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Generics

News

Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug posted 09/08/2019

On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation tech...

FDA approves rituximab biosimilar Ruxience posted 09/08/2019

US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration...

EMA approves two generics for fungal infections posted 19/07/2019

On 29 May 2019, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive o...

FDA approval for Unichem Lab’s hydrochloride medicines and Teva’s nasal spray to treat opioid overdose posted 08/07/2019

The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) f...

Teva launches generic testosterone gel and overactive bladder treatment in the US posted 31/05/2019

In April 2019, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of generic versions of Andro...

 

Research

Prices for infectious disease treatments and how to reduce them posted 16/08/2019

A recent review from Harvard Medical School explores the factors fuelling high drug prices in the US, suggesting several ways...

Generic Drug User Fee Act is a benefit to the Indian pharmaceutical industry, study finds posted 31/07/2019

The Generic Drug User Fee Act (GDUFA) has had positive effects on generics manufacturers in India, providing increased return...

Adherence to generic versus brand-name statins and associated clinical and economic outcomes posted 24/05/2019

Despite evidence supporting the efficacy of statins for the treatment and prevention of cardiovascular disease, a lack of adh...

Costs and prices of entecavir to treat Hepatitis B posted 17/05/2019

In an analysis of the costs and target prices of Hepatitis B treatment entecavir, author Andrew Hill from Liverpool Universit...

Mixed beliefs about generics among patients in a Malaysian hospital posted 03/05/2019

The Malaysian Government is heavily subsidizing public healthcare expenditure in order to provide access to health care for a...

 

General

Generics applications under review by EMA – July 2019 posted 02/08/2019

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the lo...

Gilead’s Truvada will face generics competition in 2020 posted 19/07/2019

Gilead Sciences’ HIV blockbuster Truvada will face generics competition in the US in 2020, a year earlier than expected.

Pharmacy benefit managers use spread pricing to increase profits in Michigan posted 07/06/2019

A report released in April 2019 raises new questions about the role of Pharmacy Benefit Managers (PBMs) in Michigan, specific...

Multi-state lawsuit alleges widespread generic price fixing in the US posted 20/05/2019

A sweeping lawsuit filed on 10 May 2019 by over 40 US states alleges that a number of major drug companies conspired to infla...

US Court rejects Teva’s lawsuit over generic Restasis posted 08/05/2019

The US District Court for the District of Columbia has discarded lawsuits from generics giant Teva Pharmaceutical Industries...