Transgene will close a biomanufacturing facility with the loss of 120 jobs to cut costs after Novartis pulled out of an immunotherapy collaboration last year.
The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ).
US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer.
A £10bn ‘mega-fund’ being considered by London Mayor Boris Johnson to boost drug development would be roughly equivalent to what it costs to develop six new medicines based on the latest industry estimates.
In a rare move for the UK’s MHRA (Medicines and Healthcare products Regulatory Agency), the regulator has helped to “future-proof” CMO Fujifilm Diosynth Biotechnologies’ mammalian cell culture manufacturing facility in Billingham, UK against potential...
Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.
Infectious disease vaccines for pregnant women will save countless infants, but companies need to clear practical and ethical concerns for licensure, says the US FDA.
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
The Netherlands and India have signed a MOU (Memorandum of Understanding) under which a government-based institute of the Netherlands will extend technical support for the development and manufacturing of the measles-rubella vaccine.
Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.
The National Institutes of Health’s (NIH) Pharmaceutical Development Section (PDS), which manufactures products for clinical trials, has suspended operations due to the discovery of serious manufacturing problems and contamination by US FDA inspectors.
The WHO has yet to decide how to investigate if barriers to competition are preventing vaccine price cuts after World Health Assembly members committed to probe the jabs industry.
Merck KGaA is confident it will close the $17bn acquisition of Sigma-Aldrich in mid-2015 despite competition concerns from the European Commission (EC).
There is no evidence for adverse effects due to a switch from a reference product to an approved biosimilar and the “theoretical basis of such adverse effects is weak,” according to the latest statement on biosimilars from the Finnish Medicines Agency...
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
Celltrion’s Remsima campaign rolled into the US this week with another presentation of data showing that the Remicade (Infliximab) biosimilar is equivalent to the reference drug.
A biosimilar of Roche’s Lucentis could offer a safer universal treatment for wet AMD than off-label use of Avastin - as recommended by the WHO - according to Pfenex.
If each biosimilar to a reference product doesn’t get a different HCPCS (Healthcare Common Procedure Coding System) code, providers “may not be confident that they they will receive appropriate payment,” Juliana Reed, President of the Biosimilars Forum,...
Under the bill first proposed in 2014, which won unanimous approval last week from a New Jersey Assembly committee, pharmacists would have to notify prescribers within five days of dispensing an interchangeable biosimilar.
The UK Bioindustry Association (BIA) has set out a vision to create a biotech cluster which could compete in size and scale against hubs in Massachusetts and California.
With the release of three final guidance documents on biosimilars, the FDA is offering more clarity for developers seeking to fine-tune their understanding of the science and quality of biosimilars.
Lonza has predicted that revenues and profits will grow in 2015 despite the strong franc, citing pharma portfolio optimization and demand for outsourced manufacturing services.
AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
Reluctant doctors and varying reimbursement policies are affecting biosimilar trial recruitment, experts said at the European Generics Association’s biosimilars conference in London last week.
US rheumatoid arthritis (RA) sufferers will still face high drug prices after biosimilar are available unless insurers reclassify such meds according to the author of research on biologic DMARD costs.
The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.
The EBG (European Biosimilars Group), a part of the EGA (European Generic Medicines Association), says that more complex systems for naming biosimilars increases the likelihood that physicians and pharmacists will leave something out and disrupt the tracking...
The Medicines Evaluation Board (MEB) of the Netherlands has updated its position about biosimilars, saying the relatively new products “have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality,...
Juno Therapeutics has agreed to settle litigation with Novartis and the Trustees of the University of Pennsylvania after Juno entered into a December 2013 license agreement with St. Jude Children’s Research Hospital, which owned the patent rights.
Data must drive US FDA efforts to determine biosimilar interchangeability according to a Pfizer exec who told Goldman Sachs conference delegates not to expect a definition anytime soon.
Supply of the Adenovirus Type 4 and Type 7 Vaccine to all US military personnel has been secured through a five-year contract with Teva worth $170m (€156m).
With the release of four different documents around the pricing and use of biosimilars this week, the US CMS (Centers for Medicare and Medicaid Services) is making clear it will fully encourage states to call on prescribers to use cost-effective biosimilars...
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
A Georgia bill, which passed both the state House and Senate last week, calls for new language on biosimilar labels that say that the product is “interchangeable.”
