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Kim Blackwell, incoming CEO, Zentalis Pharmaceuticals

Pfiz­er-part­nered Zen­tal­is woos new CEO, cob­bles to­geth­er $200M

Ready to transform itself into a serious mid- to late-stage cancer player that could take on rivals as big as AstraZeneca, a Pfizer-partnered biotech is embracing some big changes.

Eli Lilly vet Kim Blackwell is succeeding Anthony Sun as CEO of Zentalis. Sun, a former VC at Aisling who co-founded Zentalis in 2015, will remain at the helm of its Asia-focused joint venture, Zentera.

Blackwell’s mandate will be to speed up the development of the two lead candidates. Zentalis has also raised $200 million from an underwritten offering that priced its stock at $19.38 per share.

Mene Pangalos, AstraZeneca EVP (via YouTube)

As­traZeneca, Avil­lion de­tail the piv­otal com­bo asth­ma da­ta they're tak­ing to the FDA

Months after touting some fuzzy top-line readouts, AstraZeneca and its biotech partner Avillion today are detailing the data they’re taking to regulators for its asthma drug.

The candidate PT027 is an inhaled, fixed-dose rescue medication containing albuterol, a common asthma treatment containing short-acting beta2-agonist (SABA), and budesonide — an inhaled and commonly used corticosteroid.

Chi­nese Alzheimer's drug­mak­er says lack of fund­ing, Covid out­break forced it to shut­ter in­ter­na­tion­al PhI­II

Green Valley Pharma, the Shanghai drugmaker that scored a stunning approval to market an Alzheimer’s drug in China two years ago, has shuttered a Phase III trial that would’ve paved its way to the FDA.

A lack of funding had forced its hand, according to the biotech, which said its commercial sales had withered amid a new Covid-19 outbreak in China. It tried to raise additional financing but was unable to due to “geopolitical circumstances and a chilly capital market for biomedical investments.”

Stay­ing in the back seat to Keytru­da, Bris­tol My­ers re­ports an­oth­er piv­otal set­back in urothe­lial can­cer

Just a few weeks after Bristol Myers Squibb and Nektar put the kibosh to their combo study of Opdivo and bempeg for metastatic urothelial cancer, one of the last big flameouts that convinced the pharma giant to squash their multibillion-dollar alliance, Bristol Myers is back with more bad news for the field.

Bumping into fresh trouble trying to move into a bigger position in frontline therapy, Bristol Myers reported that their Opdivo/Yervoy combo flopped in a Phase III study of first-line therapy for previously untreated patients with the most common form of bladder cancer. We don’t know the hard numbers yet, but the study — Checkmate-901 — failed to hit on overall survival.

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Roche's TIG­IT fall­out caus­es GSK and iTeos to re-think their own I/O can­di­date

Both GlaxoSmithKline and iTeos Therapeutics are going to take a hard look at their experimental TIGIT-targeting immunotherapy in the wake of Roche’s fail earlier this week.

EOS-448, an IgG1anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR), is being “reevaluated” by the partners, iTeos revealed in its first quarter financial report Thursday. And there may even be further delays going forward: According to an iTeos company spokesperson in an email to Endpoints News, the three registration-directed trials that were due to potentially kick off around the end of the year now will have to wait until next year.

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Jean-Christophe Tellier, UCB CEO

Quash­ing block­buster hopes, FDA spurns UCB’s IL-17 drug for plaque pso­ri­a­sis

After a months-long wait, UCB has finally heard back from the FDA regarding its plaque psoriasis drug. And the verdict is no.

The agency rejected the BLA for the IL-17 inhibitor, which is already approved in Europe, the UK, Japan, Canada and Australia. According to UCB, the complete response letter states that “certain pre-approval inspection observations must be resolved before approval of the application” — although it didn’t specify the problem.

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Eylea keeps its lead in the reti­nal space as physi­cians re­main hes­i­tant on Roche's Susvi­mo — re­port

Roche trumpeted a “major advancement” in the retinal space with the approval of its eye drug Susvimo last October, touting it as a more manageable option for patients with wet age-related macular degeneration. However, safety concerns leave some physicians hesitant.

While most ophthalmologists have heard of Susvimo — 86%, according to the latest Spherix survey of 76 doctors — only one in ten believe the benefits completely outweigh the risks. And a majority of the respondents said they’d turn to Regeneron’s Eylea as a safer and more accessible option.

Jennifer Doudna (Brian Ach/Getty Images for Wired)

Cari­bou aces its first round of hu­man da­ta in search of an off-the-shelf CAR-T break­through

Caribou Biosciences just flipped its first card on human data for its lead off-the-shelf anti-CD19 CAR-T, and it’s an ace.

The biotech reported out on a tiny group of patients — just five treatment-resistant individuals suffering from B cell non-Hodgkin’s lymphoma in this first round — and came up with a 100% overall response rate with an 80% complete response rate.

Those headline numbers quickly registered as a rare win these days in the bleak biotech sector, as Caribou’s share price $CRBU surged 25%.

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Rin­voq pass­es PhI­II main­te­nance study for Crohn's dis­ease, po­ten­tial­ly set­ting the stage for la­bel ex­pan­sion

After AbbVie’s Rinvoq first got approved back in 2019, JAK inhibitors have been clouded by numerous safety issues and events, like with rival Pfizer’s Xeljanz. Now with the newest study out of AbbVie, there might be room to follow the route its sales king Humira did — expanding the drug into other indications and calming concerns about the drug class.

AbbVie announced top-line results earlier this week from a Phase III study for upadacitinib, its JAK inhibitor that had been previously approved for rheumatoid arthritis. The study, called U-ENDURE, was a 52-week maintenance study in adults with moderate to severe Crohn’s disease “who had an inadequate response or were intolerant to a conventional or biologic therapy.” Rinvoq met the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­ers builds the case for pso­ri­a­sis hope­ful as it waits in reg­u­la­to­ry lim­bo

Bristol Myers Squibb continues to tout more data for its experimental psoriasis drug that it hopes will shake up the market.

The pharmaceutical giant posted two-year results from a long-term extension study of deucravacitinib, showing the drug remained effective after two years. The drug, which analysts predict can bring in billions in sales by 2026, is an oral TYK2 inhibitor for adult patients with moderate to severe plaque psoriasis.