The Governor of California has vetoed a bill set to constrict the dispensing of biosimilars due to its premature nature, much to the disappointment of Amgen and Genentech.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
“Reports of my death have been greatly exaggerated” said American author Mark Twain, and yesterday Janet Woodcock - another American author, albeit of a number of US drug initiatives - echoed his words denying rumours of her imminent retirement.
India’s biomanufacturing sector has immense potential, but policy, infrastructure and finance-related issues are holding it back, say both Biocon and analysts.
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.
Kemwell says it intends to open the Indian market to contract biomanufacturing as it signs its first monoclonal antibody (mAb) development and manufacture agreement for a European biopharma.
Agilent Technologies has officially separated its biopharma service offerings from its electric measurement group to create two separate companies, the life science portion of which is expected to bring in about $3.9B in FY2013.
A new platform to help biopharma companies discover antibodies is also helping them go after more difficult targets and earn more collaborations with top biopharma companies.
The updated draft guidance calls for fully validated bioanalytical methods for any pivotal studies used to obtain approval or labelling, though less validation may be sufficient for a sponsor’s internal decision making.
Cytotoxics will be a key growth opportunity for third-party manufacturers as biopharma increases its injectables outsourcing over the next few years, an industry report has predicted.
Roche has agreed to research, develop and commercialize Inovio Pharmaceuticals' vaccine delivery tech as well as its multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B.
The team behind a new Malaysian biotechnology hub – the Bio-XCell Biotechnology Park - has launched a new package designed to attract biomanufacturers.
US acceptance of biosimilars is “not a question of if, only of when,” according to Hospira which received a European Commission (EC) OK of its Remicade copycat yesterday.
The $165bn biopharma market is expected to grow by about 15% annually, driven largely by increasing revenue growth from recombinant monoclonal antibodies (mAbs), according to a recent report.
Baxter and Coherus Biosciences have become the latest firms to try and develop a biosimilar version of the RA treatment Enbrel in a new collaboration announced this week.
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.
