MedImmune’s neurodegenerative disease partnership with the University of Cambridge is about working with “great scientists with great brains” according to a spokeswoman for parent company, AstraZeneca.
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
Baxter International plans to set up a new global R&D center in Cambridge, Mass, for Baxalta, its biopharmaceuticals spinoff, which is expected be formally incorporated next year and headquartered in northern Illinois.
The EGA has called for more awareness surrounding the uptake of biosimilars in Europe after a report has shown upcoming products could cut healthcare provider spending by a quarter.
Chief among the potential drivers for the world’s biosimilar market is establishing a market in the US, which continues to stall, according to a new report.
Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.
As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies.
At present Biosimilars save Europe roughly €2.40 per person, or €1.8bn a year, but by 2020 follow-on mAbs alone will shave €20bn off the continent’s healthcare bill according to researchers.
Charles River Labs (CRL) has singled out China as an area of “disproportionate growth” in biologics R&D and says it is on the hunt for preclinical acquisitions in the region.
A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist overlords, there is an Art Garfunkel or Daryl Hall solo album to illustrate the positive impact collaboration can have.
The monoclonal antibody drug Soliris has been recommended by NICE despite Alexion failing to justify the manufacturing costs contributing to the £3,150 ($5,140) price per vial.
Over the next five years the vaccine industry will see an influx of transdermal and intradermal delivery systems, as well as other more innovative administration techs, according to a new study from Frost and Sullivan.
Contract manufacturer CMC Biologics and Zymeworks have entered into a master services agreement whereby CMC will perform the process development, formulation development and cGMP clinical manufacturing of a recombinant human IgG1 bi-specific (heterodimeric)...
EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.
The American Academies of Clinical Endocrinologists, dermatologists and neurologists, as well as eight other physician groups and a number of individual physicians are calling for unique names for biosimilars to better track adverse events and ensure...
Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...
The lack of a biopharmaceutical "Orange book" means biosimilar developers face greater litigation risk than their generic counterparts according to one IP lawyer, who says full knowledge of all relevant patents is a must for such firms.
US FDA researchers are developing tools to help cell therapy developers improve how they manufacture stem cells in a new lab consortium unveiled by the agency this week.
As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.
US demand for biosimilar preclinical services is expected to rocket on the back of the US FDA’s acceptance of Sandoz’s biosimilar filing, according to Harlan Laboratories.
The US Food and Drug Administration (FDA) has issued guidance on biologics exclusivity, stipulating the evidence drugmakers must provide to ensure a 12-year exclusivity period.
With the EMA’s CHMP (Committee for Medicinal Products for Human use) recommending approval for a new insulin biosimilar early last month, some in the industry are expecting an increasingly competitive field moving forward.
As the fight over naming biosimilars continues in the US, the WHO has drafted its own system of biological qualifiers to ensure biosimilars remain unique from their biologic counterparts.
Scientists from USP (US Pharmacopoeia), Apotex and an advisory board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.
The European Medicines Agency (EMA) has released a second module of a new guideline on influenza vaccines for a six-month public consultation, which covers the non-clinical and clinical requirements for the development of new flu vaccines.
As the US FDA (Food and Drug Administration)’s biosimilars pathway is tested for the first known time following Sandoz’s filgrastim submission last week, an expert predicts imminent biosimilars submissions from Celltrion and Hospira.
Amgen says it will continue to invest in manufacturing technologies to support its biosimilar pipeline despite announcing a restructuring that will reduce its manufacturing footprint by 23%.
Bristol-Myers Squibb and Ono Pharmaceuticals have expanded their collaboration to jointly develop and commercialise the monoclonal antibody drugs Opdivo and Yervoy.
Mailroom and legal staff at Sandoz and Amgen are in for a busy six months after the US FDA agreed to review a biosimilar version of the anti-infective, Neupogen.
UK industry groups have rejected the idea their call for doctors to use brand names rather than INNs in new biosimilars FAQ documents is about protecting member firms’ market share.
Biosimilars are not analogous to small molecule generics in terms of market share loss according to Johnson & Johnson, which is confident its biopharmaceutical portfolio can withstand competition.
The acquisition of Shire for £31bn ($53bn) has moved a step closer but reliance on third party suppliers would only add two facilities to AbbVie's biomanufacturing network.
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
While the overall bioscience industry has seen 7.4% jobs growth between 2001 and 2012, the sector encompassing CROs and other research, testing and medical labs has grown by more than 28%, according to a new report from industry group BIO and Battelle.
The draft guidance aims to provide sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical...
