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FDA Exploring Whether Public Shaming Can Stop REMS Abuses

 
• By Derrick Gingery

Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.

FDA entrance sign 2016

The US FDA may resort to using its bully pulpit to lessen REMS abuses that prevent generic entry.

Agency letters to brand companies indicating it is acceptable under a Risk Evaluation and Mitigation Strategy (REMS) to sell samples...

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Tevogen Will House Generics Unit In Much-Expanded New Headquarters

 
• By Dean Rudge

Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.

Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What’s Next

 
• By Dean Rudge

In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

 
• By Dave Wallace

As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

More from Products

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.

Teva Continues Push Beyond Generics in Fosun Immunotherapy Tie-Up

 
• By Dean Rudge

Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w

IGBA Asks G7 To Consider Access Issues

 
• By Dave Wallace

The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.