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Many New Products For Forest, But Not Enough To Fill The Lexapro Gap

 
• By Jessica Merrill

The launches of Tudorza for COPD and Linzess for irritable bowel syndrome are off to strong starts, Forest executives said during the company’s fiscal fourth quarter sales and earnings call. But despite those and other recent entries, the company reported a net loss for the year after revenues nose-dived from the loss of Lexapro.

Forest Laboratories Inc. is in the midst of launching Linzess (linaclotide) for irritable bowel syndrome and Tudorza (aclidinium) for chronic obstructive pulmonary disease. Both products are off to a strong start following their December 2012 launches, management said during a fiscal fourth quarter sales and earnings call April 23.

In addition to Linzess and Tudorza, Forest has introduced a string of new products over the last five years. In 2011, the company launched Viibryd (vilazodone) for depression, Daliresp (roflumilast) for COPD and the hospital antibiotic Teflaro (ceftaroline)

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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 FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.