The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.

Biodiversity footprinting may still be a new concept for pharmaceutical companies, but they need to put a clear supply chain strategy in place now, particularly as the COP 15 conference in December is expected to discuss mandatory reporting of biodiversity risks, says Luka Brown.

Current drug classification standard was originally designed for the Medicare Part D program, which does not cover obesity drugs.

As Europe’s health emergency body HERA approaches its first anniversary, an unprecedented range of stakeholders including industry bodies will be meeting in December to discuss HERA’s achievements, while a separate event will showcase the next generation of vaccines for COVID-19 and other infections.

Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.

US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.

Court finds government failed to promptly notify Gilead of its PrEP-related patent applications as required under agreements for supply of HIV drugs used in CDC studies. Whether Gilead will have to license government patents remains undecided.

South Korea's breakthrough therapy system, Global Innovative Products Fast Track, kicks off with Roche’s follicular lymphoma drug becoming the first to test the new system. Meanwhile, a state-run group is linking with pharma firms to rapidly bring in global new drugs.

Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.

US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.

Successive waves of Alzhiemer’s therapies are going to be needed, David Ricks said as his company awaits Phase III data on donanemab, the last of three late-stage anti-amyloid drugs to report results.

Final guidance targets the ‘multiplicity problem.’ At about half the length of the 2017 draft, the final removes some sections, truncates other and drops several examples.

Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.

David Ricks says the challenging political environment is empowering regulators. The Lilly leader also talked Twitter and drug prices, in a STAT Summit interview.

Pharma CEOs must balance optimizing access and profitability, former Merck CEO and soon-to-be ex executive chairman of the company said. Frazier says health care industry must come to table and admit the “system ain’t working,” talks about the need to protect democracy, in a sweeping interview at the STAT Summit.

Regulators in Pakistan are consulting on draft rules that outline their plan to introduce a risk management approach to their inspection activities and the frequency at which manufacturers can expect to undergo an inspection.

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.