Amid a mix of controversy and clinical progress, the Alzheimer’s Association International Conference 2021 kicked off July 26 in Denver and online, delivering both new clinical data and insights into a key form of dementia affecting as many as 35 million people worldwide and growing. While interest in Biogen Inc.'s recently approved Aduhelm (aducanumab) remained high, new data on investigational therapies from Synaptogenix Inc. and Inmune Bio Inc. also drew attention, weighing on shares of both companies. New epidemiological research also revealed the first evidence that reducing air pollution may improve cognitive function and reduce dementia risk. Read More
As amyotrophic lateral sclerosis continues to make headlines, candidates bearing varied approaches proliferate and the indication likely allows for multiple players, given the prospect of a combo regimen. Read More
Sinocelltech Group Ltd. won market approval from China’s NMPA for SCT-800, a B-domain deleted recombinant human coagulation factor VIII, for the prophylactic treatment of severe hemophilia A in adolescent and adult patients. This marks the first homegrown drug for treating hemophilia A in China. Read More
As the COVID-19 pandemic continues to impact the FDA’s inspection program, U.S. lawmakers are worrying about what that may mean for future drug approvals.
“We are . . . concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections,” the bipartisan leadership of the House Energy and Commerce Committee and its Health Subcommittee said in a July 22 letter to acting FDA Commissioner Janet Woodcock. Read More
The first COVID-19 patient has been enrolled the U.S. NIH’s ACTIV-4 Host Tissue trial, a study of four agents designed to fight dysregulation of the renin-angiotensin-aldosterone system and the immune system caused by a COVID-19 infection. Read More
Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country. Read More
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Acticor, Adverum, Aurion, Denali, F-star, Immunicum, Innovent, Kyowa Kirin, Mediwound, NGM, Synlogic. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Moderna, Rhythm. Read More
