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From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.
In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.
Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.
A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
- Medical Devices
- Controlled Release
- Drug Delivery
- Consumables, Central Supplies
- Implantable Devices
- Infection Control-Sterilization
- Infusion Therapy Equipment and Supplies
- Monitoring Equipment & Devices
- Radiofrequency Devices
- Rehabilitation Equipment and Devices
Surgical Equipment & Devices
- Minimally or Less Invasive
- Other Names / Subsidiaries
- Braeburn Pharmaceuticals
- Elstar Therapeutics
- Tokai Pharmaceuticals, Inc.