BioSpace News Archive

Policy

FDA Requires Boxed Warning for Secondary Cancers on CAR-T Therapies

Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.

April 19, 2024
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2 min read
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Tristan Manalac
FDA

Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC

Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.

April 19, 2024
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2 min read
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Tristan Manalac
Business

Alvotech, Teva Enlist New Partner to Expand Access to Humira Biosimilar in US

Ahead of launching its Humira biosimilar Simlandi, Alvotech and Teva on Friday announced they have signed a long-term agreement with an undisclosed strategic partner to help boost patient access to the drug.

April 19, 2024
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2 min read
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Tristan Manalac
Business

J&J, Other Q1 Financials Beg the Question: What Does It Mean to Miss Expectations?

If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.

April 19, 2024
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2 min read
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Greg Slabodkin
Business

Sanofi Cuts Jobs in US Vaccines Division as Part of Restructuring

French healthcare and pharma company Sanofi will terminate an undisclosed number of positions in its U.S. vaccines commercial unit in an effort to streamline the strategic sales structure.

April 19, 2024
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2 min read
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Tristan Manalac
Lone Star Bio

Legacy Medical Consultants Announces Reeva FT™, a Full-Thickness Allograft for Wound Covering and Protection During Treatment

Legacy Medical Consultants (LMC) announces its newest product portfolio addition with the recent Q code approval for Reeva FT™, a terminally sterilized, full-thickness, dual-layered amnion/chorion allograft designed for covering and protection during advanced wound treatment.

April 19, 2024
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1 min read
Biotech Beach

Ensysce Biosciences’ Presentation from the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference Published

Ensysce Biosciences, Inc. today announced the Company’s webcast presentation and discussion during the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 17, 2024 is available on Ensysce’s Investor Relations website at ir.ensysce.com and can also be viewed here.

April 19, 2024
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4 min read
Business

Prescient Healthcare Group Appoints Two New Members to its Board of Directors

Prescient Healthcare Group , a leading biopharma product and portfolio strategy firm, has announced the appointment of two new members to its Board of Directors – Dr. Luke Solon and Debbie Allman – to help shape and drive Prescient’s global mission.

April 19, 2024
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3 min read
Deals

TScan Therapeutics Announces Closing of Upsized Public Offering

TScan Therapeutics, Inc. today announced the closing of an underwritten public offering of 2,472,581 shares of its voting common stock at a public offering price of $7.1300 per share.

April 19, 2024
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4 min read
Aurigene Pharmaceutical Services Ltd., and Vipergen announce a strategic partnership for offering DNA encoded library (DEL) screening and integrated drug discovery services.

Aurigene Pharmaceutical Services Ltd. (Aurigene), a global contract research, development, and manufacturing services organization (CRDMO), and Vipergen ApS, a niche small-molecule drug discovery service provider specialized in DEL technologies, entered into a strategic partnership.

April 19, 2024
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3 min read