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STAT Plus: In a blow to Catalyst, judge recommends tossing its lawsuit against FDA

Fri, 07/31/2020 - 09:49

A federal court judge recommended tossing out a lawsuit filed by Catalyst Pharmaceuticals (CPRX) that accused the Food and Drug Administration of violating the law when it approved a similar medicine by a small, family-run rival company.

The move is a blow to Catalyst in its unusual battle with the agency, which has raised thorny questions about regulatory standards and the vagaries of orphan drug designations, while also playing into the heated national debate over the rising cost of prescription medicines. Investors sent its stock down nearly 12% in mid-day trading on the news.

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Ginkgo Bioworks, Mammoth Biosciences among winners of NIH’s ‘Shark Tank’ for Covid-19 tests 

Fri, 07/31/2020 - 08:00

The National Institutes of Health selected Ginkgo Bioworks, Mammoth Biosciences, Quidel, and four other companies to receive nearly $250 million to develop new Covid-19 diagnostic tests through its Rapid Acceleration of Diagnostics program, the agency announced Friday.

Three of the tests are intended to be processed at pharmacies or doctor’s offices; four are tests meant to be run in clinical labs. The money is coming from a $1.5 billion pot allocated to the NIH in April through the same law that created the Paycheck Protection Program.

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STAT Plus: Up and down the ladder: The latest comings and goings

Fri, 07/31/2020 - 07:26

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Cellectis (CLLS) hired Steve Doares as senior vice president of U.S. manufacturing and site head of the Raleigh, N.C., manufacturing plant. Previously, he worked at Biogen (BIIB), where he was vice president, global manufacturing science.

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STAT Plus: Pharmalittle: U.S. hands Glaxo and Sanofi $2.1 billion for a Covid-19 vaccine; Moderna director resigns over conflict concerns

Fri, 07/31/2020 - 06:16

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, not surprisingly, is rather modest. We plan to tackle sundry chores, catch up on some reading and promenade with the official mascot. And what about you? This is a lovely time of year to enjoy the great outdoors. You could reach out to someone who is feeling isolated these days. You could also plan ahead to make sure you are registered to vote, however you may cast your ballot. Well, whatever you do, have a grand time. But be safe — wear a mask. Enjoy, and see you soon. …

Elizabeth Nabel, president of Brigham and Women’s Hospital, is resigning from the Moderna (MRNA) board in response to questions about whether her role at the biotech is a conflict of interest since her hospital is participating in a large study of Moderna’s experimental Covid-19 vaccine that just began, The Boston Globe reports. The study is being led partly by a Brigham infectious diseases specialist, who also is helping to run the nationwide testing.

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STAT Plus: CytoDyn CEO claims Covid-19 drug success while describing data suggesting study failure

Fri, 07/31/2020 - 05:26

CytoDyn CEO Nader Pourhassan used a conference call on Thursday evening to claim success with the company’s experimental Covid-19 drug — but his description of the clinical data, if true, suggests the drug didn’t meet the study’s primary goal.

In disjointed comments to investors, Pourhassan insisted that leronlimab delivered “positive efficacy results” in the Covid-19 study. CytoDyn intended to quickly submit the “strong results” to the Food and Drug Administration and expected to win approval for leronlimab as a new treatment for Covid-19, he added.

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Sanofi and GSK land $2.1 billion deal with U.S. for Covid-19 vaccine development and 100 million doses

Fri, 07/31/2020 - 04:00

The U.S. government’s Operation Warp Speed effort will provide up to $2.1 billion to Sanofi and GlaxoSmithKline to fund development and manufacturing of the companies’ experimental Covid-19 vaccine, the companies announced Friday.

As part of the agreement, the companies will provide the U.S. with 100 million doses of the vaccine, which will begin human trials in September. As with other vaccines in development, the Sanofi-GSK vaccine, if effective, may require two doses. The U.S. will have the option to procure up to 500 million doses; the companies say they are gearing up to be able to make 1 billion doses annually.

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Opinion: A Covid-19 vaccine, amazingly, is close. Why am I so worried?

Fri, 07/31/2020 - 01:45

A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a having a vaccine to fight it. Moderna and the National Institutes of Health recently announced the start of a Phase 3 clinical trial, joining several others in a constructive rivalry that could save millions of lives.

It’s a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements.

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Opinion: The curious link between kids’ birthdays and their getting the flu vaccine

Fri, 07/31/2020 - 01:40

Getting the influenza vaccine will be even more important for adults and children this fall because of the Covid-19 pandemic. Flu experts at the Centers for Disease Control and Prevention state that “it’s likely that flu viruses and the virus that causes Covid-19 will both be spreading. In this context, getting a flu vaccine will be more important than ever.” That’s because hospitalizations for influenza can stress hospital capacity even without a pandemic.

But in a disturbing trend, rates of routine childhood vaccination appear to have fallen dramatically in the U.S. during the coronavirus pandemic. That’s understandable: Americans have been asked to stay home and not go to their doctors’ offices unless it was absolutely necessary, though at the same time the CDC, physician groups, and medical practices urged parents to bring in their children to be vaccinated, something that can be done safely during the pandemic.

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STAT Plus: The drug industry’s new tactic in Washington: calling Trump’s bluff 

Fri, 07/31/2020 - 01:35

WASHINGTON — The pharmaceutical industry has sparred with President Trump for four years over drug pricing. Now it’s taking its biggest gamble yet: calling the president’s bluff.

The most brazen move came this week: Unlike most CEOs, who jump at the chance to visit the White House, pharmaceutical executives — newly empowered by their high-profile efforts to respond to the coronavirus and fed up with President Trump’s repeated threats — responded to his latest invitation with open contempt.

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Medical nonprofits forced to scale back as the pandemic upends their fundraising

Fri, 07/31/2020 - 01:30

Medical charities have long relied on black-tie galas, golf tournaments, and bike-a-thons to fund their operations.

But as with so many other in-person events, Covid-19 has cancelled those plans this year, leaving nonprofits with a funding shortfall that has forced them to cut staff, end grant funding, scale back activities, and in at least one case, shut down entirely.

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STAT Plus: Prominent hospital president resigns from Moderna board after conflict of interest questions raised

Thu, 07/30/2020 - 14:34

Dr. Elizabeth Nabel, president of Brigham and Women’s Hospital, said Thursday she was resigning from Moderna’s board of directors after the Globe inquired about whether her role at the Cambridge biotech company was a conflict of interest with her hospital’s participation in a large study of Moderna’s experimental COVID-19 vaccine that just got underway.

The hospital said in a statement Thursday that when Nabel joined Moderna’s board in 2015, Brigham and Women’s parent company put several guardrails in place to prevent a conflict of interest. More safeguards were imposed when the hospital was named one of 87 clinical sites for the late-stage trial trial that began Monday, it said. The study is being led partly by a Brigham infectious diseases specialist, who also is helping to run the nationwide testing.

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Listen: Inside the NBA bubble, a DIY coronavirus vaccine, and the real VC numbers

Thu, 07/30/2020 - 12:02

How much should a Covid-19 vaccine cost? What can basketball teach us about pandemic safety? And just how lucrative is venture capital?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We start with a lightning round covering the cost of Covid-19 vaccines, the latest from billionaire entrepreneur Patrick Soon-Shiong, and a DIY coronavirus prevention effort. Then, Boston Globe basketball reporter Gary Washburn joins us to discuss life inside the NBA’s Florida bubble and what it might mean for professional sports in the U.S. Finally, STAT’s Kate Sheridan calls in to discuss her work uncovering the financial performance of big-name biotech venture funds.

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STAT Plus: Pharmalittle: Drug makers build Covid-19 vaccine supply chains; VCs are still spending on biotechs

Thu, 07/30/2020 - 06:31

Hello, everyone, and how are you today? We are doing just fine, thank you, despite the hazy skies and muggy temperatures enveloping the Pharmalot campus. Our solution is to cool off with a hot cup of stimulation. This might sound counter-intuitive, but see what happens and report back to us. What have you got to lose? Meanwhile, here are a few tidbits to get you started on your journey today. We hope all goes well, despite the tumult outside your door. Stay in touch and stay safe. …

Drug makers racing to develop Covid-19 vaccines are already working behind the scenes to build the supply chains needed to deliver their drugs to billions of people as rapidly as possible, The Wall Street Journal says. To serve global demand once a vaccine is approved, a complicated and high-stakes supply chain would kick into gear on a scale that the drug industry has rarely seen. The preparations involve lining up raw materials and factory capacity to manufacture a vaccine in large volumes, and equipment needed to transport many millions of doses at once through distribution channels that will be subject to tight security and temperature controls.

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Webinar: Inside the virtual care boom: What happens when the point of care becomes anywhere?

Thu, 07/30/2020 - 05:30

Editor’s note: A recording of the webinar presentation is included below.

Virtual care and digital health tools are soaring in popularity amid the Covid-19 pandemic. A growing number of patients are forgoing face-to-face visits and instead calling, texting, and video chatting with their clinicians. The rapid change could bring clear benefits, including making care more convenient and seamless care and easier to access. But what are the potential side effects — and what elements of the shift to virtual care will stick in a post-pandemic world? 

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STAT Plus: Coles-led Cerevel Therapeutics to raise $445 million to develop brain drugs with fewer side effects

Thu, 07/30/2020 - 04:00

Cerevel Therapeutics, a Boston neuroscience company spun out from Pfizer in 2018 and led by the well-known CEO Tony Coles, is going public.

The method of the public offering is somewhat unusual: Cerevel will raise roughly $445 million by merging with a public shell company launched by the hedge fund Perceptive Advisors in June— that shell company has already raised $130 million — and by raising a private investment from other investors to make up the rest of the amount.

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STAT Plus: Drug maker settles charges of offering ‘bogus’ research grants to boost use of its medicine

Thu, 07/30/2020 - 01:50

In the latest imbroglio involving drug makers and kickbacks, Pacira Biosciences (PCRX) has agreed to pay $3.5 million to resolve allegations of paying doctors bogus research grants to persuade them to prescribe its only medicine, the Exparel painkiller, which is used during various surgical procedures.

From late 2012 through early 2015, Pacira approved and funded the grants despite receiving little or no documented description of any proposed research and then conducted little to no follow up to ensure the work was being done, according to court documents filed by the Department of Justice. In some cases, grant recipients did not conduct any research, at all.

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Opinion: The nursing science behind nurses as coronavirus hospital heroes

Thu, 07/30/2020 - 01:45

The coronavirus pandemic has given nurses a rare moment in the media spotlight. They are being heralded as lifesaving heroes on the front lines of the pandemic. The Covid-19 fight is a team effort, but nurses have a unique role. In intensive care units, 86% of patient care time comes from nurses, while only 13% comes from physicians.

Nurses have always enjoyed public respect and are routinely rated the No. 1 most honest and ethical profession in the United States. But this moment in the media spotlight highlights how little most people truly understand about nursing.

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Opinion: Sexist and incomplete data hold back the world’s Covid-19 response

Thu, 07/30/2020 - 01:40

How many women have died of Covid-19?

How many women have lost their jobs in the economic crisis it created?

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STAT Plus: Venture capitalists are still showering biotechs with cash, even as the coronavirus upends markets 

Thu, 07/30/2020 - 01:35

Venture capitalists are still spending big on biotech companies, even four months after the coronavirus pandemic cratered global markets.

Venture capitalists have already signed 240 biotech deals this year, collectively worth more than $10 billion, according to a recent SVB analysis. The average valuation for those companies has also increased since January, despite concerns about the potential impact of clinical trial delays.

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‘A huge experiment’: How the world made so much progress on a Covid-19 vaccine so fast

Thu, 07/30/2020 - 01:30

Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19.

Just six months ago, when the death toll from the coronavirus stood at one and neither it nor the disease it caused had a name, a team of Chinese scientists uploaded its genetic sequence to a public site. That kicked off the record-breaking rush to develop vaccines — the salve that experts say could ultimately quell the pandemic.

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