Biogen staffer fled to China in search of emergency Covid-19 testing, care — and now faces criminal charges

Beijing Capital International Airport (Shutterstock)

March 16, 2020 10:16 AM EDTUpdated 03:14 PM

Biogen staffer fled to China in search of emergency Covid-19 testing, care — and now faces criminal charges

Amber Tong

Editor

A Biogen employee who has contracted Covid-19 in Massachusetts fled to Beijing alongside her family. And now she faces criminal charges for lying about her condition on the way back.

The company confirmed to Endpoints News that the woman, identified by Chinese officials as Ms. Li, works for the company but said she didn’t attend the strategy meeting in Boston that gave rise to a cluster of coronavirus cases.

“We believe Ms. Li is a U.S. based Biogen employee who made a personal decision to travel to China,” a spokesperson wrote in an email. “We are deeply dismayed by the situation as reported by the media in China.”

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Nick Galakatos, Blackstone global head of life sciences

July 10, 2020 06:28 AM EDTUpdated 10:00 AM

Venture

Deals

Nick Galakatos and the Blackstone team now have a record $4.6B to invest in biopharma, with a big focus on pushing companies over the top

John Carroll

Editor & Founder

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

July 7, 2020 07:49 AM EDTUpdated 08:49 AM

R&D

Coronavirus

OWS shifts spotlight to drugs to fight Covid-19, handing Regeneron $450M to begin large scale manufacturing in the US

John Carroll

Editor & Founder

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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July 8, 2020 08:11 AM EDTUpdated 11:09 AM

R&D

Biogen shares spike as execs complete a delayed pitch for their controversial Alzheimer's drug — the next move belongs to the FDA

John Carroll

Editor & Founder

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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July 10, 2020 09:48 AM EDTUpdated 12:37 PM

R&D

Coronavirus

Gilead boasts of positive remdesivir data on mortality — but their analysis provokes the skeptics

Jason Mast

Associate Editor

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

July 10, 2020 07:18 AM EDTUpdated 09:40 AM

Coronavirus

Covid-19 roundup: BioNTech going head-to-head with Moderna as PhIII mRNA launch looms; Trial on Shinzo Abe’s once-favorite antiviral is inconclusive

Jason Mast

Associate Editor

John Carroll

Editor & Founder

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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July 9, 2020 06:29 AM EDTUpdated 07:43 AM

Coronavirus

Covid-19 roundup: CDC debating who should get first available vaccines; EU in Gilead talks after US gobbled first remdesivir doses

Jason Mast

Associate Editor

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

July 8, 2020 03:03 PM EDT

Bioregnum

R&D

Coronavirus

A new study points to $6.5B in public support building the scientific foundation of Gilead's remdesivir. Should that be reflected in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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ENDPOINTS CAREERS

Head of Biology

Orum Therapeutics

Cambridge, MA

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July 8, 2020 07:45 AM EDTUpdated 04:02 PM

Coronavirus

Covid-19 roundup: Moderna sticks to July for its Phase III as rumors swirl; Following US lead, EU buys up Covid-19 treatments

Max Gelman

Jason Mast

Associate Editor

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

July 8, 2020 02:32 AM EDTUpdated 06:49 PM

Coronavirus

Trump and Navarro press again for hydroxychloroquine. Can the FDA stay independent?

Jason Mast

Associate Editor

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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