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Shoddy manufacturing practices triggered FDA warning letters for a pair of foreign producers of over-the-counter drugs...Dibar of Mexico, a CDMO for nutritional and self-care products, and Foshan Biours Biosciences of China, which specializes in gel patches, were cited for failure to fix problems the FDA raised in April of last year...The companies have been barred from importing their products to the U.S. since last fall...READ MORE

Unlike his predecessor, President Biden is embracing a more centralized strategy for managing the COVID-19 pandemic. He signed a flurry of executive orders and presidential directives on January 21, including one that institutes new mask mandates for interstate travel, one that creates a national board to expand access to testing, and another that requires international visitors to quarantine upon arrival in the United States. Biden pitched his National Strategy for the COVID-19 Response and Pandemic Preparedness as a "wartime effort" and did not soft-pedal the grim details...READ MORE

A senior U.S. government official complained...that the World Health Organization has not shared enough information about its planned mission to China to investigate the animal origins of the coronavirus...Garrett Grisby of the U.S. Department of Health and Human Services griped that the criteria for WHO’s China mission had not been shared with other nations. He spoke during a weeklong meeting of the U.H. health agency’s member countries...“The (terms of reference) were not negotiated in a transparent way with all WHO member states,” he said via video conference, referring to the mission’s criteria. “Understanding the origins of COVID-19 through a transparent and inclusive investigation is what must be done.”...READ MORE

One hundred and forty-three day since World Health Organization member-states passed a resolution calling for the WHO to work with other agencies to identify how the coronavirus that emerged in Wuhan was able to jump from animals to humans, China has yet to agree upon an international team of experts to visit China to carry out that crucial work...Resolution WHA73.1, passed at a WHO World Health Assembly on May 19, calls on WHO, the World Organization for Animal Health, and the Food and Agricultural Organization to work jointly to “identify the zoonotic source of the virus and the route of introduction to the human population,” and refers specifically to “scientific and collaborative field missions” as part of that effort...READ MORE

China only approved its first biosimilar drug in 2019, but the market is already looking too crowded for one Big Pharma company...Pfizer has halted its biosimilar programs in China and is selling a biologics facility there to Chinese CDMO giant WuXi Biologics...The “difficult decision” came after a “comprehensive review of the biosimilars market and the company’s global manufacturing network,” Pfizer said...READ MORE

China will provide COVID-19 vaccines free of charge once they become available to general public, government authorities said...an official with China’s National Health Commission, told reporters that while manufacturing and transport of vaccines does have costs, the government will still be able to provide vaccines for free to individuals...“Our people don’t have to pay a single cent for the vaccine,”...READ MORE

Brazil’s health regulator halted clinical trials of the potential coronavirus vaccine CoronaVac, citing an “adverse, serious event,” according to a statement it posted to its website Monday night...The potential vaccine is being developed by Chinese biopharmaceutical firm Sinovac and in Brazil would be mostly produced by Sao Paulo’s state-run Butantan Institute. Butantan said in a statement that it was surprised by Anvisa’s decision and that it would hold a news conference Tuesday...The CoronaVac shot has stirred controversy in Brazil, where President Jair Bolsonaro has cast doubt on its prospective effectiveness. He sparked confusion last month when he publicly rejected it, saying Brazilians would not be used as guinea pigs. The declaration followed news that his health minister, Eduardo Pazuello, had agreed to purchase CoronaVac doses produced locally by Butantan...READ MORE

The Food and Drug Administration...cleared an antibody drug cocktail from Eli Lilly for emergency use for treating people recently diagnosed with COVID-19...The cocktail, a combination of two coronavirus-targeting antibodies, is authorized only for people with mild or moderate symptoms of COVID-19, but who are at high risk of the disease's worst effects due to age, underlying medical conditions or other preexisting conditions...The combination pairs Lilly's bamlanivimab...with another antibody called etesevimab that the drugmaker developed in partnership with China's Junshi Biosciences. Each antibody targets a separate section of the "spike" protein used by the SARS-CoV-2 virus to breach the body's cells — a feature designed to preserve the drug's effectiveness even as the virus mutates...READ MORE

While true innovation is still a rare currency in China, all but one of these 10 companies have attracted Big Pharma companies buying into their R&D...China has witnessed a biotech boom over the past decade. Many biotech entrepreneurs felt a calling to reshape the drug industry in a country that has long relied on generics with dubious quality, where demand is growing for more innovative drugs to improve treatment outcomes that can match China’s climbing economy...These so-called “sea turtles,” armed with top-notch training from foreign institutions and experience at large multinational biopharma companies, set up their own shops in the hope of creating the next blockbuster drugs out of China...READ MORE

BeiGene
Chi-Med
CStone Pharmaceuticals
Harbour BioMed
Hua Medicine
I-Mab Biopharma
Innovent Biologics
Junshi Biosciences
Legend Biotech
Zai Lab

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections...COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections...The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products...READ MORE