Actavis plc, of Singapore, opened a new regional office in Singapore to serve as the headquarters for the company’s Asia Pacific and Africa region. Read More
Dompe Group, of Milan, said it started a phase Ib/II study to assess the safety and potential efficacy of recombinant human nerve growth factor (rhNGF) eye drops in two doses vs. placebo. Read More
Gilead Sciences Inc., of Foster City Calif., said positive top-line results from a phase III trial evaluating Sovaldi (sofosbuvir) in combination with ribavirin for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection in Japan put it on track for a midyear filing with the Japanese Pharmaceutical and Medical Devices Agency. Read More
Foundation Medicine Inc., of Cambridge, Mass., and Clovis Oncology Inc., of Boulder, Colo., said they expanded their ongoing collaboration to incorporate a coordinated regulatory strategy for the development of a premarket approval companion diagnostic test, designed for use by physicians to identify patients most likely to respond to rucaparib, Clovis’ poly (ADP-ribose) polymerase inhibitor. Read More
Otologic Pharmaceutics Inc.’s $4.1 million in series A funding will help the Oklahoma City-based firm start a phase I trial this year with NHPN-1010, an oral combo therapy designed to reverse noise-induced hearing loss. Read More
In the midst of escalating criticism about its approval of Zohydro ER (hydrocodone), the FDA approved Kaleo Inc.’s Evzio (naloxone autoinjector) to rapidly reverse an opioid overdose. Read More
Tigenix NV has thrown in the towel on its efforts to obtain broad reimbursement in Europe for its Chondrocelect autologous cell therapy for regenerating cartilage in the knee and has signed over marketing and distribution rights to Swedish Orphan Biovitrum AB (Sobi) in return for double-digit sales royalties. Read More
Researchers have identified a biochemical pathway that destabilizes spines in knock-in mice bearing a protein linked to some cases of familial Alzheimer’s disease (AD). The work suggests a novel therapeutic approach to AD and age-related memory loss that is independent of the amyloid-beta processing approaches at the oft-broken heart of current drug trials. Read More
LONDON – Abbvie Inc. has withdrawn the legal case it took out to prevent the EMA from publishing the clinical study reports relating to its anti-TNF alpha drug, Humira (adalimumab), after the agency accepted a new set of redacted documents and agreed with the company’s rationale for removing certain commercially confidential information from the reports at the center of the litigation. Read More
