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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.

Leadership Executive Changes

Interviews

Interviews

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.

Generic Drugs Regulation

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.

Generic Drugs Biosimilars Value-Added Medicines
 

Commercial Explore this Topic

Set Alert for Commercial

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.

Value-Added Medicines Clinical Trials

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.

Leadership Executive Changes

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.

Sales & Earnings Rare Diseases

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.

Generic Drugs Strategy

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.

Sales & Earnings Generic Drugs

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.

Generic Drugs Regulation
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

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.

Generic Drugs Regulation

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.

Generic Drugs Legislation

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.

Generic Drugs Biosimilars

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.

Leadership United States

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.

Policy Regulation

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 United States
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

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.

Sales & Earnings Rare Diseases

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.

Generic Drugs Strategy

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.

Intellectual Property Legal Issues
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Biosimilars Explore this Topic

Set Alert for Biosimilars

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.

Complete Response Letters Biosimilars

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.

Sales & Earnings Generic Drugs

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.

Generic Drugs Regulation
See All

Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

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.

Value-Added Medicines Clinical Trials

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.

Approvals United States

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.

Approvals Biosimilars
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