| 07.09.24 | Pfizer CSO Dolsten leaving after 15 years; House speaker pledges vote on China-targeting BIOSECURE Act

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Whitepaper: Top 5 Reasons for Futureproofing Cell Therapy Development

Cell therapy developers face many challenges as they transition from benchtop to bedside.Here we examine when and how to consider transitioning from research-use-only to animal-free (AF) and GMP critical reagents. Download now.

Today’s Big News

Jul 9, 2024

Mikael Dolsten set to leave Pfizer, sparking search for CSO successor

House Speaker Mike Johnson pledges vote for BIOSECURE as China-targeting bill hangs in limbo

FDA shares draft guidance on tackling misinformation online, offering flexibility to industry

Roche nets European approval for AI-powered CGM in Type 1, Type 2 diabetes

uniQure claims latest interim data shows gene therapy can slow Huntington’s disease

US government appeals Gilead's trial win in Truvada, Descovy patent fight

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Featured

Mikael Dolsten set to leave Pfizer, sparking search for CSO successor

By Nick Paul Taylor

Mikael Dolsten’s time at Pfizer is coming to an end. After 15 years, including a career-defining pandemic period, the chief scientific officer will leave Pfizer once the drugmaker finds his successor.

House Speaker Mike Johnson pledges vote for BIOSECURE as China-targeting bill hangs in limbo

By Fraiser Kansteiner

Ahead of an election in November—and amid a period of legislative uncertainty for the China-targeting BIOSECURE Act—U.S. House Speaker Mike Johnson has pledged to hold a vote for the controversial bill before the year is out.

FDA shares draft guidance on tackling misinformation online, offering flexibility to industry

By Nick Paul Taylor

Want to challenge online misinformation about your products? The FDA has set out pointers about how to proceed—and how it will regulate companies’ responses—in draft guidance that is open for comment for 90 days.

Roche nets European approval for AI-powered CGM in Type 1, Type 2 diabetes

By Conor Hale

The Accu-Chek SmartGuide's AI forecasts blood sugar levels for up to two hours and can alert the user to the risk of developing dangerously low blood sugar within 30 minutes.

Whitepaper: Recombinant Antibody Engineering Techniques and Strategies

Dive into the cutting-edge world of recombinant antibody engineering, from optimizing your antibody plasmid to antibody maturation and humanization. Explore innovative techniques and strategies that enhance antibody efficacy, paving the way for breakthroughs in therapeutic development. Download now.

uniQure claims latest interim data shows gene therapy can slow Huntington’s disease

By James Waldron

The clinical journey for uniQure’s Huntington’s disease gene therapy got off to a bumpy start, but now the company says the latest interim data shows a slowing of disease progression.

US government appeals Gilead's trial win in Truvada, Descovy patent fight

By Fraiser Kansteiner

As Gilead Sciences tussles with a web of HIV med litigation, a case tied to patents for prevention regimens of Truvada and Descovy is not quite settled. Late last week, the U.S. government appealed Gilead's prior win in the fight.

Hologic survey uncovers ‘Screening Action Gap’ between women and preventive healthcare

By Andrea Park

Though the vast majority of women are aware of the importance of early screening for various cancers and other life-threatening health conditions, a new survey estimates that nearly half of those in the U.S. have skipped or delayed potentially life-saving tests.

Johnson & Johnson pays $50M to resolve its ugly divorce with Emergent BioSolutions

By Kevin Dunleavy

Johnson & Johnson will pay Emergent BioSolutions $50 million to settle a two-year contract squabble and bring closure to an ill-fated, government-arranged partnership between the biopharma giant and the contract manufacturer to produce COVID-19 vaccines.

FDA amplifies Inspire Medical’s sleep apnea nerve stimulator recall

By Conor Hale

The agency handed down a Class I recall designation to the effort, its most serious label, due to a manufacturing defect that could result in what it described as “electrical leakage.”

Jazz hands chief commercial role to Samantha Pearce amid reports of possible sale

By Ben Adams

Jazz Pharmaceuticals is promoting Samantha Pearce, currently its senior vice president of Europe and international, to chief commercial officer as she takes the lead in running its commercial engine.

Cancer drug from lab of bankrupt biotech works against COVID-19 and MRSA lung damage in mice

By Helen Floersh

Just in time for a summer COVID wave to remind us that SARS-CoV-2 is here to stay, researchers at the University of California San Diego have published new findings that show an experimental cancer drug developed by a now-bankrupt biotech can suppress a key driver of lung inflammation.

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Whitepaper: Reducing Reject Rates in Sterile Dosage Forms with Strategic CAPA Integration

Implementing effective corrective and preventive actions (CAPAs) to address rejects is essential to meeting regulatory requirements and to improving the manufacturing of sterile dosage forms going forward. This report examines the causes of high reject rates in sterile dosage manufacturing and describes how biopharmaceutical developers and CDMOs can work together to develop a strong CAPA strategy. Download now.

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An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing

In this white paper, Lonza experts delve into the common challenges encountered by ADC developers. They explore new drug product capabilities in relation to cytotoxic drug development and manufacturing, therefore fully completing Lonza’s integrated ADC offering. Further, they discuss how this end-to-end approach can significantly accelerate the timeline to investigational new drug filing and beyond. Read this white paper to learn more.

2024 Life Sciences Industry Outlook

The definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.

The “Best Practice Organization” & Its Importance for Success in Today’s Biopharma Industry

In a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers.

Sponsored by: Blue Matter, strategic consultants in the life sciences