Weekly Drug News Round Up - January 7, 2015
Sandoz's Biosimilar Recommended by FDA Advisory Committee
The first biosimilar may soon be available in the U.S. - here’s a few facts to get you up to speed Read More...
A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological. Biologics like Neulasta, Aranesp, and Avastin are well-known products in the U.S. Today an FDA Oncologic Advisory Committee unanimously recommended to the FDA that Sandoz’s EP2006, a filgrastim product should be approved. EP2006 may be the first biosimilar on the U.S. market and would be a counterpart to Amgen’s Neupogen. The biosimilar brand name would be Zarxio if a final FDA-approval. The biosimilar was recommended for approval for all indications appearing on the Neupogen label.
Bellafill Approved to Lessen Acne Scars
Dermal filler Bellafill is to be used only in patients over the age of 21 years Read More...
Bellafill, a dermal filler, has been approved for the treatment of acne scars. Bellafill was previously known as ArteFill, and is also used as a filler for smile line wrinkles. In December 2014, Suneva Medical announced that ArteFill has been rebranded as Bellafill. The U.S. Food and Drug Administration (FDA) approval of Bellafill was based on the outcomes of a double-blinded, randomized, placebo-controlled pivotal study. At 6 months, the response rate for Bellafill was 64% vs. 33% for the saline control group. Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%).
It’s Peak Flu Season and It’s Getting Worse
CDC still recommends you get the flu vaccine if you have not had one yet Read More...
The severity of flu from season to season is unpredictable. This flu season, flu has already hit epidemic levels in the U.S. The predominant flu strain this year continues to be H3N2 -- one that is poorly matched to this year's vaccine, according to the U.S. Centers for Disease Control and Prevention (CDC). Adults and children with flu can be treated with antiviral medications such as Tamiflu (oseltamivir) and Relenza (inhaled zanamivir), but should be started as soon as possible and within 2 days of symptom onset. Typical flu symptoms include a dry cough, fever, chills, sore throat, muscle aches and fatigue. See FDA tips to help avoid the flu.
What Possible Blockbusters Are Set for a 2015 Approval?
From psoriasis to cystic fibrosis treatments, more billion dollar pharmaceuticals are set to hit the market in 2015
Drug approvals seem to come more and more rapidly these days. In fact, in the month of December 2014 alone, the U.S. Food and Drug Administration (FDA) approved at least 24 new drugs. Many new drug approvals come along with high price tags, due to advanced biotechnology development and treatment of rare diseases. But sticker shock for the consumer and the healthcare system can mean a profit boost for drug makers.
Long-term Kaiser Study Shows Measles Vaccine is Safe
Researchers emphasized that the risk of febrile seizures is small Read More...
Researchers at the Kaiser Permanente Vaccine Study Center in California looked at almost 125,000 measles-mumps-rubella-varicella (MMRV) doses and nearly 600,000 measles-mumps-rubella and varicella (MMR + V) doses over a 12-year period. Children between the ages of 12 to 23 months received the vaccine. Results, published in Pediatrics, show that side effects of the vaccines were “extremely rare and unlikely”. The vaccines didn't increase children's risk of seven types of neurological, blood or immune system disorders. Fever-related seizures occurred in less than one of every 1,000 vaccine injections, and occur less with the MMR + V vaccine.