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News

FDA approves Farxiga generic posted 26/08/2019

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s...

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...

 

Research

Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients posted 16/09/2019

The arrival of biosimilars represents more affordable alternatives for patients in several countries, increasing their access...

TRIPS flexibilities: current and future use in the SADC region posted 13/09/2019

In response to the HIV/AIDS crisis of the late 1990s, several legal options were introduced to facilitate access to lower-cos...

Improving access to medicines: the Doha Declaration on the TRIPS Agreement posted 06/09/2019

In a recent review, authors ‘t Hoen, Kujinga and Boulet describe the role of the Doha Declaration on the World Trade Organiza...

Patent challenges in the SADC region posted 30/08/2019

High pharmaceutical prices restrict access to essential medicines. New medicines are often patent protected which sustains pr...

Generic irbesartan is safe and effective, shows phase IV trial posted 23/08/2019

Generic versions of the anti-hypertensive irbesartan are equally effective as their branded counterparts, finds a phase IV st...

 

General

China issues list of generics needed in the country posted 30/08/2019

Authorities in China have introduced an initiative which the country hopes will boost the development of generics by encourag...

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...