An invalidated Remicade patent has paved the way for Pfizer to launch Inflectra in October, but legal battles with J&J are far from over says an IP lawyer.
StemCells Inc has merged with Israeli medical devices firm Microbot Medical three months after terminating a Phase II trial of its HuCNS-SC human neural stem cells.
Lucentis biosimilar developer Formycon saw its share price jump 16% days after Pfizer abandoned efforts to create a rival version of Roche's blockbuster eye drug.
The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
The US FDA has ordered Adaptimmune to halt a trial of its candidate liposarcoma therapy and asked for more information about how the treatment is made.
Highlighting indications approved through extrapolation and manufacturing information in drug labels are attempts to raise doubts over the safety of biosimilars, according to Sandoz.
Alexion has strengthened its Soliris (eculizumab) manufacturing IP and is developing a longer-acting C5 antibody ahead of potential biosimilar competition.
Epirus Biopharmaceuticals has filed for Chapter 7 bankruptcy protection, settled with licensee Livzon Mabpharm and handed its Remicade (infliximab) biosimilar to Reliance Life Sciences (RLS).
The 280,000-square-foot facility will be built in Burlington, Massachusetts and will include a customer collaboration laboratory and training center, in addition to office space.
The EMA has said it will assess Samsung Bioepis’ version of Humira (adalimumab), which is the third biosimilar the (currently) London-based agency has accepted for review.
The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.
A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa.
The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.
The non-proprietary naming debate is “almost a little comical” says Sandoz, which argues a proposed four-letter suffix adds little to aid post-marketing surveillance of biological products.
Amgen confirms it is working on a version of Alexion's drug
Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.
Novartis will continue investing in its manufacturing network to support a biologics pipeline which includes five new biosimilars it expects to launch by 2020.
Brazil’s ANVISA has cleared Cristália Laboratory to make an API for an over-the-counter (OTC) burns treatment at a recently established $40m biomanufacturing facility in Itapira, Sao Paulo.
Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
Biosimilars will capture new patients in the first instance while existing patients will gradually switch over says Pfizer, a developer of both originator biologics and copycats.
The US FDA has updated its draft nonproprietary naming guidance allowing drugmakers to submit up to 10 suffixes for each new biologic and biosimilar product.
Mundipharma has begun the latest phase of its Remsima promotion campaign, unveiling two-year data indicating the infliximab biosimilar is as safe and effective as the originator.
According to the most recent Biopharma CEO Confidence Index, CEOs are shifting their focus back to their pipelines and have plans to increase outsourcing.
