Research & Development
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GSK Ends Tough Week With Ulcerative Colitis Therapy Termination
If bad luck comes in threes, GSK will be delighted to see the end of this week with dostarlimab approval delayed, bintrafusp failing in lung cancer and a Phase II of an ulcerative colitis drug discontinued.
Clinical Trials
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Latest From Clinical Trials
Regeneron Antibodies Prevent Symptomatic COVID-19 In Interim Phase III Data
The company said data show a lower overall infection rate and no symptomatic infections among participants receiving the drug, compared with placebo.
Lilly’s Neutralizing Antibodies Reduce Risk Of Serious COVID-19 Outcomes By 70%
The bamlanivimab/etesevimab combo, filed for US emergency authorization in November, shows ability to reduce risk of hospitalization or death in COVID-19 patients. Lilly also sees prevention role for bamlanivimab.
Roche Prepares Faricimab For Filing After Phase III AMD Data
Top-line Phase III data for faricimab in age-related macular degeneration leave Roche poised to file the bi-specific antibody for retinal diseases, but again there is no advantage with the novel dual-acting product over Eylea.
Scrip Asks…What Does 2021 Hold For Biopharma? Part 2: COVID-19 Shock Waves And Silver Linings
Executives expect the changes wrought by necessity in the face of a global pandemic to have lasting effects, both positive and negative, on the biopharma sector. Here they share their predictions for the coming year.
First-Line Bavencio Bladder Cancer OK Boosts Merck KGaA
Pfizer-partnered Bavencio has struggled to compete with other checkpoint inhibitors like Keytruda, Opdivo, Imfinzi and Tecentriq, but could carve out a lucrative niche in first-line urothelial carcinoma.
Valneva Starts COVID-19 Vaccine Production In Scotland
Valneva is scaling up manufacture of its coronavirus vaccine alongside the clinical development program, with a view to meeting its commitment to provide millions of doses for use in the UK and the EU.
Approvals
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Latest From Approvals
First-Line Bavencio Bladder Cancer OK Boosts Merck KGaA
Pfizer-partnered Bavencio has struggled to compete with other checkpoint inhibitors like Keytruda, Opdivo, Imfinzi and Tecentriq, but could carve out a lucrative niche in first-line urothelial carcinoma.
ViiV Anticipates 10%-15% Switchover To Long-Term HIV Option Cabenuva
The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.
Pipeline Watch: Phase III Starts In Hypertension, Atopic Dermatitis
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements
Merck & Co. Pushes Back On Modest Projections For Verquvo
Merck & Co.'s vericiguat, an sGC stimulator, was approved for heart failure but it enters a competitive space with a narrow indication.
Pipeline Watch: Phase III Starts In PAH, NSCLC And Seizure Disorders
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
FDA Approval Opens Up Gastric Cancer To Daiichi Sankyo/AZ’s Enhertu
The two companies can now market their HER-2 targeting antibody-drug conjugate in its second tumor type as they look to expand beyond breast cancer.
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