article thumbnail

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. He went to our site to discover that brand-name Livalo ( pitavastatin ). and arguably just as safe.

article thumbnail

Biosimilars: a rapidly maturing market

pharmaphorum

This is where biosimilars can step in: a biosimilar is defined as a biologic medical product that is highly similar or is an almost identical copy of an original, branded, product. The short story so far. Bright future for biosimilars.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

Eban’s greatest concern is with generic drugs, she hints at potential problems with brand name drugs as well, since the active pharmaceutical ingredients that go into all these medications are made in India and China, where manufacturing problems are greater, relative to the U.S. This is the heart of FDA’s mission. drug supply.

article thumbnail

Trans Healthcare: How Pharma Marketers Can Positively Impact This Underserved Community

Intouch Solutions

It, like the Nightingale Pledge for nurses, is a list of tenets that physicians abide by to uphold certain morals and to ensure healthcare professionals (HCPs) provide top-quality care to all who seek it. “I The reasons vary, but one of the most recent shortages of synthetic estrogen has largely been chalked up to a delay in FDA approval.

article thumbnail

Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Biogen’s nusinersen (brand name Spinraza) is an antisense oligonucleotide (ASO) therapy that is administered directly into the CNS by intrathecal injection through lumbar puncture. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. Nusinersen: A Landmark Therapy.

Trials 83
article thumbnail

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

article thumbnail

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. .