Drugmakers Slammed With Fines After They Fail To Report Price Hikes To California

Stat: California Fines A Dozen Drug Makers For Not Providing Drug Pricing Data
Over the past six months, California state authorities fined more than a dozen drug makers a total of $17.5 million for failing to report price hikes as required by law, and more than half of the penalties were levied since the beginning of the year, according to data obtained by STAT. To date, the state has only collected $4.8 million, as some fines were settled for lower amounts and other companies have yet to either make a payment or reach a settlement, according to a spokesperson for the Office of Statewide Health Planning and Development, which administers the law. (Silverman, 4/28)

Stat: Most Americans Believe Trump Hasn't Made Progress On Drug Prices
More than one-third of U.S. adults believe that prescription drug prices have increased a lot since 2017, the first year of the Trump administration, and only 7% think prices have dropped at all, a new poll finds. Consequently, 65% of Americans say the administration has not made very much progress or no progress at all in limiting the rising cost of medicines. (Silverman, 4/28)

Bloomberg: When Will Virus Vaccine Be Ready? Group Says Maybe This Year
A vaccine to halt the coronavirus pandemic could be available as early as this year for vulnerable groups such as health-care workers, even faster than initially thought, according to a key group at the heart of the global development effort. The Coalition for Epidemic Preparedness Innovations, which is funding nine different coronavirus vaccine projects, has previously suggested a shot could be ready within 12 to 18 months, an already ambitious target. That assessment didn’t account for the possibility of companies working closely together to accelerate the process, faster enrollment in human trials and other factors, according to Richard Hatchett, the head of the Oslo-based organization. (Paton, 4/27)

Stat: The Coronavirus Pandemic Could Shrink Biotech Startup Valuations 
Determining a private company’s value means estimating how and when it might be able to start and then complete successful clinical trials, or when it will get a regulator’s approval to manufacture and sell a drug. But the coronavirus pandemic means every step in that process has become far more uncertain in the past two months — and that added uncertainty means some biotech companies may be worth less on paper than they were before. (Sheridan, 4/23)

Bloomberg: Chinese Alzheimer’s Drug Gets U.S. Approval For Stateside Trial
A Chinese drugmaker has received approval from the Food and Drug Administration to start clinical trials in the U.S. for a breakthrough Alzheimer’s drug as it seeks global validation for the controversial therapy. Shanghai Green Valley Pharmaceutical Co. got clearance on April 8 for the U.S. part of a global trial that seeks to enroll more than 2,000 patients with mild-to-moderate Alzheimer’s across North America, Europe and Asia, according to a company statement Sunday. (4/26)

Stat: Cystic Fibrosis Drug Needs To Be Cheaper To Be Cost-Effective, Analysis Finds
Anewly approved treatment from Vertex Pharmaceuticals (VRTX) that targets roughly 90% of all cystic fibrosis patients may be a groundbreaking therapy, but requires a steep discount of at least 73% to be cost effective, a new analysis finds. And three older cystic fibrosis treatments sold by the company would also have to be similarly discounted in order to justify their pricing. Notably, the Trikafta medication, which was approved last fall by the Food and Drug Administration amid widespread praise, would need to be priced at $67,900 to $85,500 a year, according to the Institute for Clinical and Economic Review, a nonprofit that conducted the analysis. This is dramatically less than the current wholesale price of $311,740 for the drug, which patients must take for their entire lives. (Silverman, 4/27)

Bloomberg: Teva Wins Ruling On Patents For Bendeka Cancer Drug
Teva Pharmaceutical Industries Ltd. won a ruling that could keep its cancer drug Bendeka free from generic competition for more than a decade. A federal judge in Delaware on Monday ruled that proposed generic versions of Bendeka by Mylan NV, Fresenius SE’s Fresenius Kabi, closely held Apotex Inc. and Slayback Pharma LLC infringe as many as four Teva patents on the drug, which has generated more than $2 billion in sales since its 2016 launch. (Yasiejko,m 4/27)

Stat: Gilead Sues U.S., Claiming It 'Secretly' Obtained Patents On HIV Research That Led To Truvada
Gilead Sciences (GILD) has accused the U.S. government of breaching several contracts and “secretly” obtaining patents stemming from research that led to the ground-breaking Truvada HIV-prevention pill. In a lawsuit filed late Friday, the drug maker claimed the Centers for Disease Control and Prevention violated the terms of a 15-year-old collaboration by failing to notify the company of patents that were later sought and awarded on the research. (Silverman, 4/26)

Bloomberg: Coronavirus Vaccine News: Sanofi Says Manufacturing A Hurdle
As others squabble over the timing and details of how to develop such a vaccine, Sanofi Chief Executive Officer Paul Hudson points further ahead to the continent’s ability to produce enough to meet demand. "There is less concern about finding a successful vaccine than there is about making the volumes needed,” Hudson told reporters on Friday. “The biggest untold story in Europe right now is the one about the number of doses.” Sanofi is working with rival GlaxoSmithKline Plc to develop a vaccine against the new coronavirus, racing against other pharma giants such as Johnson & Johnson as well as nimbler biotechs such as Moderna Inc. Most of them aim to deliver a shot sometime next year. (Paton, 4/24)