LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
Recent news that The University of Texas MD Anderson Cancer Center is teaming up with Schrödinger Inc. to work on the latter’s WEE1 inhibitor – along with data disclosed at the 2021 meeting of the European Society for Medical Oncology (ESMO) – shone a light on the gatekeeper checkpoint kinase, which a number of players are busy exploring, though nothing in the class has been approved so far.
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease.
Boehringer Ingelheim International GmbH is the latest drug company to come into the crosshairs of the U.S. Health Resources and Services Administration over its restrictions on giving 340B drug discounts to contract pharmacies.
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
LONDON – It is both safe and effective for people to receive an influenza vaccine at the same time as a COVID-19 vaccine, with no negative impacts on the strength of the immune response produced by either vaccine and reported side effects mainly mild to moderate. Only nine of 679 participants in a U.K. study testing combinations of different flu and COVID-19 vaccines said they would not want to have two different vaccines at the same time in the future. Six of those were in the control arm of the trial, in which saline was injected as a placebo.
Astrazeneca plc’s Alexion rare diseases unit has taken an option to buy all remaining equity in Caelum Biosciences Inc., adding a rare disease drug to its pipeline in a deal worth $500 million. At the center of the deal is CAEL-101, a potentially first-in-class monoclonal antibody designed to tackle the toxic amyloid deposits that build up in organs of people with the rare disease light chain amyloidosis.
Astrazeneca plc and Merck & Co. Inc. have data for a new indication for their blockbuster PARP inhibitor class drug Lynparza (olaparib) in advanced prostate cancer in combination with standard abiraterone therapy. The companies said the Propel phase III study testing Lynparza in combination with abiraterone showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival in first-line metastatic castration-resistant prostate cancer vs. standard abiraterone care.
