Combination Pill From Myovant Reduces Pain From Endometriosis, Trial Shows

Stat: Myovant Says Endometriosis Drug Meets Its Goal In A Second Late-Stage Trial
A combination pill from Myovant Sciences met its primary goal of reducing pain from endometriosis, the biotech company said Tuesday, the second late-stage trial to show the drug’s effectiveness in women with the condition. Myovant (MYOV), a biotech based in Switzerland with U.S. operations in Brisbane, Calif., has also been testing the hormone blocker, called relugolix, as a treatment for uterine fibroids and advanced prostate cancer. On Monday, the company received a priority review of relugolix for advanced prostate cancer from the Food and Drug Administration, meaning the agency will expedite its decision on whether to approve the drug for these patients. A study comparing standard injected therapy to the oral relugolix, published in the New England Journal of Medicine on June 4, showed better outcomes for men who took relugolix. (Cooney, 6/23)

Bloomberg: Pfizer (PFE) Heart Drug Tafamidis High Price Barrier For Elderly
Pfizer Inc.’s new $225,000-a-year heart drug is being labeled by researchers critical of the cost as “the most expensive cardiac medication in history. ”When the company initially priced the drug, called tafamidis, critics warned the high cost would present a prohibitive financial barrier to some patients. A new analysis that hones in on 50 people prescribed the medication offers data suggesting that may be true for many patients. (Court, 6/18)

The Motley Fool: Meet The Pharma Company That Just Had A Bigger IPO Than Moderna's
Moderna (NASDAQ:MRNA) set the record for the biggest initial public offering (IPO) in biotech history on Dec. 6, 2018. The biotech raised over $600 million. But while Moderna's IPO was the biggest ever for a biotech, it wasn't the biggest one in the biopharmaceutical industry. That honor belongs to animal health company Zoetis, which conducted an IPO raising $2.2 billion on Jan. 31, 2013 after being spun off from Pfizer. And now there's another biopharmaceutical IPO that's even bigger than Moderna's. Royalty Pharma (NASDAQ: RPRX) went public on June 16, 2020. The $2.18 billion IPO became the second-largest biopharmaceutical IPO ever and the biggest IPO of 2020 so far. Here's why investors flocked to the drugmaker that made an even bigger initial splash than widely followed Moderna. (Speights, 6/23)

Stat: As Quality Concerns Rise, FDA Report Shows Indian Plants Had More Issues
As concerns mount over the quality of the pharmaceutical supply chain, the Food and Drug Administration has released new data showing the agency inspected more manufacturing plants located in India during the past two fiscal years and found these facilities generally had more quality problems than sites located in the U.S. or the European Union. Specifically, the FDA inspected 6% more plants in India while examining 4% fewer sites in the U.S. and 6% fewer in the European Union from fiscal year 2017 to fiscal year 2019. Meanwhile, using a simple scale of 1 to 10 to assess compliance with good manufacturing regulations, the average score for all sites globally in fiscal year 2019 was 7.4, which was not significantly different than the 7.5 seen in fiscal year 2018. (Silverman, 6/16)

Stat: Fate Of Intercept's NASH Drug Clouded By Murky FDA Review Delays
On Friday, the Food and Drug Administration is supposed to announce its decision on whether or not to approve the first treatment for the fatty liver disease known as NASH. But that plan has apparently been postponed for reasons that are still not clear. The FDA hasn’t offered an explanation, nor has Intercept Pharmaceuticals, the maker of the NASH drug under review. Reached on Monday, an Intercept spokesperson said the company intends to provide an update on “any material developments with respect to its regulatory timeline,” but has nothing to disclose at this time.An estimated 6 million people in the U.S. have NASH, making the disease a multibillion-dollar commercial opportunity for any drug maker that secures an approval from the FDA. (Feuerstein, 6/23)

Stat: Vertex And Canada Hold Talks Over Cystic Fibrosis Drug
The icy relationship between Vertex Pharmaceuticals (VRTX) and the Canadian government is showing signs of thawing a wee bit as the pan-Canadian Pricing Alliance opened talks over one of the company’s cystic fibrosis drugs, a move that comes shortly after the agency reached an agreement on a different Vertex medicine for the illness. The Alliance, which conducts joint negotiations on behalf of the provincial, territorial, and federal governments in the country, decided to proceed with the talks for the drug Orkambi in hopes of breaking a long-standing logjam with Vertex over its cystic fibrosis medicines. The clash has been closely tracked by patients and their families, who say they are being treated as pawns. (Silverman, 6/18)