Legal Issues
With another settlement secured, US states are gearing up for the first trial of the price-fixing case later this year.
‘These Decisions Created A Lot Of Uncertainty’ – Why The Supreme Court’s Skinny-Label Ruling Matters
The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.
A US class action suit alleges that a settlement between Teva and Novo Nordisk illegally delayed generic Victoza for 16 months, kept prices high and transferred an estimated $903m in value to Teva.
The CytoDyn board of directors fired Nader Pourhassan in early 2022 as the company faced US FDA scrutiny over his comments about HIV and COVID-19 candidate leronlimab and as investors sued the firm.
BMS will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company.
Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).
Alteogen’s new CEO shares his dynamic five years with the Korean biotech which led to its transformation into a global commercial stage biotech with a potential stable revenue base.
Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.