Two acquisitions of brands in as many months, Lupin has stepped up its game in the Americas. A buyout of nine established Bausch Health brands follows rights to two from Sunovion. While it awaits news on generic(g) Spiriva, the launch of gPerforomist will help expand Lupin’s respiratory franchise

Teva’s new partnerships will make patient data from its digital inhalers more accessible to healthcare providers, potentially placing Teva’s asthma platform at the forefront of emerging treatment paradigms.

In the wake of Similis Bio’s first biosimilar partnership, the JSR Life Sciences unit’s head, John Gabrielson, talks to Generics Bulletin about the Similis Bio model and how the firm believes it can help bring biosimilars to market more rapidly and efficiently.

Biocon has achieved a milestone after its Biocon Biologics subsidiary closed its $3bn deal to acquire the biosimilars business of longtime partner Viatris, in what management described as a “historic inflection point” for the Indian player.

Hikma has signed another partnership agreement to gain Middle East and North Africa commercialization rights to an ustekinumab biosimilar – although not with its US partner, Bio-Thera Solutions.

Advanz has identified three key spaces in which it is seeking to generate value: innovative assets, M&A and existing commercial infrastructure.

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.

The European Patent Office has adjusted the starting date of its transitional measures for applicants that want their patent to have unitary effect under the coming Unified Patent Court system.

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

The FDA has seemingly followed the lead of the EMA by guiding ANDA sponsors on how to develop oligonucleotide drugs, a complex class of DNA or RNA molecules.

Senator Mike Lee has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct “unnecessary” switching studies in order to obtain an interchangeability designation.

Infants and young children across the US are continuing to struggle to get access to one of the most common and recognized antibiotics, liquid-dose amoxicillin, amid a surge in demand for the drug that has hindered generics manufacturers.

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

Two acquisitions of brands in as many months, Lupin has stepped up its game in the Americas. A buyout of nine established Bausch Health brands follows rights to two from Sunovion. While it awaits news on generic(g) Spiriva, the launch of gPerforomist will help expand Lupin’s respiratory franchise

With Janssen’s Stelara set to lose its exclusivity in September 2023, the originator is looking to ward off potential biosimilar competition from Amgen by suing the firm for patent infringement in a US district court.

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

In the wake of Similis Bio’s first biosimilar partnership, the JSR Life Sciences unit’s head, John Gabrielson, talks to Generics Bulletin about the Similis Bio model and how the firm believes it can help bring biosimilars to market more rapidly and efficiently.

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

Teva’s new partnerships will make patient data from its digital inhalers more accessible to healthcare providers, potentially placing Teva’s asthma platform at the forefront of emerging treatment paradigms.

Advanz has identified three key spaces in which it is seeking to generate value: innovative assets, M&A and existing commercial infrastructure.