Formulary Watch |

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.

Multidrug-resistant HIV drug on the horizon

After a successful phase 3 study, a breakthrough therapy to treat multi-drug resistant (MDR) HIV-1 is expected to launch in the United States in 2017.

Gilead promises generic versions of new hepatitis drug

After Gilead received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of Sovaldi and Harvoni hepatitis C treatments.

Breakthrough lymphoma drug on the horizon

FDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.

Insulin makers accused of price collusion

U.S. congressmen last week asked the Department of Justice and the Federal Trade Commission to investigate three insulin makers for price collusion-the latest in concerns over insulin prices.

First olmesartan generics approved for hypertension

In a big move for patients who take blood pressure medication on a regular basis, FDA last week approved the first generic versions of 4 drugs that contain the blood pressure-lowering medication olmesartan medoxomil (Benicar, Daiichi Sankyo).

Statin prescribing varies in patients with diabetes

Wide variation exists in practice-level statin prescribing for patients with diabetes, according to a new study.

Clear skin within reach for psoriasis patients

New data presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, this week shows that secukinumab (Cosentyx, Novartis) has long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis.

Insurer diabetes program engages consumers, lowers costs

Anthem Blue Cross recently launched a year-long diabetes prevention program to educate, treat and support its qualified California members who are at risk of developing type 2 diabetes.

New antibiotic for MRSA on the horizon

As the healthcare profession continues to face challenges with antibiotic resistance, drugmakers are developing novel antibiotics that will be effective against some of the worst infections. One drugmaker submitted New Drug Applications (NDAs) for approval of IV and oral delafloxacin (Baxdela) to FDA.

Lung cancer drug approved

Soon after FDA granted accelerated approval for atezolizumab (Tecentriq, Genentech) to treat bladder cancer, the agency okayed the drug to treat metastatic non-small cell lung cancer (NSCLC).

Sharp price increases for cancer drugs

A majority of oncology drugs-particularly older cancer drugs-had price hikes in 2015, according to a study. Plus, Ariad Pharmaceuticals raised the price of its chronic myeloid leukemia (CML) drug ponatinib (Iclusig) for the fourth time this year to around $199,000 a year, according to The Street.

Big savings expected with new generic antipsychotic

FDA tentatively approved the abbreviated new drug application (ANDA) for generic quetiapine fumarate extended-release tablets (brand Seroquel XR, AstraZeneca) to treat schizophrenia and manic/mixed episodes associated with bipolar disorder.

DEA slashes opioid drug production

The US Drug Enforcement Administration (DEA) has reduced the amount of almost every Schedule II opiate and opioid medication that may be manufactured in the US by 25% or more.

Drug maker pays out millions over EpiPen charges

As Mylan continues to face criticism over price hikes on its EpiPen epinephrine injection, the company agreed to a $465 million settlement with the U.S. Department of Justice and other agencies for overcharging on the EpiPen.

Cystic fibrosis drug approved for younger patients

FDA recently expanded the use of lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals) to treat cystic fibrosis in children aged 6 to 11 years who have two copies of the F508del mutation.

First "artificial pancreas" for diabetes approved, plus 2 more FDA actions

FDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.

Aggressive blood sugar control slows diabetic eye disease progression

NIH-funded study shows less diabetic retinopathy progression among those who underwent intensive glycemic control.

Know these barriers to reduce type 2 diabetes costs

IMS Health study: Up to 15% of healthcare system costs avoidable and effective patient activation by multiple stakeholders is key to driving improvement.

FDA approves biosimilar to Humira

FDA’s pace of biosimilar approvals is picking up, as it approved two major drugs for rheumatoid arthritis and other inflammatory diseases in the past month.