Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Neuraxpharm has made its latest move into a new European market, this time opening up a new unit in the Netherlands that will be led by the firm’s German head Philipp Pohoralek as country manager.

With its own interests in the branded eye-disease space, Regeneron has commented on ranibizumab biosimilar sponsor Biogen’s fortunes during a recent conference.

Shreehas Tambe has been named as CEO of Biocon Biologics, taking over from Arun Chandavarkar, in the wake of the company’s milestone $3bn transaction for Viatris’s biosimilars business.

Dan Leonard has announced his resignation as president and CEO of the US Association for Accessible Medicines. He will be replaced on an interim basis by the group’s vice president for sciences and regulatory affairs, David Gaugh.

After nearly two difficult years for Nichi-Iko Pharmaceutical, the firm has announced at it will be acquired by a private equity fund and delisted from the Toyko Stock Exchange in 2023 and its CEO will step down from his post.

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

A science-based approach to biosimilars, exemplified by the latest statement from European regulators, makes further progress on biosimilars just a matter of time, according to Gillian Woollett, vice president and head of regulatory strategy and policy at Samsung Bioepis.

Finnish government proposals to introduce pharmacy-level substitution for biosimilars have been criticized by the country’s generics and biosimilars industry association.

Discussing the latest developments in the US biosimilars market, AmerisourceBergen’s senior director of biosimilar commercialization, Brian Biehn, talks about what we can expect from competition to Humira in 2023, how the first ophthalmology biosimilars are faring, and potential changes on the horizon at the FDA that could smooth the path to market for biosimilars sponsors.

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.

Neuraxpharm has made its latest move into a new European market, this time opening up a new unit in the Netherlands that will be led by the firm’s German head Philipp Pohoralek as country manager.

Dan Leonard has announced his resignation as president and CEO of the US Association for Accessible Medicines. He will be replaced on an interim basis by the group’s vice president for sciences and regulatory affairs, David Gaugh.

In a blow to potential US generic competition, Zydus Cadila has withdrawn its appeal to an unfavorable federal ruling involving a US Farxiga (dapagliflozin) patent.

Apobiologix’s new Lapelga autoinjector that the firm has just introduced in Canada is only the second on-body pegfilgrastim device to launch after Amgen’s Neulasta original.

With its own interests in the branded eye-disease space, Regeneron has commented on ranibizumab biosimilar sponsor Biogen’s fortunes during a recent conference.

A science-based approach to biosimilars, exemplified by the latest statement from European regulators, makes further progress on biosimilars just a matter of time, according to Gillian Woollett, vice president and head of regulatory strategy and policy at Samsung Bioepis.

In an exclusive interview with Generics Bulletin, Talat Imran, CEO of oral-dose biologics player Rani Therapeutics, talks adalimumab, partnering opportunities and financing, in the wake of kicking off pre-clinical development of its RT-111 proposed biosimilar to Janssen’s Stelara (ustekinumab) contained in its proprietary RaniPill Go ‘robotic’ capsule.

Hyloris Pharmaceuticals’ new idiopathic rhinitis treatment sets it on track to achieve its target of around 30 portfolio assets by the end of 2024. 

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.