- 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
- Speak up, docs: Bayer’s ‘AMI’ voice assistant talks prescription drug info for physicians (fiercepharma.com)
AMI, pronounced as Amy, is Bayer's new voice assistant and chatbot that can talk to physicians about prescription drugs when they say, “Hey Google, talk to Bayer Pharmaceutical” on Google Home...An acronym for assistant for medical information, AMI is meant to offer quick, hands-free and on-demand information for busy healthcare professionals. Doctors can ask about prescribing information and other details for two oncology drugs, Nubeqa and Xofigo, and three women’s health products, Mirena, Kyleena and Skyla...Bayer is the first pharma to use voice technology to access medical information through Google Home and Google Assistant...READ MORE
- As blood clot concerns mounted, J&J reached out to rival COVID-19 vaccine makers to form alliance: WSJ (fiercepharma.com)
Johnson & Johnson reached out to vaccine rivals—including AstraZeneca, Moderna and Pfizer—last week, hoping to join forces to study cases of rare and severe blood clots cropping up in some vaccinated people...The goal: to forge an alliance that would communicate the vaccines' benefits and risks to allay fears among the public...Regulators were already investigating a small number of cases possibly linked to AstraZeneca's vaccine...the FDA and its European counterparts said they were examining four cases in people dosed with the J&J shot...READ MORE
- 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
- FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys (fiercepharma.com)
Johnson & Johnson’s takeover of COVID-19 vaccine manufacturing at an error-prone Emergent BioSolutions plant in Baltimore didn’t last long...Two weeks after the U.S. stepped in and handed control of vaccine manufacturing at the plant to J&J, Emergent agreed to temporarily halt producing new drug substance there...READ MORE
- With less demand for surgical relief during pandemic, Sun cuts poppy production in Tasmania (fiercepharma.com)
For many, the sedative power of poppies was introduced by Dorothy in the Wizard of Oz, galloping through flowers before falling fast asleep...Those blooms now provide raw materials for opioid painkillers used by the millions worldwide. But like the Wicked Witch of the West, who cast that poppy spell on Dorothy, the coronavirus pandemic has put a sleeper hold on the production of poppies for pharmaceutical use...The global demand for opium-based products plummeted last year as COVID forced the cancellation of most elective surgeries, and now, that diminished need for surgical pain relief products has forced Sun Pharma of India to reduce its number of contracted poppy growers in Tasmania and to eliminate two of its field officers...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
- COVID-19 Pandemic Causes Dramatic Shifts in Prescription Drug Spending (pharmacypracticenews.com)
The COVID-19 pandemic heavily influenced U.S. spending for prescription drugs in 2020, according to ASHP's National Trends in Prescription Drug Expenditures and Projections for 2021...Shifts in care related to the pandemic will be a significant driver of drug expenditures in 2021, along with uptake in the use of biosimilars, a large pipeline of new cancer drugs and increased approvals of specialty medications...Prescription drug spending in 2020 grew at a moderate rate of 4.9% to $535.3 billion. Increased use drove the growth, which accounted for 2.9% of the total increase, according to the report. Spending on new drugs accounted for 1.8% of the increase, and price changes accounted for 0.3%...READ MORE
- More therapeutics but no surge in vaccine for Michigan, Biden administration says (reuters.com)Michigan Governor Says COVID-19 Infections Could Be Dropping (usnews.com)
Michigan Governor Gretchen Whitmer
The White House said on Monday it was prepared to send additional therapeutic treatments to the state of Michigan, which is experiencing a worrying number of COVID-19 cases, but declined to promise more vaccine as the state has sought...White House coronavirus adviser Andy Slavitt told reporters the U.S. government would work to ensure that states such as Michigan were ordering the full amount of vaccine that was available to them but said that shifting distribution was not in line with the administration’s public health strategy...READ MORE