BioSpace News Archive

Policy

FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data

The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.

April 23, 2024
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2 min read
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Tristan Manalac
Business

Novartis Beats Q1 Expectations, Raises 2024 Outlook on Strong Drug Sales

The Swiss drugmaker raised its full-year guidance Tuesday projecting net sales to grow in the high-single to low double-digit range while reporting better-than-expected first-quarter results.

April 23, 2024
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2 min read
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Tyler Patchen
Business

Sanofi Layoffs, CAR-T Warnings and a New GLP-1 Player

While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth.

April 23, 2024
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1 min read
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Greg Slabodkin, Heather McKenzie, Tyler Patchen
FDA

ImmunityBio Wins FDA Approval for First IL-15 Superagonist for NMIBC

Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.

April 23, 2024
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2 min read
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Tristan Manalac
Drug Development

5 Mid-Stage ALS Drugs to Watch

As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.

April 23, 2024
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5 min read
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Heather McKenzie
Business

BMS Initiates First Round of Layoffs in New Jersey

This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.

April 23, 2024
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1 min read
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Neil Versel
Policy

Supreme Court Denies Vanda’s Petition in Hetlioz Patent Case Against Teva

The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.

April 23, 2024
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2 min read
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Tristan Manalac
Business

BMS-Cellares CAR-T Pact Highlights U.S.-China Biopharma Tensions

While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.

April 23, 2024
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3 min read
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Neil Versel
Drug Development

Sanofi’s $3.7B Principia Buy Starts to Pay Off with Phase III Rilzabrutinib Win

Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.

April 23, 2024
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2 min read
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Tristan Manalac
Deals

Incyte Inks $750M Deal to Buy Escient and Skin Disease Drug Candidates

CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.

April 23, 2024
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2 min read
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Nick Paul Taylor