BioSpace News Archive

External view of Novartis' office in Canada

Business

Novartis Returns Cancer Asset Tislelizumab to BeiGene

After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.

September 19, 2023

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2 min read

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Tristan Manalac

Infectious Disease Contract Research Organization, Microbiologics, Expands its Biosafety Level 3 Laboratory Capacity and Capability

San Diego, California – Leading infectious disease contract research organization (CRO) Microbiologics, has announced an expansion of their Biosafety Level 3 laboratory spaces at the company’s Global Virology Center in San Diego, California.

September 19, 2023

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2 min read

Drug Development

Astellas Touts Izervay Phase III Geographic Atrophy Data, Eyes Label Expansion

The latest data show Izervay is safe and effective in a two-year trial. Just six weeks after securing FDA approval, Astellas plans to submit it to the regulator to expand its label for a longer treatment timeframe.

September 19, 2023

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2 min read

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Kate Goodwin

Pictured: Blue Sanofi sign on building in Germany at night

Business

Sanofi Sells 11 CNS Assets to Pharmanovia including Frisium and Gardenal

The French pharma company continues to pare down its central nervous system business by divesting 11 brands to U.K.-based Pharmanovia, which is expanding its neurology portfolio.

September 19, 2023

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2 min read

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Tristan Manalac

Pictured: U.S. FTC building in Washington, DC/iSto

Policy

Amgen-Horizon Merger Clearance a Setback to FTC’s Antitrust Enforcement Plans

The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.

September 19, 2023

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5 min read

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Katherine Oluwadarasimi Olowookere

Pictured: Gene therapy illustration showing an inj

Policy

FDA Accepts Orchard’s BLA for Rare Disease Gene Therapy Behind EU Approval

Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.

September 19, 2023

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2 min read

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Tristan Manalac

Pictured: Man holding a cell phone in front of com

Deals

5 Life Sciences IPOs in 2023—and the Future Forecast

After a sluggish start to the year, experts expect an uptick in IPO offerings moving into fall, although it’s unlikely 2023 will fully shrug off its slump.

September 19, 2023

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5 min read

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Amanda Heidt

Business

Replimune Announces Appointment of Emily Hill as Chief Financial Officer

Replimune Group, Inc., a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, announced the appointment of Emily Hill as Chief Financial Officer.

September 19, 2023

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4 min read

Genetown

Akari Therapeutics to Host Key Opinion Leader Webinar on Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA) and the Potential of Nomacopan to Address Significant Unmet Needs

Akari Therapeutics, Plc today announced the company will host a virtual key opinion leader event on October 19, 2023 at 11:30 am ET to discuss the patient care landscape for hematopoietic stem cell transplant-related thrombotic microangiopathy.

September 19, 2023

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5 min read

BioForest

Icosavax to Participate in the Cantor Fitzgerald Global Healthcare Conference 2023

Icosavax, Inc. today announced that the company will participate in the Cantor Fitzgerald Global Healthcare Conference 2023, taking place from September 26-28, 2023.

September 19, 2023

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1 min read