Coronavirus channel feed

Stephen Hahn, FDA commissioner (AP Images)

FDA touts ad­vanced man­u­fac­tur­ing to ad­dress Covid-19 short­falls

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the Covid-19 pandemic, Stephen Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website.

“The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures,” Hahn and Shah wrote. “The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.”

Scott Gottlieb (Getty Images)

Covid-19 roundup: FDA com­mis­sion­ers call for more ‘con­cert­ed ef­fort’ on con­va­les­cent plas­ma R&D; Re­gen­eron boosts case for an­ti­body cock­tail with new an­i­mal da­ta

Four former FDA commissioners have coalesced around a century-old treatment they believe can give the best weapon against Covid-19: Convalescent plasma.

Writing in The Washington Postformer FDA commissioners Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb said that while more work needs to be done to prove it’s safe and effective, convalescent plasma was a “promising treatment” that “could help millions of patients with the novel coronavirus both here and abroad.” They warned, though, that for it to become an effective tool in the US’ Covid-19 response, a more “concerted effort” is needed to recruit donors and run trials.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

Sanofi and GSK say they're near a vac­cine deal with EU hours af­ter fi­nal­iz­ing Warp Speed con­tract

On the heels of landing the largest Warp Speed contract to date, Sanofi and GlaxoSmithKline continued to make moves Friday afternoon.

The two companies announced they are in advanced discussions with the EU to supply up to 300 million doses of their Covid-19 vaccine candidate, coming just a few hours after securing their $2.1 billion deal with the US. Should the agreement be finalized, all EU member states will have the option to purchase the vaccine.

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President Trump speaks during an event to sign executive orders on lowering drug prices, July 24, 2020 (Alex Brandon/AP Images)

Trump’s ‘rad­i­cal’, ‘hor­ri­ble’ ex­ec­u­tive or­ders on drug pric­ing earn a C-suite back­lash this week — with one threat to do more over­seas

Once the pandemic erupted in the US, Big Pharma enjoyed a brief period of detente — if not actually warm relations — with the Trump administration.

After years of criticizing high drug prices and threatening legislation that would curb the industry’s pricing freedom, the president warmly encouraged the industry’s commitment to a pell mell race to new vaccines and drugs to fight Covid-19 — often at speeds that would have been considered impossible back in January. And it raised the possibility that biopharma could finally find a way to achieve some kind of popularity after years of public toxicity.

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Elizabeth Nabel speaks at a news conference, Oct. 7, 2019 (Elise Amendola/AP Images)

Brigham and Wom­en's pres­i­dent Eliz­a­beth Nabel fol­lows Mon­cef Slaoui off Mod­er­na's board

Amid recent scrutiny on how Moderna’s top executives have been cashing out their increasingly valuable shares, the biotech is parting ways with a board member who’s also heading a hospital where its Covid-19 vaccine is being tested.

Elizabeth Nabel — the president of Brigham and Women’s Hospital — has followed in Moncef Slaoui’s footsteps in resigning from Moderna’s board of directors. She took the role in 2015, two years before the Operation Warp Speed leader did; and as with Slaoui and MIT professor Robert Langer, her term was due to expire in 2021.

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Covid-19 roundup: Roger Perl­mut­ter hus­tles up hu­man vac­cine tri­als as Mer­ck looks to catch up on Covid-19; Chi­na hacked Mod­er­na, per of­fi­cial

Merck, the latecomer to the Covid-19 vaccine race, said today that it will push its first candidate into the clinic this quarter and move the other one there by the end of the year.

They are likely going to be single-dose regimens, Merck noted, as opposed to the prime-boost approach being adopted in Phase III studies by Moderna, Pfizer/BioNTech and AstraZeneca/Oxford.

For the first time since the company threw its name into the hat with one licensing deal and an acquisition, R&D chief Roger Perlmutter also offered his thoughts on how the frontrunners are doing, why he didn’t go with an mRNA approach despite a longstanding partnership with Moderna, and what gaps Merck’s programs might fill.

Paul Hudson, AP Images

Sanofi and GSK grab largest Warp Speed deal yet, se­cur­ing $2.1B for a vac­cine that might come next year

Sanofi and GlaxoSmithKline have become the latest members of Operation Warp Speed, landing a $2.1 billion contract to scale up manufacturing for a vaccine that is on track for completion next year. The deal secures the US 100 million doses, with an option for 500 million more.

It is the largest contract the White House has given yet in its hunt to make 300 million doses of a vaccine available to the US public by January, although Sanofi has not committed to supply vaccines by that time, potentially opening the door for other developers with longer development paths to gain funding. The cash will help Sanofi scale the vaccine, which combines their recombinant DNA technology with GSK’s immune-boosting adjuvant, to a billion doses next year.

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