The FDA’s Center for Biologics Evaluation and Research has expanded the indication for Fluarix Quadrivalent (influenza vaccine, GlaxoSmithKline) to include use in people 6 months of age and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses…
The FDA has approved the first direct-to-consumer test that can warn users of their increased risk of breast, ovarian, or prostate cancer, but only a small percentage of Americans can reap any benefit. The Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), marketed…
The National Comprehensive Cancer Network (NCCN) has released new NCCN Clinical Practice Guidelines in Oncology intended to help make sure people living with human immunodeficiency virus (HIV) infection who are diagnosed with cancer receive safe, necessary treatment. In 2010, an estimated 7,760 people…
GlaxoSmithKline (GSK) has a lot riding on Shingrix (zoster vaccine recombinant, adjuvanted), its new shingles vaccine. It’s one of the key products CEO Emma Walmsley cited as growth drivers for the languishing company. And that launch just got a major boost from CVS, according to FiercePharma. The…
Looking for healthy folks? Take a trip to San Francisco or Seattle, WalletHub suggests. But if your journey takes you through Brownsville or Laredo, Texas, don’t bother stopping. With health care costs rising and U.S. life expectancy declining for the second year in a row, the personal-finance website…
Disappointing results in the phase 3 RESULT trial have led Anthera Pharmaceuticals, Inc., to discontinue development of its drug candidate Sollpura for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis. Sollpura failed to meet the trial’s primary endpoint: noninferiority in…
The FDA has approved Toujeo (insulin glargine 300 units/mL, Sanofi) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market. The new pen holds 900 units of Toujeo, more than any other long-acting insulin pen in the U.S., and provides up to 160 units/mL of Toujeo…
The multiple sclerosis medication daclizumab (Zinbryta, Biogen/AbbVie) is being withdrawn from the market voluntarily following reports that it has been associated with inflammatory encephalitis and meningoencephalitis. The two companies said that “characterizing the complex and evolving benefit/risk…
The FDA has expanded the indication for nilotinib (Tasigna, Novartis) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). In the United States, nilotinib is now indicated…
The alarmingly high number of pediatric deaths so far during the 2017–2018 flu season reinforce the need to shift away from the traditional chicken-egg-based approach to mass production of commercial influenza vaccines, according to consultant GlobalData. The egg-based vaccines commonly induce a suboptimal…
Amazon.com, Inc., Berkshire Hathaway, and JPMorgan Chase & Co. will form a health care company aimed at cutting costs for their U.S. employees, the three partners have announced. Reuters reports that the news sent shares in the broad health care sector sharply lower. The independent company will be…
Canagliflozin (Invokana, Janssen Pharmaceutical) significantly reduced the risk of cardiovascular death or hospitalization for heart failure in patients with type-2 diabetes at high cardiovascular risk in an exploratory analysis from the CANVAS clinical program, according to a presentation at the American…
The FDA has granted accelerated approval to blinatumomab (Blincyto, Amgen) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen…
The second time proved to be the charm for the U.S. House of Representatives to pass right-to-try legislation that would provide terminally ill patients access to experimental drugs without the approval of the FDA, according to a BioSpace article. The House approved a second bill with a 267–149 vote…
A new report from Senator Claire McCaskill (D-Missouri) found that five opioid manufacturers paid nearly $9 million to 14 outside groups between 2012 and 2017, alleging that the advocacy groups often “amplified messages favorable to increased opioid use.” The groups—many of which work on chronic…
