Peter Marks (Jim Lo Scalzo/Pool via AP Images)

With­out an ad­comm, FDA signs off on sec­ond Covid-19 boost­er for those over 50

The FDA on Tues­day au­tho­rized a sec­ond boost­er shot of both the Pfiz­er-BioN­Tech and Mod­er­na Covid-19 vac­cines for all adults over the age of 50 at least 4 months af­ter re­ceipt of a first boost­er dose.

Al­though the agency re­lied on re­al world ev­i­dence from Is­rael to make its de­ci­sion, and it did not seek the opin­ion of an ad­vi­so­ry com­mit­tee of out­side ex­perts be­fore the au­tho­riza­tion, Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, didn’t think it was a con­tro­ver­sial de­ci­sion.

“I think when you see our re­view memo, we’ll be able to point to the pieces of da­ta such as the sur­vival ben­e­fits and re­duc­tion in hos­pi­tal­iza­tion that let us take these ac­tions,” Marks said on a me­dia call Tues­day. “We de­cid­ed we would open it up to the 50-plus be­cause there’s a sig­nif­i­cant amount peo­ple who are high risk in the 50 and up group.”

The safe­ty ev­i­dence for the au­tho­riza­tion is based on an Is­raeli study show­ing a fourth dose was safe among 600,000 peo­ple in Is­rael over the age of 60 who re­ceived the Pfiz­er vac­cine. But Marks said that the FDA low­ered the age rec­om­men­da­tion be­cause that would be in­clu­sive for many who are con­sid­ered high-risk, and would elim­i­nate con­fu­sion.

“If it were my rel­a­tives, I would be send­ing them out to get this again be­cause of the high­er lev­el of pro­tec­tion,” he said.

Marks al­so ex­plained how the FDA did not want to wait for an Omi­cron vari­ant-spe­cif­ic vac­cine be­cause it ap­pears that sci­en­tists are “months” away from fin­ish­ing, de­spite both Mod­er­na and Pfiz­er ini­tial­ly say­ing that they could de­vel­op an Omi­cron-di­rect­ed vac­cine in 100 days (to­day is 99 days since Omi­cron was in every state).

As it’s un­known how long the pro­tec­tion from this sec­ond boost­er might last, Marks al­so didn’t rule out the pos­si­bil­i­ty of an­oth­er boost­er shot gain­ing au­tho­riza­tion come the fall, es­pe­cial­ly af­ter see­ing ma­jor waves of the virus take out a num­ber of peo­ple in the UK and Asia, and if the US needs to shift over to a dif­fer­ent vari­ant cov­er­age.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”