→ Less than two months af­ter Ger­man biotech BioN­Tech raised a her­culean $325 mil­lion in an up­sized round of fi­nanc­ing — the Bill and Melin­da Gates Foun­da­tion have signed a pact with the com­pa­ny, mak­ing an ini­tial eq­ui­ty in­vest­ment of $55 mil­lion to de­vel­op vac­cine and im­munother­a­py can­di­dates to pre­vent HIV and tu­ber­cu­lo­sis. To­tal fund­ing un­der the deal could hit $100 mil­lion, via po­ten­tial grant fund­ing from the foun­da­tion, BioN­Tech said on Wednes­day.

→ BeiGene, a pi­o­neer and dar­ling of the grow­ing US-Chi­na biotech crowd, was the sub­ject of a fe­ro­cious short re­port pub­lished by J Cap­i­tal on Thurs­day. Shares fell rough­ly 9% on both the Nas­daq $BGNE and the Hong Kong stock ex­change (06160) on al­le­ga­tions that the com­pa­ny faked sales of the Cel­gene drugs it’s in charge of mar­ket­ing in Chi­na, in­vest­ed in bo­gus man­u­fac­tur­ing sites, and over­spent on wages for R&D staff. Tim Mur­ray, au­thor of the re­port, fur­ther ac­cused ex­ecs of “pump­ing and dump­ing,” talk­ing up BeiGene’s stand­ing with Chi­nese drug reg­u­la­tors and po­ten­tial for its drugs while covert­ly sell­ing off their own stock.

In a state­ment to the HKEX, BeiGene called the al­le­ga­tions “in­ac­cu­rate, un­found­ed and mis­lead­ing” as well as “bla­tant­ly false.”

“From its in­cep­tion, BeiGene has op­er­at­ed with an un­wa­ver­ing com­mit­ment to com­pli­ance, ethics, and in­tegri­ty,” it wrote. “BeiGene re­mains fo­cused on its mis­sion to build a bio­phar­ma­ceu­ti­cal com­pa­ny that will pro­vide the high­est qual­i­ty ther­a­pies to the great­est num­ber of pa­tients around the world.”

→ No­var­tis $NVS is palm­ing off a Chi­na-based unit for $790 mil­lion yuan (about $110.5 mil­lion), ac­cord­ing to a Wednes­day re­port by Dow Jones. The plant, which was opened a decade ago, was sold to Chi­na’s Zhe­jiang Ji­uzhou, ex­clud­ing the Swiss drug­mak­er’s tech­nol­o­gy and drug-de­vel­op­ment as­sets. The ac­qui­si­tion will help Zhe­jiang Ji­uzhou ce­ment its po­si­tion as a strate­gic sup­pli­er to No­var­tis, not­ed the re­port.

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.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Tobacco giant Philip Morris now has crossed the 50% threshold it needs for shareholder backing for its controversial, $1.5 billion takeover of asthma inhaler maker Vectura.

Investors have accepted a $2.28-per-share offer from the company behind Marlboro cigarettes, according to Sky News — and those investors represent nearly 75% of the company’s shares.

Acquiring the British inhaler maker is only a part of Philip Morris’ long term plan to develop “smoke-free” products, with a desire to ultimately become a “broader healthcare and wellness” company.