BioSpace News Archive

Concept of feminism and empowerment. Feminist protest movement. Racial equality concept. Possible use for social media communication concept, blog, business between women. Chat, dialogue or communication in the workplace or between female colleagues. Interact in the virtual community. Teamwork concept. Active participation. Comparison between women or girls. Friendship. Encounter. Globalization. Multicultural and multiracial women's community. Sharing of dialogue and exchange between women of different languages and cultures

Women’s Health

IVF Restrictions, Demise of Roe v. Wade Could Endanger Women’s Health Research

Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.

September 30, 2024

·

5 min read

·

Aayushi Pratap

Psychedelics

MDMA Drug Developers Reprioritize Following Lykos Rejection in PTSD

After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the psychiatric disease.

September 30, 2024

·

5 min read

·

Kate Goodwin

M&A

Roche Doubles Down on Breast Cancer With $850M for Regor’s CDK Inhibitors

The acquisition was featured Monday in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs.

September 30, 2024

·

2 min read

·

Heather McKenzie

Johnson & Johnson's business center in Switzerland

Drug Development

J&J Posts Positive Phase III Results for Carvykti and Darzalex Faspro in Multiple Myeloma Trials

Johnson & Johnson linked Carvykti to a 45% reduction in risk of death and Darzalex to a 61% improvement in minimal residual disease-negativity, boosting the prospects of two key growth drivers for the company.

September 30, 2024

·

2 min read

·

Nick Paul Taylor

Pictured: MRI images of the brain for neurological

Drug Development

Novartis’ Lutathera Radiopharma Therapy Improves Survival in Difficult-to-Treat Brain Tumors

Six months after treatment with the radiopharmaceutical therapy, 77.8% of patients with meningioma were alive and had not experienced further disease progression, beating the 26% benchmark established in earlier studies.

September 30, 2024

·

2 min read

·

Nick Paul Taylor

Gene Editing

Gene Editor Prime Medicine Signs BMS Cell Therapy Deal, Reprioritizes Pipeline

In an effort to expand its cash runway beyond 12 months, Prime Medicine has signed a deal with Bristol Myers Squibb worth a potential $3.5 billion, while also streamlining its pipeline to trim costs.

September 30, 2024

·

2 min read

·

Annalee Armstrong

A scientist with pill bottles in front of FDA headquarters

Regulatory

FDA Action Alert: Biofrontera, BMS and Zealand

One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.

September 30, 2024

·

4 min read

·

Tristan Manalac

FDA

Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi™* (ustekinumab-aauz)

September 30, 2024

·

5 min read

Drug Development

Gritstone bio Announces Interim Phase 2 Data for GRANITE Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer