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Policy and Regulation

Regulation Explore this Topic

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FDA Updates ‘Purple Book’ Database

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

Biosimilars FDA

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs

Industry Offers Mixed Response To Latest Brexit Advice

While the off-patent industry has welcomed concrete advice from the UK government over potential disruptions to medicines supplies when the country’s transition period with the EU expires on 31 December, concerns have been raised over the ability to build up safety stocks in the context of the COVID-19 pandemic, as well as a lack of clarity over the future regulatory landscape and pandemic-related procurement initiatives.

Brexit Trade
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Pricing Strategies; Reimbursement Explore this Topic

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Teva Sees COVID Sales Correction

In a busy second quarter for Teva, a COVID-19 slump acted as a correction to the related boost in demand seen in the first quarter of 2020.

Sales & Earnings Strategy

Coherus Will Prioritize Oncology As Inflammation Takes A Back Seat

Coherus BioSciences enjoyed another strong quarter, “exceeding expectations,” management said, as the US-based player revealed where it would invest its cash pile following a round of financing in April.

Biosimilars Strategy

Who’s Hired? ANI Names New CEO

ANI Pharmaceuticals has chosen its new president and CEO to replace interim chief Patrick Walsh who stepped in after the departure Arthur Przybyl earlier this year. Meanwhile, key personnel announcements have also been made by Teva and Mylan.

Appointments Strategy
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Intellectual Property Explore this Topic

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Teva Sees COVID Sales Correction

In a busy second quarter for Teva, a COVID-19 slump acted as a correction to the related boost in demand seen in the first quarter of 2020.

Sales & Earnings Strategy

Coherus Will Prioritize Oncology As Inflammation Takes A Back Seat

Coherus BioSciences enjoyed another strong quarter, “exceeding expectations,” management said, as the US-based player revealed where it would invest its cash pile following a round of financing in April.

Biosimilars Strategy

Who’s Hired? ANI Names New CEO

ANI Pharmaceuticals has chosen its new president and CEO to replace interim chief Patrick Walsh who stepped in after the departure Arthur Przybyl earlier this year. Meanwhile, key personnel announcements have also been made by Teva and Mylan.

Appointments Strategy
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Market Intelligence Explore this Topic

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Teva Sees COVID Sales Correction

In a busy second quarter for Teva, a COVID-19 slump acted as a correction to the related boost in demand seen in the first quarter of 2020.

Sales & Earnings Strategy

Coherus Will Prioritize Oncology As Inflammation Takes A Back Seat

Coherus BioSciences enjoyed another strong quarter, “exceeding expectations,” management said, as the US-based player revealed where it would invest its cash pile following a round of financing in April.

Biosimilars Strategy

Who’s Hired? ANI Names New CEO

ANI Pharmaceuticals has chosen its new president and CEO to replace interim chief Patrick Walsh who stepped in after the departure Arthur Przybyl earlier this year. Meanwhile, key personnel announcements have also been made by Teva and Mylan.

Appointments Strategy
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