Global

Governments should increase financial resources for novel antimicrobial drug candidates in the later stages of development and tackle shortages of existing, underused antibiotics to combat antimicrobial resistance, says a new report from the OECD.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Sterile drug manufacturers get one year to comply with most revisions in updated EU, PIC/S and WHO GMP Annex 1 guideline. PDA survey hints at scale of challenge facing firms that still use traditional open filling lines, a practice expected to end under the Annex 1 revisions.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

The World Health Organization’s C-TAP has signed new COVID-19 vaccine licensing deals with Medigen Vaccine Biologics of Taiwan and a Spanish research body, while the WHO and UNICEF say overall immunization rates are rebounding after the pandemic backslide, but not in all countries equally.

From rapidly identifying antigenic targets to automating clinical trials, AI has an important role to play in cutting vaccine development time down to 100 days, says Melanie Saville, executive director of R&D at CEPI.

Eligibility criteria, how to apply, 60-day and 110-day timetables, major objections and clock stops. These are among the topics that the Medicines and Healthcare products Regulatory Agency covers in newly published guidance for drug companies planning to use the soon to be launched IRP.

Clinical trial networks around the world have teamed up to promote good randomized control trials in low- and middle-income countries. They plan to focus on multiple health challenges and diverse contexts.

Significant financial reward awaits drugmakers that invest more in companion diagnostics during the development and marketing of precision cancer drugs, says Peter Keeling, CEO of Diaceutics – but Novartis warns that relying on pharma firms to fund these tests is unsustainable.

The UK is extending flexibilities that were introduced to ensure the supply and availability of COVID-19 and flu vaccines and has published its autumn vaccination schedule. Novavax expects to have its vaccine against the XBB strain of the virus ready by the end of September, while UK firm Infex is planning to begin clinical trials with a rival to Pfizer’s Paxlovid.

Members of the WHO’s working group on the International Health Regulations met for the fourth time last month to discuss proposed amendments to “important and substantive areas” of the IHR.

An application to add new manufacturing and quality control sites for a oncology biologic was approved in the US and the EU on the same day, a move that was said to be “a significant accomplishment” in aligning the regulators in each region on the assessment process and timeline.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Increasing the capacity for local development and production of medicines and other health technologies in Latin America and the Caribbean is among the objectives of the new deal.

A new mapping exercise is intended to identify patents filed in relation to the mRNA technology transfer program set up to help lower-income countries build their own mRNA manufacturing facilities.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.