Illustration: Assistant editor Kathy Wong for Endpoints News

Covid-19 spurred a his­toric vac­cine R&D ef­fort. What does it mean for fu­ture pan­demics?

In the historic campaign to vaccinate the world against Covid-19, Corbevax was far from the first vaccine to reach the market. While the first mRNA shot became available 326 days after the SARS-CoV-2 virus was sequenced, the journey of Corbevax — which has so far gone into the arms of 75 million kids in India and recently won approval for adults — spanned about 600 days.

But Peter Hotez, one of its co-inventors, believes it could’ve played out differently if his team had received more funding and there was a smoother regulatory path.

“That could have been probably cut in half had we had the support to move faster,” said Hotez, the co-director of the Texas Children’s Hospital Center for Vaccine Development.

There was good reason to go faster. The mad scramble for life-saving shots exposed the stark disparities between the vaccine haves and have-nots. Corbevax, a patent-free vaccine based on older but proven technology, can be affordably produced and distributed to lower-income countries.

The Corbevax story is relevant to a bigger question as the world attempts to strengthen vaccine research and development infrastructure to go even faster and more equitably distribute vaccines. Vexing scientific, regulatory and manufacturing challenges must be solved ahead of the next pandemic, public health experts and advocacy group representatives said in interviews.

The Coalition for Epidemic Preparedness Innovations, or CEPI, which launched in 2017 in the wake of the Ebola outbreak in West Africa, has proposed what it calls a moonshot goal of spurring a vaccine against a new pandemic-causing pathogen in 100 days. The initiative is known as the 100 Days Mission.

Melanie Saville, CEPI’s executive director of vaccine R&D, reckons the group would’ve been “laughed out of the room” if they had told people before the Covid-19 pandemic that a vaccine would arrive within 326 days – but already there’s a path to going faster.

“If you actually put everybody’s innovation together from Covid-19, we already probably could shave off two months by looking meticulously at every step of the process,” she said, citing a CEPI analysis based on interviews with companies, international organizations, regulatory agencies, academia and the media.

To get to 100 days, though, much more needs to be done. The key is to do as much of it upfront as possible, she added, during so-called peacetime, much like decades-long RNA research ushered in the first Covid-19 vaccines.

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Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.

Senate health committee chair Bernie Sanders (D-VT) and Moderna CEO Stéphane Bancel (Tom Williams/CQ Roll Call via AP Images)

Mod­er­na CEO de­fends Covid-19 vac­cine price change at Sen­ate com­mit­tee grilling

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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