While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines will be at the center of Thursday’s advisory committee meeting on the vaccines in general, committee members also will be asked to discuss the practicalities of continuing to conduct trials once a candidate has been granted an emergency use authorization (EUA). The meeting will provide a foundation for when the FDA convenes the Vaccines and Related Biological Products Advisory Committee in the future to evaluate individual vaccine candidates for which an EUA has been requested. But, perhaps more importantly, the FDA appears to be counting on the adcom as a public relations effort to rein in fears that the agency will bow to political pressure to open the gates to vaccines before they’re fully proven.

Biogen's 'Tec' troubles known, all eyes turn to aducanumab

Generic challenges hitting Biogen Inc.'s biggest moneymaker, Tecfidera (dimethyl fumarate), weighed on its third-quarter earnings. But prospects for aducanumab in Alzheimer's disease stole the show Wednesday, as a Nov. 6 FDA advisory committee meeting on the candidate creeps closer. The FDA has accepted Biogen's BLA for a priority review, assigning a March 7 PDUFA date while an EU marketing application has also been made. Amid the clamor, Biogen discontinued two programs: opicinumab in multiple sclerosis and BIIB-089 in spinal muscular atrophy. Company shares (NASDAQ:BIIB) fell 1.3% by midday.

Investors bring $500M to the Nuvation-Panacea merger

Nuvation Bio Inc. and Panacea Acquisition Corp. a special purpose acquisition company sponsored by Ecor1 Capital, said they will merge, with the combined company to be renamed Nuvation. Nuvation said it will use the proceeds to steer its oncology-based cyclin-dependent kinase inhibitor, BET inhibitor, WEE1 inhibitor, adenosine A2A receptor inhibitor programs toward the clinic. The company also said it plans to further develop its drug-drug conjugate platform targeting hormone-driven cancers such as prostate, breast and ovarian cancers. Investors are bringing in a little more than $500 million to the combined company. Panacea already has about $144 million in its trust. Panacea’s stock (NYSE:PANA) had dropped 1.35% at midday.

Crispr posts solid early stage allogeneic CAR T data marred by a death in the study

Crispr Therapeutics AG released interim data from the phase I Carbon study testing CTX-110, its allogeneic CAR T-cell therapy targeting CD19+ B-cell malignancies. The third dose level of the off-the-shelf product produced an overall response rate of 50% for the four patients treated, with both responders achieving a complete response. The single patient treated at the fourth dose level also had a complete response, but developed febrile neutropenia and died 52 days after the CTX-110 infusion. Shares of Crispr Therapeutics (NASDAQ:CRSP) were down $10.27, or 9.5%, in midday trading.

Huadong picks up Immunogen ADC in $305M deal as first step in oncology innovation

Chinese pharma giant Huadong Medicine Co. Ltd. licensed rights to mirvetuximab soravtansine, an antibody-drug conjugate (ADC) for ovarian cancer, from Immunogen Inc. to mark its first step into oncology innovation, as more Chinese players are now pushed to innovate. Under the $305 million deal, Huadong will pay $40 million up front and up to $265 million in milestone payments to obtain the rights to develop and commercialize mirvetuximab in mainland China, Hong Kong, Macau and Taiwan. Immunogen is also eligible to receive low double-digit to high teen royalties as a percentage of commercial sales in greater China.

Australia’s Actinogen advances lead compound Xanamem in Alzheimer’s disease, fragile X syndrome

PERTH, Australia – Sydney-based Actinogen Medical Ltd. will advance its lead compound, Xanamem, into two proof-of-concept phase II studies in Alzheimer’s disease and fragile X syndrome (FXS). On the back of data from several early stage trials, Actinogen “has data to clearly justify the fact that Xanamem is a brain-penetrant drug that selectively and effectively inhibits the 11beta-HSD1 enzyme in the brain,” Actinogen CEO Bill Ketelbey told analysts during a recent conference call. The program evolved from the premise that chronically raised cortisol in elderly people was associated with cognitive decline and Alzheimer's disease.

Also in the news

AB Science, Actinium, Adial, Affinivax, Aptinyx, Ascentage, Beyond Air, Biogen, Biomx, Briacell, Bridgebio, C4X, Cannabics, Chromotek, Cidara, Crispr, Curelab, Curis, Diurnal, Effrx, Epsilogen, FSD, Gilead, GT, Hillstream, Idorsia, Intelgenx, Kintara, Kiromic, Moleculin, Mybiotics, Myovant, Neoimmunetech, Neumentum, Noveome, Nuance, Oxeia, PCI, Pfizer, Pharming, Poseida, Praxis, Protagonist, Proteintech, Prothena, PTC, Replimune, Roche, Scynexis, Seqirus, Tarsus, Teneobio, TG, Trevi, Tscan, Union, Vir, Xeris, Zosano