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Policy and Regulation

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

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
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Pricing Strategies; Reimbursement 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

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
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Intellectual Property 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

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
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Market Intelligence 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

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
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