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 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.

Indian firm USV plans to spend $56.4m on a new drug formulations unit in Vadodara and $11.3m to upgrade its existing API unit near Mumbai as it eyes expanded capacity and additional sales in Europe.

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

China’s favorite domestic drug maker seems to have a warning for the industry - innovate or halt. After the recent round of “4+7” centralized procurement saw some off-patent drugs priced at pennies, the leading Chinese firm Hengrui has decided to halve its generics portfolio to focus on innovative new drugs.

Teva has announced a leadership change in its global operations, while Lupin has made a key appointment to focus on quality and compliance. Among other changes in leadership roles, Olainfarm has seen one of its six management board members resign. 

Having unsuccessfully asserted a patent under the previous legal framework in Canada does not preclude an originator from trying again following legislative amendments enacted in 2017, the country’s Federal Court of Appeal has ruled in a decision on Pfizer’s Nivestym filgrastim biosimilar.

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.

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

Originators that make discounts on biologic list prices conditional on hospitals not switching treatment to anti-TNF biosimilars may be breaching competition law, the Netherlands’ competition authority is warning.

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

Recognizing the benefits of value added medicines in European hospital settings can help patients and healthcare professionals, a KPMG report commissioned by Medicines for Europe suggests.

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.

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.

A German higher regional court has upheld an injunction barring Mylan from marketing its Clift rival to Teva’s Copaxone 40mg/ml multiple sclerosis treatment.

Having unsuccessfully asserted a patent under the previous legal framework in Canada does not preclude an originator from trying again following legislative amendments enacted in 2017, the country’s Federal Court of Appeal has ruled in a decision on Pfizer’s Nivestym filgrastim biosimilar.

Originators that make discounts on biologic list prices conditional on hospitals not switching treatment to anti-TNF biosimilars may be breaching competition law, the Netherlands’ competition authority is warning.

A KPMG report commissioned by Medicines for Europe finds that nine ‘key ingredients’ could maximize savings for generic and biosimilar medicines in European hospitals.

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.

An IQVIA report dives into how technology can facilitate a digital future for value added medicines, while discussing the market size, opportunities, scope of growth and challenges for this emerging sector in healthcare.

Recognizing the benefits of value added medicines in European hospital settings can help patients and healthcare professionals, a KPMG report commissioned by Medicines for Europe suggests.