FDA be­gins court-man­dat­ed re­lease of thou­sands of pages on Pfiz­er's Covid-19 vac­cine re­view

A court loss for the FDA in a Texas dis­trict court means the agency on Tues­day be­gan to re­lease a mas­sive trove of hun­dreds of thou­sands of doc­u­ments re­lat­ed to its re­view of Pfiz­er’s safe and ef­fec­tive Covid-19 vac­cine.

But what ex­act­ly will be un­cov­ered in each batch of re­leased doc­u­ments is any­one’s guess.

The non­prof­it that won the court case, known as the Pub­lic Health and Med­ical Pro­fes­sion­als for Trans­paren­cy, prompt­ly re­leased the Pfiz­er doc­u­ments on its web­site this week but did not of­fer any sort of or­ga­ni­za­tion or ex­pla­na­tion of what they show.

Some of the doc­u­ments, like one la­beled as a pri­or­i­ty re­view re­quest, in­cludes more than 100 pages worth of anony­mous safe­ty-re­lat­ed ta­bles of da­ta. Or an­oth­er ta­ble of uniden­ti­fied par­tic­i­pants’ gen­der, age and BMI.

Oth­er doc­u­ments are typ­i­cal for any drug or vac­cine ap­pli­ca­tion. For in­stance, one doc­u­ment shows the stan­dard, near­ly $2.9 mil­lion user fee pay­ment to FDA from Pfiz­er. Oth­er doc­u­ments re­leased in­clude the fast track des­ig­na­tion let­ter, which is not typ­i­cal­ly re­leased, the con­fi­den­tial non­clin­i­cal overview for the vac­cine, Pfiz­er’s re­quest for a waiv­er from adding a suf­fix to the vac­cine’s name (al­so not typ­i­cal­ly re­leased), and an­oth­er with a long list of anonymized tri­al sub­jects who didn’t re­ceive the vac­cine as ran­dom­ized.

The sheer vol­ume of pages and doc­u­ment types will give read­ers a good over­all sense of the re­quired doc­u­men­ta­tion nec­es­sary to ap­ply for a drug or vac­cine ap­proval at the FDA. But it’s still un­clear if the doc­u­ments will of­fer any new in­sight in­to the vac­cine’s safe­ty or ef­fi­ca­cy, es­pe­cial­ly giv­en the re­al-world da­ta on the vac­cine that’s al­ready been pub­lished in ma­jor med­ical jour­nals (e.g. Pfiz­er’s vac­cine ef­fec­tive­ness and safe­ty in health care per­son­nel or Is­rael).

An­ti-vax lawyer Aaron Siri, a man­ag­ing part­ner of the firm Siri & Glim­stad who rep­re­sent­ed the non­prof­it, told End­points News, “Our job was to get the doc­u­ments. We leave it to the sci­en­tists and oth­ers to an­a­lyze.”

Pre­vi­ous­ly Siri wrote on his Sub­stack that what drove this suit was that the gov­ern­ment “want­ed to hide the da­ta by wait­ing to ful­ly pro­duce what it re­lied up­on to li­cense this prod­uct un­til al­most every Amer­i­can alive to­day is dead.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

Senate health committee chair Bernie Sanders (D-VT) and Moderna CEO Stéphane Bancel (Tom Williams/CQ Roll Call via AP Images)

Mod­er­na CEO de­fends Covid-19 vac­cine price change at Sen­ate com­mit­tee grilling

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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FDA+ roundup: Leg­isla­tive asks for 2024 fo­cus on more au­thor­i­ties, gener­ic drug com­pe­ti­tion

The FDA’s legislative priorities for the next year highlight the agency’s focus on expanding generic drug competition, backstopping the supply chain and growing its current authorities.

On the new authorities front, FDA is seeking to expand its mandatory recall authority for all drugs, as the agency has been embroiled in a long process to remove some from the market. Covis Pharma refused to pull its preterm birth drug Makena, which won accelerated approval, for almost five years after failing its confirmatory trial. The company has since reversed course after a negative adcomm.

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