News

FDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.

Misreporting of data to the Centers for Medicare and Medicaid Services exposes MCOs to civil litigation and administrative penalties.

The number of deaths from prescription pain relievers dropped 5% in 2012, and new tools are helping in the fight against opioid abuse.

Research has been given a shot in the arm by Apple Corp, which recently expanded the use of ResearchKit to include clinical trials.

The revocation of Blue Shield of California's tax-exempt status raises the question of whether for-profits have a competitive advantage.

An ongoing challenge particular to plans serving duals is a gap between the plans’ reimbursement rates and the health status of the populations they serve.

The Supreme Court recently held that the North Carolina Dental Board was not insulated from federal antitrust liability under the so-called “state action” doctrine when it engaged in anticompetitive conduct to restrain non-dentists from performing teeth whitening services.

FDA’s approval of Kybella (deoxycholic acid), a less-invasive, non-surgical option for adults with moderate-to-severe fat below the chin, known as submental fat, or double chin, bodes well for the future of Kythera Biopharmaceuticals.

Despite the majority of newly diagnosed advanced non-small cell lung cancer (NSCLC) patients being tested for genetic mutations, a gap still exists for providing a personalized treatment plan for patients. An international survey, sponsored by Boehringer Ingelheim, found that 60% of US oncologists do not determine their treatment decision based on patient’s genetic mutation subtype, compared with 50% in Canada and 23% in Asia.

The Centers for Medicare & Medicaid Services on Thursday released new data on Medicare Part D prescription drugs prescribed by physicians and other health care professionals in 2013.

PwC researchers recently identified five of the biggest ACA-related trends.

A new survey from KPMG of 270 healthcare professionals found only 10% are using advanced tools for data collection with analytics and predictive capabilities.

Biologic and pharmaceutical companies, along with their financial advisors or venture capital partners, have used mergers and acquisitions over the years to create value to keep their leading positions in a changing market. The era of pharmaceutical companies relying on blockbusters for their growth is over as more and more of these drugs have faced patent expiration, with no indication that new medicinal discoveries will emerge to take their place.

Emergency department (ED) patients with opioid dependence who receive a brief intervention and ED-initiated treatment with buprenorphine/naloxone and referral to primary care for 10-week follow up, are twice as likely to be engaged in addiction treatment at 30 days compared with standard referral and a brief intervention with a facilitated referral, according to a study published in JAMA.

FDA has approved Cyramza (ramucirumab, Eli Lilly) injection for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy.

AbbVie’s investigational hepatitis C virus (HCV) cocktail has been granted FDA priority review April 23 for the treatment of adult patients with chronic genotype 4 (GT4) HCV infection-the first investigational drug combination for GT4 infection, which accounts for about 6% of HCV cases in the United States.

The FDA approved the first generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, on April 28.

Insurers and pharmacists should not switch effective therapies without patient and physician notification, according to a national survey of stabilized autoimmune patients that explored their perspectives on switching prescribed biological medicines.

Both public and private purchasers are in an important position to act as catalysts of change in managing specialty pharmacy.

Blue Cross and Blue Shield will launch a health insurance exchange this summer that will support employers’ efforts to help retirees transition from group health benefits to individual Medicare coverage that starts Jan. 1, 2016.

Data from a real-world analysis provided an early view of hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients treated with new oral anticoagulants (NOACs).

Statins could be a cost-effective tool for preventing heart attacks and other cardiovascular incidents in adults over aged 75 years, but the benefits would need to be weighed against potential side effects, a study in the Annals of Internal Medicine.

Use of bupivacaine liposome injectable suspension (Exparel) was associated with im-proved clinical outcomes and a favorable cost savings per patient compared to the standard of care, according to data presented at the 27th annual meeting and expo of the Academy of Managed Care Pharmacy in San Diego.

While generic drug prices continue to rise, analysts say they may not continue their rapid growth rate.

L.A Care Health Plan is filling a void in California for unbanked consumers who need to maintain mandated health insurance coverage but have no credit or debit account.

Soaring prescription drug prices is quickly becoming a hot-button political topic, as American consumers are saying that pricing is out-of-control.

Teva Pharmaceutical’s unsolicited $40 billion offer to acquire Mylan N.V. is expected to shake up the pharmaceutical industry, especially in the areas of generic and specialty drugs. A Teva acquisition of Mylan would be the biggest health care deal of the year so far and the largest acquisition ever proposed by an Israeli company, according to S.&P. Capital IQ, The New York Times reported.

Children who have neurological disorders such as cerebral palsy or epilepsy are no more likely to be vaccinated against influenza than children without these conditions, despite the increased risk for complications from flu these children experience, according to a study published online April 9 in Vaccine. Moreover, healthcare providers may not be familiar with the increased risk among these patients to effectively recommend influenza vaccine.

The introduction of abuse-deterrent OxyContin, couple with the removal of propoxyphene from the US prescription marketplace may have played a role in decreasing opioid prescribing and overdoses, according to a study published in JAMA Internal Medicine.

Shifting from fee-for-service to value-based pay depends heavily on five factors.