Formulary Watch |

Once-daily diabetes drug approved

FDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.

Drug approved for nighttime urination, plus two more

FDA recently approved three novel drugs: one to treat frequent urination at night, one to treat carcinoid syndrome diarrhea in cancer patients, and one for dust mite allergies. Here are the details on the three new treatments.

HIV dual therapy shows promise

A dual-drug regiment to treat HIV could soon be a reality, according to results presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Tests help aid in antibiotic control

FDA recently approved 2 tests that will aid healthcare providers in determining which antibiotics are needed, leading to better antibiotics management.

Psoriasis drug approved with boxed warning

A new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.

Popular asthma inhaler now expanded to kids

A leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.

Muscular dystrophy drug launch halts after pricing concerns

Marathon Pharmaceuticals is temporarily pausing the launch of its drug to treat a rare form of muscular dystrophy (MD) after concerns over its $89,000 price tag.

New bladder cancer, kidney disease therapies available

FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Major allergic reactions linked to common antiseptics

FDA is warning about rare but serious allergic reactions have from the widely-used skin antiseptic products containing chlorhexidine gluconate.

Diabetic patients challenge insulin makers

In the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.

Will Trump’s FDA picks speed drug approvals?

Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.

First therapy approved for rare blood cancer

FDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.

Drug distributor pays record fine

McKesson Corp., one of the largest distributors of pharmaceuticals, agreed to pay a record civil penalty for alleged violations of the Controlled Substances Act.

Constipation drug wins approval

FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.

Long-acting opioid painkiller wins approval

FDA recently approved a long-acting opioid designed to deter abuse.

Trump's drug pricing comments create debate

While President-elect Donald Trump recently said that the pharmaceutical industry is “getting away with murder” in terms of drug prices, the industry is trying to self-regulate before facing tighter rules from the incoming administration.

FDA approves hemophilia A drug for children

FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.

New 340B drug rule sets drugmaker fines

Consumer health groups are praising Health and Human Services’ (HHS) new rule on the Medicaid 340B drug discount program, which sets a ceiling on drug prices.

New device could be breakthrough for diabetics

FDA recently expanded approval of the G5 Mobile Continuous Glucose Monitoring System (Dexcom) to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.

Why 2016 drug approvals fell

While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.

Advanced ovarian cancer drug approved

FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.

FDA green lights first treatment for rare spinal disease

FDA approved nusinersen (Spinraza, Biogen), the first drug to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.

New diabetes combo drug available soon

A new combination drug for type 2 diabetes will available in the US in the coming months.

FDA issues warnings over anesthesia, diabetes drugs

FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.

FDA approves expansion of Avastin in ovarian cancer

FDA recently approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.

US drug spending predicted to drop

The US growth rate for spending on medicines is expected to fall in 2016 and beyond, according to new research.

New drug indication could net more than $1 billion

FDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.

Breast cancer biosimilar shows equivalency to brand

Two new major studies on a biosimilar to trastuzumab (Herceptin, Genentech) to treat HER2-positive metastatic breast cancer and HER2-positive gastric cancer demonstrated equivalency.

FDA approves 2 injectable diabetes drugs

Two new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.

Novel drug reduces monthly migraine days

A global phase 3 study of erenumab (Amgen and Novartis) showed that the drug was able to prevent migraines headaches.