Category:

At least three reviewers recommended against Addyi (flibanserin) approval..They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarized the analysis within the U.S. regulatory agency… One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men… FDA had rejected the drug,…in 2010 and 2013 before approving it in August...

Food and Drug Administration…have expressed concerns over likely errors in administering Purdue Pharma's fast-acting oxycodone…(Avridi) that could result in inadequate relief…The drug is designed to be taken every 4-6 hours on an empty stomach…absorption…can be substantially delayed in the presence of food,.. "food effect" may reduce the effectiveness and safety of the drug,.. Inadequate pain control caused by presence of food could lead to overdosing…

Treatment has complementary actions that help control blood glucose. A new type 2 diabetes treatment for adult patients, empagliflozin and metformin (Synjardy), was approved by the FDA…(from Boehringer Ingelheim and Eli Lilly)… is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. The 2 medicines…have complementary actions that help control blood glucose,…Empagliflozin removes excess glucose through urine by blocking glucose reabsorption in the kidney, while metformin lowers glucose production by the liver and absorption in the intestine,…

Female libido drug Addyi from Sprout stirred up its fair share of controversy last week with its FDA green light, which came despite serious potential side effects such as severe drowsiness, nausea and dizziness. But if it can succeed despite those side effect worries, it certainly wouldn't be the first drug to do so......Advair, Fosamax, Epogen, Gilenya, Tecfidera

FDA has approved aspirin extended-release capsules (Durlaza)for the prevention of stroke and acute cardiac events…is the first, and only 24-hour, extended-release aspirin capsule…allows prolonged absorption and sustained platelet exposure to aspirin…indicated to reduce the risk of death and myocardial infarction in patient with chronic coronary artery disease,...

Biologic therapy targets genetic defects found in various cancers… FDA granted Orphan Drug Designation to MTG-201 (MTG Biotherapeutics Inc.) for the treatment malignant mesothelioma…drug targets the Dickkopf-3 genetic defect found in various cancers…There is a…need for new treatment options for…mesothelioma…one of the most aggressive and poorly treated cancers. MTG-201 represents a…novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer..

Amgen has won federal approval for the second medicine in a new class of pricey biotech drugs that reduce artery-clogging cholesterol more than older statin drugs that have been used for decades…Repatha (evolocumab) could eventually help millions of Americans who face increased risks of heart disease because they cannot control their cholesterol with existing drugs and methods. .. medication's price tag—$14,100 per year

—patients with extremely high levels of LDL, or bad cholesterol, due to inherited conditions

—patients with persistently high LDL levels and a history of heart attack, stroke and other cardiovascular problems

….designed to be self-injected on a monthly or bi-monthly dosing schedule.

Smart medicines that tell doctors when their patients have taken them moved a step closer to reality after a company developing the first "digital pill" had its drug application accepted…the pill, produced by Proteus Digital Health, will help ensure patients stick to their prescriptions…Food and Drug Administration had agreed to review its device which is embedded in a schizophrenia medicine (aripiprazole)…new regulatory pathway that allows the pharmaceuticals industry to combine its medical innovation with innovation in software.."smart pill" contains a tiny ingestible sensor that detects when the drug has reached the stomach…It communicates with a wearable patch…then transmits the information to a mobile device.

Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved,..should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside. Food and Drug Administration rulings can make or break these companies…. big FDA decisions coming up on the calendar for the month of September..

1. Opko Health - expecting a rolapitant PDUFA (Prescription Drug User Fee Act ) action date on September 5. (prevention of chemotherapy induced nausea and vomiting)
2. Tesaro - tag along with Opko, has a New Drug Application for oral rolapitant under review by the FDA with the same PDUFA goal date.
3. Zosano Pharma - completed its enrollment for the Phase 2 trial for ZP-Glucagon. (significant improvement over the currently marketed products for treatment of severe hypoglycemia)
4. Xenoport - completed enrollment in its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis..
5. Apricus Biosciences - enrolled its last patient in its RayVa Phase 2a proof-of-concept study, (Raynaud’s phenomenon secondary to scleroderma)

After Regeneron and Sanofi got FDA approval for their cholesterol drug last month, today is Amgen's turn. CNBC's Meg Tirrell reports. (video)