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Tackling AMR: OECD Says Greater Investment Needed In Later-Stage Drug R&D
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.

Global Pharma Guidance Tracker – August 2023
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.

Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally
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.

Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Coronavirus Notebook: EMA OKs Updated Cominarty Vaccine, UK Brings Forward Vaccination Campaign Amid Spread Of BA.2.86 Strain
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.

How AI Can Help Reduce Vaccine R&D From A Year To ‘A Matter Of Weeks’
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.

How To Use The UK’s New International Recognition Pathway For Drug Approvals
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.

New Collaborative Initiative To Deliver Tailored Support For RCTs In Low Resource Settings
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.

Should Pharma Firms Cover CDx Costs For Precision Cancer Drugs?
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.

Coronavirus Notebook: WHO Issues New Recommendations On Access To COVID-19 Products Amid Spread Of New EG.5 Variant
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.

WHO Meeting Reveals Differences Over Sharing Of Genomic Data In Public Health Crises
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.

‘Positive & Productive’ – US, EU Regulators On First Collaborative CMC Change Assessment
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.

Global Pharma Guidance Tracker – July 2023
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.

EU, PAHO Ink €3.8m Deal To Boost Access To Health Technologies in Latin America & Caribbean
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.

Medicines Access Body Throws More Light On Global mRNA Vaccine Patent Filings
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.

Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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