25-Apr-2017 - The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
25-Apr-2017 - Fresenius Kabi has announced plans to purchase Merck KGaA’s biosimilars business.
24-Apr-2017 - Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
21-Apr-2017 - Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the...
20-Apr-2017 - Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.
18-Apr-2017 - Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes.
18-Apr-2017 - UK life science companies must become global to help offset staffing and funding problems potentially caused by Brexit, says Arecor CEO Sarah Howell.
11-Apr-2017 - American-made biosimilars hold no advantage in the US market according to patient and physician groups which place emphasis on trusted and reputable manufacturers instead.
04-Apr-2017 - Cellular Biomedicine Group Inc (CBMG) has expanded its stem cell manufacturing facility in Huishan High Tech Park in Wuxi, China.
31-Mar-2017 - Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013
29-Mar-2017 - The US FDA has approved the first systematic treatment for eczema: Sanofi and Regeneron’ monoclonal antibody Dupixent (dupilumab).
28-Mar-2017 - The UK BioIndustry Association will visit Switzerland ahead of Brexit negotiations to learn how to work in Europe without being in the EU.
22-Mar-2017 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.
21-Mar-2017 - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.
21-Mar-2017 - The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
20-Mar-2017 - Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
15-Mar-2017 - US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?
15-Mar-2017 - The US FDA has extended the comment period for its draft biosimilar interchangeability guidance until May 19.
14-Mar-2017 - The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.
10-Mar-2017 - Germany's Merck has confirmed it is divesting its biosimilars division in order to concentrate on its innovative product pipeline.
08-Mar-2017 - Roche is better positioned than Amgen, AbbVie and Janssen to defend against biosimilar competition, according to this writer and a Twitter poll.
07-Mar-2017 - Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.
07-Mar-2017 - The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths.
03-Mar-2017 - Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).
03-Mar-2017 - Sanofi Pasteur and MedImmune have partnered to develop a monoclonal antibody (mAb) based treatment for respiratory syncytial virus.