Fujifilm's flu drug Avigan has become the Trump Administration's latest pick as a potential COVID-19 treatment, as the White House is asking drug regulators to clear it for emergency use. The U.S. oral generics and dermatology transaction between Novartis and Aurobindo has fallen through after antitrust review delay. China's API output is quickly recovering after a coronavirus-related decline, a Chinese official said; but India's still restricting the export of some drug products. And more.
1. The White House is pushing FDA to clear Fujifilm's Avigan for COVID-19. Should the agency obey?
Fujifilm ramps up production of flu drug Avigan as possible COVID-19 treatment
The White House is asking the FDA to allow Fujifilm’s flu drug Avigan for emergency use against the novel coronavirus, Politico reported. Japanese Prime Minister Shinzo Abe recently endorsed the med and said his government would begin trials for a quick approval and ramp up production. In a non-randomized Chinese study, Avigan beat AbbVie’s Kaletra at shortening the time to viral clearance, and another randomized trial showed it was slightly better than another flu drug, Arbidol.
2. Novartis, Aurobindo admit defeat by FTC in aborting their $1B generics deal
After offering up several timelines for deal closure, Novartis and Aurobindo have finally called it quits on their $1 billion generics and dermatology transaction due to delays at the U.S. Federal Trade Commission. Nixing the deal marks a setback for Novartis’ plan to focus on innovative medicines, as well as Aurobindo’s ambition to become the second-largest generics player in the U.S.
3. Chinese APIs flowing but India ban hinders U.S. approval of hydroxychloroquine
The production of most Chinese APIs dropped by 10% to 20% and as much as 30% for some during the first few months of 2020, a Chinese government official recently said. It’s now quickly recovering, though shipping by ocean freight remains a bottleneck. Output at two primary producers of chloroquine is stable, the official said. In comparison, India has banned the export of the COVID-19 hopeful.
4. Pfizer sterile injectables plant in India slapped with warning letter
After Pfizer’s legacy Hospira sterile injectables plant in India got a warning letter last year, the company still had another plant in Visakhapatnam to fall back on. But now, that plant has also been slapped with a warning letter. Three issues were cited, including lack of an adequate method for testing sterility.
5. Biocon insulin operation gets FDA nod, paving way for approval of Lantus knockoff
Biocon’s insulin production plant in Malaysia has finally won FDA clearance. A previous Form 483 is now deemed voluntary action indicated, which indicates it meets at least the minimum compliance requirements. The sign-off clears the way for a possible approval of its Mylan-partnered Lantus copy.
6. Shionogi forms JV with insurance giant Ping An for expansion in China (release)
Shionogi is expanding in China. To do that, it’s teaming up with Ping An Insurance, China’s largest insurer by market value. The Japanese company is selling Ping An 2.05% voting shares for about JPY 33.53 billion ($310 million). The two will form a joint venture for drug R&D, manufacturing and sales. Besides its key markets in Japan and the U.S., “to attain our growth strategy beyond 2020, we must realize the expansion of our business in China, which is expected to show the greatest pharmaceutical market growth in the world over the next 10 years,” Shionogi said in a statement.
7. Daiichi Sankyo inks $200M licensing deal with Ultragenyx to boost gene therapy manufacturing
Daiichi has penned a non-exclusive licensing deal worth $250 million for Ultragenyx's HeLa producer cell line platform to help boost its gene therapy product manufacturing. In return, Ultragenyx will have an option to co-develop and commercialize rare disease products from the platform.
8. Brii, Chinese partners eye Q3 start for COVID-19 antibody trial
Brii Biosciences has teamed up with China’s Tsinghua University, and Shenzhen No.3 People’s Hospital to develop antibodies against COVID-19. Medical teams at the latter two responded to the outbreak during its early days and have created a pool of 206 antibody prospects taken from individuals infected with the virus. The partnership aims to get a candidate into the clinic in the third quarter.