New hires and promotions in the biopharma industry, including: Actimed, Allena, Biofrontera, Destiny, Elicio, Gain, Imago, Lipum, Oncosec, Quralis, Sangamo, Scenic, Tryp, Windtree.
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
By combining synthetic biology and RNA therapy, the team at startup Strand Therapeutics Inc. hopes to make mRNA therapy more effective. Strand recently announced an immuno-oncology deal with Beigene Ltd. that netted the company $5 million to begin with and could end up being worth more than $250 million. Beyond immuno-oncology, the company’s basic technology could be broadly useful for both mRNA- and cell-based therapies.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.
The Medicare Part D rebate rule finalized by the Trump administration last November could be in limbo for a while. As it did with other so-called midnight rules issued in the waning days of the Trump presidency, the U.S. Department of Health and Human Services, under the Biden administration, is postponing the implementation of the rule, which was intended to simplify the U.S. drug pricing system by eliminating the rebates drug makers pay to pharmacy benefit managers for formulary placement or requiring plans to pass the discounts directly to patients.
Seeking to accelerate the company's long-term growth through an expansion of its rare disease pipeline, Horizon Therapeutics plc said Feb. 1 it will buy Viela Bio Inc. for $3.05 billion, or $53 per share (NASDAQ:VIE). Once closed, the deal would add a new commercial-stage asset, Uplizna (inebilizumab), to Horizon's portfolio alongside its current lead products, Tepezza (teprotumumab) for the treatment of thyroid eye disease and Krystexxa (pegloticase) for uncontrolled gout. Dublin-based Horizon, which had $2.08 billion in cash at the end of 2020, borrowed $1.3 billion to help finance the transaction. Astrazeneca plc also enabled the deal by agreeing to divest its 26.7% share in Viela Bio for a profit of between $760 million and $780 million.
Shanghai Junshi Biosciences Co. Ltd. could receive an aggregate $1.1 billion from Coherus Biosciences Inc. for the rights to develop and commercialize Junshi’s anti-PD-1 antibody toripalimab in the U.S. and Canada. The deal is powered by Coherus’ core biosimilar business and is designed to steer the company into the business of immuno-oncology.
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