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Coronavirus Spotlight


Coronavirus Spotlight

New COVID-19 Vaccine Patent Database Launched

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.

Vaccines Coronavirus COVID-19

OUTLOOK 2021

In Vivo’s annual showcase of special features and industry league tables for pharma, medtech and generics companies


VIEW 2021 RANKINGS

Less Than Two Months Remain To Enter Global Generics & Biosimilars Awards 2021

With a looming entry deadline of 30 July, companies have a little under two months to enter the Global Generics & Biosimilars Awards 2021, ahead of the awards ceremony on 10 November.

Generic Drugs Biosimilars Value-Added Medicines

Teva: Biosimilars In The US Will Become Like Complex Generics

With a couple of major partnerships and a stable of internal projects, Teva expects to play a role in the “majority of meaningful US biosimilar launches in the next five-to-eight years,” executive vice-president for North America commercial Brendan O’Grady told Generics Bulletin in an exclusive interview.

Biosimilars Commercial Strategy
 

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Rosemont Celebrates One Year Of Independence With 49% Growth

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.

Generic Drugs Sales & Earnings

Catalent Joins Civica’s New Business Arm For Generic Manufacturing

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.

Generic Drugs Manufacturing

Lupin’s US Advair Generic Plans Turn Awry As Celon Pact Nears End

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.

Deals Strategy

Amneal Takes A Step Forward On Biosimilars

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.

Biosimilars Strategy

EU Industry Sets Out Priorities In Structured Dialog

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.

Europe Policy & Regulation

Nichi-Iko Has An Ally In Argentina On Infliximab

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

Deals Biosimilars
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Policy & Regulation Explore this Topic

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FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster

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. 

FDA Regulation

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

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.

United States Manufacturing

New COVID-19 Vaccine Patent Database Launched

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.

Vaccines Coronavirus COVID-19

Plans For EU Electronic Product Information Move Up A Gear

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.

Europe Regulation

EU Industry Welcomes New Schengen Strategy’s Green Lanes

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.

Policy Europe

Could US FDA User Fee Bill Include The Long-Sought 505(b)(2) Pathway For Biosimilars?

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

Biosimilars User Fees
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Generic Drugs Explore this Topic

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Rosemont Celebrates One Year Of Independence With 49% Growth

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.

Generic Drugs Sales & Earnings

Catalent Joins Civica’s New Business Arm For Generic Manufacturing

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.

Generic Drugs Manufacturing

Court Ruling Gives Sandoz Canada First Generic Pirfenidone

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

Generic Drugs Launches
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Biosimilars Explore this Topic

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Amneal Takes A Step Forward On Biosimilars

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.

Biosimilars Strategy

Nichi-Iko Has An Ally In Argentina On Infliximab

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

Deals Biosimilars

Alvotech Adalimumab Biosimilar Switching Study Hits Key Date

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.

Biosimilars Clinical Trials
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Value-Added Medicines Explore this Topic

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Accord Innovates With Cancer Support App

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

Value-Added Medicines Cancer

Amneal Targets Migraine With 505(b)(2) Filing

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.

Value-Added Medicines Strategy

Zentiva Invests €27m In Prague Plant

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.

Manufacturing Strategy
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