BioSpace News Archive

Policy

Novo Nordisk, Lilly Sued Over Stomach Paralysis Allegations Regarding GLP-1 Drugs

A Louisiana woman has filed a lawsuit alleging that Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro did not have warnings about the risk of severe gastrointestinal problems.

August 4, 2023
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2 min read
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Connor Lynch
Drug Development

Amgen Clinches Clinical Wins in SCLC and Colorectal Cancer

The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.

August 4, 2023
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2 min read
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Tristan Manalac
Policy

AstraZeneca, Sanofi Win CDC Support for Preventive RSV Antibody for Infants

Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.

August 4, 2023
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2 min read
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Tristan Manalac
Policy

FDA Blocks Mesoblast Cell Therapy Again, Asks for More Data

For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.

August 4, 2023
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2 min read
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Tristan Manalac
Drug Development

Opportunity and New Therapies Are Driving Interest in a Rare Cardiovascular Disease

The market opportunity for pulmonary arterial hypertension drugs stretches well beyond the 500–1,000 Americans diagnosed with the disease each year—and biopharma is taking note.

August 4, 2023
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5 min read
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David Adam
Business

Gilead’s Strong Q2 Sales Offset by Legal Settlement, COVID Cliff

Thursday, Gilead Sciences reported lower second-quarter profit due to a drop in sales of the company’s Veklury antiviral and a $525 million legal settlement, while slightly raising its sales outlook for the year.

August 4, 2023
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2 min read
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Kate Goodwin
FDA

FDA Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression

Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.

August 4, 2023
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3 min read
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Heather McKenzie
Business

Week in Review: Breakthrough Depression Drug, RSV and GLP-1 Lawsuits, and Earnings Season Shows COVID Cliff

A transformational moment in the treatment of depression, GSK takes first shot in a vaccine patent war with Pfizer, a Louisiana woman sues Novo Nordisk and Lilly, and companies face a steep COVID-19 cliff.

August 4, 2023
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3 min read
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Greg Slabodkin
Policy

Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole

Basilea Pharmaceutica Ltd, Allschwil, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that it has submitted a New Drug Application to the US Food and Drug Administration.

August 4, 2023
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6 min read
Evox Therapeutics enters into agreement to advance next generation exosome-delivered AAV gene therapy for the treatment of heart disease

Evox Therapeutics Ltd, a leading exosome therapeutics company, announced a research collaboration and option agreement with the Icahn School of Medicine at Mount Sinai in New York, NY.

August 4, 2023
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3 min read