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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,000+ biopharma pros reading Endpoints daily — and it's free.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,000+ biopharma pros reading Endpoints daily — and it's free.

Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,000+ biopharma pros reading Endpoints daily — and it's free.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,000+ biopharma pros reading Endpoints daily — and it's free.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,000+ biopharma pros reading Endpoints daily — and it's free.