Tag: Product/Service Approvals

Verano Executive Bullish on the Future of the U.S. Cannabis Industry
World

Verano Executive Bullish on the Future of the U.S. Cannabis Industry

The past year was pivotal for the legal cannabis industry’s acceptance as a mainstream business in the U.S. The Department of Health and Human Services in August recommended to the Drug Enforcement Administration that marijuana be reclassified to a less restrictive Schedule III substance from a Schedule I substance. The Senate Banking Committee, meanwhile, in September approved the Secure and Fair Enforcement Regulation Banking Act, which would give cannabis businesses greater access to banking services, and it now awaits a vote on the Senate floor. And in November, Ohio became the latest state to legalize adult recreational marijuana use, bringing the total number of U.S. states that permit recreational cannabis use to 24. Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved...
Celsius Details Plan to Focus on Bitcoin Mining Post Bankruptcy
World

Celsius Details Plan to Focus on Bitcoin Mining Post Bankruptcy

Nov. 30, 2023 7:43 pm ET|WSJ ProCrypto lender Celsius Network provided details Thursday of its plan to only mine bitcoin when it emerges from bankruptcy, a scaled-down business that reflects guidance from regulators. Earlier in November, Celsius received approval from a bankruptcy court in New York to create a new company built around Celsius’s bitcoin-mining business, staking activities and monetizing of illiquid assets that was going to be managed by Fahrenheit, an investor group backed by TechCrunch founder Michael Arrington that included US Bitcoin.Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Gene Editing Will Change Medicine—and Maybe Health Investing Too
Money

Gene Editing Will Change Medicine—and Maybe Health Investing Too

It usually takes time for scientific discoveries in the lab to make their way to the market.The groundbreaking gene-editing technology known as Crispr, which acts like a molecular pair of scissors that can be used to cut and modify a DNA sequence, has moved rather quickly from the pages of scientific journals to the medical setting. Earlier this month, about three years after Jennifer Doudna and Emmanuelle Charpentier won the Nobel Prize in Chemistry for describing how bacteria’s immune system could be used as a tool to edit genes, regulators in the U.K. approved the first Crispr-based treatment for sickle cell disease and beta-thalassemia patients. The treatment, from Vertex Pharmaceuticals and Crispr Therapeutics, could be approved by the U.S. Food and Drug Administration early next mo...
Bayer Pulling Lymphoma Drug Aliqopa From U.S.
World

Bayer Pulling Lymphoma Drug Aliqopa From U.S.

Nov. 13, 2023 10:35 am ETGerman drugs-to-crops giant Bayer is pulling Aliqopa from the U.S. after a confirmatory trial of the lymphoma drug missed its primary endpoint.Bayer on Monday said it will work with the U.S. Food and Drug Administration on a voluntary withdrawal of Aliqopa, which won accelerated approval from the agency in 2017 for adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Eli Lilly’s Mounjaro Approved for Weight Loss in the U.S.
World

Eli Lilly’s Mounjaro Approved for Weight Loss in the U.S.

Updated Nov. 8, 2023 1:01 pm ETU.S. drug regulators have approved expanding the use of Eli Lilly’s diabetes drug Mounjaro to include the treatment of obesity.The Food and Drug Administration’s decision Wednesday furthers the rapid rise of Mounjaro—and similar-acting therapies Ozempic and Wegovy from Novo Nordisk—that have in a matter of months reshaped the treatment of obesity and doctors’ understanding of its roots.Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
How Biden’s Inflation Reduction Act Killed a Cancer Study
Health

How Biden’s Inflation Reduction Act Killed a Cancer Study

President Biden has set an ambitious and laudable goal of reducing cancer mortality by half within 25 years, yet the Inflation Reduction Act (IRA) is working at cross purposes with that goal. See Seagen Inc. CEO David Epstein’s statement last week that the biotech company plans to scrap a new cancer drug study because of the law. The Food and Drug Administration approved Seagen’s antibody drug-conjugate Padcev in 2019 to treat locally advanced or metastatic bladder cancer that doesn’t respond to other therapies. Padcev uses an antibody that binds to specific proteins on cancer cells and directly delivers a payload of chemotherapy, which minimizes collateral damage to healthy non-cancerous cells.Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1c...
Obesity Drug Demand Outstrips Supply
Money

Obesity Drug Demand Outstrips Supply

Eli Lilly’s blockbuster diabetes medication Mounjaro is expected to receive Food and Drug Administration approval as an obesity treatment before the end of the year, which would lead to a surge in demand. Whether there will be enough of the drug is a different question. Both Lilly and its competitor, Denmark’s Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up.Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8