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Latest From Endo International plc
REMS Vendor Disruptions Prompt Greater US FDA Scrutiny
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
Rocket Pharmaceuticals’ CEO Talks Gene Platforms and Spiritual Leadership
The trajectory of Rocket Pharmaceuticals, a clinical-stage gene therapy company, has been marked by a series of impressive milestones. At least partial credit for those accomplishments goes to CEO Gaurav Shah, who co-founded the company in 2015 and has combined scientific, business and managerial savvy to progress the company through two regulatory filings this year. Shah recently spoke to In Vivo about the company and his own leadership style.
Mifepristone REMS For Pharmacies Contains Some Unusual Provisions, Continues Debate Over Access
After FDA clears modified REMS, certified retail pharmacists are permitted to dispense the abortion medication. Some advocates argue program is unnecessary, while others want a broader federal effort to expand access. Walgreens intends to become a certified pharmacy.
LegoChem’s $1.2bn ADC Platform Deal With Amgen Signals Continued Big Pharma Interest
LegoChem’s hefty out-licensing deal with Amgen seems to further prove global pharma’s keen interest in the Korean ADC leader’s technology, said to be differentiated with safer margins.
Company Information
- Industry
- Biotechnology
- Pharmaceuticals
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Pharmaceuticals
- Drug Delivery
- Generic Drugs
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
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- American Medical Systems, Inc.
- Anchen Pharmaceuticals, Inc.
- ASTORA Women's Health
- Auxilium Pharmaceuticals, Inc. (Actient Pharmaceuticals LLC
- Slate Pharmaceuticals)
- DAVA Pharmaceuticals, Inc
- Edict Pharmaceuticals Private Limited
- Endo Finance LLC
- Endo Health Solutions Inc.
- Endo Pharmaceuticals Holdings Inc.
- Endo Ventures Limited
- HealthTronics, Inc.
- Indevus Pharmaceuticals, Inc.
- JHP Pharmaceuticals, LLC
- Paladin Labs Inc. (Allon Therapeutics, Inc.
- Ativa Pharma S.A,
- Labopharm Inc.
- Triton Pharma, Inc.
- ViRexx Medical Corp.)
- Par Pharmaceutical Companies, Inc.
- Par Pharmaceutical, Inc.
- Penwest Pharmaceuticals Co.
- Qualitest Pharmaceuticals
- Strativa Pharmaceuticals
- Valera Pharmaceuticals
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