As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.”
Wandercraft SAS has begun commercial operations of its exoskeleton, Atalante X, in the U.S., offering another solution to the millions of people living with mobility impairments. The company also formed a partnership with the Kessler Foundation whose research team will investigate the possible benefits of the Atalante X for neurologically impaired patients, including those recovering from stroke, spinal cord injuries and motor neuron disease.
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.
“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.
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.
With an FDA approval decision on treosulfan possibly more than a year off, the U.S. Patent and Trademark Office granted Medac GmbH a third one-year extension of its method-of-use patent covering the drug, which is being developed as a conditioning agent in allogeneic hematopoietic stem cell transplantation.
Olink Holding AB likely has some euphoric investors following Thermo Fisher Scientific Inc.’s announcement of an agreement to acquire the proteomics company for $26 per share in cash. The price represents a premium of nearly 75% on its recent trading average and brings the deal’s value to a stunning $3.1 billion, with net cash of $143 million.
The vagaries of the COVID-19 market and the uncertainties of pandemic fatigue are hitting some biopharma companies in the pocketbook, at least for now. Due to lower-than-expected revenues from its COVID-19 Comirnaty vaccine and antiviral Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. reduced its 2023 revenue guidance by $9 billion after hours Oct. 13, saying it now anticipates full-year 2023 revenues to range from $58 billion to $61 billion – down from its previous guidance range of $67 billion to $70 billion.
Scientists at Washington University in St. Louis reported filing patent protection for their breath test that quickly identifies those infected with SARS-CoV-2, requires only one or two breaths to be performed, and provides results in less than a minute.
With shares dropping again, this time more than 15% on Oct. 13, Cassava Sciences Inc. has found itself entangled in a mess involving short-sellers, data that were allegedly mishandled involving its oral Alzheimer’s disease (AD) candidate simufilam, and a leaked investigation report from the City University of New York (CUNY).
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