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Pharma companies have inked a series of federal settlements over payments to charity organizations, which the federal government argues are a “conduit” to boosting drug sales. Now, after an opioid investigation, two Senators want all those charity payments disclosed publicly...And they have just the mechanism for it. Sens. Chuck Grassley and Ron Wyden have called for an expansion of the Centers for Medicare and Medicaid Services Open Payments database. That database now includes payments from pharma companies to doctors and other medical providers, but the senators propose adding payments to tax-exempt groups, too...READ MORE

The FDA warns against changing the dosing levels and schedules of COVID-19 vaccines by Moderna and Pfizer-BioNTech...Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui, Ph.D...Any changes to currently authorized vaccine dosing regimens pose a “significant risk of placing public health at risk” and undermine “the historic vaccination efforts to protect the population from COVID-19,” FDA Commissioner Stephen Hahn, M.D., and Peter Marks, M.D., Ph.D., head of the agency’s biologics department, said in a statement...READ MORE

On the drug pricing front, a major effort by the Trump administration to cut Medicare prices has been temporarily blocked by a federal judge...The president's "most favored nation" clause, which aims to tie drug prices in Medicare to lower prices abroad, has hit an early setback as a federal judge in Maryland ruled the administration didn't give the public a chance to weigh in...Judge Catherine Blake ruled the executive order was rushed unlawfully...After Trump moved to implement the measure in November, industry trade groups PhRMA and BIO sued to stop it. Blake's ruling is temporary and the Trump administration could still win the lawsuit...READ MORE

The new model will pay pharmaceutical companies upfront for access to medicines based on their usefulness to the NHS...The...model aims to stimulate investment in the development of new antimicrobials...led by the National Institute for Health and Care Excellence, NHS England and NHS Improvement, will pay pharmaceutical companies upfront for access to medicines based on their usefulness to the NHS...two treatments, cefiderocol (Fetcroja) manufactured by Shionogi, and ceftazidime with avibactam (Zavicefta) manufactured by Pfizer, have become the first two drugs to be selected to move to an innovative health technology evaluation process as part of the payment system...READ MORE

A new temporary clinic in Southern Nevada began administering COVID-19 antibody treatment on Friday, bringing new hope to lessen the severity of the virus and reduce the strain on local hospitals...Sunrise Hospital and Medical Center opened a Monoclonal Antibody Clinic with the support of the National Disaster Medical System and the U.S. Department of Health and Human Services. The clinic is expected to operate for four to six weeks but can be extended to match the community’s need...This is the third antibody infusion clinic in the country, with others opened in El Centro, California and Tucson, Arizona within the past two weeks...READ MORE

Several drug companies last year rolled out new rules on 340B-discounted medicines delivered through contract pharmacies, but the HHS Office of the General Counsel last week issued an advisory opinion stating the discounts must be offered regardless of where patients actually collect their meds...The opinion follows a months-long dispute between drug companies and 340B groups over the new restrictions. Drug companies have argued the 340B program has grown beyond its original intent and that contract pharmacies don't always pass discounts to patients. Some companies have started collecting de-identified claims data to ensure the program is working as intended, and others have prohibited discounts through contract pharmacies...READ MORE

With more than 1 billion BD injectors called for in the global fight against COVID-19, the company is looking at ways to support vaccination efforts up close and preparing for the future delivery of pandemic prophylactics...Becton Dickinson...last month surpassed 1 billion pandemic injection device orders globally...The company recently stumped up $1.2 billion to expand its pre-filled syringe capacity, sketching plans for a new plant in Europe, plus upgrades to six of the company’s existing sites in the U.S., Mexico, Europe and Japan. Those moves are expected to boost capacity by more than 50%...The company also teamed up with BARDA on a $70 million project to expand operations and dial up capacity for traditional needle and syringe devices at its Nebraska facilities. That upgrade, set to wrap in summer 2021, will provide the feds with priority access to “hundreds of millions” of injectors for COVID-19 vaccination efforts, plus supplies for future pandemics...READ MORE

With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow...With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said...All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview...READ MORE

Pharma's routine January price hikes are here once again—and not even a global pandemic seems to be slowing the number of increases...Amid ongoing scrutiny from politicians and the public, though, the level of many of the price hikes seems muted compared with previous years...drug companies large and small had raised prices on nearly 600 medicines by an average of 4.2%, GoodRx reports...READ MORE

Authorities arrested a suburban Milwaukee pharmacist Thursday suspected of deliberately ruining hundreds of doses of coronavirus vaccine by removing them from refrigeration for two nights...Police...said the Advocate Aurora Health pharmacist was arrested on suspicion of reckless endangerment, adulterating a prescription drug and criminal damage to property, all felonies. The pharmacist has been fired and police said in a news release that he was in jail. Police did not identify the pharmacist, saying he has not yet been formally charged...His motive remains unclear. Police said that detectives believe he knew the spoiled doses would be useless and people who received them would mistakenly think they’d been vaccinated when they hadn’t...READ MORE