Catch­ing up with J&J and Ab­b­Vie on the BTK in­hibitor front, As­traZeneca says Calquence has hit a home run in a Phase III tri­al for first-line chron­ic lym­pho­cyt­ic leukemia.

At an in­ter­im analy­sis, re­searchers say the drug, when com­bined with Roche’s Gazy­va (obin­u­tuzum­ab), has al­ready demon­strat­ed a pro­gres­sion-free sur­vival ben­e­fit over the chemo-based reg­i­men fea­tur­ing chlo­ram­bu­cil and obin­u­tuzum­ab. The pri­ma­ry end­point win was both sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful, the com­pa­ny says, with­out dis­clos­ing any num­bers.

José Basel­ga As­traZeneca

A third group, which re­ceived Calquence monother­a­py, al­so did bet­ter in PFS than the stan­dard-of-care — a sec­ondary end­point. There was, how­ev­er, no word on oth­er out­come mea­sures such as ob­jec­tive re­sponse rate, time to next treat­ment and over­all sur­vival.

José Basel­ga, who has laid out his am­bi­tion for the on­col­o­gy R&D group that he now leads in a se­ries of re­cent in­ter­views, said the re­sults will ce­ment reg­u­la­to­ry sub­mis­sions lat­er this year.

The dossier will al­so in­clude re­sults from a pre­vi­ous Phase III on pa­tients with re­lapsed or re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia.

Im­bru­vi­ca — the block­buster de­vel­oped by J&J and Ab­b­Vie — in com­bi­na­tion with Gazy­va be­came the first non-chemother­a­py, an­ti-CD20 reg­i­men to be sanc­tioned for treat­ment-naïve CLL this Jan­u­ary, mark­ing the 10th ap­proval since its 2013 launch. The FDA has al­so OK’d its use in this set­ting on its own.

In 2018 Im­bru­vi­ca racked up $2.6 bil­lion in sales, dwarf­ing Calquence — ap­proved for man­tle cell lym­phoma late 2017 — which gen­er­at­ed $62 mil­lion. And Chi­na’s BeiGene is com­ing up from be­hind with its own ‘break­through’ can­di­date.

Im­age: Shut­ter­stock

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.