Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.
Bayer is investing over €500m ($700m) in manufacturing recombinant factor VIII (rFVIII) products citing growing demand for long-term prophylactic treatment rather than ‘on-demand’ haemophilia drugs.
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.
Proposals in President Obama’s 2015 budget to reduce the market exclusivity period for biologics could save the US $4bn (€2.9bn) but have been labelled unproductive by industry groups.
Proteomics International has agreed to collaborate with inVentiv Health to develop biosimilars and biologics, which will begin with structural and functional characterization.
Big Biopharma has backed passage of Indiana substitution laws that require doctors to grant pharmacists permission to switch a biologic for a biosimilar.
The biosimilar market is expected to ramp up in Asia and Europe, even as it’s yet to be initiated in the US, with AbbVie, Amgen and Roche’s blockbuster biologics the most threatened, Moody's Investors Service says in a new report.
Seattle Genetics has been upgraded to ‘outperform’ by an analyst based on its antibody-drug conjugate (ADC) technology platforms, pipeline and the potential of Adcetris to become a blockbuster.
Antibody-drug conjugates (ADCs) are fully covered by current regulations, the EMA says, though a surge of applications is not expected in the light of Roche’s recent success.
Most EU member states “strongly supported” the idea that biosimilars should be closely aligned with their reference products, according to a summary of the European Commission’s pharmaceutical committee meeting released Monday.
Inflectra has been launched in Central and Eastern Europe (CEE) and, as the world’s first monoclonal antibody biosimilar drug goes from strength-to-strength, has also been approved by Health Canada.
The new Centre for Cell Manufacturing Ireland (CCMI) in Galway means Ireland-based scientists will be able to manufacture culture-expanded stem cells for drug research for the first time.
Industry group BIO has responded to a petition by the Generic Pharmaceutical Association (GPhA) in the latest bout of the debate over the international non-proprietary name (INN) for biosimilars.
Mylan says it will continue to manufacture and sell its Indian version of trastuzumab despite an injunction by Roche restricting reference to it as a biosimilar of Herceptin.
AbbVie has invested $320m (€432m) into its first Asian manufacturing facility and says it will support an emerging antibody-drug conjugate (ADC) pipeline.
BioOutsource says it has quadrupled its revenue from biologics testing and biosimilar characterisation in the last 18 months and is opening a new facility to cope with continued demand.
It is no clearer how the US will govern biosimilar naming, approval and substitution despite a day-long Federal Trade Commission (FTC) workshop that produced heated debate but few concrete answers.
German regulators have approved a 3D manufacturing process that Pluristem Therapeutics claims can produce cell therapies faster and more cheaply than standard methods.
Biologics could be delivered by routes other than injection using nanobodies one tenth the size of an antibody, Ablynx says as it extends its license with Merck & Co.
Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.
The end of Lonza’s biosimilar joint venture with Teva will not affect manufacturing capacity, the firm says, as it reports a drop in overall revenue for 2013.
Biosimilars could save the US healthcare budget a quarter of a trillion dollars, says Hospira who expects to submit its first application to the USFDA within a year.
Biocon has defended criticism of the high price of its Trastuzumab biosimilar which will become the world's first copycat version of Roche’s Herceptin when launched next month.
The evaluation of Genmab’s Duobody platform for the discovery and development of bispecific antibodies strengthens Eli Lilly’s biologics programme, the firm says.
Chinese authorities have given Thermo Fisher Scientific the green light to buy Life Technologies on the condition it discounts certain products sold in the coutry.
Hospira says its biosimilar partnership with Celltrion is secure even if the South Korean manufacturer is acquired as several media reports have speculated.
Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...
AstraZeneca has become the third Big Biopharma to strike a deal with Immunocore to license its Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology.
Good news for stem cell scientists this week with new data indicating that patients support the use of induced pluripotent stem cells (iPSC) in biopharmaceutical research if proper consent is obtained.
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.
Roche has teamed with Molecular Profiles to test if short protein sequences can be used to target conjugated cancer drugs when antibodies prove to large.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
