SteadyMed submits new drug application for Trevyent
Cardiome Pharma Corp. partner SteadyMed Ltd. has submitted a New Drug Application for Trevyent with the U.S. Food and Drug Administration. Read More »
Alexion attains support for Strensiq to address HPP
Pediatric-onset hypophosphatasia, an extremely rare metabolic disease affecting bone structure and strength, came into sharper focus recently when Alexion Pharmaceuticals won funding for its Strensiq medication from two sources via a managed access agreement. Read More »
FDA grants Biohaven's BHV-5000 orphan drug status
New Haven, Connecticut-based Biohaven Pharmaceutical Holding Company Ltd.’s BHV-5000 compound developed to treat Rett syndrome recently attained orphan drug designation from the U.S. Food and Drug Administration (FDA), its fourth product to achieve the status. Read More »
DelMar leaders join brain tumor society's research roundtable
Two DelMar Pharmaceuticals Inc. executives recently accepted requests to join the National Brain Tumor Society's Research Roundtable, attending its premiere meeting in Washington, D.C. to consider ways research can improve clinical trials for regulatory approval. Read More »
GSK reveals 10-year study success with lupus drug
A decade-long study of GSK’s Benlysta — the longest to date — recently culminated with indications of the drug’s safety and efficacy against active systemic lupus erythematosus, when administered with standard care. Read More »
FDA seeks additional details on Egalet’s Oxaydo application
Egalet Corp. of Pennsylvania recently obtained a complete response letter from the U.S. Food and Drug Administration about its Oxaydo tablets in 10 mg and 15 mg dosage strengths. Read More »
DelMar presents info on new cancer-fighting product at pediatric neuro-oncology conference
DelMar Pharmaceuticals recently presented a poster on dianhydrogalactitol at the Society for Neuro-Oncology's 4th Pediatric Neuro-Oncology Basic and Translational Research Conference, which took place at the Wyndham New Yorker Hotel in New York City in June. Read More »
Pfizer study shows Xeljanz on par with Humira for treating rheumatoid arthritis
Pfizer Inc. recently published noninferiority results from its study of Xeljanz, a twice-daily monotherapy to be used in combination with methotrexate in treating patients with moderate to severe rheumatoid arthritis. Read More »
FDA OKs Darzalex immunotherapy for multiple myleoma patients
Janssen Biotech's Darzalex immunotherapy was approved by the U.S. Food and Drug Administration for treating patients with multiple myeloma in combination with pomalidomide and dexamethasone. Read More »
Lexicon releases results from diabetes drug studies
Lexicon Pharmaceuticals Inc. recently presented its two sotagliflozin studies, inTandem1 and inTandem2, at the 77th American Diabetes Association Scientific Sessions in San Diego, California. Read More »
CSL Behring's drug for reducing HAE attacks approved
CSL Behring's Haegarda drug, the only subcutaneous therapy for preventing hereditary angioedema attacks in both adolescents and adults, was approved by the U.S. Food and Drug Administration. Read More »
Ipsen's Dysport approved for expanded use by FDA
Ipsen Biopharmaceuticals Inc., an affiliate of Ipsen SA, has had its Dysport injection for treating spasticity in adults approved for expanded use by the U.S. Food and Drug Administration. Read More »
Advair Diskus application accepted by FDA
Sandoz's Abbreviated New Drug Application for fluticasone propionate/salmeterol combination product, a substitutable generic version of Advair Diskus, was accepted by the U.S. Food and Drug Administration. Read More »
Amgen's Mimpara given position opinion in Europe
Amgen recently announced that its Mimpara drug has been given a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
AbbVie's HCV injection drug Maviret receives positive opinion
AbbVie's chronic hepatitis C virus infection drug, Maviret, was granted a positive opinion by the European Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
Halozyme technology used in newly FDA-approved Genentech drug
Halozyme Therapeutics Inc.'s Genentech’s Rituxan Hycelatm, which uses Halozyme’s hyaluronidase human enhance technology, was approved by the U.S. Food and Drug Administration for subcutaneous injection in multiple blood cancer indications. Read More »
Lannett nets approval for added doses of hydrocodone bitartrate and acetaminophen
Lannett Company Inc. now has access to “the lion's share of the market” for newly approved dosage strengths of its hydrocodone bitartrate and acetaminophen tablets following recent FDA authorization, according to Lannett CEO Arthur Bedrosian. Read More »
Takeda, Biological E offer low-cost vaccine combos for Asia
The rights to vaccine technologies designed to combat measles and pertussis will be transferred to an India-based business following a pair of recent licensing agreements to hasten affordable protection in India, China and additional nations. Read More »
Baxter launches cutting-edge drug order integration with Epic
Introducing an innovative “bi-directional integration” between two existing systems, Baxter International Inc. recently combined its DoseEdge pharmacy workflow management system with the Epic Willow Inpatient Pharmacy System. Read More »
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