The European Commission has angered the biopharma industry by proposing to relax the rules detailing when companies can manufacture biosimilars and generics in the region.
TapImmune would consider a partnership deal with a major pharmaceutical firm in a non-Caucasian country, such as Japan or China, if “very compelling” from a financial standpoint, says CEO.
The US Department of Justice has filed a lawsuit to stop US Stem Cell Clinic from performing autologous stem cell procedures at the request of the US Food and Drug Administration (FDA).
Merck & Co. and Roche have ceased enrolment in separate clinical studies trialling Keytruda and Tecentriq as single therapies, due to a lower rate of survival in patients.
The FDA has approved Pfizer’s Retacrit, a biosimilar alternative to Amgen’s Epogen and J&J’s Procrit, which the company will price at a "significant discount."
Agilent's 15,000-square-foot expansion will increase its capacity to meet a growing demand for next-generation sequencing products from its genomics group.
Roche’s immunotherapy combination has received priority review after Phase III trial results showed potential to provide significant survival benefit in the initial treatment of NSCLC.
Novartis has scored a second US FDA approval for CAR T-cell therapy Kymriah, indicated to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma.
Johnson & Johnson has reported plans to cut costs across its supply chain as it looks to shifts focus from “older parts” of its portfolio to newer technologies and capabilities, such as in biologics, says CFO.
There is a lack of third-party capabilities in the autologous cell therapy space says the new editor of PharmSource ahead of this year’s Interphex Convention.
The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.
Mundipharma says it is not concerned at arriving second to market with a trastuzumab biosimilar after inking a deal to commercialise Celltrion’s Herzuma in seven European countries.
Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.
Patient advocacy groups have called on Congress to address patient safety concerns in oversight hearings, following an influx of US FDA biosimilar drug approvals.
Celgene will add chimeric antigen receptor (CAR) and T-cell receptor (TCR) technologies through the acquisition of its immune-oncology partner Juno Therapeutics.