| 12.14.21 | Pfizer's COVID-19 antiviral expected to fight Omicron; Merck’s HIV program falters with 13 clinical holds

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Today's Rundown

Pfizer's COVID-19 antiviral is expected to work against the omicron variant Merck's HIV program suffers 6 full, 7 partial clinical holds from FDA Sanofi's hemophilia hopeful reduces bleeds in phase 3 studies, but adverse events persist Sponsored: 7 Applications for Formalin-Fixed Paraffin-Embedded (FFPE) Tissue Specimens Bristol Myers doubles down on Immatics with new $770M biobucks collab for solid tumor bispecific Takeda previews early response data for 'Wave 2' multiple myeloma med in follow-up to Velcade ASH: Novartis posts early clinical data on next-gen CAR-Ts, sets sights on 2022 registration trials Novartis tags Molecular Partners for next radioligand play in $560M biobucks deal Employer insurance costs jumped in 2021—and the future is murky FDA panel rejects BrainsGate neurostimulation implant for ischemic stroke CSL to buy Vifor for $11.7B in biopharma's largest M&A deal this year Centene mulls divestiture of $2B international business as part of value creation effort

Featured Story

Pfizer's COVID-19 antiviral is expected to work against the omicron variant

By Annalee Armstrong

Pfizer said it expects its antiviral pill Paxlovid to provide protection against the omicron variant of the coronavirus, amid worldwide concern that existing medications and vaccines would not work against the newly mutated version.

This week's sponsor is Bio-Rad.

Merck's HIV program suffers 6 full, 7 partial clinical holds from FDA

By Kyle LaHucik

The FDA has added to the woes already troubling Merck's HIV portfolio by slapping 13 clinical holds on its broad-based program for the confounding disease.

Sanofi's hemophilia hopeful reduces bleeds in phase 3 studies, but adverse events persist

By Kyle LaHucik

Sanofi's hemophilia drug, put on pause last year, could be closer to the FDA's doorstep on new late-stage data that shows the treatment significantly reduced bleeds. But the adverse events that raised red flags are still persisting in one study.

Bristol Myers Squibb is doubling down on Immatics with $150 million upfront to get access to a preclinical bispecific targeting solid tumors.

Takeda previews early response data for 'Wave 2' multiple myeloma med in follow-up to Velcade

By Kyle LaHucik

Takeda is looking for its next shot at multiple myeloma beyond Velcade and is now previewing some early data showing partial responses in 38% of patients in one dose group for the next-in-line candidate modakafusp alfa.

ASH: Novartis posts early clinical data on next-gen CAR-Ts, sets sights on 2022 registration trials

By Nick Paul Taylor

The next phase of Novartis’ CAR-T R&D strategy is well underway. With early clinical data on CD19 and BCMA-directed cell therapies in hand, the Big Pharma is preparing to move into registration trials next year.

Novartis tags Molecular Partners for next radioligand play in $560M biobucks deal

By Annalee Armstrong

Novartis is padding out its radioligand portfolio with yet another deal, this time a partnership with Molecular Partners. The duo plans to develop cancer candidates that target tumors for $20 million upfront plus $560 million in biobucks.

Employer insurance costs jumped in 2021—and the future is murky

By Paige Minemyer

Employer health insurance costs spiked in 2021, and it remains unclear if this is a one-off course correction or the beginning of a new trend, according to a new Mercer survey.

FDA panel rejects BrainsGate neurostimulation implant for ischemic stroke

By Andrea Park

Nearly two years after BrainsGate submitted its implantable neurostimulation device for FDA premarket approval, an advisory panel for the agency struck a major blow to the Israeli company’s plans.

CSL to buy Vifor for $11.7B in biopharma's largest M&A deal this year

By Kevin Dunleavy

In a move to diversify its business, Australian biopharma CSL has agreed to acquire Vifor Pharma for $11.7 billion. The deal would give CSL—heavily dependent on vaccines and blood plasma products—Vifor’s attractive kidney disease and iron deficiency franchises.

Centene mulls divestiture of $2B international business as part of value creation effort

By Paige Minemyer

As part of its ongoing examination of its portfolio, Centene Corporation is "evaluating strategic alternatives" for its businesses abroad.

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