Apple Tree Partners
http://www.appletreepartners.com
Questions?
Please contact Sales at: (212) 520-2765 or email [email protected]
Latest From Apple Tree Partners
Lecanemab Set A New Bar In Alzheimer’s, Now Many Drugs Are Seeking To Raise It
Drug makers are more enthusiastic than ever about the outlook for developing drugs for Alzheimer's. Scrip reports back on the latest developments at CTAD.
Former FDA Commissioner Frank Young Passes Away At 88
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.
US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade
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.
US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says
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.
Company Information
- Industry
- Biotechnology
- Medical Devices
- Pharmaceuticals
-
Pharmaceuticals
-
Drug Delivery
- Controlled Release
-
Drug Delivery
-
Medical Devices
- Consumables, Central Supplies
- Implantable Devices
- Infection Control-Sterilization
- Infusion Therapy Equipment and Supplies
- Laser
- Monitoring Equipment & Devices
- Radiofrequency Devices
- Rehabilitation Equipment and Devices
-
Surgical Equipment & Devices
- Minimally or Less Invasive
- Other Names / Subsidiaries
-
- Braeburn Pharmaceuticals
- Elstar Therapeutics
- Galaxy Medical
- Tokai Pharmaceuticals, Inc.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Company
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
DCD.EmailPopout.Notice