Will Saunders Bring Transformation To Forest?

The specialty pharma long has been scrutinized for its decisions regarding the patent cliff and business development. Now, a new CEO will have the chance to keep the company on its current course or mirror the transformations he’s put in motion at other companies.

Forest Laboratories Inc. will be under the care of a new leader come Oct. 1, when former Bausch & Lomb Inc. CEO and Forest board member Brenton Saunders takes the reins. For some investors, the changing of the guard at the specialty pharma signals a new direction for the company, even if management has yet to announce a change in strategy; meanwhile others see the appointment of an insider as just more of the same.

The way Forest is run has been under scrutiny for the last few years as investors have attempted to oust...

More from United States

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By 

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

More from North America

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.