Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Covid-19 roundup: Glax­o­SmithK­line man­dates vac­cines as lat­est phar­ma to join the push; South Africa's As­pen wants to li­cense J&J jab

Glax­o­SmithK­line will join the grow­ing list of biotechs that man­date vac­ci­na­tions for its US em­ploy­ees, and a com­pa­ny spokesper­son said it is look­ing in­to UK pol­i­cy as well.

Com­ple­men­tary work­ers and vis­i­tors to its sites will al­so need to be ful­ly vac­ci­nat­ed, the com­pa­ny said. The pol­i­cy will be put in­to place in the next few weeks, and ex­cep­tions will be made for those with dis­abil­i­ties, med­ical con­di­tions or re­li­gious ex­emp­tions.

“At GSK and Vi­iV, the health and safe­ty of our em­ploy­ees are of para­mount im­por­tance,” the com­pa­ny said in a state­ment. “To that end, we will now re­quire US em­ploy­ees to be ful­ly vac­ci­nat­ed against COVID-19, where al­lowed by law and where vac­cine sup­ply is read­i­ly avail­able.”

Just last week, Mod­er­na came down with a man­date for all of its US em­ploy­ees to get vac­ci­nat­ed by Oct. 1. Pfiz­er, Eli Lil­ly, J&J, Io­n­is Phar­ma, No­var­tis and Gilead have all in­stalled man­dates as well. A re­cent poll con­duct­ed by End­points News found that 79% of our read­ers agreed with a man­date. An­oth­er 51% of the mid-Au­gust poll said that their com­pa­ny had man­dat­ed vac­cines.

South Africa’s As­pen wants to li­cense J&J jab

A South African man­u­fac­tur­er of Covid-19 vac­cines that re­cent­ly got a big source of fund­ing from the US gov­ern­ment is look­ing to to get a li­cense to make the J&J jab.

Stephen Saad

As­pen Phar­ma­care’s CEO Stephen Saad told Reuters that he is look­ing to mod­el the busi­ness plan off of In­dia’s Serum In­sti­tute.

“At the mo­ment, J&J could take all the prod­uct we make be­cause it’s their prod­uct, and sell it to Eu­rope, for ex­am­ple, sell it to the U.S. or Ko­rea, wher­ev­er they choose to. We have no say in that,” he told Reuters.

The US gov­ern­ment dumped $200 mil­lion in­to As­pen’s plant in Gqe­ber­ha to ex­pand pro­duc­tion. But J&J has been ex­port­ing the mil­lions of dos­es that were bot­tled and pack­aged in South Africa to Eu­rope. It’s hap­pen­ing at a time when Africa is des­per­ate­ly need­ing to get shots in­to arms of its peo­ple. Just 2% of Africans are vac­ci­nat­ed, com­pared with more than 60% of adults in Eu­rope.

Saad went on CNN in Ju­ly and talked about build­ing up vac­cine ca­pac­i­ty for the con­ti­nent.

“You don’t have any ca­pac­i­ty, you don’t have any prod­uct. No one’s go­ing to sup­ply you prod­uct be­fore their own coun­try so at best you have your own ca­pac­i­ty,” Saad told CNN.

As­traZeneca and EU to set­tle vac­cine short­age out of court

Af­ter months of dis­put­ing the time­li­ness of As­traZeneca’s de­liv­ery of vac­cines to Eu­rope, the Eu­ro­pean Com­mis­sion and the drug­mak­er have reached a set­tle­ment and end­ed lit­i­ga­tion in Brus­sels.

The set­tle­ment leaves As­traZeneca com­mit­ting 60 mil­lion dos­es of Vaxzevria to the EU by the end of Q3 2021, and 75 mil­lion by the end of Q4. It al­so has an­oth­er 65 mil­lion shots on the books for Q1 2022.  Eu­ro­pean Com­mis­sion­er for Health and Food Safe­ty Stel­la Kyr­i­akides an­nounced the set­tle­ment on Twit­ter on Fri­day morn­ing.

“Vac­cine sol­i­dar­i­ty is and re­mains our trade­mark,” she tweet­ed.

The Eu­ro­pean Com­mis­sion filed a law­suit against the drug­mak­er in May, crit­i­ciz­ing it for a lack of a re­li­able plan to en­sure de­liv­er­ies.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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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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 rather narrow 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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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.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.