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Optimer Teams With AztraZeneca To Bring Dificid To South America

 
• By Jessica Merrill

Optimer has signed a string of partnerships to commercialize the antibiotic around the world; the latest is with AstraZeneca, which will market the drug in South America, Central America, Mexico and the Caribbean.

Optimer Pharmaceuticals Inc. has signed several regional partners to commercialize its antibiotic Dificid (fidaxomicin) for Colstridium difficile infection in different parts of the world. The latest is AstraZeneca PLC, which will market the antibiotic in South America, including in Brazil, Central America, Mexico and the Caribbean in a deal announced Dec. 3.

AstraZeneca – one of a few big pharmas still investing in antibiotic drug development – has the infrastructure in place...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US Return Of GSK’s Blenrep Threatened By Ocular Toxicity, Dosage Optimization Questions

 
• By Sue Sutter

The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 
• By Francesca Bruce

A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.