English pharmacists are not free to dispense biosimilars in place of reference biologics, the country’s National Health Service says in its latest guidance.
Army training is ideal preparation for a biopharma career according to the US National Center for Therapeutics Manufacturing, which is seeking former military personnel interested in learning about bioprocessing.
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).
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.
Aspyrian Therapeutics has selected CDMO Goodwin Biotechnology to complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC).
Biologics and focused R&D spending are driving the market for lyophilisation according to Symbiosis Pharmaceutical Services, which says its freeze-drying tech investment reflects this surge in demand.
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
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.
Chicago-based Rottendorf Pharmaceuticals, a top 20 contract development and manufacturing organization (CDMO), has signed three formulation development projects and two commercial transfer projects with multiple top pharma and biotech companies in the...
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
India-based CMO Piramal has acquired US-based sterile injectable CDMO (contract development and manufacturing organization) Coldstream Laboratories for $30.65m.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Biomanufacturing costs and the risk of extractables and leachables can be reduced by developing more compatible plastics, Sabic told Biopharma-Reporter.com at CPhI in Paris.
Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.
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...
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.
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.
Boehringer Ingelheim has entered a collaboration to develop a peptide candidate for cardio-metabolic diseases in a deal that could net partner Zealand Pharma up to €295m ($395m).
Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.
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.
A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).
Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.
Malvern Instruments will buy GE Healthcare’s MicroCal business in a deal that adds protein analysis and formulation development tech to its expanding drug industry offering.
The biotechnology and pharmaceutical bodies AusBiotech and Medicines Australia have asked the Australian Minister for Industry to invest in biopharma R&D and secure patents.
CMC Biologics, a contract manufacturing organization (CMO), has been picked by biopharmaceutical company MacroGenics to make its oncology candidate as "an extension of their own technical team."
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
The US Food and Drug Administration (FDA) has approved a second “Breakthrough Therapy” biologic but it is still unclear whether the programme speeds drugs to market, says an expert.
Covance has announced that its recently expanded large molecule bioanalytical space at its laboratory facility in Indianapolis will come online in late 2014.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.
Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.
Crescendo Biologics has secured funding to develop a range of Ab fragment-based drugs using its genetically modified mouse platform, including a psoriasis treament that could rival blockbusters like Remicade and Humira.
Almac says it is in a unique position to offer Carbon-14 ADME radiolabeling for the growing antibody-drug conjugate (ADC) market and has already performed the service on a Pfizer candidate.
Parexel has seen small and mid-sized biopharma demand for development services decline in recent months according to an anaylst who attended the CROs presentation at the Jefferies Global Healthcare conference this week.
Biopharmas should stop green lighting safe, mediocre candidates and focus on developing drugs that are genuine scientific breakthroughs to control spiralling R&D costs, according to industry guru Bernard Munos.
Big Pharma interest in antibody drug conjugates (ADC) hit another high this week with Roche ,Novartis and AstraZeneca each announcing investments that boost their ability to develop and manufacture these small-molecule monoclonal antibody (mAb) drug...
Investing in antibody-drug conjugates (ADCs) made sense despite CMO competition and the fact few of these hybrid drugs have been approved to date says Carbogen Amcis CEO, Mark Griffiths.
