Joe Jimenez. No­var­tis

No­var­tis CEO Joe Jimenez has been busy giv­ing in­ter­views at Davos this week.

In a sit-down with Reuters the Basel-based ex­ec not­ed that Trump’s tax poli­cies could help set the stage for build­ing new man­u­fac­tur­ing fa­cil­i­ties in the US. And he al­so tapped two late-stage drugs as among his fa­vorites in the pipeline.

Those two fa­vorites are CTL-019, the pi­o­neer­ing CAR-T that No­var­tis is steer­ing to a near-term ap­pli­ca­tion at the FDA, and BAF-312 for sec­ondary pro­gres­sive mul­ti­ple scle­ro­sis.

No­var­tis, which looks for any clin­i­cal short­cut it can find to short­en the time it takes to reach reg­u­la­tors, is ex­plor­ing now if it can go ahead and file ear­ly for BAF-312 based on a sin­gle Phase III study.

In­ves­ti­ga­tors for the phar­ma gi­ant turned up at the an­nu­al meet­ing of the Eu­ro­pean Com­mit­tee for Treat­ment and Re­search in Mul­ti­ple Scle­ro­sis last fall to say that they tracked a 21% re­duc­tion in the risk of dis­abil­i­ty pro­gres­sion in the drug arm, com­par­ing it to the place­bo group. They al­so mapped a “sig­nif­i­cant” im­prove­ment in pa­tients’ an­nu­al­ized re­lapse rate but failed to see the da­ta pan out for an im­prove­ment in a 25-foot walk­ing test, a clas­sic way to check for im­prove­ments in phys­i­cal func­tion.

“We have a num­ber of cat­a­lysts that are com­ing,” Jimenez told Reuters. “From the end of 2017 we will be com­plete­ly out from un­der that gener­i­ciza­tion and the com­pa­ny should en­ter its next growth phase be­gin­ning in 2018.”

In the mean­time, Jimenez is ex­pect­ing to see grow­ing pres­sure on drug pric­ing.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.