically spend billions of dollars to develop a drug, and often spend billions of dollars to develop drugs that never get approved. But a surprising critic of the U.S. system of pricing drugs is Leonard Schleifer.
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The Galien Foundation Debuts 2018 Prix Galien USA Nominees in "Best Biotechnology Product," "Best Pharmaceutical Product," and"Best Medical Technology" Categories
7/26/2018
Winners will be Announced by Committee of Distinguished Scientific Leaders on October 25, 2018 at the Prix Galien USA Awards Ceremony
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Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences has returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.
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President Donald Trump was able to claim a victory in the drug pricing wars after Pfizer announced it would walk back the price increase of 40 prescription medications announced earlier this month.
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The president’s predictions for lower drug prices fell on deaf ears at pharma giant Pfizer as it was reported that the company increased the price of 40 of its most popularly-prescribed medications by nearly 10 percent.
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New England Journal of Medicine Publishes Two Positive Phase 3 Trials Showing DUPIXENT® (dupilumab) Improved Moderate-to-Severe Asthma
5/21/2018
Results showed DUPIXENT demonstrated a significant improvement in multiple asthma endpoints in two Phase 3 clinical trials.
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Regeneron Pharmaceuticals and its developmental partner Sanofi are eying the third quarter of this year to seek regulatory approval for Dupixent (dupilumab) as a potential monotherapy treatment for moderate-to-severe atopic dermatitis in adolescents.