As California approves a Bill constraining biosimilar substitution, the US FDA says it is concerned at efforts to undermine strict federal legislation already in place.
Investors on Tuesday seemed a little less sure of biopharma behemoth Amgen’s decision to purchase cancer specialist Onyx for more than $10B over the weekend.
A third Novartis biopharmaceutical has received breakthrough designation status from the FDA allowing ‘fast-track’ development and review without compromising safety, the company says.
Biomanufacturing is offsetting a decline in Ireland's small molecule industry caused by the patent cliff and cheaper manufacturing options in the East say industry groups.
Mammalian cell culture know-how and location won Rentschler Biotechnologie its new anticancer MAb manufacturing deal according Austrian BioPharma Apeiron Biologics.
A trend to outsource storage solutions is being driven by a need to cut costs, says Vindon, though uptake amongst biomanufacturers trails that of small molecule manufacturers.
GlaxoSmithKline is gambling $50M on a venture capital fund that will invest in 20 projects that pioneer bioelectric drugs and technologies that aim to target individual nerve fibres or specific brain circuits to treat an array of conditions.
Agilent Technologies is partnering with SomaLogic to expand the dissemination of Soma’s proteomic assay to at least five academic and contract research centers by the end of the year as demand for the tool has skyrocketed among biopharma companies.
inVentiv Health and Oncobiologics are employing a unique risk-sharing partnership to bring a number of the biggest blockbuster biologics to market as biosimilars.
Piramal is upgrading its ADC (antibody drug conjugate) manufacturing capacity in response to demand from clients in late phase trials looking to ramp up production.
Quality concerns and high shipping costs mean BioPharmas currently prefer Western CMOs, but improving standards and market opportunities may soon make Chinese contractors more attractive, experts say.
Stem cell therapeutics firm ReNeuron will conduct clinical development and – eventually – manufacturing at a new UK base in Wales in a move facilitated by Arthurian Life Sciences.
Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.
The European Medicine’s Agency (EMA) has approved the first biosimilar monoclonal antibodies and expects to approve increasingly complex biosimilars as the regulatory framework becomes more flexible.
Ambrx and Zhejiang Medicine have selected Wuxi to accelerate the development of a potential ADC (antibody drug conjugate) targeting Her2-positive breast cancer.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
The Japanese joint venture between Dr. Reddy’s and Fujifilm has been called-off though both say future collaboration remains likely, especially in API production.
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
Globalisation, outsourcing and a move towards biopharmaceuticals are leading innovation for pharma distribution companies, according to DHL Global Forwarding.
Bristol Myers-Squibb says its $250m (€191m) expansion of its US biologics facility will centralize its processes and become a springboard to launch new products.
Early phase clinical trial provider CPR Pharma Services has expanded its bioanalytical offerings with a ligand-binding assay service for its clients developing large molecules such as biologics, monoclonal antibodies and biosimilars.
Merck Serono says “fast progress” in its restructure programme helped double its net savings guidance for 2012 though headcount dropped by almost 2,000 with more cuts to come.
Ajinomoto says its flexible approach to tech licensing differs from rivals who are more focused on locking customers into manufacturing services contracts.
As anticipation swells over how the biosimilar market will shape up in the US, some contract biologic manufacturing executives don’t seem to think the size of the market is worth all of the hype yet.
Biopharmaceutical CMOs have seen their business slowly shrink as companies seek less volume and smaller batches, but outsourcing is expected to increase over the next three years.
Quintiles painted a rosy picture of the CRO sector in its much anticipated IPO, predicting that biopharma R&D spending will increase and demand for outsourced research will grow.
Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).
ADC Biotechnology has secured funding to take its cost-cutting antibody drug conjugate (ADC) tech to market and says pharma demand will drive partnerships and maybe even attract CMO takeover bids.
All parties involved in the distribution of biologics in India must take responsibility for quality and keep seasonal temperature variations in mind says the CDSCO.
Menarini has committed millions of euros to an antibody drug conjugate (ADC) clinical development and manufacturing pact with Oxford BioTerapeutics (OBT).
