The U.S. FDA has approved the monoclonal antibody Enflonsia (clesrovimab) from Merck & Co. Inc., for preventing respiratory syncytial virus infection (RSV) lower respiratory tract disease in newborns and infants. The preventive, long-acting monoclonal antibody now takes its place in the pediatric market alongside monoclonal antibodies Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. It also steps into a gray area, with increased risk to vaccine manufacturers such as Merck after U.S. CDC Advisory Committee for Immunization Practices members were terminated on June 9. The committee’s June 25-27 meeting is slated to make recommendations for Enflonsia in infants. RSV is the prime cause of hospitalization for infants younger than 1 in the U.S., posting an average that’s 16 times higher than the annual hospitalization rate for influenza.

Vaccines meeting to go on in wake of ACIP demolition

Despite yesterday’s gutting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP), the Department of Health and Human Services says the committee’s June meeting will continue as scheduled late this month. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting. “At best, it will take time for the new members to ramp up on the content and ACIP process, which could delay less controversial recommendations such as for Merck's . . . pediatric RSV monoclonal antibody, clesrovimab,” which was approved by the FDA yesterday, Leerink Partners LLC analyst Daina Graybosch said.

Phase II home run: Insmed’s TPIP hits hypertension endpoints

Insmed Inc.’s chair and CEO, Will Lewis, called the phase IIb trial of TPIP in pulmonary arterial hypertension a “clear and unequivocal success,” with analysts and investors wholeheartedly agreeing, as the company’s shares surged 27% in early trading June 10. TPIP, or treprostinil palmitil inhalation powder, met all endpoints – primary, secondary and exploratory – exceeding expectations to a high degree and threatening approved treprostinil products Tyvaso, from United Therapeutics Corp., and Yutrepia, from Liquidia Corp. On the primary endpoint, it showed a 35% placebo-adjusted reduction from baseline in pulmonary vascular resistance, much higher than the 20%-25% benefit the company wanted to see. Insmed’s shares (NASDAQ:INSM) rose $19.17 to $89.85 by midday, while United’s (NASDAQ:UTHR) fell 15% to $276.59, and Liquidia’s (NASDAQ:LQDA) dropped 19% to $14.46.

Aribio fortifies Arcera alliance with $600M AR-1001 supply deal

Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting the latter commercial rights to its oral Alzheimer’s disease therapy, AR-1001, in select countries including the Middle East. Under the terms announced June 10, Acino gains exclusive rights to commercialize AR-1001 in its key markets, including Latin America, the Middle East, Southern Africa, Ukraine and select Eurasian countries. Aribio will be responsible for manufacturing and supplying the product.

Gut microbiome leads to metabolic and immune changes after transplant

Is fecal microbiota transplant effective? Is it really safe? And is it really all the same? Scientists at the University of Chicago have investigated the regional differences in gut environments to question these interventions to analyze the microbiome differences and their effects after transplantation form different intestine areas. The results show how host-microbe mismatches after these interventions could affect gut health.

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