Author: Peter

The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use...The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27...“This is the first marketing authorization of a COVID-19 vaccine in the EU. It is valid in all 27 member states at the same time,” said EMA Executive Director Emer Cooke. “There is a firm scientific foundation for roll out,” she said...READ MORE

Drug manufacturers have had little choice but to act on their own to identify and mitigate the impact of duplicate 340B discounts...Marcy Imada...director at Deloitte & Touche LLP... said preventing duplicate 340B discounts “has proven to be a challenging and long-standing problem for the industry, and in particular for manufacturers. There have been numerous government studies and recommendations provided over the years to try to address this duplicate discounts challenge.”...manufacturers have been left with little choice but to take “more proactive steps” and implement “new strategic initiatives,”... “At least a couple of manufacturers have communicated plans to limit sales at 340B discounted prices billed to a covered entity and shipped to 340B contract pharmacies,” she said...READ MORE

A Food and Drug Administration advisory panel recommended Thursday that Moderna Inc.’s MRNA 5.09% Covid-19 vaccine be cleared for broad use, setting the stage for the FDA to grant an expected emergency-use authorization by late Friday...The advisory panel’s vote was 20-0, with one abstention, to recommend use of the Moderna vaccine for people 18 years of age and older. That puts it in line to become the second Covid-19 vaccine to be granted an emergency use authorization, following the FDA’s green light of a vaccine from Pfizer Inc. and BioNTech SE last week...READ MORE

Prime Minister Justin Trudeau said Tuesday that Canada has contracted to receive up to 168,000 doses of the Moderna COVID-19 vaccine before the end of December, pending approval by the country’s health regulator...Canadians began receiving vaccine shots developed by Pfizer and BioNTech on Monday and Trudeau said Canada expects to receive about 200,000 doses from Pfizer next week. Canada received an initial batch of 30,000 this week...READ MORE

Why did Christie Smythe upend her life and stability for Martin Shkreli, one of the least-liked men in the world?...she chucked it all...Over the course of nine months, beginning in July 2018, Smythe quit her job, moved out of the apartment, and divorced her husband. What could cause the sensible Smythe to turn her life upside down? She fell in love with a defendant whose case she not only covered, but broke the news of his arrest. It was a scoop that ignited the Internet, because her love interest, now life partner, is not just any defendant, but Martin Shkreli: the so-called “Pharma Bro” and online provocateur, who increased the price of a lifesaving drug by 5,000 percent overnight and made headlines for buying a one-off Wu-Tang Clan album for a reported $2 million. Shkreli, convicted of fraud in 2017, is now serving seven years in prison...READ MORE

The Food and Drug Administration is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in multiple states after it began to be administered this week...Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters late Friday that the reactions had been reported in more than one state besides Alaska and that the FDA is probing five reactions...“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said...READ MORE

The U.S. Centers for Medicare and Medicaid Services issued a proposed rule Thursday aimed at improving the electronic exchange of healthcare data among payers, providers and patients...The rule would require Medicaid, CHIP and QHP programs to build HL7 FHIR-based APIs to support data exchange and prior authorization. It also includes a proposed API standard for healthcare operations nationwide...The proposed rule seeks to enhance the patient access API by requiring the use of specific HL7 implementation guides by impacted payers...READ MORE

• Safety Issues Related to Labeling, Packaging, and Nomenclature
• Safety Issues Associated With Order Communication and Documentation
• Problems Involving Drug Information, Patient Information, Patient Education, and Staff Education
• Safety Issues Related to Medical Devices and Equipment
• Other Discussion Items
• SMP’s Targeted Medication Safety Best Practices for Hospitals...READ MORE

Today, the U.S. Food and Drug Administration issued an emergency use authorization for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older...READ MORE

University Medical Center became the first hospital in Nevada to administer the COVID-19 vaccine on Monday, marking a major turning point...UMC began administering the vaccine at 11:45 a.m., and by 4 p.m., the hospital had vaccinated more than 200 frontline health care workers in line with guidance from the Centers for Disease Control and Prevention and the state, said UMC CEO Mason Van Houweling...ICU nurse Roshele Ward was the first UMC employee — and the first Nevadan — to be vaccinated...READ MORE