Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
The UK beats Finland for business opportunities according to the CEO of microbial growth system developer BioSilta, who said moving the firm to St. Ives, Cambridgeshire has improved its access to larger markets.
Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.
Eli Lilly’ manufacturing network will give it the edge in the glargine insulin market, the firm says having received tentative approval of its “Lantus look-alike” from the USFDA.
Personalized immunotherapy developer Argos Therapeutics has broken ground on a new 100,000 square-foot biomanufacturing facility in Durham, North Carolina.
The products, unveiled at BioProcess International in Boston this week, will help industry with their upstream and downstream processing and include an anti-CHO host cell protein detection kit, the first single-use fermentor, and a new mammalian expression...
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.
Close relationships between vendors and biomanufacturers are critical according to Sartorius, which was been awarded an accolade for the design of WuXi AppTec’s biologics production facility in China.
As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.
Biopharmas struggle to comply with GMP requirements for personalised meds and the outstanding questions mean some are reluctant to invest according to German firm immatics.
Amgen is reviewing data from chronic kidney disease (CKD) patients to assess what impact switching to a 'biosimilar' version of its blood cell booster Aranesp (Darbepoetin Alfa) has had on their disease.
Ramesses II didn't need Enbrel, Remicade, Humira or any other TNFα blocker according to a study that rejects the idea the pharaoh was plagued, all puns intended, by ankylosing spondylitis.
An Eli Lilly small molecule plant in Puerto Rico has been earmarked for closure as the company shifts its focus towards its insulin and biologics pipeline.
Increased efficiency, local manufacturing and specialty products are driving demand for smaller more flexible facilities, according to bioprocessing consultant Howard Levine.
MedImmune’s neurodegenerative disease partnership with the University of Cambridge is about working with “great scientists with great brains” according to a spokeswoman for parent company, AstraZeneca.
Despite a $17bn bid from Merck KGaA, it’s “business as usual” at Sigma-Aldrich which has signed a distribution agreement with reagent-based microbial growth systems firm BioSilta.
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
Fujifilm has launched a mammalian cell line it says can deliver titers up to 3g/L before subsequent optimisation and will complement its microbial-based 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.
US academics have licensed a mobile clean room design from Xoma for a vaccine and medical countermeasure plant being built in Texas as part of an HHS-funded project.
Baxter International plans to set up a new global R&D center in Cambridge, Mass, for Baxalta, its biopharmaceuticals spinoff, which is expected be formally incorporated next year and headquartered in northern Illinois.
The EGA has called for more awareness surrounding the uptake of biosimilars in Europe after a report has shown upcoming products could cut healthcare provider spending by a quarter.
Nova’s vaccine stabilisation device, which enables vaccines to be dried and stabilized across a wide range of temperatures, has been awarded a US patent, though one researcher questions the utility of the device.
Development of continuous fermentation has been driven by the increased production of monoclonal antibodies says GEA, with Asia-Pacific the new growth driver for such technologies.
Chief among the potential drivers for the world’s biosimilar market is establishing a market in the US, which continues to stall, according to a new report.
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.