STAT

NOVEMBER 16, 2023

Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S.

FDA 125

FDA 125

Med Ed 101

JUNE 4, 2017

The CMS F-tag, F-329 Unnecessary Medications tag is by far (in combination with F-428) the most common survey deficiency that a consultant pharmacist can help a facility avoid. The F-tags have been changed, get the update at LTCPHARMD.com – my […].

Nursing Homes 40

Nursing Homes 40

Pharmaceutical Technology

NOVEMBER 9, 2022

On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application. million price tag. The post Can gene therapies for haemophilia defend their high price tags?

FDA 111

FDA 111

pharmaphorum

DECEMBER 12, 2022

Vyvgart is already approved to treat generalised myasthenia gravis, getting a green light for that indication from the FDA a year ago, and launched with a $225,000 per annum price tag in competition with rival gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

Immunization 52

Immunization Labelling FDA 52

pharmaphorum

NOVEMBER 27, 2022

Highly exact data monitoring and modular set ups will one day allow production facilities to switch between producing a number of similar products, or alike products that use ingredients from different suppliers in minutes. This means batch sizes can be tailored to daily demands rather than market forecasts.

Communication 105

Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

Pharmaceutical Technology

MAY 2, 2023

IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000. Patients and healthcare facilities across markets often experience difficulties getting these agents reimbursed. Cost-related unmet needs also scored highly.

Immunization 52

Immunization Vaccines 52

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

Labelling 105

Labelling Data Entry Communication FDA 105