US halts use of GSK/Vir mon­o­clon­al in 8 states as FDA says it can't de­feat new Omi­cron sub­vari­ant

With the emer­gence of the new but not nec­es­sar­i­ly more dan­ger­ous Omi­cron sub­vari­ant BA.2, the FDA on Fri­day an­nounced that Glax­o­SmithK­line and Vir’s block­buster mon­o­clon­al an­ti­body to treat Covid-19 will no longer be used in 8 states in the North­east and two US ter­ri­to­ries.

New da­ta in­clud­ed in the FDA’s health care provider fact sheet show how sotro­vimab is un­like­ly to be ef­fec­tive against the BA.2 sub-vari­ant, the agency said. And based on CDC da­ta, the BA.2 sub-vari­ant is es­ti­mat­ed to ac­count for more than 50% of cas­es across 8 states — Con­necti­cut, Maine, Mass­a­chu­setts, New Hamp­shire, Rhode Is­land, Ver­mont, New Jer­sey, and New York — as well as Puer­to Ri­co and the Vir­gin Is­lands.

The pause for sotro­vimab, of which the US bought about $1.9 bil­lion worth of dos­es, comes af­ter sev­er­al oth­er mAbs were paused when Omi­cron ini­tial­ly emerged, in­clud­ing mAb com­bos from Re­gen­eron and Eli Lil­ly.

The FDA notes that there are sev­er­al oth­er ef­fec­tive treat­ments against this BA.2 sub­vari­ant, in­clud­ing Pfiz­er’s pill Paxlovid, Mer­ck’s mol­nupi­ravir, Gilead’s Vek­lury (remde­sivir) and Eli Lil­ly’s bebtelovimab. But sup­plies of those treat­ments are like­ly to run thin as Con­gress has dropped the ball on pro­vid­ing ad­di­tion­al funds for fur­ther pur­chas­es.

A se­nior Biden of­fi­cial said ear­li­er this month that the gov­ern­ment had planned to pur­chase ad­di­tion­al mon­o­clon­al an­ti­bod­ies (from GSK and Lil­ly) but, “With­out ad­di­tion­al fund­ing, we are can­cel­ing those plans,” the of­fi­cial said, not­ing ship­ments of mon­o­clon­al an­ti­body treat­ments sent to states were re­duced by 30%.

The call to break the fund­ing stale­mate comes as Con­gress punt­ed on in­clud­ing about $15 bil­lion — Biden ini­tial­ly want­ed al­most $23 bil­lion — in pan­dem­ic funds in a larg­er an­nu­al spend­ing pack­age ear­li­er in March.

On the an­tivi­ral front, the Biden ad­min­is­tra­tion not­ed that be­cause pills like Pfiz­er’s Paxlovid can take more than 6 months to man­u­fac­ture, the US will “like­ly not have enough of these treat­ments by the end of the year. And be­ing un­able to make ad­di­tion­al pur­chase com­mit­ments now like­ly means that few­er treat­ments will be avail­able next year as well.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.