The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.

A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.

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

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.

Purdue’s opioid settlement is making headlines for the size of the financial penalty. But the plan to re-imagine Purdue as a ‘public benefit company’ could have far-reaching significance for the industry – if it ever gets off the ground.

CMS final rule for hospital payment in 2021 includes enhanced payment for six novel antibiotics – including one that is not yet approved by FDA. New policies to encourage antibiotic innovation are clearly having an impact in the context of Medicare payments.

Medicare’s doubts about trial design for Sage’s postpartum depression therapy suggests even ‘breakthrough’-designated products can struggle with the ‘substantial clinical improvement’ standard for NTAP status. Denial of enhanced payment for Zulresso ends a long winning streak by innovators.

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

US pharmacy group says that 10 to 12 states have indicated through an informal survey that they do not have the manpower or funding to implement the US FDA’s final MOU on inordinate compounding. They say what is at stake in these states is patient access to compounded medicines.

Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.

Ensuring patients have access to approved medicines is a key priority for Emer Cooke, the soon-to-be new head of the European Medicines Agency. Cooke says she will probably be a very different type of “captain” of the “wonderful ship” that is the EMA.