European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
The US FDA is faced with lapsed funding appropriations as the US government shutdown continues, causing the agency to focus on addressing immediate threats to consumer safety.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
Eli Lilly and Innovent announced that their jointly developed anti-PD-1 drug gained approval in China, becoming the second domestically produced treatment of this type.
With nearly 300 cell and gene therapies in development, targeting more than 100 diseases, 2019 could be set to be a big year for cell and gene therapies.
Rentschler Biopharma will buy Shire’s development and manufacturing facility in Milton, Massachusetts, where the latter makes haemophilia A product, Obizur, for commercial production.
The US regulator has validated Celltrion and Teva’s biosimilar version of Roche’s Herceptin, marking the partnership’s second approval in as many months.
A number of global ‘mega-trends’, such as dated technology and manufacturing inefficiencies, present major challenges for the drug industry, according to Dave Tudor
Chinese investors are looking abroad for technology that will provide short-term returns and long-term health benefits to its large patient population, according to Panacea Ventures partner.
At least 80% of patients currently taking AbbVie’s blockbuster drug could be switched to “the best value biological medicine” within 12 months, according to the UK National Health Service.
Bayer looks to boost investor confidence by cutting away its animal health unit, selected consumer health brands and a number of jobs to focus on its life sciences businesses.
Celltrion and Teva have overcome regulatory hurdles to secure approval for Truxima in the US, a biosimilar to non-Hodgkin’s lymphoma treatment, Rituxan.
Nurses can take the lead when ‘making the switch’ between an originator and biosimilar medicine, says nurse practitioner Hanneke Voorneveld-Nieuwenhuis.
Pfizer has launched the first biosimilar to J&J’s Procrit and Amgen’s Epogen in the US at a ‘significant discount’ to competitors’ wholesale acquisition costs.
Unlike the European system, manufacturing authorisation holders in Jordan must own or operate from a manufacturing facility to apply for biosimilar approval, says JFDA executive.
We will not stand behind non-competitive pricing schemes that undermine the incentive to innovate and invest in drug development, says BIO VP of industry research, David Thomas.
