Amid a mix of controversy and clinical progress, the Alzheimer’s Association International Conference 2021 kicked off Monday 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.

ALS well that ends with a cure; mechanisms abound in tough space

As amyotrophic lateral sclerosis (ALS) continues to make headlines, candidates bearing varied approaches proliferate and the indication likely allows for multiple players, given the prospect of a combo regimen.

Sinocelltech’s SCT-800 wins NMPA approval; first homegrown drug for hemophilia A

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.

FDA inspection delays a worry for the future

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 Subcommittee on Health said in a recent letter to acting FDA Commissioner Janet Woodcock. Since preapproval inspections often occur well in advance of targeted drug approval dates, the lawmakers said, “drug applications and approvals may be affected in the future if inspections continue to be postponed, possibly delaying patient access to needed medications.”

Trevena’s study of TRV-027 in COVID-19 begins

The first COVID-19 patient has been enrolled the NIH’s ACTIVE-4 Host Tissue trial, a study of four agents designed to fight dysregulation of the renin-angiotensin-aldosterone system (RAAS) and the immune system caused by a COVID-19 infection. Trevena Inc.’s TRV-027, an AT1 receptor selective agonist for binding to and then rebalancing AT1 receptor activation in the RAAS. About 1,600 patients at more than 50 U.S. sites are expected to enroll in the study, with other arms expected to be added later. Each intervention will be studied for TRV-027’s impact on recovery, supplemental oxygen use, the need for mechanical ventilation, organ failure and mortality.

Shionogi starts trial for COVID-19 treatment, aiming for first domestically developed treatment in Japan

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.

Also in the news

Aadi, Abbvie, Abeona, Agex, Allarity, Allegro, Allergan, Alzinova, Antengene, Apellis, Asahi Kasei, Astrazeneca, Athenex, Aurion, Basilea, Beigene, Biomind, Biomx, Biontech, Cassava, Cassiopea, Cortexyme, Cytokinetics, Da Volterra, Denali, Eledon, Fidia, F-star, Glaxosmithkline, GNT, Immunicum, Incyte, Inhibikase, Inmune, Innovent, Intec, Iterum, Iveric, Kyowa Kirin, Lantern, Lee’s, Liscure, Lumira, Lygenesis, Mediwound, Neoimmunetech, Nuvalent, Ocean, Otsuka, Polarityte, Prothena, Puma, Radius, Relief, Sagimet, Saniona, Selecta, Sesen, Sun, Synaptogenix, Tarsus, Tonix, Trevena, Virios, Xenetic