Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, recently announced that its Toca 511 was awarded PRIME designation by the European Medicines Agency for treating high grade glioma patients. Read More »
Accord Healthcare has acquired Essential Pharmaceuticals, a New Jersey company that provides products, services and contributions to transplant medicine. Read More »
New Jersey-based Merck recently introduced Renflexis (infliximab-abda) in the United States as a biosimilar of Remicade (infliximab) following its FDA approval last April for all eligible indications. Read More »
Lexicon Pharmaceuticals Inc.'s Xermelo, a carcinoid syndrome diarrhea treatment created in collaboration with Ipsen, has been given a positive opinion for Marketing Authorization Application by the Committee for Medicinal Products for Human Use, the committee of the European Medicines Agency responsible for human medicines. Read More »
Thermo Fisher Scientific Inc. recently announced the availability of a fully integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). Read More »
Eisai Inc.'s supplemental New Drug Application for Fycompa CIII has been accepted by the U.S. Food and Drug Administration. Read More »
Pfizer Inc. recently announced positive results for its Reflections B7391003 study, which evaluated the safety and efficacy of PF-06439535 as compared to Avastin (bevacizumab). Read More »
Because acute myeloid leukemia (AML) impacts relatively few individuals nationwide, gilteritinib — an anti-cancer medication developed by Tokyo-based Astellas Pharma Inc. — recently attained orphan-drug designation from the U.S. Food and Drug Administration. Read More »
EnvisionRx, a pharmacy benefit manager (PBM) and division of EnvisionRxOptions, a wholly owned subsidiary of Rite Aid Corporation, recently announced that the health care accrediting organization URAC renewed the company’s accreditation for pharmacy benefit management. Read More »
Vizient Inc. recently released its July 2017 Drug Price Forecast, which provides pharmacy leaders and health system executives with insights on pricing and practice changes throughout the pharmaceutical industry. Read More »
New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin Topical Gel USP, 2%. Read More »
Los Angeles-based Puma Biotechnology Inc.’s FDA-approved Nerlynx (neratinib) tablets — a kinase inhibitor developed to treat breast cancer — will be circulated by Cary, North Carolina’s Biologics Inc. as per a limited distribution agreement between the companies. Read More »
In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration (FDA) recently issued a Complete Response Letter. Read More »
The U.S. Food and Drug Administration is creating new regulation on tobacco and nicotine to reduce diseases and death brought on by tobacco use. Read More »
Phoenix-based Insys Therapeutics Inc. recently revealed that its new branded liquid formulation Syndros (dronabinol oral solution) is on the market to address side effects of AIDS and chemotherapy such as weight loss and related symptoms. Read More »
LabCorp, a provider of diagnostic solutions and breakthrough medicines, recently announced plans for its all-cash acquisition of international contract research firm Chiltern of England for approximately $1.2 billion, enhancing LabCorp’s portfolio and capabilities. Read More »
Innovus Pharmaceuticals Inc., an expanding commercial-stage medication company that provides over-the-counter products for both men and women, will be filing a product licence application in Canada for its drug, Xyralid. Read More »
Filling a need for those youngsters who fear needles or find pills unmanageable, Denver-based Silvergate Pharmaceuticals Inc. recently released Xatmep, the first methotrexate oral solution to gain approval from the U.S. Food and Drug Administration. Read More »
Formulated to detect the presence of the potent opioid fentany in urine, California-based Immunalysis Corp.’s branded immunoassay Sefria — the first of its kind — recently achieved 510(k) clearance from the U.S. Food and Drug Administration. Read More »
Boston-based biopharmaceutical firm Parexel International Corp. has had two of its leaders earn a place on PharmaVOICE magazine’s annual list of the life science industry’s top 100 “inspiring people” for their overall industry contribution and highest level of commitment. Read More »
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