• Molecular Partners AG, of Zurich, Swizterland, said results from a Phase I/II study published in the American Journal of Ophthalmology showed that MP0112, a long-acting anti-VEGF DARPin, was found to be safe in patients with diabetic macular edema and showed suppression of VEGF-A concentrations in aqueous humor after a single intraocular injection, with a pharmacokinetic half-life of about two weeks.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has had another Glybera moment, turning down the rare disease drug Raxone (idebenone) by a narrow majority, despite the rapporteurs on an expert committee recommending approval of the drug, which treats a hereditary cause of blindness.
LONDON – Mesoblast Ltd. is preparing to discuss plans for Phase III development with regulators and weighing the partnering strategy after reporting positive Phase II results for its Neofuse cell therapy for treating degenerative disc disease by lumber spinal fusion.
LONDON – An unexpected finding about how tadpoles control the regeneration of a tail that has been lost will trigger new research into healing and regeneration of wounds and tissues in humans.
The plan to introduce value-based pricing of drugs in the UK in January 2014 lacks clarity, with the arrangements for the new system still not agreed on and companies that will have to work with the new arrangements uncertain about what they will mean in practice.
With an established reputation for its generic drugs, Mumbai, India-based Lupin Ltd. has expanded into biosimilars in its quest to become a global biopharma powerhouse. But like the foggy view from the 32nd-floor penthouse location of the Asia track at the J.P. Morgan Healthcare Conference last week, the firm's chief financial officer provided limited insight into the company's biosimilars strategy despite audience questions.
• MorphoSys AG, of Martinsried, Germany, said it completed the sale of research and diagnostic antibody division AbD Serotec to Bio-Rad Laboratories Inc., of Hercules, Calif., for about $70 million in cash.
Although Galapagos NV is best known for its whopper of an alliance with AbbVie Inc. for its JAK inhibitor, GLPG0634, the company's rapidly growing drug discovery services business is set to expand further in 2013, following the acquisition of Cangenix Ltd., a UK-based specialist in structure-based discovery, and the establishment of its Fidelta unit in Croatia as an externally focused services arm.
Undeterred by the recent string of high-profile failures in the field, Kareus Therapeutics SA moved its first-in-class drug candidate for Alzheimer's disease, KU-046, into a Phase I trial in healthy volunteers.
arGEN-X BV is making strides in the commercialization of its antibody platform, announcing an extension of its existing collaboration with Shire plc in rare diseases and at the same time advancing the lead in-house program into a Phase Ib first-in-man trial.