Amgen and Allergan submit biosimilar candidate for Herceptin
Amgen and Allergan submitted a Biologics License Application for ABP 980, a biosimilar candidate to Herceptin, to the U.S. Food and Drug Administration. Read More »
Pharmacy Times ranks highest for ad visibility and readership
Pharmacy Times, the leading media resource for pharmacists and the pharmacy industry, ranked highest in ad visibility and highest in readership in the 2017 Kantar Media Pharmacy Readership study. Read More »
Neovac moves forward with dermatomyositis treatment
Neovacs, a company focusing on immunotherapies that treat autoimmune diseases, recently announced its Investigation New Drug application for IFNalpha Kinoid was cleared by the U.S. Food and Drug Administration. Read More »
Collaborative drug for AML gains FDA approval
Celgene Corp. and Agios Pharmaceuticals Inc. recently received U.S. Food and Drug Administration approval for IDHIFA as a treatment for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. Read More »
Spectrum Pharmaceuticals completes enrollment for Rolontis study
Spectrum Pharmaceuticals Inc., a biotechnology company focusing on hematology and oncology, recently completed enrollment for its Rolontis Phase 3 Advance pivotal study. Read More »
Vertex nets FDA approval for Kalydeco to treat cystic fibrosis
Following successful clinical results, Vertex Pharmaceuticals Inc. recently gained approval from the U.S. Food and Drug Administration (FDA) to treat more than 600 cystic fibrosis (CF) patients with its proprietary Kalydeco (ivacaftor) product. Read More »
Dexrazoxane from Cumberland Pharmaceuticals approved for U.S. oncology patients
Cumberland Pharmaceuticals, specializing in therapies for underserved populations, has begun shipping its Totect brand of dexrazoxane, for alleviating certain side effects of chemotherapy during cancer treatment, to U.S. wholesalers. Read More »
Zoetis acquires Nexvet Biopharma for pet pain management products
Animal health specialist firm Zoetis of Parsippany, New Jersey recently completed an approximately $85 million acquisition of Irish biologic therapeutics business Nexvet Biopharma PLC, with the deal expected to boost the company’s market share. Read More »
Bracco obtains FDA approval for Varibar Nectar Oral Suspension
To better assess patients’ oral and pharyngeal functioning for the purpose of easing swallowing disorders, the U.S. Food and Drug Administration recently approved Bracco Diagnostics Inc.’s Varibar Nectar (barium sulfate) Oral Suspension. Read More »
Spectrum Pharmacy Products and IPA form partnership
Spectrum Pharmacy Products, a top manufacturer and distributor of pharmaceutical chemicals and supplies, is partnering with the Independent Pharmacy Alliance (IPA), a retail pharmacy and trade group that represents thousands of pharmacies in the Northeastern U.S., PR Newswire reported. Read More »
Parexel leaders named to 2017 PharmaVOICE's 100 inspiring people
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 »
Immunalysis’ Sefria earns FDA approval for opioid screening
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 »
Silvergate delivers FDA-approved oral med Xatmep for children
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 »
Innovus Pharma seeks to release hemorrhoid pain relief cream in Canada
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 »
LabCorp to acquire Chiltern in $1.2 billion cash deal
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 »
Insys Therapeutics rolls out ‘milestone’ Syndros formula
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 »
FDA plans to curb tobacco deaths with new regulation
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 »
Eagle Pharmaceuticals receives FDA reply for Ryanodex
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 »
Biologics named limited distributor of Nerlynx
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 »
Teligent's topical erythromycin gel receives FDA approval
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 »
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