An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.

Sweeping regulatory reforms put China in catch-up mode for the approval of oncology drugs, some of which have been cleared for marketing only in the country. But how does the deluge of new products measure up in terms of actual overall survival benefits? A new study by Peking University scholars and specialists unveils some surprising results.

The company known for compounding versions of Martin Shkreli’s Daraprim and Allergan’s Restasis is hit with a warning letter for promotions in professional periodicals about its compounded eye drop.

Hutchmed is in discussions with the European Medicines Agency on the path forward for its drug for advanced neuroendocrine tumors, whose marketing authorization application has now been withdrawn.

The UK government says that the UKHSA will be able to “harness the strengths” of the Vaccines Taskforce, including its “excellent relationships with industry” and “expertise in innovation.”

The European medicines regulatory network is giving sponsors of marketed medicines that contain chemically synthesised active substances an extra 12 months to apply for manufacturing changes to address nitrosamine-related risks.

ICER’s take on the Amylyx analyses raises questions about whether FDA will take a similar view and suggests payers may restrict coverage upon approval, at least initially, should it carry a very high price tag.

With enactment of the drug pricing reform provisions in the Inflation Reduction Act, stakeholders now turn their attention to the implementing regulations that will be developed by the Centers for Medicare and Medicaid Services.

Congressional Democrats achieved a long-sought goal in passing major legislation to control drug prices in Medicare. A complete lack of Republican support suggests the programs established by the bill will face the same kind of legislative and legal challenges that confronted the Affordable Care Act, which was enacted in a similar manner.     

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

Pharma’s opponents believe passage of the Inflation Reduction Act represents a momentum shift that will make it easier for politicians (even some Republicans) to take on the industry. They’ll need to count on that as they still have a long list of targets ahead on their lower-drug pricing agenda.

Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

Biden administration will run out of supply of Lilly’s covid antibody bebtelovimab in August, forcing a shift to commercial market due to lack of funds. The transition will require changes to the emergency use authorization and involve a price hike.

The European medicines regulatory network is giving sponsors of marketed medicines that contain chemically synthesised active substances an extra 12 months to apply for manufacturing changes to address nitrosamine-related risks.

Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.

The advanced therapies sector is undergoing something of an industrial revolution, but access issues for products coming to market remain, says Miguel Forte, CEO of Bone Therapeutics. However, there are opportunities to create a better environment for the sector, including regulatory change and more harmonization of HTA processes.