| 11.14.22 | Roche's ph. 3 Alzheimer's failure keeps Eisai in lead; Roivant forced into staff-cutting mode

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Today's Big News

Nov 14, 2022

Roche's anti-amyloid antibody gantenerumab fails phase 3 in major blow to Alzheimer's ambitions

Roivant cuts 12% of workforce to save cash, a blow to the larger divide-and-conquer 'vant' strategy

2022's Fiercest Women in Life Sciences

3 more biotechs look to cull, partner assets in hopes of forging ahead

Ionis, Metagenomi pen Big Pharma-sized genetic target pact that could total almost $3B

POINT well made: Lantheus promises up to $2B for 2 of the biotech's cancer radiopharmaceutical therapies

Intellia is ready to talk 'functional cure' for HAE with interim data in hand for 2nd CRISPR candidate

Sellas retunes leukemia trial as patients live longer than expected. Is the biotech’s drug behind survival boost?

Satsuma in the red after 2nd phase 3 migraine flop spurs search for strategic alternatives

Souped-up oncolytic virus warms up cold brain cancer tumors


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Thank you to Bridge Bank for sponsoring our editorial feature: 2022's Fiercest Women in Life Sciences

Featured

Roche's anti-amyloid antibody gantenerumab fails phase 3 in major blow to Alzheimer's ambitions

By Nick Paul Taylor

Roche’s bet on the resurrection of Alzheimer’s disease candidate gantenerumab has flopped. The drug candidate failed to improve the rate of cognitive and functional decline in a pair of phase 3 clinical trials, delivering yet another blow to the field.

Roivant cuts 12% of workforce to save cash, a blow to the larger divide-and-conquer 'vant' strategy

By Max Bayer

Roivant is cutting 12% of its staff as part of a larger effort to extend the company's cash runway into 2025. The company's statement did not elaborate on which spinoff companies would be affected.

2022's Fiercest Women in Life Sciences

By Andrea Park

2022 is undoubtedly a fraught time in the history of the women’s movement, but it is also an inspiring one, as people from every corner of the globe come together in support of the idea that women deserve equal rights. That double-edged sentiment echoes throughout this year’s list of the 20 fiercest women in life sciences.

Patients want more info about clinical trials. Here’s how biopharma can help

3 more biotechs look to cull, partner assets in hopes of forging ahead

By Gabrielle Masson

The third quarter of 2022 has proved to be the season of biotech pipeline culls, with three more companies setting out plans this morning to shed programs in hopes that the lighter load will allow them to forge ahead in rocky market conditions.

Promise of mRNA technology creates new manufacturing challenges

Sponsored by ThermoFisher Scientific

Every mRNA manufacturing process step adds complexity and cost, so it’s important to ensure steps are compatible and integrated with each other. Explore each intertwined step in this infographic.

Ionis, Metagenomi pen Big Pharma-sized genetic target pact that could total almost $3B

By Max Bayer

Ionis and gene editing company Metagenomi have signed onto a research pact that could ultimately total eight targets worth up to almost $3 billion. It's a gargantuan deal with a value ceiling that rivals and exceeds similar deals from the world's largest pharmas.

POINT well made: Lantheus promises up to $2B for 2 of the biotech's cancer radiopharmaceutical therapies

By James Waldron

Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1.8 billion tied up in biobucks.

Intellia is ready to talk 'functional cure' for HAE with interim data in hand for 2nd CRISPR candidate

By Annalee Armstrong

Intellia Therapeutics has a few more drops of evidence that its second gene editing candidate may offer a functional cure for hereditary angioedema, a rare inherited disorder that causes rapid swelling all over the body.

Sellas retunes leukemia trial as patients live longer than expected. Is the biotech’s drug behind survival boost?

By Annalee Armstrong

Patients are living longer than expected in Sellas Life Sciences’ phase 3 trial for an acute myeloid leukemia drug. That’s great news for patients and has spurred a protocol amendment for the study—but the question remains: Is it because of the biotech’s drug?

Satsuma in the red after 2nd phase 3 migraine flop spurs search for strategic alternatives

By Nick Paul Taylor

New device, new trial, same flop. That is the story at Satsuma Pharmaceuticals, which suffered a second stock-crushing phase 3 bellyflop after tweaks to its migraine nasal drug delivery device failed to yield an asset capable of beating placebo.

Souped-up oncolytic virus warms up cold brain cancer tumors

By Helen Floersh

A next-generation oncolytic virus carrying a tumor-tackling protein armed with cytokines and cetuximab showed survival benefits in mouse models of glioblastoma multiforme, a type of brain cancer.

AstraZeneca and Sanofi win big as Europe's human medicines committee endorses approvals, label expansions

By Fraiser Kansteiner

Cancer, COVID-19 and copycat drugs dominated the agenda at last week's meeting of the European Medicines Agency’s human medicines committee, which has endorsed four new pharmaceuticals and pushed for label extensions on 11 others.

HLTH22 news flash—Walgreens, VillageMD take Las Vegas; Wolters Kluwer taps Microsoft for cloud tech

By Healthcare Staff

Fierce Healthcare's editorial team brings you the latest news and trends from the HLTH 2022 conference and expo in Las Vegas.

Exscientia tapped by MD Anderson for the cancer center's drug discovery efforts

By Conor Hale

The collaboration will start with jointly identified oncology targets and then employ Exscientia’s AI platform to design small-molecule drugs.

BioNTech buys Novartis plant in Singapore, will retrofit for mRNA vaccine production

By Kevin Dunleavy

The rush is on as biopharma companies from the west are flocking to Asia and, more specifically, to business-friendly Singapore in their hopes of tapping into a massive and growing market. Monday, BioNTech revealed more about its plan to establish a stronghold on the island nation, saying it had acquired a manufacturing facility from Novartis that will also serve as its Asia-Pacific regional headquarters.

Johnson & Johnson 'Save Legs. Change Lives' campaign brings PAD amputation awareness to Black community

By Jacqueline Renfrow

Johnson & Johnson’s R&D unit Janssen is driving awareness among Black Americans of the risks for PAD-related amputations in the “Save Legs. Change Lives” campaign.

Fierce podcasts

Don't miss an episode

'The Top Line': A recap of Fierce Biotech's Cell & Gene Therapy Forum

This week on “The Top Line,” we share some highlights from Fierce Biotech's Cell and Gene Therapy Forum in case you missed it.

'Podnosis': What charity care policies really mean, and Fierce Healthcare's Women of Influence honorees

‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

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.

Resources

Whitepaper

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

Webinar

Webinar: Writing the Future of Antibody Discovery Solutions

Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Presented by: Twist Bioscience

Whitepaper

Scaling life sciences companies: Discover resources to support growth and innovation

Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals.

Commercializing Gene Therapies – Supply Chain Considerations

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

Discover why you should choose the Gibco™️ Efficient-Pro™️ system

Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video.

The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Sponsored by: Catalent

Research

Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Sponsored by: Catalent

Whitepaper

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

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Sponsored by: Catalent

Whitepaper

Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Softgel Formulation Enables Oral Delivery of Testosterone

Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy.

Sponsored by: Catalent

Whitepaper