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Pharma News

2016 V17A06

Top 10 most read GaBI Online articles in 2016

Home/Pharma News | Posted 06/01/2017

It has once again been a busy year for biosimilars. An important milestone for biosimilars in 2016 was the adoption by the European Medicines Agency (EMA) of new guidance on monitoring biologicals. While the US Food and Drug Administration (FDA) approvals of infliximab and adalimumab biosimilars were also important events in 2016. Other subjects of interest for biosimilars were the differences between biosimilars and reference biologicals, biosimilarity and switching biosimilars. Biosimilars remain the hot topic for GaBI Online during 2016.

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Strategic biologicals alliance between Sanofi and JHL Biotech in China

Home/Pharma News | Posted 06/01/2017

Sanofi and JHL Biotech (JHL) announced on 5 December 2016 that they were forming a strategic biologics alliance in China.  The two companies will be collaborating on the development and commercialization of biological therapeutics in China, with potential for further international expansion.

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Sun Pharma to acquire Russia’s Biosintez

Home/Pharma News | Posted 09/12/2016

Sun Pharmaceutical Industries (Sun Pharma) announced on 23 November 2016 its acquisition of Russian pharmaceutical company JSC Biosintez at a cost of US$24 million, demonstrating the company’s commitment to the Russian market.

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India’s Cipla to establish biosimilars facility in South Africa

Home/Pharma News | Posted 25/11/2016

Indian generics maker Cipla has announced a deal to set up South Africa’s first biosimilars manufacturing facility, at an estimated cost of over US$91 million.

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Richter and DM Bio make deal for trastuzumab biosimilar

Home/Pharma News | Posted 11/11/2016

Hungary-based Gedeon Richter (Richter) announced on 19 October 2016 that it had signed a technology transfer and in-licensing agreement with South Korea-based biologicals specialist DM Bio for the development and commercialization of DM Bio’s trastuzumab biosimilar.

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China’s CFDA rejects more than 80% of drug applications

Home/Pharma News | Posted 28/10/2016

Data released by China Food and Drug Administration (CFDA) revealed that between January 2015 and January 2016, 1,184 drug applications submitted to CFDA were rejected or withdrawn due to incomplete or fraudulent clinical data.

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Dr Reddy’s expands collaboration with Amgen in India

Home/Pharma News | Posted 14/10/2016

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) is expanding its collaboration with US-based biologicals specialist Amgen with an agreement to market and distribute three of Amgen’s biological medicines in India in the therapy areas of oncology and osteoporosis.

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Sun Pharma announces Japanese distribution pact with Mitsubishi Tanabe

Home/Pharma News | Posted 07/10/2016

Sun Pharmaceutical Industries (Sun Pharma) has announced it will transfer marketing authorizations for 14 of its prescription drugs to Mitsubishi Tanabe Pharma (Mitsubishi Tanabe), allowing the company to manufacture and market them in Japan.

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Pfizer antibiotics banned across the EU

Home/Pharma News | Posted 16/09/2016

An inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has resulted in the ban of several drugs produced by a Pfizer manufacturing site in India. 

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EMA reports ‘critical deficiencies’ in Chinese API producer Jinan Jinda

Home/Pharma News | Posted 02/09/2016

A recent European Medicines Agency’s (EMA) follow up on Jinan Jinda Pharmaceutical Chemi Co Ltd (Jinan Jinda) revealed that the Chinese pharmaceutical company is far off meeting EU standards.