September 7, 2021 07:14 AM EDT
Cell/Gene Tx

'A missed op­por­tu­ni­ty': The biggest take­aways from the FDA's un­der­whelm­ing gene ther­a­py hear­ing

Jason Mast

Editor

Researchers and executives hoping that the FDA’s two-day hearing on gene therapy would offer a clear direction for the field’s future came away disappointed.

For 16 hours, the agency listened to presentations and debated everything from AAV-driven cancers in mice to how concerned we should be about strange MRI results in patients given direct injections in the brain. But few firm conclusions or recommendations ever arrived.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

January 27, 2023 10:30 AM ESTUpdated 02:20 PM
People
Pharma

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Kyle LaHucik

Associate Editor

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

January 28, 2023 07:15 AM EST
Weekly

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Loxo@Lilly CEO
January 27, 2023 03:19 PM EST
R&D
Pharma

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Kyle LaHucik

Associate Editor

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO
January 27, 2023 02:12 PM ESTUpdated 02:48 PM
Pharma
FDA+

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

Nicole DeFeudis

Editor

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Steve Harr, Sana Biotechnology CEO
January 27, 2023 11:03 AM EST
Cell/Gene Tx
FDA+

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Lei Lei Wu

News Reporter

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Ying Huang, Legend CEO
January 27, 2023 10:43 AM ESTUpdated 10:55 AM
R&D
Pharma
Cell/Gene Tx

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

Max Gelman

Senior Editor

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

January 27, 2023 08:30 AM EST

#JPM23: BeiGene CEO John Oyler on the com­pa­ny's big am­bi­tions

Drew Armstrong

Executive Editor

BeiGene CEO John Oyler and Endpoints News Executive Editor Drew Armstrong spoke one-on-one about where the drugmaker is headed in its quest to become a diversified multinational, and what it will take to get there. This transcript has been edited for brevity and clarity.

Drew Armstrong:

I am joined today by BeiGene CEO John Oyler. By way of introduction, John and I met about a little over three years ago for the first time in Beijing, when I was doing some reporting. I got to travel around the country and I had this huge notebook full of reporting on interesting things that his company was doing and some of the other companies were doing over there. And I came back to the states ready to write a great magazine story about BeiGene and about innovation that was happening globally. And then I think we all know what happened about a week and a half after I returned, in January of 2020. And unfortunately that work never saw the light of day.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)
January 27, 2023 07:10 AM EST
Deals

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

Amber Tong

Senior Editor

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

CBER Director Peter Marks (Susan Walsh/AP Images)
January 27, 2023 06:53 AM ESTUpdated 01:41 PM
Pharma
FDA+

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

Nicole DeFeudis

Editor

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

'A missed op­por­tu­ni­ty': The biggest take­aways from the FDA's un­der­whelm­ing gene ther­a­py hear­ing

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

#JPM23: BeiGene CEO John Oyler on the com­pa­ny's big am­bi­tions

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries