FDA’s Record Year: Agency That Has Long-Promised To Pick Up Drug Approval Pace Reaches Milestone
The agency just hit its 46th approval of 2017, the most in at least a decade. But more than one year of data is needed to predict a trend. In other pharmaceutical news: a judge will rule on hospitals' efforts to block cuts to the 340B drug program; Biogen's Alzheimer's trial has disappointing results; a look at the most noteworthy drug approval of the years; and more.
Stat:
The FDA Has Had A Banner Year For Drug Approvals
The FDA just broke a recent record for most new drug approvals in a year, hitting a not-entirely meaningful (but not altogether meaningless) milestone for an agency that has long promised to pick up the pace. With today’s green light of La Jolla Pharmaceutical Company’s Giapreza, a treatment for dangerously low blood pressure, the FDA hit 46 approvals for the year. That’s the most in at least a decade. (Garde, 12/21)
Stat:
Judge Promises To Rule Quickly On Cuts To Drug-Discount Program For Hospitals
A federal judge promised to rule on hospitals’ efforts to block a looming Trump administration policy that will slash $1.6 billion in Medicare payments before the cut is set to take effect Jan. 1. Judge Rudolph Contreras pledged to issue the speedy decision after American Hospital Association lawyers sparred for nearly two hours Thursday with government attorneys in the first public hearing on cuts to the so-called 340B program in a case before the U.S. District Court for the District of Columbia. (Mershon, 12/21)
Stat:
Biogen Shares Drop After Alzheimer’s Drug Trial Setback
Shares of Biogen (BIIB) dropped more than 3 percent Thursday after the Cambridge, Mass., biotech reported that an experimental Alzheimer’s drug it’s co-developing with a Japanese company showed disappointing results in a mid-stage clinical trial. But the setback affects only one of a half-dozen compounds Biogen is developing to target Alzheimer’s disease, the memory-ravaging neurodegenerative disorder that is expected to affect about one in nine baby boomers and cost the nation $1 trillion by 2050. (Weisman, 12/21)
Stat:
Pioneering Cancer Therapy Makes Two CAR-T Drugs The Approvals Of The Year
This biopharma superlative is a no-brainer: The most noteworthy drug approval of the year goes, hands-down, to the two CAR-T drugs that hit the market earlier this year. Kymriah, from Novartis (NVS), was approved in late August, with a price tag set at $475,000. And Yescarta, developed by Kite Pharma and acquired by Gilead Sciences (GILD), was approved in October, with a $373,000 set price. Both work with just a single infusion. (Keshavan, 12/22)
Stat:
Roche Is Buying Biotech Firm Ignyta And Its Experimental Lung Cancer Drug For $1.7 Billion
Swiss pharma giant Roche (RHHBY) is buying the smaller U.S. biotech firm Ignyta (RXDX) for $1.7 billion in cash, picking up an experimental pill in the late stage of development that targets lung cancer caused by a rare gene defect. Ignyta is being acquired for $27 per share, the companies said Friday. That’s a 74 percent premium to Ignyta’s closing price on Thursday. Roche aims to close the deal in the first half of 2018. (Feuerstein, 12/22)
Bloomberg:
‘I Am Going To Die Without This’: Regulators Target A Health-Care Lifesaver
Like hundreds of thousands of Medicare patients who can’t afford the copays on astronomically priced drugs, [Irene] Adkins has turned to help from a fast-growing corner of the convoluted U.S. health system: patient assistance charities, which are funded almost entirely by drugmaker contributions and help Medicare patients with out-of-pocket expenses. Now that help is in peril. For the past two years federal regulators have issued subpoenas and scrutinized relationships between drug companies and the charities, which are supposed to operate independently from industry donors. In November the U.S. Department of Health and Human Services yanked its approval from one charity, Caring Voice Coalition Inc., which gave $129 million in aid to tens of thousands of patients in 2016. Caring Voice now says it may not be able to help patients next year. It plans to announce its decision about its future in January. (Langreth and Elgin, 12/21)
Kaiser Health News:
Arthritis Drugs Show How U.S. Drug Prices Defy Economics
Renda Bower knows well the cost of drugs to treat rheumatoid arthritis – her husband, son and daughter all have the painful, disabling autoimmune disease. And the family’s finances revolve around paying for them. Even with insurance, Bower’s family last year faced $600 a month in copayments for the drug, plus additional payments on another $16,000 in medical bills racked up in 2016 when a former insurer refused to cover all the doses her 9-year-old daughter needed. (Appleby, 12/22)
Kaiser Health News:
Biosimilars, Biologics And New Legal Challenges For RA Treatments
Early last winter, Pfizer launched its new rheumatoid arthritis treatment, Inflectra, pricing it 15 percent below the $4,000-a-dose wholesale price of Remicade, the drug for which it is a close copy. Pfizer figured its lower price would attract cost-conscious insurers. A year later, though, its drug has barely scratched the market and Pfizer has filed an antitrust suit against its rivals, alleging they are thwarting lower-priced competition through “exclusionary contracts” and rebates. (Appleby, 12/22)
The Associated Press:
California Court Exposes Drug Makers To Additional Liability
A sharply divided California Supreme Court ruled Thursday that pharmaceutical companies can be held liable for warning labels on generic versions of drugs they once made even after they've sold the drugs to other companies and stopped manufacturing them. The 4-3 decision was a victory for consumer advocates, but the pharmaceutical industry had argued that such a finding would stifle innovation and lead to extraneous warnings on drugs that could deter people from using them. (Thanawala, 12/21)
