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Mylan agrees to pay fine over EpiPen rebates

US-based drugmaker Mylan announced on 7 October 2016 that it had agreed to pay US$465 million to the US Department of Justice (DOJ) and other government agencies. The agreement, the company says, will resolve questions that have been raised about the classification of its EpiPen injectors for the Medicaid Drug Rebate Program. The deal has also been made without the company having to admit any wrongdoing.

Teva recalls antibiotic and anti-seizure drug

Recent US Food and Drug Administration (FDA) reports have caused Israeli generics producer Teva Pharmaceutical Industries (Teva) to recall a treatment for seizures, as well as an antibiotic made at its sterile manufacturing plant in Hungary.

Allergan allows Amneal to market Alzheimer’s generic in 2025

Allergan has reached a deal with Amneal Pharmaceuticals (Amneal) over Allergan’s Alzheimer’s drug Namzaric. The agreement will enable Amneal to market generic versions of the drug from 2025 onwards. 

Patent wins and losses for Teva

Teva Pharmaceutical Industries (Teva) – the world’s largest generics manufacturer – has reported a string of patent updates recently. In the first of Teva’s patent-related news, Forest Laboratories (Forest) – an American pharmaceutical company acquired by Actavis [1] – made a deal with Teva regarding a patent licensed to them and held by Mayne Pharma (an Australian specialty injectables company now owned by Pfizer).

Senators continue to raise concerns over price of Mylan’s EpiPen

On 30 August 2016, a group of 20 US senators led by democrat Elizabeth Warren sent a letter to Mylan’s CEO Heather Bresch expressing their ‘serious concerns’ about the company’s recent significant price hikes for the life-saving EpiPen Auto-Injector.

New generic versions of imatinib mesylate join the US market

Two new generic versions of Novartis’ imatinib mesylate (marketed as Gleevec® and Glivec®) were launched in the US in early August 2016.

Launches, approvals and court cases for Sun Pharma

India’s largest drug manufacturer Sun Pharmaceutical Industries (Sun Pharma) has launched ready-to-administer anticancer drug gemcitabine in six European countries and gained approval for a generic version of prescription cholesterol medicine Crestor, while also facing legal action from protesting employees.

FDA approves first generic nilutamide for treatment of prostate cancer

US generics producer ANI Pharmaceuticals (ANI) announced on 18 July 2016 that it had received US Food and Drug Administration (FDA) approval for its generic version of prostate cancer treatment Nilandron (nilutamide).

Glenmark gains approval for anti-epileptic generic

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 19 May 2016 that it had received final approval from the US Food and Drug administration (FDA) for a generic version of Eisai’s epilepsy treatment Banzel (rufinamide).

Dr Reddy’s to buy US generics from Teva

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) announced on 11 June 2016 that it had made a deal with Teva Pharmaceutical Industries (Teva) and an affiliate of Allergan to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US.

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