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Three leaders from pharma ingredients and innovation firm Lonza share views on challenges and opportunities likely to face the industry in coming months...It likely is safe to say no professionals in drug development and manufacturing has a reliable crystal ball that can provide a crystal-clear picture of exactly what will happen in the coming 12 months. However, seasoned and savvy professionals can offer educated opinions, and advice on preparing for what might lie ahead...To get a clearer perspective on what 2021 might have in store for the pharma field, Outsourcing-Pharma (OSP) checked in with three Lonza executives, asking their thoughts on 2020 as well as the new year...READ MORE

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

The Trump administration sued Walmart Inc. Tuesday, accusing the retail giant of helping to fuel the nation’s opioid crisis by inadequately screening for questionable prescriptions despite repeated warnings from its own pharmacists...The Justice Department’s lawsuit claims that Walmart sought to boost profits, understaffed its pharmacies and pressured employees to fill prescriptions quickly. That made it difficult for pharmacists to reject invalid prescriptions, enabling widespread drug abuse nationwide, the suit alleges...Walmart, the country’s largest retailer by revenue, has been expecting this complaint and sued the federal government in October to fight the allegations pre-emptively...In its suit, Walmart accuses the Justice Department and Drug Enforcement Administration of attempting to scapegoat the company for what it says are the federal government’s own regulatory and enforcement shortcomings...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. government is close to a deal to acquire tens of millions of additional doses of Pfizer's vaccine in exchange for helping the pharmaceutical giant gain better access to manufacturing supplies...the deal is under discussion and could be finalized shortly...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