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.
Kadcyla has become the second antibody-drug conjugate (ADC) to be available in Europe, triggering a $5m milestone payment by Roche to technology partner Immunogen.
Biosimilar clinical trials are increasing but levels of physician oversight and regulatory decisions are still hurdles to overcome, say Parexel, PPD and Vince & Associates.
Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.
Genentech has recommissioned plans to make a Californian facility the largest biologics plant worldwide after anticipated revenue drop from biosimilars did not materialise.
Bioinvent has been granted a US patent for its FIRST screening platform and says it is unique in selecting antibodies without any prior knowledge of target identities.
Orgenesis has partnered ATMI and established a subsidiary in Belgium in order to manufacture cells for clinical trials of its insulin-producing regenerative drug.
A new vitamin E-based hydrogel technology could improve how cancer busting mAbs are delivered and help biopharmas cut costs according to developer IBM.
Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
Corba Biologics has opted for a HyClone bioreactor to boost its antibody production capacity citing customer demand and biosimilars as the drivers for the investment.
Piramal’s COO Vijay Shah described antibody-drug conjugates (ADCs) as “a concept whose time has come” at the CPhI annual report press conference and recent investors in the technology echo his words.
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...
Biotech developer Regeneron is investing as much as $300m in its New York manufacturing plants and for a new site in Ireland as part of preparations for a potential new blockbuster monoclonal antibody that treats high cholesterol.
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.
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.
MIT engineers have developed a new nanoparticle that can protect a vaccine long enough to generate a strong immune response on mucosal surfaces far from the vaccination site.
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.
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.
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.
Mitsubishi Tanabe Pharma (MTPC) is closer to adding two plant-based expression techs to its manufacturing arsenal after Medicago shareholders back its takeover bid.
Eli Lilly has extended its collaboration with Immunogen to use its antibody-drug conjugate (ADC) technology for development of a specific antigen target.
Rani Therapeutics announced Wednesday that it has closed its Series B round of funding after pulling in more than $10m from Google Ventures, InCube Ventures and VentureHealth, a healthcare crowdfunding portal.
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.
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.
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.
The global bioseparation systems market is projected to almost double in size from $3.25B in 2012 to $6B in 2018, at a compound annual growth rate of about 11%, according to a recent report on the market.
New flexible vaccine technology could pave the way for pneumococcal, TB and staphylococcus aureus vaccines that are cheaper to produce and more effective.
PharmAthene and Theraclone Sciences announced plans to merge and continue the joint development of monoclonal antibodies (mAbs) and vaccines on the verge of progressing to Phase II and III trials.
Genesis Biopharma has merged with Lion Biotechnologies and says its tumor-infiltrating lymphocyte (TIL) technology can offer higher potency cancer drugs with lower manufacturing costs.
inVentiv Health and Oncobiologics are employing a unique risk-sharing partnership to bring a number of the biggest blockbuster biologics to market as biosimilars.
