Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.

Following a consultation last year, Medsafe has set new fee levels that take account of both cost-recovery principles and a 4.2% increase in the consumer price index. 

Commissioner Robert Califf wants Woodcock to improve food operations and processes, but lawmakers question whether she is the best overseer for the area.

Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.

The monkeypox cases reported this month are evidence of chains of transmission of the virus, according to the European Centre for Disease Prevention and Control, which says that vaccination of high-risk close contacts should be considered after a benefit-risk assessment.

While Japan enters annual drug price revisions with frequent regulation changes, several major corporate players in the country warn again that government policies mean that the country is at risk of “losing attractiveness.”

While the much-anticipated Innovative Medicines Fund is likely to benefit rare diseases in particular, other products must gain too.

CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

International regulators have issued an updated statement on the benefits and safety of COVID-19 vaccines for use by health professionals, while the UK BioIndustry Association has welcomed a MAb licensing deal between AstraZeneca and UK-based biotech firm RQ Bio.

US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.

Pfizer’s acquisition of Arena without FTC intervention and Hikma’s acquisition of Custopharm with one product divestiture shows the commission is bound by anticompetitive facts of a deal. A more controversial merger may not get through, former FTC attorney says.

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements. 

Japan has passed a new law which will require the providers of certain products to cooperate in securing supplies to the country. For the pharma industry, there are a couple of signs which specific drugs will be within the scope of the legislation and how this will impact the sector.