- Pfizer CEO says third Covid vaccine dose likely needed within 12 months (cnbc.com)Moderna watches for 'waning immunity' as new data show durable vaccine protection (biopharmadive.com)
Pfizer CEO Albert Bourla said people will "likely" need a booster dose of a Covid-19 vaccine within 12 months of getting fully vaccinated..Bourla said it's possible people will need to get vaccinated against the coronavirus annually..."A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role,"...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
- Senate committee advances bill to create ‘988’ mental health hotline, set plan for allocating opioid settlement funds (thenevadaindependent.com)
A legislative committee unanimously passed a bill that would create a state fund to house proceeds from opioid settlements, such as those against prominent pharmaceutical companies accused of helping fuel the opioid crisis...The bill would establish the “Nevada Fund for Healthy Communities,” which would hold the proceeds of state litigation against opioid manufacturers, distributors, sellers and marketers — including the $45 million Nevada is set to receive from the settlement of a lawsuit against consulting firm McKinsey & Company, which provided services for opioid manufacturers...READ MORE
- CDC, FDA Recommend Pausing J&J COVID-19 Vaccine Rollout Over Blood Clots (biospace.com)J&J says delaying rollout of COVID-19 vaccine in Europe (reuters.com)U.S. FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots (reuters.com)
The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson...That is six cases out of more than 6.8 million doses that have been given in the U.S...The blood clots are cerebral venous sinus thrombosis, which were observed in combination with low levels of blood platelets. All cases were in women between 18 and 48 years of age. The symptoms occurred six to 13 days after vaccination...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
- 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