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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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