The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.
Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.
The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.
Roche is confident its biologics pipeline and plan to reformulate some of its top selling monoclonal antibodies can offset sales erosion resulting from biosimilar competition.
Pfizer dropped the US price of Inflectra, its version of Johnson & Johnson's Remicade, just weeks before Merck & Co. launched its infliximab biosimilar, Renflexis.
Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.
Regulators have granted CureVac a European patent for its mRNA vaccine and anti-PD-1 antibody technology designed to prevent and treat cancers and infectious diseases.
GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.
Following months of importation restrictions, Proliant Biologicals has announced it is eligible to export bovine serum albumin (BSA) from its Feilding, New Zealand-based facility to China.
Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation
Emergent BioSolutions will pay up to $125m (€108m) for Sanofi’s smallpox vaccine ACAM2000 in a deal that includes a plant and 10-year supply contract with the US Government.
Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.
An increase of quality, process control and specification issues contributed to a rise in reported vaccine manufacturing deviations last year, a US FDA report finds.
Lonza expects to complete its $5.5bn (€5.2bn) takeover of Capsugel SA in the next few days having secured approval from competition authorities around the world.
Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
ImmunoCellular Therapeutics Ltd has halted a Phase III trial of its brain cancer cell therapy ICT-107 due to a lack of funds and is looking for a buyer or partner for the programme.
Seattle Genetics announced it has discontinued its Phase III Cascade trial of Vadastuximab Talirine (SGN-CD33A) for the treatment of frontline acute myeloid leukaemia (AML), due to patient deaths.
Merck & Co has halted two Phase III studies examining its drug Keytruda (pembrolizumab) in combination with other therapies after reports of patient deaths.
CEO Ken Frazier has told investors investments and partnerships, such as collaboration with messenger RNA firm Moderna Therapeutics, have bolstered Merck & Co.’s vaccine division.
Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.
Swiss-headquartered Novartis Pharmaceuticals plans to add 40 positions to its manufacturing facility in Morris Plains, New Jersey, to focus on cell therapies.
An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.
Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.
Novartis will add around 350 Swiss jobs to support its innovative biologics pipeline as it looks to cut 500 more “traditional” development and manufacturing roles.
Thermo Fisher says Patheon will become the most competitive biologics CDMO in the market through direct access to its bioprocessing technologies and capabalities.
Long life-cycles and significant consolidation in the manufacturing space have led to a lack of skilled workers in the vaccine space, says Sanofi Pasteur.
Eli Lilly has confirmed it will build a three-story biomanufacturing facility at its site in Kinsale three months after rumours the project had been put on hold.
The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.
Biologics contracting drove growth in fiscal Q3 according to Catalent, which predicted the proportion of revenue it generates from large molecule work will continue to increase.
