“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years. Read More
A week before the U.S. Senate Health, Education, Labor and Pensions Committee is scheduled to vote on the confirmation of Monica Bertagnolli as the next NIH director, she faced a grilling by the committee fueled by drug pricing agendas and deals the Biden administration made with certain lawmakers to advance her nomination. Read More
Nkarta Inc. is looking to return to the heady heights it hit three years ago when its shares were going for around $70 each. The company is reinventing itself as a cancer fighter and branching out as an autoimmune specialist. Nkarta joins at least four other companies looking at expanding their cell therapies into other autoimmune indications. Read More
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news. Read More
While biopharma dealmaking remains active, a strong third quarter (Q3) was not enough to bring it to the same level seen during each of the last three years, although values are coming close. At the same time, M&As appear to be rising above 2022, but even with the increase, they still lag behind other years. If the Pfizer Inc./Seagen Inc. merger, worth $43 billion, closes before the end of 2023, for example, M&As will still not come close to the overall value seen in 2019 and 2020. Read More
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps. Read More
To resolve a U.S. SEC insider trading charge related to Pfizer Inc.’s $11.4 billion acquisition of Array Biopharma Inc. in 2019, Brian Rubin consented Oct. 17 to a judgment ordering him to disgorge $90,458, plus prejudgment interest of $16,914, and to pay a civil penalty to be determined by the court. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advicenne, AN2, Avanzanite, Cessation, Currax, G1, Generation Bio, Ligand, Ovid, Talaris, Tourmaline, Traverse, Ultragenyx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bloomsbury, Canbridge, Diakonos, Lisata, Merck & Co., Nkarta, Northsea, Rezolute. Read More
