To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022. 

After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.

Innovent Biologics has broadened its international reach by striking a licensing deal with PT Etana Biotechnologies in Indonesia for its Byvasda bevacizumab biosimilar.

Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.

Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.

Teva CEO Kåre Schultz believes his prediction is coming true for the Truxima biosimilar in-licensed from Celltrion, as he gave the latest update on Teva’s efforts to settle significant legal issues around the US opioid crisis.

Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”

The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.

Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.

The agreement on trade and cooperation between the UK and the EU requires both sides to offer regulatory data exclusivity and supplementary protection certificates, but it does not specify any minimum periods of protection.

As part of a wider overhaul of the FDA’s Center for Drug Evaluation and Research, the agency is reorganizing its Office of Generic Drugs, including adding a new Office of Safety and Clinical Evaluation within the OGD.

US FDA’s interpretation of ‘protein’ is reasonable and owed deference, the court concludes in tossing Teva suit which challenged Copaxone’s exclusion from list of drugs transitioned to being regulated as biologics.

 To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022. 

Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”

Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.

After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.

Innovent Biologics has broadened its international reach by striking a licensing deal with PT Etana Biotechnologies in Indonesia for its Byvasda bevacizumab biosimilar.

Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.

Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.

Neuraxpharm has expanded its footprint outside of Europe with the launch of its first product in Japan, in the form of the Buccolam value-added midazolam product gained through a deal with Takeda.

Following positive trial results, Teva says it is exploring options with the US FDA for filing a long-acting subcutaneous injectable version of risperidone that it is developing with MedinCell.