Neurological Disease

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy. Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.) Last November, eight committee members…

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy. The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. STAT…

Migraines are an ancient condition. In about 400 B.C., Hippocrates described visual symptoms of migraine aura that precede headache onset. But up until recently, neurologists had relatively few tools at their disposal to help migraine patients. The treatment landscape has evolved considerably in recent years, explains Alexander Feoktistov, a neurologist at the Synergy Integrative Headache…

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies. Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability…

FDA has approved the Aduhelm (aducanumab) from Biogen (BIIB), the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase. “Alzheimer’s disease is a devastating illness that can…

Migraines are a prevalent condition, affecting about one billion people across the world. “In the U.S., about 13% of the population experiences migraine headaches regularly,” said Dr. Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago.  In the following interview, Feoktistov shed light on the prevalence of the condition and shares his…

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B). The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use. In clinical trials, Novo Nordisk people…

The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…

A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.  Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although…

A group of scientists from the U.S. and China injected human stem cells into 132 macaque embryos, which then developed for up to 20 days. While the research holds promise for organ transplants, studying disease and testing new drugs, it also prompts controversy. The research was published this month in Cell. The scientists began with blastocysts…

Ovid Therapeutics (NSDQ:OVID) has named MIT professor Robert Langer as the chair of its scientific advisory board. The biopharma company focuses on rare neurological diseases. “The neurosciences are on the cusp of a scientific and, hopefully, therapeutic revolution,” said Langer in a statement. “Ovid has an exciting approach to tackling the key questions that drive…

For almost every major common disease, researchers have less understanding of the severe forms than milder cases. And as a result, people with severe forms of diseases often have few treatment options available.   Thus, the significant unmet medical need for many diseases ranging from multiple sclerosis to Alzheimer’s is to halt disease progression and treat severe…

Developing disease-modifying therapies for neurodegenerative diseases remains a pressing need. The incidence of neurodegenerative disease is ramping up in the U.S. and elsewhere as much of the global population ages. One out of three seniors dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association. Parkinson’s disease is also becoming more…

The need for therapies that change the course of Parkinson’s disease is considerable. “There are zero disease-modifying treatments for Parkinson’s,” said Dr. Allan Levey, professor and chairman of Emory University’s department of neurology.  Parkinson’s disease affects some 10 million people worldwide, according to the Parkinson’s Foundation.  Current drugs for Parkinson’s make it possible to “reverse…

European Medicines Agency (EMA) official Marco Cavaleri said there was a link between AstraZeneca’s COVID-19 vaccine and rare reports of blood clots, including pulmonary embolism, deep vein thrombosis and thrombocytopenia, according to a Reuters report. Two separate research groups in Europe had reached similar conclusions regarding the blood clots in March. AstraZeneca had previously downplayed the possibility that…

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment. Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease,…

Alzheimer’s disease has one of the highest financial burdens. The Alzheimer’s Association estimates that the cost of the disease in the U.S. will hit $355 billion in 2021. “Not only is Alzheimer’s one of the most expensive, it’s probably one of the most devastating diseases of humans,” said Dr. Allan Levey, professor and chairman of…

Privately-held Genuity Science and Emory University are collaborating with the hopes to accelerate drug research and development for neurodegenerative diseases such as Alzheimer’s and Parkinson’s. Clinical breakthroughs for neurodegenerative diseases are rare. The most recent drug to win FDA approval for Alzheimer’s, Namenda (memantine) from AbbVie-acquired Allergan, did so in 2003. And Levodopa, one of the most-effective Parkinson’s…

Biogen (NSDQ:BIIB) has entered into a licensing agreement with Sage Therapeutics (NSDQ:SAGE) to commercialize zuranolone (SAGE-217) and SAGE-324.  It will pay $1.5 billion in addition to potential milestone payments.  Zuranolone is an investigational neuroactive steroid that could treat major depressive disorder, postpartum depression, insomnia and other psychiatric disorders.  SAGE-324 could potentially treat essential tremor and…

An experimental drug appeared to restore normal memory and cognition function in mice, according to researchers at the University of California, San Francisco (UCSF). Known as ISRIB, the drug is an integrated stress response inhibitor. Earlier laboratories suggested the drug holds promise in treating disorders ranging from traumatic brain injury to noise-related hearing loss to…

Biotechnology traces its roots to the Neolithic era when early civilizations discovered how to ferment grains to prepare alcoholic brews and bread. It wasn’t until genetic engineering became mainstream in the mid-1970s, however, that biotechnology, as we know it today, was launched. The field continues to evolve today. The advent of new technology has revolutionized the market…

The neurodegenerative-diseased-focused biotech Amylyx Pharmaceuticals announced that it had received orphan drug designation for AMX0035, a proprietary blend of sodium phenylbutyrate and tauroursodeoxycholic acid. The Cambridge, Mass.-based company won that designation to treat Wolfram syndrome, a rare genetic disease associated with diabetes, progressive optic atrophy, hearing loss and severe neurological disabilities.  The prognosis for patients…

The U.S. pharmaceutical industry has fared better than most sectors in 2020, but the industry still faces tailwinds, according to recent IQVIA research. Total prescription sales are down 2.1% year over year in the fourth quarter of 2020 to date, according to an analysis of the IQVIA data by the investment bank UBS. New prescriptions…

The FDA announced that it awarded six new clinical trial research grants to principal investigators totaling more than $16 million over four years. Awarded through the Congressionally-funded Orphan Products Grants Program, the research grants seek to enhance the development of medical products for patients with rare diseases, according to a news release. More than 90…

For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing…