The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies (MAbs) targeting amyloid beta in Alzheimer’s only to clinical trials. Biogen Inc., clearly the target, along with its Alzheimer’s treatment Aduhelm (aducanumab), was among the first to respond. In an early morning conference call on Jan. 13, Michel Vounatsos, Biogen’s CEO and director, expressed the company’s “strong disagreement” with the NCD because it would “deny nearly all Medicare beneficiaries” access to Aduhelm and “will also block access to future amyloid therapies for the indefinite future.” The NCD would, Vounatsos said, shrink the number of patients from millions to only a few hundred and is based on incomplete and inaccurate assessments of data. CMS said that no trial of an anti-amyloid MAb has confidently demonstrated a clinically meaningful improvement in health outcomes such as cognition and function.

Salarius enters protein degrader fray with 'transformative' Deuterx deal

Salarius Pharmaceuticals Inc. is joining the red-hot protein degradation space with an acquisition of a portfolio of oral small-molecule protein degraders from Deuterx LLC it’s calling "transformative." The lead asset, SP-3164, is a cereblon-binding molecular glue that Salarius plans to move to the clinic in 2023 as a potential treatment for hematological cancers and solid tumors. Salarius paid Deuterx $1.5 million in cash and 1 million shares of restricted stock (NASDAQ:SLRX) up front. Deuterx also stands to receive as much as $53 million in clinical and regulatory milestones attached to '3164, plus up to $84 million in milestone payments for each of two future products. Further rewards for privately held Deuterx could come in the form of sales milestones and royalties, the companies said.

AZ delves further into AI, signing deals with Scorpion Therapeutics and Benevolentai

Astrazeneca plc has announced two significant R&D deals with Scorpion Therapeutics Inc. and Benevolentai Ltd., which it hopes will sharpen its research into cancer, lupus and heart failure. Both of the deals involve artificial intelligence (AI) to as a way to increase the probability of success during the clinical development process and reduce the chances of costly trial failures. The deal with Boston-based Scorpion is based around research into proteins called transcription factors, which are seen as “undruggable” targets that nevertheless play a key role in certain cancers.

Sana acquires rights to two CAR T constructs

Sana Biotechnology Inc. has acquired rights to two CAR T constructs through a pair of deals, one with partners Innovent Biologics Inc. and Iaso Biotherapeutics Co. Ltd. and a second with the National Cancer Institute (NCI). In the Innovent-IASO deal, Sana secured nonexclusive commercial rights to a B-cell maturation antigen-targeted CAR T construct for in vivo gene therapy and ex vivo hypoimmune cell therapy applications. The NCI deal, for exclusive commercial rights to the NCI’s CD22 CAR asset, could help Sana “address key relapse challenges for CD19-directed CAR T-cell therapies,” the company said.

Divided HELP vote moves Califf closer to second turn as US FDA commissioner

Robert Califf moved a step closer to his second stint as head of the U.S. FDA when the Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-8 Jan. 13 to favorably send his nomination to the full Senate for a confirmation vote. In Califf’s first time around in 2016, when he was nominated by then-President Barack Obama, the cardiologist received unanimous support from the committee, but only because Sen. Bernie Sanders (I-Vt.) didn’t vote as he was on the campaign trail. This time, Sanders and Sen. Maggie Hassan (D-N.H.) joined six Republican colleagues in objecting to Califf’s confirmation as the next FDA commissioner.

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