Brazil health minister Marcelo Queiroga [DIDA SAMPAIO/ESTADAO CONTEUDO (Agencia Estado via AP Images)]

Covid-19 roundup: Brazil backs out of Sput­nik V vac­cine deal; White House im­ple­ments new mask, vac­cine man­dates

In March, Brazil’s gov­ern­ment signed a con­tract with Rus­sia for 10 mil­lion dos­es of the Sput­nik V vac­cine. Now, the coun­try is back­ing out of that agree­ment with its health min­is­ter cit­ing a lapsed reg­is­tra­tion dead­line as the rea­son why.

Brazil is bat­tling one of the tough­est out­breaks in the world. There has been a re­cent drop in dai­ly cas­es, but the coun­try is still see­ing a sev­en-day av­er­age of over 45,000 in­fec­tions.

Health min­is­ter Marce­lo Queiroga said the lapsed dead­line in the reg­is­tra­tion process with health reg­u­la­tor An­visa — whose emer­gency ap­proval is need­ed — was to blame, and added the na­tion­al im­mu­niza­tion pro­gram doesn’t cur­rent­ly need the Russ­ian vac­cine, Reuters re­port­ed.

Queiroga al­so can­celed a $316 mil­lion con­tract for 20 mil­lion dos­es of Co­v­ax­in, the jab made by In­dia’s Bharat Biotech. Bharat is be­ing in­ves­ti­gat­ed over ac­cu­sa­tions of ir­reg­u­lar­i­ties, ac­cord­ing to Reuters.

Brazil has had near­ly 20 mil­lion Covid-19 cas­es and 554,000 deaths since the start of the pan­dem­ic.

White House im­ple­ments mask man­date in­side fed­er­al build­ings, vac­cine man­date for work­ers

Urg­ing in a speech that a mask is not a po­lit­i­cal state­ment and warn­ing the coun­try was not yet out of the woods, US Pres­i­dent Joe Biden en­act­ed a vac­ci­na­tion man­date for all fed­er­al em­ploy­ees Thurs­day.

The move comes af­ter civil­ian hos­pi­tals and the De­part­ment of Vet­er­an Af­fairs have an­nounced their own man­date. Any fed­er­al em­ploy­ee who is not vac­ci­nat­ed will be re­quired to wear a mask and be test­ed twice a week for work. Those em­ploy­ees will al­so not be able to trav­el for work. The same ini­tia­tives will be ap­plied to fed­er­al con­trac­tors.

“If you want to do busi­ness with the fed­er­al gov­ern­ment, get your work­ers vac­ci­nat­ed,” he said.

All vis­i­tors to fed­er­al build­ings will al­so have to wear a mask in­doors, Biden said. The up­date comes along with the CDC’s rec­om­men­da­tion to wear a mask in­side a pub­lic place, such as the gro­cery store or the work­place. The in­crease of cas­es of the Delta vari­ant, which orig­i­nat­ed in In­dia, has raised cause for con­cern, as a vac­ci­nat­ed per­son who is pro­tect­ed from se­vere ill­ness could still pass on the vari­ant to an un­vac­ci­nat­ed per­son.

“The bot­tom line is: If you’re ful­ly vac­ci­nat­ed, you’re high­ly pro­tect­ed from COVID-19,” Biden said. “But I al­so know that many of you who are vac­ci­nat­ed are con­cerned about what’s called ‘break­through cas­es.’ Yes, some ful­ly vac­ci­nat­ed peo­ple will still test pos­i­tive, and some will show some symp­toms of COVID-19. That’s ex­pect­ed with al­most every vac­cine there is for oth­er dis­eases.”

The fed­er­al gov­ern­ment will now re­im­burse small-to-medi­um sized busi­ness­es that of­fer em­ploy­ees paid time off to get vac­ci­nat­ed them­selves, or to bring their fam­i­ly mem­bers to get vac­ci­nat­ed. It’s al­so of­fer­ing $100 to any­one who gets ful­ly vac­ci­nat­ed.

“I know that pay­ing peo­ple to get vac­ci­nat­ed might sound un­fair to folks who’ve got­ten vac­ci­nat­ed al­ready, but here’s the deal: If in­cen­tives help us beat this virus, I be­lieve we should use them,” Biden said.

About 190 mil­lion Amer­i­cans have had at least one shot, and more than 163 mil­lion of those peo­ple have re­ceived both. Still, less than 50% of Amer­i­cans have got­ten the shot. Biden al­so de­fin­i­tive­ly told Amer­i­cans that there is no need for boost­er shots at this mo­ment. But if the sci­ence in­di­cates oth­er­wise in the fu­ture, his stance on that will change.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection:

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).