A year on from being spun-out of Perrigo and acquired by private equity, liquid generics specialist Rosemont Pharmaceuticals has revealed new details of the UK-based firm’s operations.

CDMO Catalent and US health insurance giant Anthem have joined up with non-profit Civica’s new outpatient-focused generics business arm, CivicaScript, with plans to begin rolling out products as early as next year.

Lupin’s plans for a US generic to GSK’s Advair Diskus have turned awry as its contract with Celon Pharma is close to being terminated. The company has focused on other respiratory drugs like generic ProAir and Fostair even as the revenue potential for Advair has been shrinking post Mylan’s launch.

The FDA’s acceptance of Amneal’s filing for bevacizumab brings the company a step closer to its goal of launching a US biosimilar every year to 2023.

As part of a “structured dialog” initiated with pharmaceutical industry stakeholders by the European Commission, local off-patent industry association Medicines for Europe has set out the key reforms needed to bolster the sector.

Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.

To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

As part of its drive to maximize global access to coronavirus vaccines, the Medicines Patent Pool has developed a publicly accessible resource giving information on the patent status of approved and candidate vaccines.

Stakeholder agreement on the technical features of electronic product information (ePI) will pave the way for launching a proof-of-concept exercise and a roadmap on how ePI will be rolled out in the EU.

Planned reforms to the EU’s Schengen open border system that will allow for transport “green lanes” to be reactivated when necessary have been welcomed by off-patent industry association Medicines for Europe.

Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.

A year on from being spun-out of Perrigo and acquired by private equity, liquid generics specialist Rosemont Pharmaceuticals has revealed new details of the UK-based firm’s operations.

CDMO Catalent and US health insurance giant Anthem have joined up with non-profit Civica’s new outpatient-focused generics business arm, CivicaScript, with plans to begin rolling out products as early as next year.

A favorable court ruling has allowed Sandoz Canada to launch the first generic version of Roche’s Esbriet to treat idiopathic pulmonary fibrosis.

The FDA’s acceptance of Amneal’s filing for bevacizumab brings the company a step closer to its goal of launching a US biosimilar every year to 2023.

Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.

Alvotech underlined that it could “save US consumers and taxpayers billions annually,” after hitting a key landmark in its Phase III switching study for its high concentration 100mg/ml biosimilar Humira product.

Accord Healthcare has launched an app to support cancer patients and help manage symptoms, incorporating expert data from Macmillan Cancer Support.

Amneal is setting its sights on the migraine and cluster headache market in the US with a new hybrid 505(b)(2) filing for a dihydroergotamine autoinjector.

Zentiva has announced that it is investing a further €27m in expanding its flagship manufacturing plant in Prague, having already pumped €35m into the site over the past three years.