BioSpace News Archive

Drug Development

Relay Therapeutics Pauses Lirafugratinib Rare Cancer Plans Due to IRA

The biotech will pause its lirafugratinib program for a rare bile duct cancer to target a larger FGFR2-altered solid tumors population, citing the Inflation Reduction Act as a driving decision factor.

October 13, 2023
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2 min read
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Kate Goodwin
Deals

Early October Sees Torrid Pace of Biotech M&A—Will It Continue?

The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal.

October 13, 2023
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2 min read
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Greg Slabodkin
DaVita Casts Doubt on Novo’s Chronic Kidney Disease Results for Ozempic

Dialysis giant DaVita on Thursday raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.

October 13, 2023
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2 min read
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Tristan Manalac
Drug Development

Experts Implore FDA to Accept Biomarker Evidence in Ultra-Rare Diseases

Last year, the FDA declined to approve a drug that appears to reverse a rare and debilitating enzyme deficiency. Some experts say it’s emblematic of a need for more flexibility around therapeutics targeting rare diseases.

October 13, 2023
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6 min read
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Heather McKenzie
Business

BioNTech Inks Potential $1B Deal with MediLink for Cancer-Focused ADCs

The German biotechnology company has teamed with Suzhou-based biotech MediLink Therapeutics to develop next-generation antibody-drug conjugates for cancer.

October 13, 2023
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2 min read
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Tristan Manalac
Drug Development

Cassava Defends Alzheimer’s Asset in Response to Data Manipulation Allegations

The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor.

October 13, 2023
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2 min read
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Tristan Manalac
Drug Development

FDA Approves Pfizer’s Ulcerative Colitis Drug, $6.7B Arena Buy Pays Off

The regulator’s approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.

October 13, 2023
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2 min read
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Connor Lynch
Drug Development

Foresee Pharmaceuticals Announces First Patient Dosed in the Casppian, Phase 3 Clinical Trial of Leuprolide (FP-001) injectable emulsion, 42 mg for the treatment of Central Precocious Puberty patients.

Foresee Pharmaceuticals, announces that the first patient has been dosed in the Casppian Phase 3 registration study.

October 13, 2023
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4 min read
Vitrolife AB (publ): Conference call interim report - October 13, 2023

Invitation to attend Vitrolife AB conference call regarding presentation of the interim report Q3, 2023. The presentation will be held in English.

October 13, 2023
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1 min read
Business

Cerevel Therapeutics to Report Third Quarter 2023 Financial Results and Business Updates on Wednesday, November 1, 2023

Cerevel Therapeutics announced it will report third quarter 2023 financial results and business updates on Wednesday, November 1, 2023, before the U.S. financial markets open.

October 13, 2023
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4 min read