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Biotech Stocks Facing FDA Decision In December 2019

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As we begin the final month of the year, it's time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision.

Before we look ahead at what's coming next over the horizon on the regulatory front, here are some of the regulatory news that made headlines in November.

On November 5, 2019, Vela Diagnostics USA Inc's Sentosa SQ HIV Genotyping Assay received FDA approval, becoming the first next-generation sequencing test for detecting HIV-1 drug resistance mutations. According to the CDC, there were more than 1 million Americans living with HIV in 2016. Sentosa SQ HIV Genotyping Assay provides a new way to select effective treatment options for patients who are beginning antiviral therapy and also for those who have developed resistance to HIV drugs by helping to identify mutations in the HIV-1 virus that can impact the effectiveness of certain drugs.

Reblozyl, the first therapy to treat patients with beta-thalassemia, a rare blood disorder, received the FDA nod on November 8, 2019. Developed by Celgene, this therapy will help decrease the number of blood transfusions.

Pentax Medical Video ED34-i10T2 model duodenoscope, the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses, secured marketing approval in the U.S. on November 15, 2019.

A couple of other notable firsts were also achieved on November 15, 2019.

Novartis' Adakveo was greenlighted by the FDA on November 15, 2019, becoming the first targeted therapy to treat patients with painful complications of sickle cell disease. CooperVision Inc.'s MiSight, the first contact lens indicated to slow the progression of nearsightedness in children was also approved that day.

On November 25, 2019, Global Blood Therapeutics' Oxbryta was granted accelerated approval for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older, making one more tool available in the battle against sickle cell disease.

Now, let's take a look at the pending FDA decisions in December 2019.

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