As BioNTech makes inroads with Pfizer for their COVID-19 vaccine in the Western world, the German biotech has agreed to supply 100 million doses for its Chinese partner, Fosun Pharma. Samsung Biologics promoted John Rim to take over as CEO. Japan's drug reviewers were unsure whether Fujifilm's flu drug Avigan should be allowed to treat COVID-19. And more.
BioNTech struck a deal with its Chinese partner, Fosun Pharma, to supply 100 million doses of its COVID-19 vaccine, BNT162b2, in China in 2021. The vaccine is currently in a phase 2 bridging trial in China, and the results will be combined with those from the global phase 3 for its local regulatory submission.
Samsung Biologics officially named John Rim as its president and CEO to succeed Kim Tae-han. Rim joined the South Korean CDMO in 2018 and had most recently served as an EVP overseeing operations at its Plant 3, the world’s largest manufacturing capacity at a single site. Before Samsung, Rim worked for Roche/Genentech and Astellas. Rim will lead the company’s next phase of growth, with a fourth, 256,000-liter “super plant” front and center.
Japan’s drug reviewers at the Pharmaceuticals and Medical Devices Agency have not been able to reach a conclusion on whether Fujifilm’s Avigan should be allowed to treat COVID-19. Government sources told Kyodo News that the reviewers took issue with the clinical trial’s open-label nature and the lack of clarity on determining whether symptoms had improved. A final decision is expected from the health ministry on Monday.
Employees at Japanese drugmaker Kobayashi Kako made a “grave” manufacturing error that caused the death of a woman in her 70s and side effects in hundreds more people who took its antifungal drug Itraconazole 50 Meek. The company’s own investigation revealed 5 mg of a sleep med rilmazafone had been added to the drug, according to local reports. The amount is 2.5 times what’s typical of a single rilmazafone pill.
Merck and Eisai’s Keytruda and Lenvima combo triggered more responses, extended the time patients lived without their tumors growing and, most importantly, cut the risk of death compared with chemotherapy in previously treated women with endometrial cancer. The two firms plan to use the phase 3 data to turn a conditional nod doled out under Project Orbis—a collaborative program among three countries’ drug regulators—into a full one.
6. NIH adds Brii's antibodies in COVID-19 master trial (release)
The NIH’s National Institute of Allergy and Infectious Diseases has added new COVID-19 contenders to its ongoing ACTIV-3 master trial. Among them, a sub-study is evaluating Sino-American company Brii Biosciences’ antibody cocktail of BRII-196 and BRII-198 on top of standard of care in hospitalized patients with more severe COVID-19. The master trial previously tested and found that Eli Lilly’s antibody drug bamlanivimab didn’t work in hospitalized patients.
Has people's view of pharma changed with its COVID-19 work? Not really, a new Takeda survey in the U.K. has found. Only 17% of adults polled in October agreed that their perception of the drug industry had improved, while 54% said their opinion hasn’t changed. In a silver lining, among healthcare providers, 68% have a favorable view of the industry.
Indian CDMO Piramal Pharma Solutions will invest some $32 million into its manufacturing plant in Riverview, Michigan, for APIs over the next two years. It will add more than 25,000 square feet of space, including 8,500 square feet for production. The expansion is expected to boost its API capacity by 30% to 40%, a company spokesperson said. The move follows a $10 million expansion at the site in 2019.
SK Life Science, a subsidiary of South Korea’s SK Biopharmaceuticals, debuted the immersive “Step into Their Shoes” experience at the American Epilepsy Society annual meeting. The program brings users into the lives of four patients with seizures—one real and three composites—so they can see their efforts to reduce seizures using the company’s Xcopri.