BioSpace News Archive

Drug Development

FDA Says ‘Systemic Bias’ in Amgen’s Lumakras Trial Ahead of Adcomm Meeting

In its briefing document for Thursday’s FDA advisory committee meeting, the regulator contends that the company’s confirmatory CodeBreaK 200 trial for Lumakras is not an “adequate and well-controlled” study.

October 4, 2023
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2 min read
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Connor Lynch
Drug Development

Vertex Touts Promising Data for Stem Cell-Based Type 1 Diabetes Treatment

New Phase I/II trial results show that one more type 1 diabetes patient achieved insulin independence after treatment with Vertex Pharmaceuticals’ investigational stem cell therapy VX-880.

October 4, 2023
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2 min read
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Tristan Manalac
Drug Development

First RNA Editing Therapy Nears Clinic as Excitement Mounts

Its reversible nature offers the potential for RNA editing to go beyond rare diseases, eliciting excitement and buy-in from large pharmas like GSK and Eli Lilly.

October 4, 2023
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5 min read
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Mollie Barnes
Business

Pharma Companies Form Coalition to Fight FTC Antitrust Overhaul

AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.

October 4, 2023
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2 min read
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Connor Lynch
Policy

Ten Companies Register to Participate in Medicare Drug Price Negotiation Program

Despite lawsuits by some companies challenging the negotiations under the Inflation Reduction Act, the manufacturers of the first 10 drugs selected for Medicare price talks will participate in the program.

October 4, 2023
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2 min read
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Tristan Manalac
Business

Sanofi, Teva Ink Potential $1.5B Deal Aimed at Blockbuster IBD Drug

The French pharma paid $500 million upfront, with up to $1 billion in future milestone payments, to co-develop and co-commercialize Teva’s Phase II anti-TL1A antibody for inflammatory bowel disease.

October 4, 2023
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2 min read
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Kate Goodwin
Job Trends

GSK Seeks Talent to Boost Data Science Capabilities

The pharmaceutical giant aims to hire another 50 people by the end of this year to work on a new platform dedicated to harnessing data and AI insights in drug discovery.

October 4, 2023
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2 min read
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Shawna Williams
Business

Regeneron, Intellia Expand CRISPR Pact to Neurological and Muscular Diseases

The companies are expanding their long-standing CRISPR/Cas9 gene editing collaboration for the second time, now seeking to target neurological and muscular conditions.

October 4, 2023
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2 min read
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Tristan Manalac
Job Trends

Press Release: Sanofi and Teva announce exclusive collaboration to deliver inflammatory bowel disease treatment

Sanofi and Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. announce a collaboration to co-develop and co-commercialize asset TEV’574, currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn’s Disease, two types of inflammatory bowel disease.

October 4, 2023
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10 min read
Policy

Majority of Newborn Babies With Spinal Muscular Atrophy (SMA) Treated With Genentech’s Evrysdi Able to Sit Independently After 1 Year of Treatment

Genentech, a member of the Roche Group, presented positive results from the primary analysis of the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi® in babies with pre-symptomatic SMA, aged from birth to 6 weeks.

October 4, 2023
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9 min read