Increased cell and gene therapy production and reduced development timelines are listed among bioprocessing trends predicted over the next five years, says consultant.
Having now secured regulatory approval for all three of its haemophilia A therapies made in Berkeley, Bayer is implementing “organisational changes” across the facility.
Novartis’ experimental marketing strategy, whereby the pharma giant used its scale to insure against failed CAR-T therapies, helped defend Kymriah from competition, says consultant.
Eli Lilly’s migraine treatment was approved by the US FDA, closely following a positive CHMP opinion, and will potentially be made available without cost for the first year.
The California Department of Insurance has sued AbbVie for allegedly providing monetary gifts to health-care providers for prescribing its biologic, Humira.
As the stream of executives flowing from large pharma companies to smaller biotechs builds into a torrent, another month has passed with a number of significant switches. Notably, two former Genentech employees, responsible for work on some of its bestselling...
Regulatory setbacks at Teva’s CMO facility in Korea have not halted the regulatory progression of preventive migraine treatment Ajovy, which has received US FDA approval.
BioPharma-Reporter (BPR) discusses with Jennifer Fox (JF), co-chair of Brinks Gilson & Lione’s biopharma practice group, the provisional detail revealed from the US administration’s proposed trade deal with Mexico, and its potential impact on the...
Major pharmaceutical companies and CMOs in the US have announced emergency contingency plans, including facility closures and the relocation of drug products, as Hurricane Florence approaches southeastern shores.
On the eve of Boston Biotech Week, a report was released by MassBio that claimed 48% of all biotech investment in 2017 was accounted for by Massachusetts-based companies.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.
Preparations for an “unlikely” ‘no deal’ Brexit are underway in the UK, with the government instructing pharmaceutical companies to build their medicine reserves before March 2019.
Cryoport is supporting a record number of clinical trials driven by rapid growth in regenerative medicine – a space that will continue to grow and outpace the pharmaceutical industry, says CCO.
Biotech M&A started off a bang this year and as the first half of the year has drawn to a close, biotech IPOs have reached a number that could see 2018 become a record-breaker.
The US Food and Drug Administration has rejected Regeneron’s eye candidate, Eylea, but the biotech says it expects a final regulatory decision within two months.
A US district court has denied Johnson & Johnson’s motion to dismiss Pfizer’s Inflectra lawsuit, a case claiming anticompetitive practices blocked US uptake of the Remicade biosimilar.
Eusa Pharma has completed the acquisition of global rights for J&J’s Sylvant, shortly after selling its critical care business to Serb Pharmaceuticals.
PTC Therapeutics will acquire Agilis Biotherapeutics to continue work on gene therapy for rare monogenic diseases affecting the central nervous system.
Just days after the release of its Biosimilar Action Plan to encourage generic competition, the US FDA has approved another biosimilar product: Pfizer’s answer to Amgen’s Neupogen, ‘Nivestym’.
