American Pharmacy News Reports Stories

Gilead first received regulatory approval for Epclusa in June 2016.

Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration. Read More »

Biothera Pharmaceuticals begins patient dosing for cancer study

The trial brings together a promising combination approach that may increase patient responses to Keytruda.

Biothera Pharmaceuticals Inc. recently announced that the patient dosing has begun in a Phase 1b/2 clinical study at the Big Ten Cancer Research Consortium to evaluate Biothera’s Imprime PGG in combination with the Merck anti-PD-1 therapy, Keytruda (pembrolizumab), in second-line non-small cell lung cancer. Read More »

Cidara Therapeutics publishes data from study of echinocandin as IAC treatment

Cidara undertook the study in part because of the current treatments’ 40 percent failure rate.

Cidara Therapeutics Inc., a biotechnology company with a focus on developing anti-infective immunotherapies, recently published data from a study analyzing its next-generation echinocandin agent as a comparison to the treatment for intra-abdominal candidiasis. Read More »

Thermo Fisher Scientific's new opioid treatment gains 501(k) clearance

Mark Iandolo | Aug 11, 2017

Buprenorphine can be a more practical and often more effective alternative to methadone in treating opioid addiction.

Thermo Fisher Scientific recently received U.S. Food and Drug Administation 510(k) clearance for the company’s new immunoassay for the specific detection of buprenorphine and its three major metabolites. Read More »

Novartis reports positive 5-year efficacy data from Cosentyx study

Cosentyx works by specifically inhibiting the IL-17A cytokine that plays a role in driving inflammation.

Novartis, an immunology and dermatology company, recently reported positive five-year efficacy and safety results for Cosentyx after completing a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis. Read More »

Amgen and Allergan submit biosimilar candidate for Herceptin

Allergan and Amgen are collaborating on four oncology biosimilars.

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’ departments work together to deliver content on the evolving pharmacy industry.

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

The trial will examine the immunogenicity, tolerability and biological and clinical efficacy of IFNalpha Kinoid.

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

$IDHIFA is a treatment for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.$

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

CEO Rajesh Shrotriya said the drug can change the company’s growth timeline.

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

Kalydeco is administered orally in 150 mg tablet doses for patients age 6 years and older.

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

Totect is approved by the U.S. Food and Drug Administration as an oncology intervention.

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

Zoetis’ product line features chronic pain management meds for dogs and cats.

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

Viscosity, important in modified barium swallow exams, was designed to provide tolerable texture and taste.

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 will offer IPA members some of the broadest selection of compounding chemicals in the industry.

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

Dr. Sy Pretorius has worked at Parexel for over two decades in global managerial roles.

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

Until now, immunoassay tests for fentanyl were restricted to forensic use.

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

For leukemia patients, the medication is meant to be taken in combination with chemotherapy.

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