FDA law experts do not buy the outsourcers’ argument that the agency must go through notice-and-comment rulemaking to remove a drug from the shortage list.
Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.
Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.
As Sandoz publishes a report on US drug shortages, including a call for policy and other improvements, the firm’s North America head and AAM Chair Keren Haruvi discussed potential solutions to ongoing supply-chain failures.
New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.
The US FDA Commissioner pushed for rebalancing the US’s pharmaceutical supply chains while also stressing that US-China commerce has a role that would be risky to compromise.
The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.
There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025, writes the ABPI's Rick Greville.
The newly published revised code of practice from the UK drug industry association moves certain elements from “guidance” to “mandatory” status, includes an option for providing prescribing information via QR codes, and promises to resolve complaints faster.
Although the FTC’s administrative complaint focuses only on insulins, the commission hopes it will have a broader impact by driving reforms of rebate and contracting practices for other drugs as well.
Improvements in the UK’s manufacturing and clinical trial ecosystems are on the “Christmas list” of Ioana Parsons, Ipsen’s general manager for the UK & Ireland.
Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.
European pharmaceutical industry group, EFPIA, says it is committed to supporting clinical trial transparency, but wants greater clarity on how disclosed data are effectively contributing to public health improvements so that investments can be prioritized in areas providing the greatest benefit.
A senior McKinsey executive discusses trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.
Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.
With the BIOSECURE Act halfway to congressional approval, stakeholders are pushing for a financial boost to ensure the US gains the business Chinese companies will lose, but that may be a big lift.
The revised EU Urban Wastewater Treatment Directive, which obliges pharmaceutical and cosmetic industries to contribute at least 80% towards the costs of removing micropollutants from wastewater through quaternary treatments, will place an additional burden of around €2bn per year on German manufacturers, says Pharma Deutschland.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.