As GSK and Sanofi promise to produce a Covid-19 vaccine at Indy 500 speed, some experts start to push back on timelines

April 14, 2020 04:11 PM EDT

As GSK and Sanofi promise to produce a Covid-19 vaccine at Indy 500 speed, some experts start to push back on timelines

John Carroll

Editor & Founder

GlaxoSmithKline and Sanofi turned a few heads today as the two giant vaccine rivals joined hands and technologies as they set off on what they promised would be a lightning-fast development program for a new Covid-19 vaccine — something billions of people around the world have been devoutly praying for.

But this latest promise to move mountains and do something that would have been widely considered impossible just 2 months ago is beginning to garner some pushback from skeptics who believe these players are probably making promises they can’t keep.

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Biotech and Big Pharma: A blueprint for a successful partnership

Noël Brown

Managing Director and Head of US Biotechnology Investment Banking

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

October 25, 2021 06:32 AM EDTUpdated 07:01 AM

R&D

Novartis' second attempt to replicate a stunning cancer result falls flat

Jason Mast

Editor

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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October 26, 2021 08:03 AM EDTUpdated 10:45 AM

China

In Focus

How China turned the tables on biopharma's global dealmaking

Amber Tong

Senior Editor

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

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October 26, 2021 10:23 AM EDT

R&D

Pharma

Novartis dumps AveXis program for Rett syndrome after failing repeat round of preclinical testing

Paul Schloesser

Editorial Intern

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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October 26, 2021 07:16 AM EDTUpdated 07:51 AM

R&D

FDA+

FDA is much worse than its regulatory peers at proactively disclosing data, researchers find

Zachary Brennan

Senior Editor

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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October 26, 2021 10:58 AM EDTUpdated 11:27 AM

Manufacturing

As pressure to share technology mounts, BioNTech selects Rwanda for latest vaccine site

Josh Sullivan

Associate Editor

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

October 26, 2021 09:17 AM EDTUpdated 11:07 AM

R&D

UPDATED: Eli Lilly tosses a marquee pain drug and hits the gas on Alzheimer’s — as Biogen’s suffering opens market to rivals

John Carroll

Editor & Founder

Max Gelman

Editor

The furious chorus of critics that brought sales of Biogen’s ultra controversial Alzheimer’s drug aducanumab (sold as Aduhelm) to a near halt is opening up some big opportunities for a major league rival that has long sought the lead role in this largely untapped megamarket.

In its Q3 update today, Eli Lilly — noted for its dogged persistence in attempting for years to get solanezumab across the FDA finish line — said that it has begun a rolling submission of its rival Alzheimer’s drug donanemab in search of an accelerated approval. Anne White, senior VP of Lilly’s neuroscience unit, acknowledged during the investor call the challenges Biogen has faced with uptake and noted Lilly may face similar hurdles.

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Aaron Siri, Siri & Glimstad

October 26, 2021 07:29 AM EDT

Coronavirus

FDA shuts down anti-vax lawyer's petition to end Moderna and J&J EUAs

Josh Sullivan

Associate Editor

Despite the efforts of a law firm leading the charge on the anti-vaccination movement, the emergency use authorization for Moderna and J&J’s Covid-19 vaccines will not be revoked, the agency said in a response letter Monday.

The FDA said so in a letter to an anti-vax lawyer based in New York City. Aaron Siri, from Siri & Glimstad, requested in a formal petition that the EUAs granted to Moderna and J&J be revoked after weeks of back-and-forth email correspondence with Peter Marks, Lorrie McNeill and others at the FDA.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

October 26, 2021 07:17 AM EDT

Deals

With Sandoz continuing to drag on Novartis, Vas Narasimhan says he may finally be ready for a sale or spinoff

John Carroll

Editor & Founder

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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