- FTC joins overseas antitrust regulators in reexamination of pharma M&A (biopharmadive.com)
The U.S. Federal Trade Commission will join European, British and Canadian regulators, as well as with counterparts at the U.S. Justice Department and states attorneys general, to update their approach to reviewing pharmaceutical acquisitions, a move the commission's acting chair said was prompted by the "high volume of these mergers," increasing drug prices and other anti-competitive issues...Antitrust regulators watch drugmaker mergers closely to determine whether tie-ups could impede development of newer and potentially better medicines...READ MORE
- Abbott announces its Pandemic Defense Coalition (worldpharmanews.com)
Abbott announced the formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind global scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats. By connecting global centers of excellence in laboratory testing, genetic sequencing and public health research, the program will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing and assess public health impact in real time...READ MORE
- AstraZeneca’s COVID-19 vaccine faces distrust in Europe, even as it gets rave reviews in neighboring UK, survey finds (fiercepharma.com)
AstraZeneca’s COVID-19 vaccine is facing a wave of mistrust in Europe—but that's a striking difference from its stellar reputation in the U.K...A recent survey from YouGov found that 81% of Britons believe the AZ vaccine is safe, on par with a similar 79% of U.K. citizens who trust the Pfizer vaccine. However, in Germany only 43% think the AZ vaccine is safe, and in France, just 33% consider it safe...READ MORE
- GlaxoSmithKline’s doctor payments double as relaxed policy plays out (fiercepharma.com)
GlaxoSmithKline payments to doctors are on the rise again, as its relaxed payment policy continues. It notched a 40% increase from $11 million in 2017 to more than $15 million in 2019 in the U.S., likely reflecting its loosening of a formerly strict physician payment policy...The company's 2016 policy...banned direct payments to doctors speaking on behalf of the pharma and contributed to a hefty drop in payouts from $30.6 million in 2016 to $11 million the following year, according to data from the U.S. Open Payments database. GSK’s tally dropped even further in 2018 to $8.9 million before increasing in 2019...READ MORE
- Overworked, understaffed: Pharmacists say industry is in crisis, putting patient safety at risk (msn.com)
From the moment Marilyn Jerominski walks into her pharmacy every morning, her time is in demand. As pharmacy manager of a busy 24-hour Walgreens in Palm Desert, California, she is responsible for the safety and accuracy of the thousands of prescriptions the store dispenses every week..."There's so much stress," Jerominski said. "You're not only running to the drive-thru but to the front, to the vaccination station to give a vaccination, then to the phone. ... It's almost impossible for any human to keep that momentum day in and out."...Jerominski is one of an estimated 155,000 pharmacists working at chain drugstores who, over the past decade, have found themselves pushed to do more with less. They're working faster, filling more orders and juggling a wider range of tasks with fewer staff members at a pace that many say is unsustainable and jeopardizes patient safety...READ MORE
- Pfizer’s COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report (fiercepharma.com)
About a month before Pfizer and BioNTech won an emergency nod for their COVID-19 vaccine in Europe, regulators raised flags about lower-than-expected levels of intact mRNA in commercial batches, the BMJ reports...The European Medicines Agency outlined “a significant difference" in the RNA in clinical batches and the proposed commercial batches, according to information leaked from an EMA cyberattack in December, which the BMJ subsequently reviewed...While the production issue has since been resolved—and Pfizer's vaccine has since won approval in Europe—the leaks show the “complexities of quality assurance” for mRNA vaccines, especially with regards to RNA instability, the BMJ said. It’s an issue that affects all mRNA developers, including Moderna and CureVac. That instability is the reason for the shots’ frigid cold chain requirements and the need to encapsulate mRNA in lipid nanoparticles, BMJ said...READ MORE
- Novartis’ Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first (fiercepharma.com)
Here's a hypothetical: What happens when the FDA grants exclusivity to a new drug ingredient that isn't exactly new?...Novartis' generics unit claims the agency did just that with Sanofi's multiple sclerosis med Aubagio—but the dispute isn't necessarily just about the New Chemical Entity exclusivity itself. That's no longer in force according to the FDA Orange Book. It's also about the 180-day exclusivity drugmakers win when they're first to file for copycat approval—and right now, 20 generics are poised to hit the scene simultaneously in 2023...READ MORE
- Nevada pharmacies now vaccinating 55+ with health conditions (reviewjournal.com)
People from 55 to 64 with certain medical conditions are now eligible to get COVID-19 vaccinations at Nevada pharmacies, with no proof of medical status required...The state opened up eligibility this week to those in this age group with conditions ranging from cancer to smoking that put them at higher risk for serious disease from COVID-19...Eligibility also has been extended to those with conditions that only potentially put them at higher risk, such as asthma or dementia, as well as to those with disabilities or who are experiencing homelessness...READ MORE
- Major European nations suspend use of AstraZeneca vaccine (apnews.com)EXPLAINER: Why countries are halting the AstraZeneca shot (apnews.com)
A cascading number of European countries — including Germany, France, Italy and Spain — suspended use of AstraZeneca’s COVID-19 vaccine Monday over reports of dangerous blood clots in some recipients, though the company and international regulators say there is no evidence the shot is to blame...The EU’s drug regulatory agency called a meeting for Thursday to review experts’ findings on the AstraZeneca shot and decide whether action needs to be taken...Germany’s health minister said the decision to suspend AstraZeneca shots was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven cases of clots in the brains of people who had been vaccinated...READ MORE
- Countering payers, drugmakers say net prices declined in 2020 (biopharmadive.com)
About half of gross drug sales earned by three large drugmakers in the U.S. are returned to insurers as rebates or discounts, the companies said in annual pricing reports that showed the net prices of their products declined last year when averaged across their businesses...In a report...Sanofi said its net price, or what it keeps after rebates and discounts have been factored, declined 7.8% in 2020, following earlier reports from Merck & Co. and Novartis, which reported drops of 0.9% and 0.5%, respectively...The disclosures from the companies contrast with reports from insurers and pharmacy benefit managers, which often focus on list, or wholesale, prices...READ MORE