Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
Sanofi has teamed with JHL Biotech to develop biosimilar products, including a version of Rituxan (rituximab), for the Chinese and international markets.
A lack of investment and government support has stunted biomanufacturing in India, but Biocon says this will change through the country’s 'Make in India' programme.
The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19 target played a part.
Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.
A plan to attract advanced medicinal therapy manufacturing to the UK has emphasised the importance of the MHRA having a leading role in development of global regulatory standards.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.
US public health programmes will use lower dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year.
Biocon says it is well-positioned to up production of its Lantus biosimilar after the insulin glargine – co-developed with Mylan – was accepted for review in the EU.
Pfizer has said it will stop working on bococizumab and cease late phase trials of the monoclonal antibody (mAb) cholesterol buster being run by Ireland-based CRO, Icon.
Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.
Lonza has raised its 2016 guidance and predicted higher spending on manufacturing equipment after growth of its biopharma businesses in the third quarter.
Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.
The US FDA has told Aduro Biotech not to enrol subjects in trials of its listeria-based immunotherapies after one study subject tested positive for the bacteria.
Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drugmakers. We ask therefore how industry and the media should refer to biosimilar products?
Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
A two year-long Phase IV study has shown Celltrion’s infliximab biosimilar is not inferior to its originator Remicade, but a physician group still urges caution when switching.
Japan’s early approval process for cell and gene therapies still suffers from clinical recruitment challenges and a solid manufacturing framework, says regenerative medicine group FIRM.
Long-awaited interchangeability guidance will strengthen the public’s confidence in biosimilars, but is likely to only affect 20% of all biological products, MedImmune and Biocon said at CPhI.
Teva has partnered with Celltrion to commercialise versions of Roche’s Herceptin and Rituxan, helping fill a gap in its second wave biosimilars pipeline.
The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
J&J cannot stop Inflectra arriving in the US in October but warns Pfizer of the risk of launching it while the patent surrounding Remicade’s manufacture remains unresolved.