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Policies & Legislation

Australia’s regulatory body proposes transparency reforms

Australia’s Therapeutic Goods Administration (TGA) has issued a number of proposed transparency reforms for feedback from industry stakeholders, including earlier notification of generics applications.

COVID-19 brings new collaborations to Australia and the EU

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.

Five key questions about the ‘patent dance’ answered

Law firm Fish and Richardson have provided answers to five key questions for biosimilar makers when it comes to the patent dance.

CMS launches insulin co-pay at US$35

The Centers for Medicare & Medicaid Services (CMS) in the US has launched a new model to reduce co-pays for insulin products to US$35.

Alberta delays deadline for forced medication switch by six months

The Canadian province of Alberta has delayed its introduction of a switching policy to biosimilars for patients using biologicals for six months.

Opposition party in Alberta, Canada fights biosimilar switching policy

The opposition New Democratic Party (NDP) in Alberta, Canada has urged the province not to force patients to switch to biosimilars, citing concerns about patient safety.

Hospira asks Federal Circuit to reconsider Safe Harbor ruling

In December 2019, Federal Circuit judges upheld a Delaware district court’s judgment of patent infringement and its order that Hospira pay US$70 million in damages to Amgen [1]. Then in January 2020 Hospira filed a petition for rehearing ‘en banc’ asking the full Federal Circuit to reconsider the Safe Harbor ruling and reverse the judgment of infringement.

Allergan, Ironwood settle Linzess patent dispute

In early 2020, Allergan and Ironwood Pharmaceuticals (Ironwood) reached agreements with Mylan Pharmaceuticals (Mylan), Sandoz and Teva Pharmaceutical Industries (Teva) to protect their irritable bowel syndrome (IBS) treatment Linzess (linaclotide).

China’s procurement programme cuts drug prices by half

China’s national generics procurement programme, the second phase of which ended in January 2020, included 33 different drugs and cut prices by 53% on average.

US patent office rules in Biogen’s favour on Tecfidera

Biogen has won a patent challenge from Mylan over multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

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