ACG Inspection’s CEO talks about a ‘fear’ of the disruption caused by advanced medicine, which prevents big pharma companies from investing in the supply chain.
Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
Executives from the largest companies in the industry discuss the increasing prevalence of biologics and the future focus for therapeutics at Pharma Integrates.
After Finch Therapeutics extends partnership with Takeda, the biotech’s CEO outlines how next year could be a defining one for microbiome-based therapies.
The high growth rate in the uptake of biologics in emerging markets represents a major opportunity for those companies developing biosimilars, suggests one pharma exec.
BioLife announces acquisition of Custom Biogenic Solutions, with the company’s latest deal adding liquid nitrogen laboratory freezers and cryogenic equipment to its portfolio.
AbbVie frames forecast-beating ex-US sales of Humira as a consequence of prices stabilising earlier than expected after the arrival of biosimilar competitors.
US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
Merck announces that it has reallocated Gardasil from the US CDC stockpiles, as a surge in demand sees revenues from the vaccine rise 26% year-on-year.
Bavarian Nordic buys vaccines against rabies and tick-borne encephalitis from GlaxoSmithKline for €301m, with up to €495m more in milestones payments to follow.
Modifications on the regulatory framework and focus on funding schemes are the first steps on the path for healthcare systems to adapt to ATMPs’ ‘new ground’, says ARM head for Europe.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
During this year’s Festival of Biologics conference, one track saw a focus on biosimilars that brought together experts from across the industry to map the future for such treatments in the EU and US.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
The gene therapy space is a rapidly developing areas in the industry, as a result those with expertise are finding their knowledge is invaluable to companies looking to advance in the space.
HSAC will acquire 100% of the shares of Immunovant, taking the biotech public with $100m in cash and a lead product that set to go through Phase II trials.
Shanghai Pharma and Biocad established a joint venture to commercialize the latter’s portfolio of biosimilars and biologic treatments for the Chinese market.
US FDA provides information to patients on biosimilars, emphasizing that the treatments provide the same benefits and are as safe as originator products.
South Korea looks to accelerate review timelines and study start-up with a new five-year plan that will benefit biotechs looking for locations outside the US to ‘ramp up’ clinical development programs, says CRO.
Noile-Immune signs its second high profile agreement, the latest with Adaptimmune to combine the companies’ technology in pre-clinical studies for the treatment of cancer.
