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Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

The Factory Floor: Suanfarma Expands API Capacity With Sandoz Deal In Italy

Suanfarma acquires an API manufacturing facility in Italy to accelerate its growth in Europe, while CapsCanada relocates its headquarters as part of its growth strategy. Meanwhile, Glenmark, Aurobindo and Cipla struggle with quality issues.

Manufacturing Regulation

AAM Slams California Pay-For-Delay Ban

US off-patent industry association the AAM has blasted as unconstitutional a groundbreaking California law banning so-called ‘pay-for-delay’ deals under which brand companies pay rivals to keep generics off the market.

Regulation Legislation

FDA Fights Problems With Pre-ANDA Meeting Requests

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

Regulation Generic Drugs
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Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

German Funds Deny Tenders Link To Shortages

Leaked political proposals to stop German insurance funds awarding tender contracts to just one supplier would not help to prevent drug shortages, insists the leading AOK group of funds.

Germany Generic Drugs

Alvogen Strikes Deals For Pfenex’ Teriparatide

Alvogen has signed marketing deals with local firms in Canada, Israel and South Korea for the teriparatide drug it has licensed from Pfenex. In the US, Pfenex has just completed a human factors study it feels should support a therapeutic equivalence rating for its Forteo rival.

Deals Value-Added Medicines

Actavis Faces Wait Until 2027 On US Pennsaid

Teva’s Actavis has lost the patent battle over osteoarthritis drug Pennsaid 2% due to a lack of “clear and convincing evidence” and “unpersuasive arguments” over obviousness.

Intellectual Property Generic Drugs
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Intellectual Property Explore this Topic

Set Alert for Intellectual Property

German Funds Deny Tenders Link To Shortages

Leaked political proposals to stop German insurance funds awarding tender contracts to just one supplier would not help to prevent drug shortages, insists the leading AOK group of funds.

Germany Generic Drugs

Alvogen Strikes Deals For Pfenex’ Teriparatide

Alvogen has signed marketing deals with local firms in Canada, Israel and South Korea for the teriparatide drug it has licensed from Pfenex. In the US, Pfenex has just completed a human factors study it feels should support a therapeutic equivalence rating for its Forteo rival.

Deals Value-Added Medicines

Actavis Faces Wait Until 2027 On US Pennsaid

Teva’s Actavis has lost the patent battle over osteoarthritis drug Pennsaid 2% due to a lack of “clear and convincing evidence” and “unpersuasive arguments” over obviousness.

Intellectual Property Generic Drugs
See All

Market Intelligence Explore this Topic

Set Alert for Market Intelligence

German Funds Deny Tenders Link To Shortages

Leaked political proposals to stop German insurance funds awarding tender contracts to just one supplier would not help to prevent drug shortages, insists the leading AOK group of funds.

Germany Generic Drugs

Alvogen Strikes Deals For Pfenex’ Teriparatide

Alvogen has signed marketing deals with local firms in Canada, Israel and South Korea for the teriparatide drug it has licensed from Pfenex. In the US, Pfenex has just completed a human factors study it feels should support a therapeutic equivalence rating for its Forteo rival.

Deals Value-Added Medicines

Actavis Faces Wait Until 2027 On US Pennsaid

Teva’s Actavis has lost the patent battle over osteoarthritis drug Pennsaid 2% due to a lack of “clear and convincing evidence” and “unpersuasive arguments” over obviousness.

Intellectual Property Generic Drugs
See All
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