Pharmaceutical Technology

JUNE 12, 2023

In 2022, the FDA awarded VX-548 breakthrough therapy and fast-track designations for post-operative pain, and the drug is forecast to reach sales of $416m by 2029. Currently, Jazz Pharmaceuticals’s nabiximols is the only cannabinoid approved for pain, receiving approval in Israel, in August 2010.

Medical 143

Medical Prescription Management Manufacturing 143

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Food and Drug Administration 98

Food and Drug Administration Marketing FDA Pharmaceutical 98

Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

Pharmaceutical 97

Pharmaceutical Doctors Healthcare Provider Prescription 97

Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. Of those 131 approved FDCs, 98 were oral dosage forms.

Manufacturing 52

Manufacturing Physicians Prescription Pharmaceutical 52

Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Biosimilars with this designation are beneficial to payers as they eliminate the need for another prescription, she explains An interchangeable biosimilar can be automatically substituted for Humira at a pharmacy, Bhat adds.

Marketing 104

Marketing Physicians Competition Patients 104

Pharmaceutical Technology

MAY 29, 2008

Important elements within this expectation are the build up of strong contributions from Rotarix, Cervarix and Tykerb, while the outlook for GSK’s important asthma franchise becomes less clear beyond 2010. PT: Glaxo shares have fallen 17% in the past year. .

Pharmaceutical 40

Pharmaceutical Marketing Sales Prescription 40