Investigational drugs from Outlook Therapeutics and Vertex/CRISPR could become first-of-their-kind products if they win marketing approval.

The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.

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

The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

In 2022, a total of five companies chose to exit the UK’s voluntary scheme that manages branded medicines spending. The departure of two big firms – AbbVie and Lilly – is seen as a deliberate tactic to send a clear signal to government that the scheme is not working for industry and is jeopardizing investment and access to medicines in the UK.

Vaccines and Related Biological Products Advisory Committee also said that more data is needed to determine the groups that potentially could receive more than one periodic vaccine booster.

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.

Increased application of utilization management controls expected as plans face higher costs under the redesign. However, the formulary advantages available to drugs in the protected classes may lead developers to sharpen their focus on those categories.

Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

The WHO’s proposed “TB Vaccine Accelerator council” will focus on the need for firm political and funding commitments, drawing on the high-level coordination that helped in the rapid development of COVID-19 vaccines.

Industry leaders are concerned about the outlook for small molecule drugs in particular, but execs at the J.P. Morgan Healthcare Conference were also optimistic there could be chances to shape the implementation of certain policies.

However, similar claim in materials directed at health care providers need not be discontinued, National Advertising Division says in challenge brought by Lilly; NAD decisions in Rx promotion disputes are rare, but voluntary resolution process could become more appealing to pharma firms.

Inflation Reduction Act means that industry ‘will have to adjust’ to new market realities, especially for small molecule drugs.

The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.