The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.
Development of a successful HIV vaccine will rely on broadly neutralising antibodies (bNAbs), says the Director of the National Institute of Allergy and Infectious Diseases.
Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.
Remicade biosimilars have had no meaningful impact on AbbVie’s parallel TNF inhibitor Humira, management says, despite international Q2 sales of the mAb being down 14% year-on-year.
Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.
With Pfizer closing in on Hospira and Sandoz set to launch Zarxio in the US, it’s been a defining week for biosimilars, our BioFinance Vision feature explains.
Novartis’ Sandoz unit will begin selling a biosimilar for Amgen’s cancer treatment Neupogen on September 2, thanks to an appeals court ruling released Tuesday.
Sales of Jonson & Johnson’s Remicade have been hit by biosimilar competition but the firm remains confident it will maintain leadership in the immunology space.
CDMO (contract development and manufacturing organisation) Goodwin Biotechnology is working with CNS biotech Q Therapeutics to produce mAbs for a clinical trial to treat motor neuron disease.
A Medicare reimbursement policy proposing that biosimilars have the same pricing code as their reference products could ultimately reduce R&D investment, according to an industry group.
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).
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.
Takeda is closing three US R&D facilities and relocating its global HQ to a site in Massachusetts as part of plans to consolidate its vaccine business.
Innovate UK has awarded Crescendo Biologics a grant to fund development of drugs combining cytotoxic small molecule payloads with antibody fragments known as Humabodies.
Biomay has licensed a yeast-based expression system from fellow Austrian biotech VTU Technologies to use for the commercial production of its recombinant allergens.
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
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.
Pfizer has invested $87.5m in Dutch biopharma AM-Pharma B.V., which develops recombinant human Alkaline Phosphatase (recAP) therapies for orphan inflammatory diseases.
Alexion will expand its manufacturing network with a €450m ($507m) biologics facility in Ireland, a week after entering an $8.4bn agreement to acquire Synageva.
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.
Cheaper disposable manufacturing techs and increased demand for outsourced production will see more CMOs enter the contracting sector according to HighTech Business Decisions
Merck & Co. will invest €11.5m ($12.5m) at a plant in Ireland to manufacture its oncology drug Keytruda, an anti-PD1 mAb recently approved by the US FDA.
Medgenics has expanded a partnership with Harvard University to use its Transduced Autologous Regenerative Gene Therapy (TARGT) platform for potential applications involving the central nervous system.
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.
