Covid-19 roundup: FDA’s Stephen Hahn personally helped a doctor set up hydroxychloroquine trial

May 28, 2020 07:20 AM EDTUpdated 10:08 AM

Covid-19 roundup: FDA's Stephen Hahn personally helped a doctor set up hydroxychloroquine trial — report

Amber Tong

Senior Editor

As President Donald Trump took to the presidential podium to champion hydroxychloroquine despite its unproven effects against Covid-19, FDA commissioner Stephen Hahn apparently did more than issue an emergency use authorization for the drug.

He also personally assisted a self-described “simple country doctor” in Monroe, New York in navigating the process of setting up an outpatient clinical trial involving some 950 infected people, Vanity Fair reported. Text messages and email records show that Hahn introduced Vladimir Zelenko to officials at FEMA to obtain pills for the study — a highly unusual act that sharpens fears of politicization of the malaria med.

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Biotech Halftime Report: After a bumpy year, is biotech ready to rebound?

Brian Abrahams

Co-Head of Biotechnology Research

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

October 18, 2021 07:01 AM EDTUpdated 04:19 PM

Pharma

FDA+

UPDATED: Boehringer nabs FDA's first interchangeability designation for its Humira competitor — but will it matter?

Zachary Brennan

Senior Editor

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

October 17, 2021 05:42 PM EDTUpdated 19 hours ago

R&D

Biogen hit by ALS setback with PhIII failure for tofersen — but follows a familiar strategy highlighting the positive

John Carroll

Editor & Founder

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Venture Analyst

Sofinnova

Menlo Park, CA, USA

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October 18, 2021 08:23 AM EDTUpdated 10:46 AM

Manufacturing

Two drugmakers hit with PDUFA date delays from FDA amid backlog of inspections

Josh Sullivan

Associate Editor

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

October 18, 2021 07:30 AM EDTUpdated 01:29 PM

R&D

Cell/Gene Tx

Vertex gets much-needed win with ‘extraordinary’ first patient results on potential diabetes cure

Jason Mast

Editor

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Thomas Lingelbach, Valneva CEO

October 18, 2021 07:13 AM EDTUpdated 08:29 AM

R&D

Coronavirus

Small biotech says its Covid-19 vaccine spurs more antibodies than AstraZeneca’s. Will supply deals come now?

Amber Tong

Senior Editor

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

October 16, 2021 06:00 AM EDT

Weekly

Covid-19 vaccine boosters earn big thumbs up, but Moderna draws ire over world supply; What's next for Merck’s Covid pill?; The C-suite view on biotech; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Venture Associate

Sofinnova

Menlo Park, CA, USA

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October 15, 2021 10:21 AM EDTUpdated 11:05 AM

R&D

Novartis development chief John Tsai: 'We go deep in the new platforms'

John Carroll

Editor & Founder

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

October 18, 2021 04:00 PM EDT

Financing

Crinetics spins out radiopharma efforts into a new company, highlighting the growing field's allure

Max Gelman

Editor

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.