NY Can Tax Drugmakers Under Opioid Stewardship Act, Appeals Court Rules
Since New York passed its law, two other states – Delaware and Minnesota – enacted similar measures, and other states are considering the approach, Stat reports.
Court Rules New York Tax Drug Makers To Address Opioid Crisis
A U.S. appeals court upheld a controversial New York state law to require drug makers and distributors to fund a program for covering costs for treatment, prevention, and recovery related to the opioid crisis. Under the Opioid Stewardship Act, which was enacted three years ago, any manufacturer or wholesaler licensed to sell or distribute opioids in New York would pay a collective $100 million a year into a fund. At the time, state officials estimated that $600 million in surcharges would be collected over a stipulated six-year period. (Silverman, 9/15)
FDA Warns Sprout For Failing To Mention Risks In Radio Ad For Addyi
The Food and Drug Administration has admonished Sprout Pharmaceuticals for running a radio ad that omitted all possible risks associated with its controversial female libido pill and also for giving listeners a misleading impression about the extent to which it can improve a woman’s desire. In an Aug. 31 warning letter, the agency noted the ad for the pill, known as Addyi, failed to mention that women should avoid alcohol and certain antifungal medicines, which was described as “material information” that is found in a so-called black box warning on the product labeling. (Silverman, 9/15)
Compass Pathways Set To Become The First Psychedelic Biotech IPO
Compass Pathways isn’t the first company to fashion FDA-regulated therapies out of psilocybin, but it intends to be the first one to go public. This week, the British company is seeking to raise about $100 million at a $570 million valuation. Compass, which counts Thiel Capital among its private investors, intends to sell 6.7 million shares for between $14 and $16 each. The funds will support an ongoing Phase 2b trial intended to prove that psilocybin-based therapy can help patients with treatment-resistant depression. (Garde, 9/15)
What Will It Take For Gilead To Break Even On Its $21 Billion Deal?
For years, investors have pestered Gilead Sciences with the same question in myriad phrasings: When are you going to buy something big? Now, before the ink has even dried on the company’s commitment to a $21 billion acquisition, they’re wondering just how Gilead can justify that price. (Garde, 9/15)
Pfizer Seeks To Paint A Picture Of A Research Turnaround
Pfizer has been making headlines because of its work developing a Covid-19 vaccine. On Monday and Tuesday, the company is hoping some of that buzz will rub off on its other research projects, which will be presented in a two-part investor day Monday and Tuesday. (Herper, 9/14)