| 12.02.22 | Pfizer CEO stung on kids' COVID vax claims; Eisai makes Alzheimer's drug case after patient deaths

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This Week

Dec 2, 2022

Pfizer CEO Bourla stung by UK's pharma marketing regulator over kids' COVID vax claims: report

Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths

Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal

Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line

Philips adds another 91 reported deaths to ventilator recall, bringing total to 260

In surprise move, GSK pulls Blenrep's accelerated approval only days after confirmatory trial flop

AstraZeneca forges deeper into cell therapies with $200M takeover of solid tumor TCR biotech

‘Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says

Catalent to lay off hundreds at manufacturing sites in Texas, Maryland and Indiana

Elusive universal flu vaccine sees success in animals with mRNA tech

'The Top Line': The initial reactions to Biogen's new CEO, plus this week's headlines

Webinar: IND-enabling CMC Strategies for mAb and bsAb: Faster and Better

Tuesday, December 6, 2022 | 10am ET / 7am PT

The development of therapeutic antibodies has been challenged by the difficulty to generate such intricate molecules. Here, we show that ProBio has established proprietary fast CMC platform guaranteeing the delivery of monoclonal antibody with high titer. Register now.

Featured

Pfizer CEO Bourla stung by UK's pharma marketing regulator over kids' COVID vax claims: report

By Ben Adams

Pfizer’s chief executive Albert Bourla is in hot water for claims he made during a BBC interview late last year about his then-unapproved COVID vaccine for younger kids. The claims have been branded “misleading” and “overly promotional," according to a press report.

Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths

By Annalee Armstrong

Two deaths have dimmed the initial glow surrounding Eisai and Biogen’s next Alzheimer’s disease therapy lecanemab. But the Japanese company now has more answers on the risks patients may need to learn to accept to receive treatment.

Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal

By Nick Paul Taylor

Concerns are mounting about the safety of Eisai and Biogen’s Alzheimer’s disease prospect lecanemab. Ahead of the presentation of the full phase 3 dataset on Tuesday, Science has reported on the death of a second recipient of the anti-amyloid antibody who suffered a brain hemorrhage.

Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line

By Zoey Becker

CSL Behring and uniQure's newly approved hemophilia B gene therapy, Hemgenix, comes with an eye-popping price tag of $3.5 million. The one-time treatment can replace regular prophylactic infusions of factor IX replacement therapy for patients.

Webinar: Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets

Tuesday, December 7th, 2022 | 10am ET/7am PT

In this presentation we’ll review how we established GOCHO™ cells from an adherent CHO-K1 cell line to meet current industry standards, how the choice of cloning media drove cell culture media choices for the entire cell-line development process, and more. Register now.

Philips adds another 91 reported deaths to ventilator recall, bringing total to 260

By Andrea Park

Nearly a year-and-a-half into Philips’ recall of about 5.5 million of its CPAP and BiPAP machines and other respiratory devices, complaints about the affected machines are still rolling in.

In surprise move, GSK pulls Blenrep's accelerated approval only days after confirmatory trial flop

By Angus Liu

GSK is setting a new standard for speed when it comes to withdrawing an accelerated approval after a confirmatory trial failure. The British drugmaker is pulling Blenrep off the U.S. market just 15 days after announcing a phase 3 flop. The move comes despite potentially imminent readouts from two other phase 3 trials.

AstraZeneca forges deeper into cell therapies with $200M takeover of solid tumor TCR biotech

By Nick Paul Taylor

AstraZeneca is stepping up its pitch for a slice of the cell therapy space, paying $200 million upfront for a solid tumor player that recently hustled an autologous, fully individualized, multispecific prospect into the clinic.

'Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says

By Kevin Dunleavy

The courtroom drama surrounding Bristol Myers Squibb and its subsidiary Celgene over their efforts to restrict competition for lymphoma drug Revlimid has raged for more than a decade. And it's not going away any time soon, as three union pension funds have brought a class action antitrust suit against Bristol Myers and a raft of generic drugmakers.

Catalent to lay off hundreds at manufacturing sites in Texas, Maryland and Indiana

By Kevin Dunleavy

Catalent is laying off more than 210 workers at two sites in Maryland and one in Texas according to Worker Adjustment and Retraining Notifications (WARN) posted in the states. The company also is reducing 400 staffers at its sprawling site in Bloomington, Indiana. The layoffs come as the company is cutting costs as revenue from COVID-19 products is in sharp decline.

Elusive universal flu vaccine sees success in animals with mRNA tech

By Helen Floersh

An mRNA vaccine targeting 20 different subtypes of the flu protected mice and ferrets from severe disease and death, opening a door to a universal flu vaccine.

Fierce podcasts

Don't miss an episode

'The Top Line': The initial reactions to Biogen's new CEO, plus this week's headlines

This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition.

'Podnosis': Is virtual-first care here to stay, and what can be done about skyrocketing US drug prices

'The Top Line': Celebrating the 2022 Fiercest Women in Life Sciences honorees

'Podnosis': How public-private employer coalitions can force innovation, and how to fix the healthcare system

Webinar: Optimizing your data for the reimagined drug supply chain

Monday, December 5, 2022 | 11am ET / 8am PT

The data behind the scenes must match and reflect the physical goods moving through the supply chain. In this webinar, we will discuss the four major components of compliance and how to get the data right to let the product flow. Register now.

Resources

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Plan Your ASH’22 Attendance In No Time | Interactive Planner

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Presented by: Twist Bioscience

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Enhance the cost-effectiveness of your chemical supply chain

Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific.

Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.

Sponsored by: Thermo Scientific Production Chemicals and Services

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This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success.

THE BIODRUG REVOLUTION

Accelerating bioproduction towards high performance and scale

Navigating the Data Deluge: Turning Data Into Insight Across the Health Care and Life Sciences Industries

Learn the benefits of unlocking data insights across the healthcare and life sciences ecosystem.

EHR vs Registry Data for RWE – Heart Failure as a Case Study

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Scale-Up Strategies for Late-Stage Cell Therapies

Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more.

Sponsored by: Catalent

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Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

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Sponsored by: Catalent

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Linear Compression vs. Parallel Processing: Speeding Biologics Through Development and Into Clinical Trials

Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more.

Sponsored by: Catalent

eBook

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

The keys to success when switching from vials to prefilled syringes and intravenous to subcutaneous formulations for Biologics

Download now to learn about the benefits of transitioning from intravenous to subcutaneously administration, the advantages of using prefilled syringes, and explore challenges and solutions for transitioning from vials to prefilled syringes.

Presented by: Catalent

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Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.

Sponsored by: Catalent

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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.

Sponsored by: Catalent

Research

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

Sponsored by: Catalent