Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er, BioN­Tech say vac­cine is 95% ef­fec­tive, EUA sub­mis­sion 'with­in days'

Pfiz­er and BioN­Tech have done the fi­nal ef­fi­ca­cy analy­sis for their Phase III Covid-19 tri­al, and the re­sults con­firm the head­line-grab­bing re­lease from last week: Their vac­cine is 95% ef­fec­tive at pre­vent­ing Covid-19.

They al­so said the vac­cine was 94.5% ef­fec­tive in old­er adults, mit­i­gat­ing con­cerns that the first Covid-19 vac­cines might not work as well in one of the pop­u­la­tions most sus­cep­ti­ble to se­vere dis­ease.

The two com­pa­nies said they have al­so crossed the FDA’s key safe­ty thresh­old of two-months fol­low-up and will sub­mit for an emer­gency use au­tho­riza­tion “with­in days.” Al­though the agency will con­vene an ad­vi­so­ry com­mit­tee be­fore mak­ing a de­ci­sion, the an­nounce­ment like­ly sets up the Big Phar­ma and their biotech part­ner to ob­tain the first FDA OK for a Covid-19 vac­cine.

Pfiz­er CEO Al­bert Bourla said at dif­fer­ent con­fer­ences yes­ter­day af­ter­noon that they had passed the safe­ty thresh­old and would soon sub­mit to reg­u­la­tors. The com­pa­nies an­nounced last week that their vac­cine was “over 90% ef­fec­tive” in an in­ter­im analy­sis.

Mod­er­na, which an­nounced Mon­day that their vac­cine was 94.5% ef­fec­tive at an in­ter­im analy­sis, is al­so ex­pect­ed to re­lease fi­nal ef­fi­ca­cy da­ta and head to reg­u­la­tors soon. CEO Stéphane Ban­cel pre­dict­ed the first ad­vi­so­ry com­mit­tee hear­ings for any vac­cine to come Dec. 7th or Dec. 14th. The two vac­cines both use mR­NA and are high­ly sim­i­lar.

To­day’s ef­fi­ca­cy da­ta came from an analy­sis of 170 Covid-19 cas­es in their 44,000-per­son tri­al — 162 cas­es in the place­bo group and 8 cas­es in the vac­cine group. It al­so in­clud­ed Pfiz­er’s first safe­ty re­sults; the most se­vere side ef­fects were fa­tigue, which oc­curred in 3.8% of re­cip­i­ents, and headache, which oc­curred in 2% of re­cip­i­ents.

Pfiz­er said they saw 9 cas­es of se­vere dis­ease in the place­bo group and 1 in the vac­cine group, in­di­cat­ing the vac­cine can help pre­vent hos­pi­tal­iza­tion and death. Mod­er­na’s first analy­sis had shown 11 se­vere cas­es on place­bo and 0 in the vac­cine group.

Key ques­tions, how­ev­er, still re­main on how durable the vac­cine will be.

Al­though oth­er ques­tions re­main about how ef­fec­tive­ly Pfiz­er will be able to dis­trib­ute its vac­cine, which re­quires stor­age at -70 de­grees Cel­sius (-94 Fahren­heit), Bourla ex­pressed con­fi­dence yes­ter­day that roll­out would go far more smooth­ly than out­side ex­perts have feared.

The com­pa­ny has in­vest­ed in freez­er box­es to ship and store their vac­cines on dry ice. State health of­fi­cials have raised con­cerns about how well these will work for get­ting the vac­cine to rur­al ar­eas. Mod­er­na has less strin­gent cold-chain re­quire­ments.

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

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.

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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.

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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?’”

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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.”

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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.