article thumbnail

STAT+: Pharmalittle: We’re reading about a Merck drug-label controversy, Astellas pulling an application, and more

STAT

The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. At issue is a medicine called posaconazole that was approved in 2006 in the U.S. At issue is a medicine called posaconazole that was approved in 2006 in the U.S.

article thumbnail

STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

STAT

The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. At issue is a medicine called posaconazole that was approved in 2006 in the U.S. And the company has refused to update the language. but is now also sold by generic companies.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

RFID: The future of smart labelling?

Pharmaceutical Technology

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain.

Labelling 105
article thumbnail

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

The FDA Law Blog

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

article thumbnail

Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

We asked them to explain how the company has integrated its isotopic labeling and human ADME testing services to help streamline the drug development process and accelerate the time it takes to get drugs to market. How are human ADME studies designed? How does your unique Synthesis-to-Clinic® offering streamline the drug development process?

article thumbnail

AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

pharmaphorum

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. In September last year Mylan and Kindeva argued in the trial that each asserted patent claim is invalid under US patent laws.

article thumbnail

Sanofi extends its Pompe range with first Nexviazyme OK

pharmaphorum

Myozyme was first to market in 2006 for infantile-onset Pompe, with Lumizyme reaching the market four years later to treat late-onset Pompe in children aged over eight. In 2010, Lumizyme’s label was expanded to the under-right group as well.

FDA 98