Biology Digest

  Fresenius Kabi Oncology fell afoul of the FDA in 2013 when the agency discovered employees had hidden records before a manufacturing inspection. Now, the drug ingredients manufacturer is admitting fault—and has reached a deal with the U.S. Department of Justice to put the investigation to bed. The Fresenius Kabi unit  agreed  to pay a $30 million fine, forfeit another $20 million and plead guilty to concealing and destroying records ahead of a 2013 FDA inspection in Kalyani, India, Justice Department prosecutors said. The company also promised to set up compliance and ethics programs to prevent future violations in its cancer drug manufacturing process—including regular reports to the DOJ, Germany’s Fresenius Kabi said in  its own statement . The company “sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for U.S. consumers,” Brian Boynton, DOJ acting...

  As COVID-19 continues to run rampant, the FDA has struggled to keep its manufacturing inspection schedule on track. This week, Mallinckrodt became the latest regulatory victim.  Mallinckrodt will have to wait a bit longer for an FDA decision on its regenerative skin tissue therapy StrataGraft, as COVID-19 travel restrictions  forced the delay  of a manufacturing plant inspection, the company said Friday. It's a similar tune to the one other drugmakers have been singing during the pandemic era, with the FDA delaying a slate of reviews last year for similar reasons.  In the case of StrataGraft, in development to treat adults with deep second-degree burns, the FDA was due to make a decision on Feb. 2, 2021, Mallinckrodt  said  in August when it announced the regulator had accepted its Biologics License Application.  Mallinckrodt didn't specify which manufacturing site is awaiting review, and a spokesperson for the...

  Robert F. Kennedy Jr. is now blocked from Instagram after he repeatedly undercut trust in vaccines. Kennedy has also spread conspiracy theories about Bill Gates, accusing him of profiteering off vaccines and attempting to take control of the world's food supply. "We removed this account for repeatedly sharing debunked claims about the coronavirus or vaccines," a spokesperson for Facebook, which owns Instagram, told NPR on Thursday. Kennedy has been a prominent voice in the anti-vaccine community for years, speaking out against childhood vaccines and promoting controversial and disproven claims that seek to link vaccines with autism. In the past year, Kennedy's beliefs about vaccines have intersected with the COVID-19 pandemic. He has told his followers not to trust "mainstream media, government health officials" and doctors who say the coronavirus vaccines are safe, recently highlighting a rare and tragic case in which a woman died hours after receiving th...

 SYDNEY (Reuters) - New Zealand will first administer COVID-19 vaccines to quarantine personnel, front line health workers and airline staff, COVID-19 Response Minister Chris Hipkins said, as the government formally approved its use on Wednesday. Doses of Pfizer-BioNTech COVID-19 vaccine sit in a fridge at the Foch hospital in Suresnes, near Paris, France, February 8, 2021. REUTERS/Benoit Tessier New Zealand’s medicines regulator last week provisionally approved the use of the COVID-19 vaccine jointly developed by U.S. drugmaker Pfizer Inc and Germany’s BioNTech. “Now we’ve reached the crucial stage of approval for the first vaccine, we are in a much better position to start having a conversation with New Zealanders about how we plan to proceed,” Hipkins said in a statement. Authorities expect the Pfizer vaccine to arrive in the country by end-March but they had expressed concerns about export curbs. Pressure has been mounting on Prime Minister Jacinda Ardern to start inoculations ...

  WUHAN, China (Reuters) - The head of a World Health Organization-led team probing the origins of COVID-19 said bats remain a likely source and that transmission of the virus via frozen food is a possibility that warrants further investigation, but he ruled out a lab leak. Peter Ben Embarek, who led the team of independent experts in its nearly month-long visit to the Chinese city of Wuhan, where the outbreak first emerged at a seafood market in late 2019, said the team’s work had uncovered new information but had not dramatically changed their picture of the outbreak. “The possible path from whatever original animal species all the way through to the Huanan market could have taken a very long and convoluted path involving also movements across borders,” Embarek told a nearly three-hour media briefing. Embarek said work to identify the coronavirus’s origins points to a natural reservoir in bats, but it is unlikely that they were in Wuhan. Investigators were also looking for Chines...

  SACRAMENTO, Calif. (Reuters) - California on Tuesday was poised to surpass New York as the U.S. state with the most coronavirus deaths, a grim reminder of the pandemic’s toll even as the vaccine rollout and a sharp drop in new cases offer hope that life will eventually return to normal. Fatalities from COVID-19 reached 44,495 late Monday in California, the most populous U.S. state, according to a Reuters tally that will be updated later on Tuesday. In New York, which was especially hard hit in the pandemic's early days, the death toll stood at 44,693.  here “This is a heart-wrenching reminder that COVID-19 is a deadly virus, and we mourn alongside every Californian who has suffered the tragic loss of a loved one during this pandemic,” Dr. Mark Ghaly, head of the state’s Health & Human Services Agency, said of the milestone in an email to Reuters. Part of the reason for California’s high death toll is the state’s huge population: 40 million people. When considered in term...

  Drug Farm has  raised  $56 million to take its lead hepatitis B treatment into the clinic. The series A round will equip Drug Farm to start learning whether its mutagenesis-based approach to drug target discovery translates into effective therapies.  Sino-American biotech Drug Farm is built on a way to generate libraries of genetic mutations in mice and analyze the animals for insights into potential drug targets linked to host immunity. Tian Xu, Ph.D., founder and chair of Drug Farm, and his collaborators  published  an overview of their approach to genomewide, phenotype-driven mutagenesis in PNAS in 2019. Drug Farm has used the platform to create a pipeline led by a treatment for hepatitis B infection. The drug candidate, DF-006, is a first-in-class, orally bioavailable small molecule that is on the cusp of the clinic. “We have successfully leveraged our forward genetics technology, piggyBac transposon mutagenesis to discover new targets, connect them t...