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AAM Departures Lead To Change Of Chair For IGBA
The AAM has confirmed the departure of three executives, one of whom had also been serving as chair of the IGBA. As a result, the global generics industry association has brought in a new interim chair, at the same time as the head of one of the industry’s largest players has joined its CEO Advisory Committee.
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Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks to Generics Bulletin about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.
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GGB Awards Returns To Barcelona In Its 10th Year
Celebrating its tenth anniversary year, the Global Generics & Biosimilars Awards 2023 will take place on Wednesday 25 October in Barcelona, Spain.
Commercial Explore this Topic
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Hyloris Lines Up Hectic Year Of Clinical Trials And Major US Launch
Hyloris has an eventful year ahead as it plans to conduct numerous trials for products in its ever-expanding pipeline and launch Maxigesic IV in the US.
AAM Departures Lead To Change Of Chair For IGBA
The AAM has confirmed the departure of three executives, one of whom had also been serving as chair of the IGBA. As a result, the global generics industry association has brought in a new interim chair, at the same time as the head of one of the industry’s largest players has joined its CEO Advisory Committee.
Successful Cortrophin Gel Launch Could Drive Growth At ANI For Years To Come
The launch of ANI Pharmaceutical’s Cortrophin gel has reignited interest in the ACTH drug category, and appears set to drive growth at the company for the foreseeable future.
Eagle: ‘No Room, No Reason’ For A Generics Business, As Vasopressin Pulled
In something of a surprise, Eagle Pharmaceuticals has announced its exit from the generic vasopressin market – one year after a hard-fought and hard-won launch.
Amneal Continues To See Value In Complexity
With Amneal delivering what it described as a “solid” set of financials for 2022, the company has reaffirmed that it sees more value in moving increasingly into complex generics and bolstering its nascent biosimilars business.
Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks to Generics Bulletin about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.
Policy & Regulation Explore this Topic
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Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks to Generics Bulletin about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.
The Same But Different: Biden Budget Proposes Flexibility For Generic Drug-Device Combos, ‘Skinny Labels’
President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster.
IGBA Seeks To Underline Value And Access
Speaking with Generics Bulletin at the IGBA’s annual conference in February, chair Jonathan Kimball explained how the association is conveying the value of generics and biosimilars to international industry stakeholders.
AAM’s Baeder Takes A Focused Approach To Articulating Industry Priorities
Christine Baeder, Teva’s chief operating officer for US generics and biosimilars, was named chair of the AAM’s board in February. Speaking with Generics Bulletin, she sets out her priorities against the backdrop of a US generics industry that is now at an “inflection point” for sustainability.
AAM Warns Over Biden Budget Plans To Extend IRA
US generics and biosimilars association the AAM has offered a frosty response to budget plans announced by the Biden administration that include expanding the scope of price negotiation under the Inflation Reduction Act.
Generic Drugs Outlined As ‘Significant Public Health Priority’ For FDA
The FDA Office of Generic Drugs has published its annual report, highlighting its contributions to the approval of Viatris’ generic cyclosporine rival to Restasis, alongside updates to bioequivalence standards and support for competition.
Generic Drugs Explore this Topic
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Successful Cortrophin Gel Launch Could Drive Growth At ANI For Years To Come
The launch of ANI Pharmaceutical’s Cortrophin gel has reignited interest in the ACTH drug category, and appears set to drive growth at the company for the foreseeable future.
Eagle: ‘No Room, No Reason’ For A Generics Business, As Vasopressin Pulled
In something of a surprise, Eagle Pharmaceuticals has announced its exit from the generic vasopressin market – one year after a hard-fought and hard-won launch.
Blow For EU Tecfidera Rivals As Biogen Triumphs In Legal Battle
Developers of generic dimethyl fumarate have received a setback after a CJEU ruling in Biogen’s favor gave Tecfidera EU regulatory marketing protection until at least February 2024.
Biosimilars Explore this Topic
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Deficient Aseptic Filling And Freeze Drying Hamstring Sandoz’s US Herceptin
Sandoz spoke to Generics Bulletin in the wake of confirming a recent complete response letter for its partnered biosimilar Herceptin candidate in the US.
Amneal Continues To See Value In Complexity
With Amneal delivering what it described as a “solid” set of financials for 2022, the company has reaffirmed that it sees more value in moving increasingly into complex generics and bolstering its nascent biosimilars business.
Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks to Generics Bulletin about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.
Value-Added Medicines Explore this Topic
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Hyloris Lines Up Hectic Year Of Clinical Trials And Major US Launch
Hyloris has an eventful year ahead as it plans to conduct numerous trials for products in its ever-expanding pipeline and launch Maxigesic IV in the US.
Fresh Competition Coming For Narcan In US
Further US hybrid and generic rivals to Narcan are in the works, with Amphastar having just received an FDA nod for its naloxone nasal spray in a proprietary device as Amneal files an ANDA for a further generic version.
Coherus Pulls A Rabbit Out Of The Hat With Inventive Pegfilgrastim Form
Coherus’ year-end financial results included a surprise – a newly approved formulation of pegfilgrastim.
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