Covid-19 roundup: As­traZeneca pub­lish­es da­ta on blood clots as­so­ci­at­ed with vac­cine; Glax­o­SmithK­line and Vir ink mAb sup­ply deal with EU

Thir­teen cas­es of throm­bo­sis with throm­bo­cy­tope­nia syn­drome in re­cip­i­ents of the As­traZeneca Covid-19 vac­cine have led to a num­ber of coun­tries paus­ing its au­tho­riza­tion. On Wednes­day, the UK drug­mak­er pub­lished cor­re­spon­dence in The Lancet show­ing that the es­ti­mat­ed rate of TTS in pa­tients who take their first dose of Vaxzevria is 8.1 per mil­lion, com­pared to 2.3 per mil­lion for those two weeks af­ter the sec­ond dose.

EU reg­u­la­tors have been look­ing in­to TTS cas­es since March, and found a link be­tween Vaxzevria and J&J’s vac­cine. As a re­sult, many gov­ern­ments have is­sued tem­po­rary holds on us­ing the vac­cine. In May, the EMA rec­om­mend­ed against re­ceiv­ing a sec­ond As­traZeneca shot for peo­ple who re­port TTS af­ter the first.

As­traZeneca said that 13 cas­es of TTS were iden­ti­fied af­ter the sec­ond dose, oc­cur­ring 1–13 days post-vac­ci­na­tion, in­clud­ing 8 in­di­vid­u­als with pul­monary em­bolism, co-oc­cur­ring with cere­bral ve­nous si­nus throm­bo­sis in two in­di­vid­u­als; one in­di­vid­ual with CVST oc­cur­ring alone; one in­di­vid­ual with deep vein throm­bo­sis; one in­di­vid­ual with throm­bot­ic stroke; and two in­di­vid­u­als with un­spec­i­fied em­bolisms.

Near­ly 400 cas­es of TTS were re­port­ed af­ter the first dose of the shot. — Josh Sul­li­van

GSK and Vir ink sup­ply deal with EU

Glax­o­SmithK­line and Vir Biotech­nol­o­gy have signed an agree­ment with the Eu­ro­pean Com­mis­sion to sup­ply up to 220,000 dos­es of sotro­vimab, its sin­gle-dose mAb to treat Covid-19 pa­tients ages 12 and up.

The joint pro­cure­ment agree­ment al­lows the EU to quick­ly buy dos­es of the drug to treat pa­tients. Sotro­vimab is for pa­tients who don’t need oxy­gen sup­ple­men­ta­tion who are at risk of pro­gress­ing to a more se­vere case of Covid-19.

In a state­ment, Vir CEO George Scan­gos said that it is clear that the world will need more treat­ment op­tions to curb the pan­dem­ic. It has main­tained suc­cess against vari­ants of the virus, in­clud­ing Delta and Lamb­da, he said. The two com­pa­nies reached a sim­i­lar sup­ply agree­ment in Sin­ga­pore at the end of June.

The com­pa­ny plans to sub­mit a bi­o­log­ics li­cense ap­pli­ca­tion to the FDA in the sec­ond half of this year, fol­low­ing its EUA in May. Sotro­vimab has al­so been grant­ed emer­gency use au­tho­riza­tion in Bahrain, Kuwait, Qatar, Sin­ga­pore and the UAE. — Zachary Bren­nan

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).