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Policy and Regulation
Regulation Explore this Topic
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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.
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.
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.
Pricing Strategies; Reimbursement Explore this Topic
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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.
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.
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 Explore this Topic
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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.
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.
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.
Market Intelligence Explore this Topic
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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.
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.
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.
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