| 02.14.22 | Roche, Lilly rebuke being put under same umbrella as Aduhelm; Yes, a new Vant is in town

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Despite robust funding and government initiatives for the development of orphan drugs and personalised medicines, small and emerging biotechs are typically very lean on resources, lacking the infrastructure required to bring their innovation to the market. Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. Learn more.

Today's Rundown

Roche, Lilly push back against CMS painting their Alzheimer’s meds with the same brush as Biogen’s Aduhelm Roivant decants another Vant armed with Eisai blood cancer drug and plans to start phase 1/2 soon FDA fingers tox assessment as cause of Denali clinical hold, leaving biotech with a to-do list to regain momentum Sponsored: A New Way to Access Scientific Papers? Metacrine lays off half its staff, mainly researchers, and ditches more work to focus on IBD after NASH disaster 2seventy bio plucks Turnstone Biologics exec Bernstein to be new CMO FDA signs off on Lilly's new antibody drug, bebtelovimab, which is effective against the omicron variant At the CrossRoads: J&J's DePuy Synthes acquires foot and ankle implant system maker Moderna eyes UK for next leg of mRNA vaccine manufacturing journey: report Musk's Neuralink disputes accusations of animal abuse in brain implant experiments House Republicans press HHS to end COVID-19 emergency, but hospitals want extension Improving RNA editing for genetic diseases by recruiting the body’s natural protein

Featured Story

Roche, Lilly push back against CMS painting their Alzheimer’s meds with the same brush as Biogen’s Aduhelm

By Annalee Armstrong

In a rare moment of solidarity among fierce competitors, Biogen’s peers Roche and Eli Lilly are rallying behind the company’s troubled Alzheimer’s disease therapy, Aduhelm, in an effort to change the Centers for Medicare and Medicaid Services’ restrictive ruling against monoclonal antibodies for the condition.

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Roivant decants another Vant armed with Eisai blood cancer drug and plans to start phase 1/2 soon

By Nick Paul Taylor

Roivant Sciences has spawned another Vant. The latest addition to the clan is Hemavant, a biotech that starts life with a former Eisai drug and plans to start a study in patients with myelodysplastic syndromes this year.

FDA fingers tox assessment as cause of Denali clinical hold, leaving biotech with a to-do list to regain momentum

By Nick Paul Taylor

Denali Therapeutics now knows what it needs to do to get its Alzheimer’s disease drug DNL919 back on track. Almost one month after the FDA informed Denali of a clinical hold via email, the agency has sent a formal letter setting out what needs to happen before it OKs a study of the Takeda-partnered prospect.

Metacrine has laid off about half of its staff, mainly in the research department, to save cash as it takes a failed NASH drug into a phase 2 study in people with inflammatory bowel disease. The San Diego biotech also ended work on a preclinical NASH program.

2seventy bio plucks Turnstone Biologics exec Bernstein to be new CMO

By Max Bayer

2seventy bio has hired oncologist and former Turnstone Biologics exec Steven Berstein, M.D., to be its chief medical officer, effective Monday. The hire charts the path forward for 2seventy after its recent split from bluebird bio to focus on oncology program.

FDA signs off on Lilly's new antibody drug, bebtelovimab, which is effective against the omicron variant

By Kevin Dunleavy

The FDA has approved Eli Lilly’s new COVID-19 monoclonal antibody treatment bebtelovimab, granting it emergency authorization. Bebtelovimab can be used for the treatment of mild-to-moderate COVID-19 and has been shown to be effective against the omicron variant.

At the CrossRoads: J&J's DePuy Synthes acquires foot and ankle implant system maker

By Andrea Park

When met with a crossroads—that is, Memphis, Tennessee-based CrossRoads Extremity Systems—DePuy Synthes, the orthopedics and neurosurgery division of Johnson & Johnson, opted for a familiar path.

Moderna eyes UK for next leg of mRNA vaccine manufacturing journey: report

By Fraiser Kansteiner

Moderna has already seized domestic manufacturing opportunities in Canada, Australia and Africa. Now, the mRNA pioneer is setting its sights on the U.K.'s "Golden Triangle" for the next leg of its vaccine journey, the Financial Times reports.

Musk's Neuralink disputes accusations of animal abuse in brain implant experiments

By Andrea Park

The Physicians Committee for Responsible Medicine filed a federal complaint with the USDA regarding the alleged treatment of monkeys at the University of California, Davis in connection with Neuralink’s experiments.

House Republicans press HHS to end COVID-19 emergency, but hospitals want extension

By Robert King

A group of House Republicans wants HHS to end the COVID-19 public health emergency, while hospital groups are hoping it is extended beyond April.

Improving RNA editing for genetic diseases by recruiting the body’s natural protein

By Angus Liu

In the search for more efficient and safer RNA-editing tools, two research teams from the U.S. and China have developed novel ways to recruit a naturally occurring protein inside the body to repair disease-causing mutations in RNA.

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