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Drugmakers may face stricter rules to ensure the supply of medicines in the European Union, EU officials said...as the bloc tries to reduce its imports of pharmaceutical products from China and other foreign "autocracies"...At the onset of the COVID-19 pandemic last year, the 27-country bloc encountered protracted problems in obtaining a wide range of medicines and their ingredients from India and China, as supplies tightened amid lockdowns and export restrictions...The planned rules change is also aimed at reducing the EU's reliance on medicine ingredients produced abroad, as the Commission estimates that two-thirds of the global supply is concentrated in India and China...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

A landmark opioid trial is getting underway in Cleveland. For the first time, pharmacies...will be on trial, and there will be far-reaching implications for big-ticket policy questions far afield of the opioid crisis...On one side will be Walgreens, CVS, and Walmart. On the other, two Ohio counties...The basic theory that will be trial-tested is whether pharmacies are legally responsible for creating a public nuisance by overlooking so-called “red flags” when filling customers’ prescriptions for FDA-approved opioids...READ MORE

No matter how you slice it, the pharmaceutical industry is the central engine of the global health establishment. The industry's larger corporations provide funding for the FDA, the CDC, the WHO; they do this both directly and through NGOs like the EPDA...The ties between the FDA and Big Pharma run deep, and their relationship has become so symbiotic that neither could exist without the other unless massive reforms were to take place. Big Pharma relies on the FDA to approve and rush its products to market, and the FDA relies on Big Pharma to receive its funding...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

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

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

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

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

Ahead of a highly anticipated meeting that could influence how soon coronavirus booster shots become widely available in the U.S., staff at the Food and Drug Administration appeared to take a neutral view of whether the agency should authorize a third dose of Pfizer's vaccine..."Some observational studies have suggested declining efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not," the reviewers said in the document, using the brand name for Pfizer's vaccine. "[B]ut FDA has not independently reviewed or verified the underlying data or their conclusions."...READ MORE