AbbVie touts new data for Humira successor; Gilead inks discovery deal

June 13, 2019 10:09 AM EDT

AbbVie touts new data for Humira successor; Gilead inks discovery deal

Endpoints Staff

→ AbbVie is touting new positive data comparing their aging blockbuster Humira with their hoped-for blockbuster upadacitinib. Over 48 weeks a larger proportion of patients taking the experimental drug experienced clinical remission than in the control arm with Humira. Their drug brought in $20 billion last year, topping the scales in the number 1 slot.

→ Gilead has turned to Vancouver-based AbCellera for its latest discovery deal. AbCellera will use its know-how in “single-cell screening of natural immune sources” to find antibody candidates for Gilead to pursue in the infectious disease field. The deal includes an upfront and milestones.

→ Mereo BioPharma $MREO notes that Celgene has informed the company that they won’t be licensing etigilimab, the anti-TIGIT antibody, one of two product candidates Mereo acquired through its April 2019 merger with OncoMed. The drug is up on the auction block in case you’re interested.

AUTHOR

Endpoints Staff

editor@endpointsnews.com

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.

The flu virus (CDC)

November 24, 2020 07:52 AM EST

Pharma

Regulatory

Roche tacks on another Xofluza indication as flu season meets pandemic

Nicole DeFeudis

Associate Editor

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

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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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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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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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

November 23, 2020 08:04 PM ESTUpdated 08:50 PM

Pharma

Regulatory

Alnylam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

John Carroll

Editor & Founder

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

November 23, 2020 11:52 AM ESTUpdated 02:51 PM

Startups

Bob Nelsen raises $800M and recruits a star-studded board to build the 'Foxconn' of biotech

Jason Mast

Associate Editor

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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November 23, 2020 11:07 AM EST

News Briefing

News briefing: AbbVie partner Teneobio expands tech license with CAR-T player Poseida; Argenx buys PRV from Bayer for $98M

Amber Tong

Editor

Max Gelman

Associate Editor

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.