Thomas Lingelbach, Valneva CEO

Covid-19 roundup: Val­ne­va runs in­to EMA ques­tions, still ex­pects March au­tho­riza­tion; Cana­da ap­proves first plant-based vac­cine

In Feb­ru­ary 2021, the Eu­ro­pean Med­i­cines Agency be­gan a rolling re­view of French biotech Val­ne­va’s Covid-19 vac­cine, which is a whole virus, in­ac­ti­vat­ed, ad­ju­vant­ed vac­cine.

About a year lat­er, Val­ne­va says the EMA still has ques­tions, al­though the com­pa­ny said Fri­day that it’s “con­fi­dent that it will be able to re­spond to these in the com­ing days. Fol­low­ing the Com­pa­ny’s re­sponse, the EMA will pro­vide a timetable to­wards an­tic­i­pat­ed con­di­tion­al ap­proval.”

Val­ne­va, which ear­li­er ac­knowl­edged that its vac­cine on­ly per­formed well af­ter a pri­ma­ry se­ries of the Val­ne­va vac­cine can­di­date, al­so said it an­tic­i­pates re­ceiv­ing a pos­i­tive CHMP rec­om­men­da­tion for con­di­tion­al ap­proval of its Covid vac­cine can­di­date for adults 18 to 55 years old by the end of March. Fol­low­ing a con­di­tion­al ap­proval, the com­pa­ny said it ex­pects to de­liv­er the first ship­ments of VLA2001 to Eu­ro­pean coun­tries ear­ly in Q2.

The Eu­ro­pean Com­mis­sion signed a sup­ply deal with Val­ne­va in ear­ly No­vem­ber for up to 60 mil­lion dos­es in 2022 and 2023.

Thomas Lin­gel­bach, CEO of Val­ne­va, said in a state­ment, “We are pleased with the ini­tial CHMP as­sess­ment and look for­ward to pro­vid­ing our re­spons­es as soon as pos­si­ble. VLA2001 is the on­ly in­ac­ti­vat­ed COVID-19 vac­cine in clin­i­cal de­vel­op­ment in Eu­rope, and this brings us clos­er to our ob­jec­tive of pro­vid­ing a dif­fer­en­ti­at­ed vac­cine op­tion to the pop­u­la­tion and physi­cians who need it.”

Cana­da ap­proves GSK/Med­ica­go’s plant-based Covid-19 vac­cine

Que­bec-based Med­ica­go and Glax­o­SmithK­line said Thurs­day that Health Cana­da ap­proved its plant-based Covid-19 vac­cine.

This is the first ap­proval for the two com­pa­nies, which paired GSK’s ad­ju­vant with promis­ing anti­gens to de­vel­op the pro­tein-based, re­frig­er­a­tor-sta­ble vac­cine. Known com­mer­cial­ly as Cov­ifenz, the vac­cine is in­di­cat­ed to pre­vent Covid-19 in in­di­vid­u­als 18 to 64 years of age.

The vac­cine showed 71% ef­fi­ca­cy in a late-stage tri­al against all vari­ants of SARS-CoV-2 among more than 24,000 adults in Cana­da, the US, UK, Mex­i­co, Ar­genti­na and Brazil. In Oc­to­ber 2020, the com­pa­ny reached an agree­ment with Cana­da to sup­ply up to 76 mil­lion dos­es of its vac­cine, and Med­ica­go al­so re­ceived $173 mil­lion in fund­ing sup­port from the Gov­ern­ment of Cana­da for its vac­cine R&D.

“We’re al­so grate­ful for the Gov­ern­ment of Cana­da’s sup­port in the de­vel­op­ment of this new vac­cine, and we are man­u­fac­tur­ing dos­es to start ful­fill­ing its or­der,” Takashi Na­gao, pres­i­dent and CEO at Med­ica­go, said in a state­ment.

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.

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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.”

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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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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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.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.