New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The con­cerns keep mount­ing over Pres­i­dent Don­ald Trump’s politi­ciza­tion of the FDA and oth­er fed­er­al agen­cies guid­ing the de­vel­op­ment of a safe and ef­fec­tive vac­cine. And to­day, the telegenic New York gov­er­nor An­drew Cuo­mo ap­peared to in­tro­duce even more pol­i­tics in­to the mat­ter — lat­est in an on­go­ing se­ries of in­ci­dents that have cast the proud­ly in­de­pen­dent FDA in stark­ly po­lit­i­cal terms.

Dur­ing his dai­ly press con­fer­ence Cuo­mo said that the state will re­view any coro­n­avirus vac­cines ap­proved by the fed­er­al gov­ern­ment, cit­ing a lack of trust in the Trump ad­min­is­tra­tion. The an­nounce­ment comes one day af­ter Trump ac­cused the FDA of mak­ing an “ex­treme­ly po­lit­i­cal” move in propos­ing stricter vac­cine guid­ance.

“Frankly, I’m not go­ing to trust the fed­er­al gov­ern­ment’s opin­ion, and I wouldn’t rec­om­mend to New York­ers, based on the fed­er­al gov­ern­ment’s opin­ion,” Cuo­mo, a De­mo­c­rat, said.

States aren’t typ­i­cal­ly in­volved in the vac­cine ap­proval process, but they could de­lay the dis­tri­b­u­tion of a po­ten­tial­ly au­tho­rized vac­cine, ac­cord­ing to a New York Times re­port.

Cuo­mo’s plan to over­see what’s been fed­er­al gov­ern­ment over­sight in­cludes cre­at­ing a “Clin­i­cal Ad­vi­so­ry Task Force” com­pris­ing sci­en­tists, doc­tors and health ex­perts. The task force will re­port to Cuo­mo to de­ter­mine whether or not an au­tho­rized vac­cine is safe and ef­fec­tive.

“New York State will have its own re­view when the fed­er­al gov­ern­ment is fin­ished with their re­view and says it’s safe,” Cuo­mo said. “We’re go­ing to put to­geth­er a group for them to re­view the vac­cine, so I can look at the cam­era and I can say to New York­ers that it’s safe to take.”

The gov­er­nor al­so high­light­ed the dis­tri­b­u­tion chal­lenges fac­ing the state when a vac­cine should be ap­proved, giv­en that near­ly 20 mil­lion peo­ple live in New York and some lead­ing vac­cine can­di­dates re­quire two dos­es.

Cuo­mo said the pan­el would look at the most ef­fec­tive ways to im­ple­ment a dis­tri­b­u­tion net­work and work on pri­or­i­tiz­ing who should get the vac­cine first.

Pres­i­dent Trump has re­peat­ed­ly made op­ti­mistic fore­casts of vac­cine avail­abil­i­ty com­ing be­fore No­vem­ber 3 de­spite on­ly one com­pa­ny — Pfiz­er — say­ing pub­licly that they’d know be­fore then whether or not their vac­cine works. CEO Al­bert Bourla has said Pfiz­er could be able to tell in Oc­to­ber.

Though Cuo­mo ap­peared to in­sert pol­i­tics in­to the vac­cine ap­proval dis­cus­sion, po­ten­tial­ly fur­ther sow­ing doubts about the FDA’s abil­i­ty to roll out a safe vac­cine, he ex­pressed con­fi­dence in Com­mis­sion­er Stephen Hahn dur­ing his press­er and in­stead cast blame on the pres­i­dent.

“I don’t think Dr. Hahn is run­ning for any­thing,” Cuo­mo sar­cas­ti­cal­ly asked one of the health of­fi­cials at the brief­ing.

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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'Bank of BAR­DA': In­ves­ti­ga­tion finds HHS raid­ed pan­dem­ic pre­pared­ness funds for decade be­fore Covid-19

Before 2020, few Americans had ever heard of the Biomedical Advanced Research and Development Authority, BARDA, or its far-flung mission to stave off future pandemics and bio-threats. Allegedly, that made it a pretty good target for others in HHS who needed to scavenge some extra cash.

Over the last decade, other HHS officials raided BARDA’s coffers and misappropriated millions of dollars that Congress had earmarked to fund vaccine research and prepare for public health emergencies like Covid-19, according to a new report from the US Office of Special Counsel, which investigated a whistleblower report.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.