Covid-19 roundup: Ger­many puts J&J on the hot­seat for vac­cine back­o­rder; Top EMA of­fi­cial sug­gests for­go­ing As­traZeneca shot

Short­ly af­ter it was an­nounced that the FDA has re­quired J&J to dis­card tens of mil­lions of Covid-19 vac­cines that were con­t­a­m­i­nat­ed at an em­bat­tled Emer­gent plant in Bal­ti­more, MD, Ger­many has de­mand­ed that the com­pa­ny de­liv­er 6.5 mil­lion dos­es to make up for a short­fall, Reuters re­port­ed.

The FDA said Fri­day that two batch­es of the drug sub­stance used in J&J’s jab would be re­leased from quar­an­tine af­ter mil­lions of dos­es were held from dis­tri­b­u­tion at the Emer­gent site. While that frees up about 10 mil­lion dos­es, The New York Times re­port­ed Fri­day morn­ing an­oth­er 60 mil­lion dos­es were or­dered to be tossed out.

Emer­gent’s Bayview plant was pre­vi­ous­ly tak­en over by the FDA, caus­ing a sig­nif­i­cant short­age in J&J vac­cines be­ing shipped to coun­tries in need. Ger­many has been hit par­tic­u­lar­ly hard, as the coun­try was owed 10.1 mil­lion dos­es of the sin­gle-dose jab in the sec­ond quar­ter, the min­istry of health told Reuters.

In ad­di­tion to the quar­an­tined dos­es, Emer­gent was forced to halt any fur­ther pro­duc­tion as the FDA took over the Bal­ti­more Bayview plant to ob­serve its op­er­a­tions.

Top EMA of­fi­cial ad­vis­es against As­traZeneca’s jab

The EMA’s head of vac­cine strat­e­gy has rec­om­mend­ed the EU avoid As­traZeneca’s vac­cine in sit­u­a­tions in which an al­ter­na­tive is avail­able, The Brus­sels Times re­port­ed Mon­day. He al­so rec­om­mend­ed the J&J jab on­ly be used in pa­tients above the age of 60.

Mar­co Cav­a­leri made the com­ments to the Ital­ian news­pa­per La Stam­pa over the week­end. Italy re­strict­ed the use of As­traZeneca’s vac­cine in pa­tients un­der the age of 60 be­cause of the fear of rare but dan­ger­ous blood clots.

When asked if it was bet­ter to halt us­ing As­traZeneca al­to­geth­er for all age groups, Cav­a­leri agreed, and said that it’s an op­tion many coun­tries are tak­ing in­to con­sid­er­a­tion as the sup­ply of mR­NA vac­cines from Mod­er­na and Pfiz­er be­comes more read­i­ly avail­able.

PhI­II tri­al re­sults for Cell­tri­on’s an­ti­body treat­ment shows pos­i­tive re­sults

Cell­tri­on’s ex­per­i­men­tal Covid-19 an­ti­body treat­ment re­duced the treat­ment pe­ri­od for pa­tients by five days, the com­pa­ny an­nounced Mon­day.

The tri­als, which in­clud­ed pa­tients from 13 coun­tries in­clud­ing the US, South Ko­rea, Spain and Ro­ma­nia, were safe, the com­pa­ny said.

Rekirona gained South Ko­re­an reg­u­la­to­ry ap­proval in Feb­ru­ary, as it be­came the coun­try’s first lo­cal­ly made Covid-19 treat­ment. Phase III tri­al re­sults showed the an­ti­body re­duced the risk of the virus pro­gress­ing by 70%, Reuters said.

Cell­tri­on plans to sub­mit an ap­pli­ca­tion for reg­u­la­to­ry ap­proval with both the FDA and EMA in the com­ing months, The Ko­rea Her­ald re­ports.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

So­cial im­age: An­gela Merkel (AP Pho­to/Michael Sohn)

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.

Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

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.

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.

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.

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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.