麻豆女优

Skip to main content

The independent source for health policy research, polling, and news.

Subscribe Follow Us
  • Trump 2.0

    Trump 2.0

    • Agency Watch
    • State Watch
    • Rural Health Payout
  • Public Health

    Public Health

    • Vaccines
    • CDC & Disease
    • Environmental Health
  • Audio Reports

    Audio Reports

    • What the Health?
    • Health Care Helpline
    • 麻豆女优 Health News Minute
    • An Arm and a Leg
    • Health Hub
    • HealthQ
    • Silence in Sikeston
    • Epidemic
    • See All Audio
  • Special Reports

    Special Reports

    • Bill Of The Month
    • The Body Shops
    • Broken Rehab
    • Deadly Denials
    • Priced Out
    • Dead Zone
    • Diagnosis: Debt
    • Overpayment Outrage
    • Opioid Settlement Tracking
    • See All Special Reports
  • More Topics

    More Topics

    • Elections
    • Health Care Costs
    • Insurance
    • Prescription Drugs
    • Health Industry
    • Immigration
    • Reproductive Health
    • Technology
    • Rural Health
    • Race and Health
    • Aging
    • Mental Health
    • Affordable Care Act
    • Medicare
    • Medicaid
    • Children’s Health

  • Emergency Room Boarding
  • Device Coverage by Medicare
  • Planned Parenthood Funding
  • Covid/Flu Combo Shot
  • RFK Jr. vs. Congress

TRENDING TOPICS:

  • Emergency Room Boarding
  • Device Coverage by Medicare
  • Planned Parenthood Funding
  • Covid/Flu Combo Shot
  • RFK Jr. vs. Congress

Morning Briefing

Summaries of health policy coverage from major news organizations

  • Email

Tuesday, Jan 5 2016

Full Issue

In 2015, First-Of-A Kind Drug Approvals On The Rise

This trend reflected an industry-wide focus on drugs for rare and hard-to-treat diseases. Meanwhile, Gilead's hepatitis C combo drug gets a Food and Drug Administration priority review, a gene-editing drug maker files for an IPO and some testing of another drug is suspended.

Approvals for first-of-a-kind drugs climbed last year, pushing the annual tally of new U.S. drugs to its highest level in 19 years. The rising figures reflect an industry-wide focus on drugs for rare and hard-to-treat diseases, which often come with streamlined reviews, extra patent protections and higher price tags. (Perrone, 1/4)

Gilead Sciences Inc. said the U.S. Food and Drug Administration granted a priority review of its experimental hepatitis C combination drug. The Foster City, Calif., drugmaker filed a new drug application for the treatment鈥攁 combination of the biopharmaceutical company鈥檚 Sovaldi with velpatasvir鈥攊n late October. The FDA is expected to decide whether to approve the combination therapy by June 28. (Stynes, 1/4)

Editas Medicine Inc., the drugmaker whose backers include Bill Gates and Google Ventures, filed to become the first publicly traded company to specialize in a new technology to edit flaws in genes. The company, which uses a gene-editing technique called Crispr, filed Monday for the IPO with an initial size of $100 million. That鈥檚 a placeholder amount used to calculate fees and will probably change. (Chen and Barinka, 1/4)

Teva Pharmaceutical Industries Ltd. and Active Biotech AB said Monday they were ending the higher-dose portions of two multiple-sclerosis studies with the drug Laquinimod after eight patients suffered nonfatal cardiovascular events. The companies said the incidents occurred in the higher-dose components of a phase 3 and a phase 2 clinical trial. The lower-dose and placebo components of the tests will continue. (Hufford, 1/4)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
Newsletter icon

Sign Up For Our Newsletter

Stay informed by signing up for the Morning Briefing and other emails:

Recent Morning Briefings

  • Today, April 27
  • Friday, April 24
  • Thursday, April 23
  • Wednesday, April 22
  • Tuesday, April 21
  • Monday, April 20
More Morning Briefings
RSS Feeds
  • Podcasts
  • Special Reports
  • Morning Briefing
  • About Us
  • Republish Our Content
  • Contact Us

Follow Us

  • RSS

Sign up for emails

Join our email list for regular updates based on your personal preferences.

Sign up
  • Editorial Policy
  • Privacy Policy

漏 2026 麻豆女优