Rituxan receives breakthrough status from FDA
Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration. Read More »
FDA approves Symproic once-daily tablets to treat OIC
Shionogi Inc. and Purdue Pharma L.P.'s Symproic 0.2 mg tablets C-II have been approved by the U.S. Food and Drug Administration for use as a once-daily oral peripherally-acting mu-opioid receptor antagonist medication in treating opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Read More »
Phase 3 trials for sarecycline meet primary endpoints
Allergan PLC and Parateks Pharmaceuticals' Phase 3 trials of sarecycline met their 12-week primary efficacy endpoints. Read More »
Bavencio treatment for Merkel cell carcinoma patients gains FDA approval
EMD Serano, the biopharmaceutical business of Merck KGaA, and Pfizer Inc. recently received approval from the U.S. Food and Drug Administration to market Bavencio Injection 20 mg/mL for intravenous use. Read More »
Auryxia by Keryx has been picked up by nation's largest Medicare Part D sponsor
Keryx Pharmaceuticals Inc.'s largest Medicare Part D plan sponsor in the United States has added the company’s Auryxia drug to its Medicare Part D plan formularies. Read More »
CVS Health to bring Pharmacists Teach program to Pittsburgh public schools
CVS Health recently announced a partnership with the University of Pittsburgh School of Pharmacy and the Pittsburgh Public Schools that will showcase the company’s Pharmacists Teach prescription drug prevention program to public school students with the help of student pharmacists from the university. Read More »
FDA fast-tracks Shire's SHP655 for patients with ADAMTS13
Shire PLC's recombinant ADAMTS13 drug, SHP655, has been given fast-track designation by the U.S. Food and Drug Administration. Read More »
Study shows Repatha can reduce chances of heart attacks and strokes
Based on 27,564 patient cardiovascular outcomes study, Amgen has established that maximally reducing low-density lipoprotein cholesterol levels with Repatha leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations. Read More »
Allergan to sell FDA-approved Restasis in first multi-dose bottle
Restasis MultiDose will now be available and approved by the U.S. Food and Drug Administration for help treating patients with a type of Chronic Dry Eye by helping them make more of their own tears. Read More »
Data analysis shows Eliquis leads to fewer strokes than warfarin
Bristol-Myers Squibb Company and Pfizer Inc. recently announced findings from a real-world data analysis of the U.S. Medicare database that compares risk of stroke or systemic embolism and rate of major bleeding among patients with non-valvular atrial fibrillation who were treated with direct oral anticoagulants versus warfarin. Read More »
Allergan's Juvéderm Vollure XC approved for sale in the U.S.
The U.S. Food and Drug Administration has approved Allergan PLC’s Juvéderm Vollure XC for use correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21. Read More »
FDA tentatively OKs Mylan's HIV/AIDS drug for developing nations
Mylan N.V., a global pharmaceutical company, recently announced the U.S. Food and Drug Administration (FDA) tentatively approved the company's New Drug Application for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg ("TLE400"). Read More »
CVS Health launches Reduced RX discount program with Novo Nordisk
CVS Health has launched a prescription savings program called Reduced RX that will provide various discounts for certain medications through CVS Caremark directly to patients. Read More »
Amgen receives European approval to market Amgevita
Amgen recently announced that the European Commission (EC) granted the company authorization to bring to market Amgevita in all available indications. Read More »
Teva launches authorized generic of Minastrin 24 Fe as oral contraceptive
Teva Pharmaceuticals Industries Ltd. has launched its authorized generic of Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) 1 mg/20 mcg in the U.S. Read More »
Rxight genetic testing panel can help ADHD patients assess prescription drugs
MD Labs, the makers of the Rxight genetic testing panel, recently announced that the U.S. Food and Drug Administration warns that ADHD medications can cause adverse psychiatric effects and that the Rxight genetic testing can help patients better assess prescription drugs. Read More »
DEA rule would classify Syndros drug as controlled substance
An interim final rule introduced by the Drug Enforcement Agency would result in Insys Therapeutics Inc.'s Syndros product being placed in Schedule II of the Controlled Substances Act. Read More »
Alkermes to launch Phase 3 study for ALKS 8700
Alkermes PLC has launched a Phase 3 study for its product ALKS 8700 – a novel, oral monomethyl fumarate drug in development that will be used for patients with relapsing forms of multiple sclerosis. Read More »
Majority of PCSK9 inhibitor prescription claims initially rejected
Amgen's data from two studies shows that for appropriate patients in the United States, the majority of prescription claims for PCSK9 inhibitors, such as Repatha (evolocumab), were initially rejected. Read More »
McKesson's oncology pharmacy to provide KISQALI
Biologics Inc., an oncology pharmacy services company owned by McKesson Specialty Health, was selected by Novartis to be a specialty pharmacy provider for KISQALI (ribociclib). Read More »
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