Merck KGaA and Pfizer have bagged FDA breakthrough therapy designation for avelumab, the pair's anti-PD-L1 monoclonal antibody. And while the immunotherapy is lagging behind rivals' PD-1 and PD-L1 drugs in some indications, Merck KGaA and Pfizer think the breakthrough status could help them steal a lead in metastatic Merkel cell carcinoma.
Partners Merck KGaA and Pfizer are looking to prove their 5th-place immuno-oncology treatment can contend with the leaders in the field, launching a late-stage lung cancer study to establish the antibody's promise.
Merck KGaA has teamed up with Selvita to discover small molecule drugs against multiple oncology indications. The alliance builds on an earlier two-year research collaboration into the discovery of enzyme inhibitors to regulate metabolic processes in cancer cells.
Merck KGaA, long troubled by pipeline setbacks, said it's back on track thanks to some high-profile partnerships and a particular focus on immuno-oncology.
Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.
Merck KGaA is bringing cladribine--the multiple sclerosis pill scuttled by regulatory rejections on both sides of the Atlantic four years ago--back from the dead.
Scientists in Scotland have been grabbing headlines with news that their preclinical research into an experimental single-dose antimalaria compound has shown real promise, spurring Merck KGaA to pick up the development and commercialization rights.
Merck KGaA, long plagued by clinical setbacks, is pushing into Phase III with a Pfizer-partnered cancer treatment, believing it can eventually catch up with rivals already on the market.
Four months after Pfizer stepped up with a $2.85 billion promise to partner with Merck KGaA on a preclinical PD-L1 oncology effort, the German pharma company has turned around to partner with Intrexon on an upstart CAR-T cancer drug development project.
After gaining an option on Opexa's experimental drug for secondary progressive multiple sclerosis for only $5 million, Merck KGaA's Serono division has come up with an extra $3 million to support the biotech's ongoing Phase IIb study.