Shares of Zalicus tumbled to an all-time low today after the company said it is ending development of its most advanced experimental drug. The pain drug developer said drug candidate Z160 failed in two mid-stage clinical trials.
Shares of Arena Pharmaceuticals continued to rise today after the company expanded a marketing partnership with Eisai Co. of Japan on its weight-loss drub Belviq.
Shares of Alnylam Pharmaceuticals Inc. rose faster than the broader market today after the drug developer said its potential treatment for a rare, fatal disease received a fast-track designation from U.S. regulators.
The Food and Drug Administration is seeking a rule change to allow generic drugmakers to quickly update their warning labels with new safety information for doctors and patients.
Pharmaceutical company Novartis says it is selling part of its diagnostics business to the Spanish health care company Grifols for $1.68 billion. The deal requires customary regulatory approvals but is expected to be completed in the first half of 2014.
Breast cancers that initially respond to hormone therapies such as tamoxifen eventually become resistant to treatment, and a new study finds this may be because of a mutation in the receptor present in the cancer cell to which tamoxifen binds.
Sunovion Pharmaceuticals Inc. today announced that the U.S. FDA approved Aptiom (eslicarbazepine acetate), an antiepileptic drug (AED), for use as adjunctive treatment of partial-onset seizures. So what will Aptiom offer people with partial-onset seizures? Find out...
Genentech, a member of the Roche Group, announced new, positive data from the second stage of the CLL11 study. This Phase 3 study compared Gazyva in combination with chlorambucil to Rituxan in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL). People treated in the Gazyva arm lived nearly a year longer without their disease worsening.
As part of its “One Shire” program, Shire announced that it has initiated an employee consultation process at its site in Basingstoke as the company looks to to discontinue a number of research programs in the attempt to strengthen its rare disease pipeline.
Bayer HealthCare has submitted an application for marketing authorization of VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME) to the European Medicines Agency (EMA).
Boehringer Ingelheim and Eli Lilly and Co. announce new data that reinforce the efficacy and tolerability of linagliptin in people with Type 2 Diabetes (T2D) and liver disease, as well as Asian people with T2D aged 65 years or older.
Forest Laboratories Inc. and Forest Laboratories Holdings Ltd. announced today that they have entered into a settlement agreement with Actavis Inc. in patent infringement litigation brought by Forest in response to Actavis’s abbreviated new drug application seeking approval to market generic versions of Bystolic tablets.
Emergent BioSolutions Inc. presented preclinical data on its lead bispecific Adaptir therapeutic, ES414, at the 5th Annual Protein and Antibody Engineering Summit (PEGS) in Lisbon, Portugal. Why is the preclinical data on this drug so encouraging? Find out...
Aeterna Zentaris Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ghrelin agonist, macimorelin acetate (AEZS-130).
Testosterone treatments may increase risks for heart attacks, strokes and death in older men with low hormone levels and other health problems, a big Veterans Affairs study suggests.
Keryx Biopharmaceuticals said Zerenex worked better than a placebo in a mid-stage study that involved patients with chronic kidney disease who weren't on dialysis. The drug is designed to treat hyperphosphatemia, or elevated levels of phosphates, in patients with chronic kidney disease. So when is FDA approval expected? Find out...
Immunocore Limited announced that its most advanced ImmTAC drug, IMCgp100 for the treatment of late stage melanoma, has reached Maximum Tolerated Dose (MTD) and the dose escalation part of this phase 1 clinical study has been completed. How are melanoma cancer cells killed by T cells when activated by the drug? Watch now...
Shire plc has announced positive top-line results from two identically designed randomized placebo-controlled phase 3 studies evaluating the efficacy and safety of Vyvanse Capsules (CII) versus placebo in adults with binge eating disorder (BED). So when will the company submit an application to the U.S. FDA? Find out...
The generic drug gabapentin, which is already widely prescribed for epilepsy and some kinds of pain, appears to be safe and effective in the treatment of alcohol dependence. The finding comes from a 150-patient randomized, placebo-controlled, double blind clinical trial.
Endo Health is buying the Canadian specialty drug maker Paladin Labs for about $1.5 billion, and both will then be folded into a newly-formed Irish holding company.
Merck’s experimental cancer drug MK-3475, which has already shown promise in the treatment of melanoma, might also be an effective treatment for non-small cell lung cancer. So what did the analysis of the data on safety and activity from a cohort of 38 patients with non-small cell lung cancer discover? Find out...
Gilead's new drug therapies continue to show promise for some hepatitis C sufferers whose transplanted livers are threatened by a recurrence of the disease, including some patients who have had no treatment options. So what did researchers find in two new studies on sofosbuvir? Find out...
Fifty years after it was first discovered, research reports how valproate, one of the world’s most highly prescribed treatments for epilepsy, works to block seizure progression.
Biotie today announced that its partner H.Lundbeck A/S has expanded its existing alliance with Otsuka Pharmaceutical Co. Ltd. to include development and commercialization of nalmefene, a treatment for the reduction of alcohol consumption, in Japan.
AstraZeneca announced that the United States Court of Appeals for the Federal Circuit has reversed and remanded for further proceedings a trial court decision that generic defendants involved in the litigation do not infringe a patent protecting Pulmicort Respules in the United States.