India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
The non-proprietary naming debate is “almost a little comical” says Sandoz, which argues a proposed four-letter suffix adds little to aid post-marketing surveillance of biological products.
Amgen confirms it is working on a version of Alexion's drug
Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.
Novartis will continue investing in its manufacturing network to support a biologics pipeline which includes five new biosimilars it expects to launch by 2020.
Brazil’s ANVISA has cleared Cristália Laboratory to make an API for an over-the-counter (OTC) burns treatment at a recently established $40m biomanufacturing facility in Itapira, Sao Paulo.
Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
Biosimilars will capture new patients in the first instance while existing patients will gradually switch over says Pfizer, a developer of both originator biologics and copycats.
The US FDA has updated its draft nonproprietary naming guidance allowing drugmakers to submit up to 10 suffixes for each new biologic and biosimilar product.
Mundipharma has begun the latest phase of its Remsima promotion campaign, unveiling two-year data indicating the infliximab biosimilar is as safe and effective as the originator.
According to the most recent Biopharma CEO Confidence Index, CEOs are shifting their focus back to their pipelines and have plans to increase outsourcing.
The US Government is set to extend an anthrax vaccine supply contract, and Emergent Biosolutions believes its new commercial-scale facility coming online was a driving factor.
Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.
Octapharma has withdrawn one lot of its immune deficiency treatment Octagam after receiving reports of reports of allergic skin reactions in patients treated with the product.
Lonza plans to expand mammalian cell culture-based drug and viral manufacturing capacity after growth in both businesses helped it to record first quarter sales.
Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).
Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.
Pfizer remains confident it will launch its biosimilar Inflectra in the US this year despite J&J assuring stakeholders it will defend Remicade’s IP beyond 2018.
Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.
Heat Biologics has announced several "necessary" but "incredibly difficult" cost cutting measures, including a workforce reduction of approximately 22%.
Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.
Biosimilar labeling will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
Drug companies were a more important source of revenue for Lonza in 2015 than in previous years with four of its five biggest spending customers coming from the pharmaceutical sector.
