Ganetespib, a drug that indirectly impairs the function of several cancer-driving proteins, including anaplastic lymphoma kinase, may be an effective new treatment for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer.
Merck announced that the Biologics License Application for its investigational Timothy grass pollen allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration. Merck previously submitted a BLA to the FDA for its investigational ragweed pollen AIT.
Drugmaker Pfizer Inc. said that its new rheumatoid arthritis drug, Xeljanz, has been approved for use in Japan. Xeljanz, known chemically as tofacitinib, is the first approved pill in a new class of medicines called JAK inhibitors. It was approved in the United States in November.
Shire plc is acquiring SARcode Bioscience, and SARcode's Phase 3 compound Lifitegrast—which is being developed for the signs and symptoms of dry eye disease—into Shire’s portfolio. Shire anticipates launching Lifitegrast in the United States as early as 2016.
Boehringer Ingelheim and Eli Lilly and Company announced that a New Drug Application for the investigational sodium glucose co-transporter-2 inhibitor empagliflozin was recently submitted to the U.S. Food and Drug Administration for the treatment of type 2 diabetes mellitus in adults.
Researchers believe they have found exactly how Kalydeco, the first drug to treat the underlying cause of cystic fibrosis, works and how to improve its effectiveness in the future. A key regulatory process in a defective protein could change the way scientists approach the lethal genetic disease.
Baxter has closed its acquisition of a potential hemophilia treatment from Ipsen and Inspiration Biopharmaceuticals in a deal that could be worth more than $180 million. Baxter said in January it agreed to buy the drug, labeled OBI-1, and related manufacturing operations.
Amgen Inc. reported that its innovative melanoma drug, which uses a virus as a Trojan horse to infiltrate and destroy tumors, shrank far more tumors than a standard treatment in a late-stage test. The partial study results show promise for similar vaccines other companies are developing.
Cerecor, a development-stage biotechnology company, said it agreed to acquire potential treatments for Parkinson's disease and other central nervous system disorders from Merck & Co. Cerecor Inc. of Baltimore said it is gaining the worldwide rights to develop and market drugs called COMT inhibitors.
Biotron Limited has announced preliminary results from a human trial of its lead antiviral drug BIT225 to treat HIV infection 'hidden' in reservoir precursor cells. The Phase 1b/2a trial has demonstrated that Biotron's BIT225 targets HIV replication in monocyte cells in treated patients. These cells become infected with HIV and are the seeds of hidden HIV pools in patients.
Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Company announced the initiation of a Phase 3b trial to evaluate the glycemic efficacy and safety of linagliptin in patients with type 2 diabetes with prevalent albuminuria, while remaining on current standard therapy for diabetic nephropathy.
Merck Serono, a division of Merck in Darmstadt, Germany, announced a strategic alliance with Nordic Bioscience Clinical Development A/S on Merck Serono’s investigational drug sprifermin (recombinant human FGF-18) in osteoarthritis (OA) of the knee. This agreement underscores Merck Serono’s commitment to osteoarthritis research and development.
Galena Biopharma Inc. said Monday it acquired the U.S. rights to a fast-acting drug designed to treat severe pain in cancer patients. Galena is acquiring a drug called Abstral from Orexo AB of Sweden. Abstral is a tablet form of fentanyl, a powerful pain drug, and it is designed to dissolve under the tongue within seconds.
A Johnson & Johnson subsidiary is going to South Carolina's Supreme Court later this week to argue why it shouldn't have to pay the state hundreds of millions of dollars for deceptive drug marketing. On Thursday, attorneys for Janssen Pharmaceutica Inc. — a subsidiary of the New Brunswick,...
Merck & Co. said that the U.S. Food and Drug Administration have delayed a decision on whether to approve Bridion, a drug, already rejected once, for helping anesthetized patients "wake up" after surgery. The FDA told Merck it will need an additional three months to review the research data.
Novartis AG said that its experimental cancer drug LDK378 was designated as a breakthrough therapy by the Food and Drug Administration. The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements.
Autism results from abnormal cell communication. Testing a new theory, researchers have used a newly discovered function of an old drug to restore cell communications in a mouse model of autism, reversing symptoms of the devastating disorder.
Acorda Therapeutics Inc. and collaborator Vanderbilt University Medical Center announced data from a Phase 1 clinical trial of glial growth factor 2 designed to study safety, tolerability and exploratory measures of efficacy in people with heart failure who were already on optimized regimens of currently available therapies.
Spectrum Pharmaceuticals said it licensed a potential treatment for multiple myeloma from Ligand Pharmaceuticals. Ligand's drug candidate is a form of melphalan, which is already used to treat multiple myeloma. The new version eliminates ingredients that are reported to cause kidney and heart side effects.
The Food and Drug Administration is looking into new evidence that a group of recently approved diabetes drugs can increase the risk of pancreatitis and other problems. The agency said samples of pancreas tissue taken from a small number of patients showed inflammation of the pancreas and cellular changes that often precede cancer.
Gilead Sciences Inc. announced data from a Phase 4 TERISA study, which demonstrated that the addition of ranolazine to background antianginal therapy in chronic angina patients with type 2 diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy.
The Food and Drug Administration has approved a new imaging drug to help doctors locate lymph nodes in patients with breast cancer and skin cancer. The drug Lymphoseek from Navidea Biopharmaceuticals Inc. is a radioactive imaging agent that is intended to help determine if breast cancer or melanoma has spread to a patient's lymph nodes.
The Food and Drug Administration is warning doctors and patients that a widely used antibiotic from Pfizer can cause rare but deadly heart rhythms in some patients. Doctors should consider prescribing other antibiotics to patients at risk of heart problems.
Merck & Co. announced that a data safety monitoring board recommended that a study of its cholesterol drug Vytorin should continue. The study is meant to determine whether Vytorin reduces the risk of heart attack, stroke, and death in heart disease patients.
Ampio Pharmaceuticals Inc. it is ready to conduct a new clinical trial of its premature ejaculation treatment Zertane. Ampio said the Food and Drug Administration has questionnaire to be used in pivotal trial of Zertane. The study will measure the duration of sex and the patients' responses to the questionnaire.