Geography

The JPY330bn package bundles existing and new support funds for the biopharma industry, with the national government recognizing its importance for both national security and economic growth.

Flagship Pioneering is first partner in initiative aimed at giving drug developers early, informal, joint advice to fast-track the ‘most promising’ health care innovations. Pathway builds on an artificial intelligence collaboration between the UK MHRA and Singapore’s Health Sciences Authority.

For 127 products in the annual price negotiations for inclusion in China's National Reimbursement Drug List, the "success rate" this year was 88.19%, the highest ever, although the extent of related price cuts was not revealed.

A review of South Korea's GIFT fast track initiative for high-need drugs reveals that foreign firms have been the main beneficiaries over the first three years.

The European Medicines Agency has said that Anavex’s Alzheimer’s candidate should not be authorized for use in the EU due to safety and efficacy concerns. Seven other products, including two new cancer drugs, received positive opinions.

Scientific advances in pharmacogenomics have prompted the European Medicines Agency to propose revisions to its existing guideline to ensure its continued relevance and applicability.

Flagship Pioneering is first partner in initiative aimed at giving drug developers early, informal, joint advice to fast-track the ‘most promising’ health care innovations. Pathway builds on an artificial intelligence collaboration between the UK MHRA and Singapore’s Health Sciences Authority.

A slash in rebate rates is only a first step towards restoring the competitiveness of the UK’s pharmaceutical industry, according to the ABPI.

Flagship Pioneering is first partner in initiative aimed at giving drug developers early, informal, joint advice to fast-track the ‘most promising’ health care innovations. Pathway builds on an artificial intelligence collaboration between the UK MHRA and Singapore’s Health Sciences Authority.

New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.

Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.

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

Argentina’s medicines regulator, ANMAT, is updating the national pharmacopeia with new guidelines on advanced therapies.

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

The Medicines Control Authority of Zimbabwe has begun to publish public assessment reports for medicines it approves or rejects, in line with the World Health Organization’s highest maturity level benchmarking.

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.

Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.

A Friends of Cancer Research working group believes “seamless” trial designs could be used more frequently for rare cancer drug development, but advanced planning is key.

The FDA previously rejected AstraZeneca’s bid to convert the Factor Xa inhibitor reversal agent from accelerated to regular approval amid concerns about adverse events and the clinical meaningfulness of benefits seen in the confirmatory trial.

As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.