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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Implementing resilience in the clinical trial supply chain

Nina Vas

Vice President, Clinical Distribution, Cell and Gene Supply Chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

November 23, 2020 05:43 AM ESTUpdated 02:00 PM

Coronavirus

UPDATED: AstraZeneca, Oxford on the defensive as skeptics dismiss 70% average efficacy for Covid-19 vaccine

Amber Tong

Editor

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

November 24, 2020 09:58 AM ESTUpdated 11:20 AM

R&D

Vas Narasimhan's 'Wild Card' drugs: Novartis CEO highlights potential jackpots, as well as late-stage stars, in R&D presentation

Max Gelman

Associate Editor

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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November 23, 2020 07:27 AM EST

Deals

Coronavirus

In final days at Merck, Roger Perlmutter bets big on a little-known Covid-19 treatment

Jason Mast

Associate Editor

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

November 23, 2020 06:32 AM EST

Regulatory

Coronavirus

Trailing Eli Lilly by 12 days, Regeneron gets the FDA OK for their Covid-19 antibody cocktail

Jason Mast

Associate Editor

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

November 24, 2020 11:14 AM EST

R&D

Genmab axes an ADC development program after the data fail to impress

John Carroll

Editor & Founder

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

November 24, 2020 08:37 AM EST

Bioregnum

Regulatory

The aducanumab conundrum: The PhIII failed a clear regulatory standard, but no one is certain what that means anymore at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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November 24, 2020 07:38 AM EST

Pharma

Coronavirus

A poll suggests vaccine data boosted Pfizer's public image, but other data point to long road ahead

Jason Mast

Associate Editor

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

November 24, 2020 07:38 AM EST

Coronavirus

Covid-19 roundup: Russia prices vaccine 'two or more times cheaper' than mRNA shots; Sinovac PhIII data expected in early December

Amber Tong

Editor

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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