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.

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.

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.

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.

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.

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.

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.

President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster.

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.

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.

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.

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.

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.

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.

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.

Sandoz spoke to Generics Bulletin in the wake of confirming a recent complete response letter for its partnered biosimilar Herceptin candidate in the US.

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.

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.

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.

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’ year-end financial results included a surprise – a newly approved formulation of pegfilgrastim.