Author: Peter

...the Pharmaceutical Research and Manufacturers of America filed a complaint in the U.S. District Court for the Eastern District of Arkansas challenging provisions in Arkansas Act 1103 that seek to require manufacturers to provide federal 340B program pricing to Arkansas-based pharmacies contrary to federal statute...PhRMA...General Counsel James C. Stansel stated:“The 340B pricing mandate provisions of Arkansas Act 1103 violate both the Supremacy and Commerce clauses of the U.S. Constitution because they impermissibly clash with the statutory requirements of the federal 340B program. This misguided state mandate places requirements on manufacturers that directly conflict with the federal 340B statute and attempts to regulate commercial transactions that occur outside of Arkansas...READ MORE

Even while pediatric COVID-19 cases remain high in the United States, there remains significant resistance by parents to vaccinate their children. Amid this reluctance, Pfizer and BioNTech have asked the FDA to authorize their vaccine for children aged 5 to 11, the companies revealed...An FDA advisory committee has scheduled a meeting on Oct. 26 to discuss authorization. The submission potentially sets up the vaccine for emergency use approval...but the companies may face a tough sell trying to convince parents that the shot is safe...Last month, only 34% of parents in the U.S. with children ages 5 to 11 said they would vaccinate them “right away,”...READ MORE

Pharmacy operators including CVS Health Corp and Walmart Inc fueled the U.S. opioid epidemic by failing to stop massive quantities of addictive painkillers from reaching the black market, a lawyer for two Ohio counties said at the start of a trial...Mark Lanier told a federal jury in Cleveland hearing the first trial the pharmacy chains have faced in nationwide litigation over the epidemic that the companies bore responsibility for drug abuse in the counties of Lake and Trumbull..."They just dispensed like a vending machine," Lanier said in his opening statement...READ MORE

Five weeks after Japan suspended the use of three lots of the Moderna COVID-19 vaccine, the company and its Japanese distributor Takeda have concluded that “human error” caused the presence of metallic particles in vials...The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The fourth and fifth lots from the series were held back...READ MORE

Moderna on Thursday said it will build a plant in Africa to produce shots for COVID-19 as well as other vaccines for other diseases, although it has yet to pick a site or a country for the planned factory...The Massachusetts biotech intends to spend as much as $500 million on the plant, which it claims will be able to produce as many as 500 million vaccine doses a year. Along with manufacturing the actual vaccine product, the plant will also fill vial vials and package doses, Moderna said...African nations are well behind the rest of the world in COVID-19 vaccinations. Only 7% of the continent's population has had at least one dose, compared with 66% for the U.S. and Canada, 58% for Latin America and 57% for Europe...READ MORE

No pharmaceutical company is eager to broadcast the role that abortion-derived fetal cell lines played in the development of the COVID-19 vaccine, and that reportedly includes Pfizer...Project Veritas released a video Wednesday in which Melissa Strickler, Pfizer manufacturing quality auditor, produced what she identified as internal emails that showed top officials discussing how to downplay in corporate communications the role of embryonic cell lines in the COVID-19 vaccine program...“If they’re being this deceptive about it, I don’t feel comfortable being silent,” said Ms. Strickler in the video interview with Project Veritas President James O’Keefe...READ MORE

The...Supreme Court...cleared the way for New York to collect a $200 million surcharge imposed on opioid manufacturers and distributors to defray the state's costs arising from the deadly epidemic involving the powerful painkilling drugs...The justices declined to hear an appeal by two trade groups representing drug distributors and generic drug makers and a unit of British-based pharmaceutical company Mallinckrodt Plc of a lower court's decision upholding the surcharge...The law's challengers included the Association for Accessible Medicines, whose members include drugmakers Teva Pharmaceutical Industries Plc...and Mallinckrodt, and the Healthcare Distribution Alliance, which represents wholesale distributors...The alliance's members include the three largest opioid distributors in the United States, McKesson Corp, AmerisourceBergen Corp and Cardinal Health...READ MORE

After nearly nine months without a permanent FDA leader and after watching the agency withstand a torrent of criticism, President Joe Biden finally ready—almost—to announce a nominee for the beleaguered agency...Speaking to reporters on Tuesday in response to NIH Director Francis Collins’ retirement announcement, Biden said in reference to the FDA post, “We’ll be talking about that in a little bit.”...READ MORE

The past several months have seen thousands of hospitals announce COVID-19 vaccination requirements for staff and clinicians as a condition of employment...Although controversial, the policies picked up steam when Pfizer and BioNTech’s Comirnaty received a full regulatory approval and then really kicked into gear when the Biden administration made workforce vaccination a requirement for Medicare and Medicaid participation...Most health system leaders and professional organizations have been supportive of the requirement, with some describing vaccination as “the logical fulfillment of the ethical commitment of all healthcare workers to put patients as well as residents of long-term care facilities first.”...READ MORE

The Securities and Exchange Commission has charged a former Goldman Sachs compliance analyst of using confidential information to make more than $471,000 in ill-gotten gains including more than $77,000 on two deals involving at least four biopharmaceutical companies...The suit alleges that Jose Luis Casero Sanchez made a profit of more than $70,000 by using advance information on Jazz Pharmaceuticals’ acquisition of G.W. Pharmaceuticals. Additionally, Sanchez made more than $7,000 on his purchase and sale of stock surrounding Horizon Therapeutics' acquisition of Viela Bio. The two M&A deals were announced two days apart in February of this year...READ MORE