Geography

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.

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

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.

The standard baseline of regulatory data protection will remain at eight years under the new pharma package, while market protection will drop to a year as standard. However, innovative products that fulfil certain criteria could get up to 11 years of market exclusivity.

The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.

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.

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.

A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.

Former agency officials who now represent industry worry that a deregulatory bent could be driving the "Simple Reform" plan to merge all medical product and clinical research inspectorates and that the specialist expertise gained in the 2017 "Program Alignment" initiative will be reversed.

“Section viii cannot function as Congress intended,” if a Federal Circuit Court ruling stands, the US solicitor general argued in urging the Supreme Court to review and reverse the closely-watched Hikma Vascepa skinny-label case.