FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’

Patrizia Cavazzoni, CDER

June 14, 2021 04:45 PM EDTUpdated June 16, 11:24 AM

FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’

Zachary Brennan

Senior Editor

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantial reforms to the advisory committee process at the agency.

Short on examples of the adcomms she was referring to, Cavazzoni said at a BIO event aired on Monday that some recent committees show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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May 24, 2022 08:49 AM EDTUpdated 03:54 PM

R&D

In Focus

A new era of treatment: How biomarkers are changing the way we think about cancer

Nicole DeFeudis

Editor

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

May 24, 2022 02:29 PM EDT

FDA+

Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation

Zachary Brennan

Senior Editor

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

May 24, 2022 06:56 AM EDT

China

FDA+

House Republicans attack China-only data in FDA submissions, seek new investigation into research inspections

Zachary Brennan

Senior Editor

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Associate Director, Information Scientist, Library & Information Services

Gilead Sciences

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Janet Woodcock (Greg Nash/Pool via AP Images)

May 23, 2022 09:05 AM EDT

FDA+

'I really don’t look back': Janet Woodcock on her transition away from drugs

Zachary Brennan

Senior Editor

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

May 24, 2022 01:29 PM EDT

Coronavirus

Law

Moderna seeks to dismiss Alnylam suit over Covid-19 vaccine component, claiming wrong venue

Zachary Brennan

Senior Editor

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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May 24, 2022 12:48 PM EDT

Pharma

Marketing

Cracks in the facade: Is pharma's pandemic ‘feel good factor’ waning?

Beth Snyder Bulik

Senior Editor

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

May 24, 2022 10:37 AM EDTUpdated 01:33 PM

R&D

UPDATED: Planning ahead for crowded ulcerative colitis market, Pfizer spells out PhIII data on $6.7B Arena drug

Amber Tong

Senior Editor

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Todd Zavodnick, Dermavant CEO

May 24, 2022 09:14 AM EDTUpdated 09:32 AM

FDA+

With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients

Nicole DeFeudis

Editor

Dermavant CEO Todd Zavodnick has been plotting to upend the plaque psoriasis market for years now. And with the company’s first approval on Tuesday, he’s pulling the trigger.

The FDA on Tuesday approved Dermavant’s “cosmetically elegant” vanishing cream tapinarof, the first steroid-free topical medication in its class, now marketed as Vtama. And unlike other launches, which could take months, Zavodnick is ready to roll it out as early as next week.

Raymond Tesi, INmune Bio CEO

May 24, 2022 07:30 AM EDT

FDA+

Manufacturing concerns spur clinical hold on small biotech's Alzheimer's trial — shares plunge

Amber Tong

Senior Editor

The FDA is keeping an experimental Alzheimer’s therapy out of the US for now, placing a clinical hold on INmune Bio’s IND for a Phase II trial until it can provide additional information on chemistry, manufacturing and controls.

INmune Bio, which gets its name from the approach of leveraging the innate immune system to fight disease, said it was informed about the hold via email and expects more details in a later letter. In a brief statement, it said the agency was looking for more information about CMC “of the newly manufactured XPro1595.”

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