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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

South Korean Olympic table tennis team player Lee Sang-su receiving the first dose of the Pfizer/BioNTech Covid-19 coronavirus vaccine in Seoul (Chung Sung-Jun/Pool Photo via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech do­nate their vac­cine to the Tokyo Olympics; No­vavax, Pfiz­er/BioN­Tech vac­cines ap­pear to be less ef­fec­tive against vari­ants

The long-delayed 2020 Olympics in Tokyo will feature gymnast Simone Biles in what is likely her last Summer Games, and skateboarder Nyjah Huston in what will be his first. But the players with the most impact on the games could be Pfizer and BioNTech. After a meeting between Pfizer CEO Albert Bourla and Japan’s Prime Minister Yoshihide Suga, a plan has been outlined to donate doses of their Covid-19 vaccine for the Olympic Games.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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