FDA Says It Will Review Experimental ALS Treatment
Meanwhile, Amgen said it's found improved tumor response rates when it combines a KRAS-blocking drug with another targeted cancer drug. Separately, generic Zantac makers said they will seek legal expenses after a failed lawsuit where people alleged they were damaged by the heartburn pills.
Stat:
FDA Does About-Face On Review Of Potential ALS Treatment From Amylyx
The Food and Drug Administration has reversed an internal decision and will now review an experimental treatment for amyotrophic lateral sclerosis — a victory for ALS patients and advocates who have been pressuring regulators to act with more urgency against the fatal, neurodegenerative disease. Amylyx Pharmaceuticals, a Cambridge, Mass.-based drug maker, said Wednesday that it will submit an application for its ALS treatment, called AMX0035, “in the coming months.” (Feuerstein, 9/15)
Stat:
With KRAS-Blocking Drug, Amgen Sees Improved Response In Colon Cancer
A combination treatment that pairs Amgen’s KRAS-blocking drug Lumakras with another of its targeted cancer medicines showed improved tumor response rates in patients with advanced colon cancer, the company said Thursday. Amgen secured U.S. approval of Lumakras in May to treat patients with lung cancer caused by a genetic mutation to the KRAS protein. But the pill’s benefit in other types of solid tumors where KRAS also plays a role has proven to be more modest, necessitating a search for combination treatments that might boost efficacy. (Feuerstein, 9/16)
Stat:
Generic Zantac Makers Plan To Seek Legal Expenses From Consumers
A few months ago, a federal court judge dismissed all claims against more than a dozen generic manufacturers over allegations that their versions of the Zantac heartburn pill may contain a carcinogen. Now, those companies are seeking to recover potentially significant costs from approximately 1,000 people who filed the lawsuits alleging they were harmed by the pills. (Silverman, 9/15)
Stat:
Safety-Net Hospitals Take Big Markups On Cancer Drugs For Commercially Insured Patients, Study Finds
Hospitals participating in a federal drug discount program marked up cancer medicines four times for privately insured patients, and often charged cash-paying consumers the same as commercial insurers, a practice that does not “fit the mission” of serving low-income populations, a new analysis found. Specifically, the median price charged for cancer treatments to commercial insurers or cash-paying patients was 3.8 times what was paid by 123 hospitals participating in the so-called 340B program. Moreover, the hospitals did not reduce prices charged to insurers or patients when their own purchase prices decline, according to the analysis by Moto Bioadvisors, a consulting firm. (Silverman, 9/15)
Also —
The Wall Street Journal:
Prenetics, A Covid-19 Testing Startup, To Go Public In SPAC Merger
Hong Kong-based Prenetics Group Ltd. is going public on the Nasdaq Stock Market via a special-purpose acquisition company, in a deal that values the medical diagnostic startup at $1.25 billion. Prenetics, whose revenue has surged during the coronavirus pandemic, will merge with Artisan Acquisition Corp. , a blank-check company founded by Adrian Cheng, grandson of the late Hong Kong real estate and jewelry magnate Cheng Yu-tung. The younger Mr. Cheng invested in Prenetics last year and held a 0.8% stake in the startup before the latest deal. (Yang, 9/16)
Axios:
Jennifer Doudna's CRISPR Startup Mammoth Biosciences Goes Unicorn
The gene-editing tool CRISPR is moving toward the market, promising better tests, disease cures — and maybe even a woolly mammoth. CRISPR is already a historic scientific achievement, but we're just now entering the moment when it will begin to impact patients and possibly the planet. (Walsh, 9/15)
