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A number of Big Pharma companies, including Gilead and Merck, engaged in what’s known as “pay-for-delay” deals, settling with up-and-coming generic rivals to stall their market entry and costing drug buyers hundreds of millions in lost savings as a result, a handful of high-profile new lawsuits claim...two of the nation’s largest pharmacy chains—CVS and Ride Aid—are going head-to-head with Gilead, Bristol Myers Squibb and Teva for engaging in a “multifaceted scheme to suppress and delay” generic rivals of Gilead’s HIV meds, according to a filing in the U.S. District Court...READ MORE

Pfizer...announced that the U.S. Food and Drug Administration has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series...READ MORE

Results from a new HDA Research Foundation survey indicate that the pharmaceutical supply chain is entering a critical phase in achieving the transaction data connections required to comply with the Drug Supply Chain Security Act in 2023...The DSCSA requires transaction data with product identifiers to be provided with physical product on November 27, 2023...“many healthcare supply chain trading partners are realizing there is work to be done to establish proper business-to-business connections; ensure data are formatted, transmitted and received successfully; that processes for troubleshooting are created; and that products in inventory have the right data attached to them for shipping after November 27,” said Perry Fri...COO of the HDA Research Foundation. “The Foundation’s survey shows...what might be leading to slow implementation rates across the supply chain.”...READ MORE

...the U.S. Food and Drug Administration announced the reorganization of the agency's information technology, data management and cybersecurity functions into the new Office of Digital Transformation...The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission...READ MORE

New York hospitals on Monday began firing or suspending healthcare workers for defying a state order to get the COVID-19 vaccine, and resulting staff shortages prompted some hospitals to postpone elective surgeries or curtail services...New York City Mayor Bill de Blasio told a news conference the city's hospitals were not yet seeing a major impact from the mandate, adding he worried about other areas of the state where vaccination rates are lower...A spokeswoman for Catholic Health, one of the largest healthcare providers in Western New York, said it had reached full compliance, counting staff members who had been vaccinated, those with exemptions and some who had been suspended without pay...READ MORE

National Community Pharmacists Association President Brian Caswell spoke to the Federal Trade Commission during its open meeting...about anticompetitive pharmacy benefit manager issues in the pharmaceutical supply chain...I have watched a steady increase of patients being forced or coerced into mail order which, more often than not, is owned by the (pharmacy benefit manager)...Also, a growing number of restricted medications which are classified as ‘specialty,’ with no clear clinical definition of why it is specialty, are contractually not allowed to be filled by the patient’s preferred pharmacist. Again, the prescription is steered towards the PBM’s own mail order....READ MORE

An FDA advisory panel knocked down Pfizer and BioNTech's pitch for COVID-19 booster shots for everyone, but rebounded on the committee's follow-up allowance for third shots in the elderly and high-risk people...he committee voted 16-2 to reject Pfizer’s bid for a full approval for boosters for people 16 and older...“It may eventually be indicated for the general population,” committee member Ofer Levy, M.D, said. “I just don’t think we’re there yet in terms of the data.”...READ MORE

Nearly a quarter of healthcare providers report increased mortality rates following ransomware attacks...Ransomware impacts patient care in more ways than one, with 70% or more of healthcare organizations reporting a longer length of stay or delays in procedures that lead to poor outcomes, according to a Ponemon Institute report...A majority of organizations also report an increase in patient transfers, while more than a third report increased complications from medical procedures...Healthcare delivery organizations are under siege, as 67% have been victims of ransomware attacks. One-third of those said they experienced two or more...READ MORE

The National Community Pharmacists Association is using social media, digital advertising, and a grassroots effort to push congressional budget makers to include a provision eliminating pharmacy benefit manager spread pricing under the Medicaid program and reimburse pharmacies in a fairer and more transparent manner...“PBM spread pricing costs federal and state taxpayers hundreds of millions of dollars every year. It does nothing to reduce the cost of drugs for Medicaid patients, and it drives local pharmacies out of business,” said NCPA CEO B. Douglas Hoey...Spread pricing is what happens when pharmacy benefit managers, known as PBMs, charge insurance plans like Medicaid one price for prescription medications, reimburse pharmacies that dispense them a much lower price, and then keep a big chunk of the difference for themselves...READ MORE

As officials in Washington weigh contentious drug-pricing measures, there's even more evidence that pharma companies are worried about potential reform...In an open letter to Congress, the heads of major biopharma companies...wrote that one proposal in particular—allowing Medicare to negotiate drug prices—would "threaten patients' access to medicines and sacrifice future medical advances."...READ MORE