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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 Gastrointestinal Strategy

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.

Research & Development BioPharmaceutical

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.

Coronavirus COVID-19 Clinical Trials

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.

Clinical Trials Companies

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.

Coronavirus COVID-19 Research and Development Strategies

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.

Approvals ImmunoOncology

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.

United Kingdom Sweden
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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.

Approvals ImmunoOncology

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.

Approvals Business Strategies

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

Pipeline Watch Approvals

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.

Approvals Business Strategies

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.

Pipeline Watch Approvals

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.

Approvals United States
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