- J&J scores backing from Chamber of Commerce, PhRMA and more in Supreme Court appeal of $2.1B talc verdict (fiercepharma.com)
Johnson & Johnson has ginned up major support in its quest to challenge a $2.1 billion verdict over claims that its talc-based powders cause cancer...The U.S. Chamber of Commerce and other business groups...pressed the Supreme Court to review the verdict, taking aim at the merging of 22 plaintiffs' cases and the damages J&J was subsequently asked to shell out...In a 2018 trial, a Missouri jury ordered Johnson & Johnson to pay $4.69 billion after hearing the combined claims of 22 women who alleged the company’s talc powder caused their ovarian cancer...the Missouri Court of Appeals for the Eastern District knocked the verdict down to $2.1 billion...READ MORE
- Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents (worldpharmanews.com)
Pfizer Inc. and BioNTech SE...requested amendments to the U.S. Emergency Use Authorization of the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine...READ MORE
- Oxford pauses COVID-19 vaccine study in kids, awaits more data on blood clot issues (reuters.com)Johnson & Johnson's COVID-19 vaccine under scrutiny at EMA after 4 'serious cases' of unusual blood clots (fiercepharma.com)
The University of Oxford said...it had paused a small UK trial testing the COVID-19 vaccine it developed with AstraZeneca Plc in children and teenagers, as it waits for more data on rare blood clotting issues in adults who received the shot...The trial disruption is the latest blow to the vaccine, once hailed as a milestone in the fight against the pandemic, after several countries restricted its use in light of reports of medical issues after inoculations...READ MORE
- FDA authorizes first AI-powered armband for COVID-19 screening (pharmacist.com)Tiger Tech snares first EUA for machine learning algorithm applied to COVID-19 screening (bioworld.com)
FDA granted an emergency use authorization for the first machine learning–based COVID-19 nondiagnostic screening device. The Tiger Tech COVID Plus Monitor identifies certain biomarkers that may be indicative of SARS-CoV-2 infection. It can also detect hypercoagulable conditions, such as sepsis or cancer, or hyper-inflammatory states in asymptomatic individuals over the age of 5 years...FDA said the device, which is an armband embedded with light sensors and a small computer processor, is intended for use by trained personnel to help prevent exposure to and the spread of COVID-19...READ MORE
- Clinical trial completion rates decline during COVID-19 pandemic (worldpharmanews.com)
Social distancing and lockdowns may have reduced the spread of COVID-19, but researchers from Penn State College of Medicine also report those actions may have affected clinical researchers' ability to finish trials. Study completion rates dropped worldwide between 13% and 23%..."The pandemic has made it more difficult for researchers to recruit and follow up on patients in clinical trials," said Hawila, a research assistant from the Department of Public Health Sciences. "This analysis revealed that the impact was substantial -- particularly for trials funded by government, academic or medical entities."...READ MORE
- FibroGen admits to messing with roxadustat safety data, upending hopes for the AZ-partnered anemia drug (fiercepharma.com)
...FibroGen admitted to presenting roxadustat data manipulated to make the anemia drug look safer than it is...The...announcement sent FibroGen shares tumbling and prompted analysts to reassess the potential first-in-class therapy ahead of an FDA decision...The company changed parameters used to analyze heart safety data for roxadustat in patients with anemia from chronic kidney disease...The false criteria yielded more flattering data...READ MORE
- Australia calls for release of 3.1 million vaccine doses, if EU not blocking exports (reuters.com)Australia to continue AstraZeneca vaccine rollout, review EU findings (reuters.com)
Australia said on Wednesday it will ask the European Union to release more than 3 million doses of AstraZeneca PLC's COVID-19 vaccine, testing Brussels claim it is not blocking shipments, as the country struggles to vaccinate its population...The European Union...denied blocking vaccine shipments to Australia, which has fallen dramatically behind in its scheduled vaccination programme...READ MORE
- CEOs of COVID-19 Vaccine Makers See Boost in Salaries (biospace.com)
The global pandemic played a key role in an economic downturn with the lockdowns and work interruptions. Despite those woes, the heads of some biopharmaceutical companies developing vaccines that are playing a key role in the battle against COVID-19 saw boosts in their annual compensation...READ MORE
- Albert Bourla, Pfizer $21 million
- Ugur Sahin, BioNTech $7 million
- Stéphane Bancel, Moderna $12 million
- Alex Gorsky, Johnson & Johnson $25 million
- Pascal Soriot, AstraZeneca $21 million
- A third of COVID survivors suffer neurological or mental disorders: study (reuters.com)
One in three COVID-19 survivors in a study of more than 230,000 mostly American patients were diagnosed with a brain or psychiatric disorder within six months, suggesting the pandemic could lead to a wave of mental and neurological problems...Researchers who conducted the analysis said it was not clear how the virus was linked to psychiatric conditions such as anxiety and depression, but that these were the most common diagnoses...“Although the individual risks for most disorders are small, the effect across the whole population may be substantial,”...READ MORE
- Emergent BioSolutions’ plant behind the lost J&J vaccine batch hit with several FDA red flags last year: report (fiercepharma.com)
With Johnson & Johnson's COVID-19 vaccine rollout off to a slower than expected start, the recent news that millions of doses were ruined in a production error came as a rude awakening. But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before...An FDA investigator last April discovered improper training, record keeping, testing procedures and more at Emergent BioSolution's Baltimore Bayview facility...The inspection came just two months before the CDMO snared an eye-popping $628 million deal from the U.S. government to scale up production capacity...READ MORE