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Psychedelic Drug Research Making a Comeback

In the 1950s and early 1960s, researchers within both academic and governmental institutions extensively investigated the clinical potential of psychedelic drugs, notably both LSD and psilocybin, the psychoactive substance in “magic mushrooms.” This early research aimed to understand the biological underpinnings of schizophrenia and to find new treatments for psychological disorders such as depression, anxiety...

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Long Awaited CMS Rules on Medicare Coverage for CAR-T Therapies

In August, the Centers for Medicare and Medicaid Services (CMS) finalized long-sought rules framing the coverage of chimeric antigen receptor T-cell (CAR-T) treatments. Two CAR-T therapeutics are currently on the market: Gilead’s Yescarta and Novartis’ Kymriah, both approved for diffuse large B-cell lymphoma (DLBCL) with the latter also approved for acute lymphocytic leukemia (ALL). Under...

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New Approvals for Tumor-Agnostic Cancer Treatments — and the Questions They Raise

On August 15, the U.S. Food and Drug Administration granted accelerated approval to Genentech/Roche’s Rozlytrek (entrectinib) for the treatment of adult and adolescent patients with solid tumors that exhibit neurotrophic tyrosine receptor kinase (NTRK) fusions and for whom there are no existing effective treatments. While NTRK fusions are rare, appearing in about 1% of solid...

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Focusing on NASH

Non-alcoholic fatty liver disease (NAFLD), the build-up of fat in the liver that is not caused by alcohol, affects almost 100 million people in the United States alone. With no drug therapies available for the condition, treatment has focused mostly on weight loss. The more severe form of NAFLD, non-alcoholic steatohepatitis (NASH), causes the liver...

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Zolgensma Launch “On Track,” but Significant Challenges Remain

On July 18, Novartis told analysts its Zolgensma launch was “on track.” Despite the gene therapy’s $2.1 million price tag, the company states the launch is “one of the most successful launches from an access standpoint in rare diseases.” Novartis said it had reached coverage deals with more than 20 commercial insurance plans, covering approximately 40%...

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Building a Better Market for Biologics: The US vs. Europe

The advent of generics has dramatically impacted the cost of small molecule drugs following the expiry of the patent protection for the originator therapeutics, with the cost of a small molecule generic often as little as 10% of that of the originator drug. This price difference results from several factors, including lower R&D costs, fewer...

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Landmark Approvals in Depression

Depression is a challenging condition to treat. Most antidepressants take four to six weeks to take effect, and patient response to such drugs varies widely from person to person. As a result, most patients must try several drugs over a period of months before they can find relief. In March, the U.S. Food and Drug...

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FDA Fosters Innovation in Diabetes Care Through New Device Classification

Digital technologies are becoming an increasingly important part of modern healthcare. Medical devices  have the ability to connect to and communicate with other devices or systems. Not only are new types of devices being created, but many existing devices are being updated with digital capabilities. As a result, the U.S. Food and Drug Administration (FDA)...

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Wearables Evolve from Wellness to Clinical Medicine

Wearables – including consumer products like FitBit wristbands and smartwatches – are quickly moving beyond their use as wellness products that track steps and sleep patterns to incorporate serious medical device capabilities and clinical applications.   In September 2018, the Apple Series 4 model smartwatch became the first such product to have its software officially...

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FDA and Direct-to-Consumer Genetics Testing

When 23andMe launched its first genetic test to the consumer market in 2013, the U.S. Food and Drug Administration (FDA) quickly ordered the company to stop marketing the test without necessary approvals as a medical device, citing the potential for harm to patients who change medication doses or have unnecessary surgeries based on test results....