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Glenmark and Lupin gain FDA approval for nervous system agents posted 12/11/2019

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for...

AB004665 Alimta and Orfadin generics approved by FDA posted 15/10/2019

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cance...

AB004665 EMA approves leukaemia and multiple myeloma generics posted 05/10/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 th...

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...

 

Research

Generics transition brings economic benefits to Canada posted 13/11/2019

Economic analysis of genericization of cancer medicines in Canada has confirmed their cost-effectiveness. This rare example o...

A call for economic reassessment of drug regimens posted 12/11/2019

Canadian researchers have called for the cost-effectiveness of drug products to be routinely reassessed. Their study, publish...

Pharmacy chain drives choice among US generics manufacturers posted 25/10/2019

A recent study shows that the dispensing pharmacy chain is a strong driver of generics manufacturer choice in the US, which c...

First pregabalin generics approved by FDA posted 23/10/2019

In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (preg...

Strong generics nocebo effect found in US posted 15/10/2019

In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a c...

 

General

16704526_l UK Labour Party proposes state run generics manufacturer posted 25/10/2019

In a speech at the 2019 Labour Party Conference, leader Jeremy Corbyn introduced the ‘Medicines For The Many’ initiative, whi...

Ranitidine recalls escalate as FDA declares ‘unacceptable’ levels of NDMA in the drug posted 23/10/2019

On 2 October 2019, the US Food and Drug Administration (FDA) declared that it had found ‘unacceptable’ levels of the probable...

Carcinogen contamination halts distribution of generic Zantac posted 07/10/2019

Heartburn drug Zantac (ranitidine) is being taken off markets worldwide following findings that the medications may be contam...

FDA’s global inspection strategy strengthened posted 27/09/2019

The US Food and Drug Administration (FDA) has implemented a modernized approach to ensure the safety and quality of globally...

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...

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