Merck & Co. Inc.'s $1.05 billion acquisition of Peloton Therapeutics Inc. in 2019, a big bet on the hypoxia inducible factor-2 alpha inhibitor belzutifan, has paid off with FDA approval of the drug for cancers associated with von Hippel-Lindau disease (VHL). The green light triggers a $50 million milestone payment for former Peloton shareholders. Another $50 million awaits them upon the first commercial sale in the U.S., plus up to $1.05 billion in sales-based milestones thereafter. The therapy will be marketed as Welireg.

Vectura accepts £1.1B bid from tobacco giant Philip Morris

Inhaled drugs developer Vectura Group plc. has accepted a takeover bid from tobacco firm Philip Morris International Inc. (PMI), a move that has sparked revulsion from health campaigners but has been supported by investors. Shares in both firms ticked up in trading on Friday after Chippenham, U.K.-based Vectura accepted a bid worth around £1.1 billion (US$1.5 billion), rejecting a rival bid from U.S.-based private equity firm Carlyle Group. Carlyle had decided not to improve on its 155 pence per share bid for Vectura, leaving the company’s board free to accept the 165 pence per share offer from PMI and avoid an auction overseen by the U.K.’s Takeover Panel. Vectura’s advisers, J.P Morgan Cazenove and Rothschild & Co., consider the terms to “fair and reasonable,” according to a statement that said the PMI bid has been accepted in line with the board’s “fiduciary duties.”

FDA allows mRNA vaccine booster for certain immunocompromised patients

The FDA has made allowances for a third COVID-19 vaccine dose to protect certain people with compromised immune systems. The amended emergency use authorization (EUA) amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc. The decision came late on Aug. 12, following hints earlier in the day from the White House that the amendments were imminent. The EUAs allow for boosters for those with solid organ transplants or those diagnosed as having an equal level of immunocompromise, patient populations the FDA labeled as a “small, vulnerable group that may benefit from a third dose” of the vaccines. Those who are similarly immunocompromised, the FDA added, are vulnerable to infections, particularly COVID-19.

ACIP to address hot topic of COVID-19 vaccine boosters

The CDC’s Advisory Committee on Immunization Practices (ACIP) is taking up the matter of COVID-19 booster shots. Panel members will vote whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary series.” An update on circulating variants also is on ACIP’s agenda, too.

Innovent’s PCSK9 inhibitor meets primary endpoint in phase III HeFH study in China

Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients. Although there are imported PCSK9 inhibitors on the China market, there is a lack of Chinese clinical trials data in HeFH, according to Yujie Zhou, the lead researcher of the study and vice president of Anzhen Hospital from the Capital Medical University. “For the first time, Chinese researchers have confirmed that an anti-PCSK9 monoclonal antibody can significantly reduce low-density lipoprotein cholesterol levels with an overall favorable safety profile in such a patient population through a randomized, double-blind, controlled study.”

Australian government unveils framework for a patent box to offset R&D for drugs and devices

PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget. The government is encouraging investment in Australian med tech and biotech by introducing a patent box that will reduce taxes on income from innovative research to encourage businesses to undertake research and development in Australia and keep intellectual property in the country. A new discussion paper outlines the key design features and includes questions to industry.

While clinical activity is up by 9% over last year, pandemic news drops

Clinical data activity in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity. Only 13.2% (316) of clinical data so far in 2021 involve the development of therapeutics and vaccines for COVID-19. A year ago, about 24% of all clinical news by this point was focused on the SARS-CoV-2 virus.

Also in the news

Advanced Chemotherapy Technologies, Ampio, Atea, Bexson Biomedical, Biontech, Calliditas, Cytocom, Cytodyn, Dermata, Eliem, Fusion, Immune-Onc, Ipsen, Jazz, Laboratorios Richmond, Longeveron, Medivir, Moderna, Mustang, Novatek, Nyrada, Pfizer, Pharmacyte, Protalix, Rigel, Sen-Jam, Theratechnologies, Trigone