Geography

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

The health technology assessment institute, NICE, said the price BioMarin was asking for Brineura was too high, even though its appraisal committee applied a cost-effectiveness threshold ten times higher than usual.

Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.

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.

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

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.

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.