- Eli Lilly faces employee complaints, FDA troubles at factory making COVID-19 drug: report (fiercepharma.com)
Quality control problems have already plagued one COVID-19 vaccine manufacturer in Baltimore, Maryland. Now, it appears they’re threatening to trip up a major pandemic therapeutic supplier as well...Eli Lilly employees have accused an executive at the drugmaker’s Branchburg...manufacturing site of altering FDA-required documents in an effort to downplay serious quality control problems...citing internal complaint documents...The complaint, dated April 8, said the executive tasked with quality controls rewrote findings from Lilly’s technical experts at the facility, which produces doses of the company’s COVID-19 antibody treatment bamlanivimab, in order to make them look more favorable...READ MORE
- British regulator cites 41 more blood clot reports following AstraZeneca shots (reuters.com)
Britain’s medicine regulator on...said there had been a further 41 reports of rare blood clots after doses of AstraZeneca’s COVID-19 vaccine, but that the benefits of the shot continued to outweigh the risks for the majority of people...In a weekly update on side effects from COVID-19 vaccines, the Medicines and Healthcare products Regulatory Agency said there were a total of 209 clots with low platelet counts following vaccination with AstraZeneca's shot, compared to a total of 168 reported last week...READ MORE
- U.S. to send more than $100 mln in COVID supplies to India (reuters.com)
The United States is sending supplies worth more than $100 million to India to help it fight a surge of COVID-19 cases...The supplies...include 1,000 oxygen cylinders, 15 million N95 masks and 1 million rapid diagnostic tests...The United States also has redirected its own order of AstraZeneca manufacturing supplies to India, which will allow it to make over 20 million doses of COVID-19 vaccine...READ MORE
- Johnson & Johnson says it has negotiated Covid-19 vaccine warning label with FDA (msn.com)
Johnson & Johnson said Friday that it has negotiated a warning label for its Covid-19 vaccine to make health care providers aware of a potentially increased risk of rare but severe blood clots and low platelet counts...The vaccine maker revealed the warning text, which it said the Food and Drug Administration had agreed to, during a presentation Friday before a Centers for Disease Control and Prevention vaccine advisory panel...Neither the FDA nor CDC has said they will adopt a warning label...READ MORE
- Denmark removes J&J from vaccination program over clot fears (apnews.com)
Denmark...removed the single-dose Johnson & Johnson COVID-19 shot from its vaccination program to investigate reports of rare but potentially dangerous blood clots...Denmark, which has been very cautious with all vaccines, has already taken the AstraZeneca shot out of its vaccination program for the same reason. Both the J&J and AstraZeneca shots are made with similar technology...The Danish Health Authority said in a statement that it “has concluded that the benefits of using the COVID-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect.”...READ MORE
- Biopharma Companies Wrestle with Staffing Situations and Shortages from Pandemic (biospace.com)
Work-at-home arrangements created to respond to the COVID-19 pandemic have forced numerous companies in most sectors to reevaluate their work deals. This has also resulted in rethinking site locations and real estate needs. Here’s a look...READ MORE
- Sanofi Closing Pennsylvania Plant, Laying Of 75
- Pfizer, Novartis and Moderna Studying Onsite/At-Home Work Arrangements
- Switzerland’s Lonza Recruiting Nestle Workers
- EU sues AstraZeneca over breach of COVID-19 vaccine supply contract (reuters.com)
The European Commission said on Monday it had launched legal action against AstraZeneca for not respecting its contract for the supply of COVID-19 vaccines and for not having a "reliable" plan to ensure timely deliveries...Under the contract, the Anglo-Swedish company had committed to making its "best reasonable efforts" to deliver 180 million vaccine doses to the EU in the second quarter of this year, for a total of 300 million in the period from December to June...But AstraZeneca said in a statement on March 12 it would aim to deliver only one-third of that by the end of June, of which about 70 million would be in the second quarter. A week after that, the Commission sent a legal letter to the company in the first step of a formal procedure to resolve disputes...Read More
- Emails show high-powered teachers union pressured CDC to change school reopening guidance (washingtonexaminer.com)The CDC’s cruel, irrational guidance traps our kids in the forever pandemic (nypost.com)
The American Federation of Teachers successfully lobbied the Centers for Disease Control and Prevention to change its guidance on school reopenings, emails show...As the CDC was preparing to issue guidance that it was safe to reopen schools fully in February, emails obtained through a Freedom of Information Act request revealed that the AFT was behind the scenes, lobbying the agency and the Biden administration to adjust the guidance to make it friendlier to school closures and hybrid learning...The CDC was preparing to update its guidance to reflect its belief that schools could fully reopen, regardless of community spread of COVID-19...READ MORE
- Just how much COVID-19 vaccine money is on the table? A whopping $157B through 2025, report says (fiercepharma.com)
Drugmakers who seized the opportunity to develop vaccines against the coronavirus are on their way to reaping significant revenues...In its annual forecast for global drug spending, the IQVIA Institute for Human Data Science put the figure at $157 billion through 2025...In regard to global COVID-19 vaccine spending, IQVIA projects roughly $53 billion this year and $51 billion in 2022. The group sees a precipitous drop in total spending in 2023, to roughly $23 billion...READ MORE
- U.S. Lifts Pause, Will Restart J&J Vaccinations with Warning (nationalreview.com)FDA, CDC Decide Benefits of J&J Vaccine Outweigh the Risks (biospace.com)
The United States will resume Johnson & Johnson COVID-19 vaccinations after health officials lifted an 11-day pause on the shots at the recommendation of a Centers for Disease Control and Prevention advisory panel...The panel voted 10 to 4 to recommend restarting the vaccinations, saying the benefits of the shot outweigh the rare risk of blood clots. However, the group suggested that the vaccine include a warning about the increased risk of the very rare but severe blood clots...READ MORE