Pharma Leaders

JUNE 27, 2023

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Pfizer obtained the licence for gene therapy from Spark Therapeutics in December 2014.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Engineering 52

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. The difference is that purified water can be used for non-parenteral drugs, while WFI must be used for parenteral drugs.

Food and Drug Administration 98

Food and Drug Administration Pharma Manufacturing Pharmaceutical 98

Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

Food and Drug Administration 52

Food and Drug Administration Side effects Prospecting FDA 52

European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

JUNE 8, 2023

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. 1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. The AIs for NNN and NNK are 96.0 Internet] NHS Digital.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug. The plant is set to be operational before the end of 2023.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Medicine Pharma 105

Pharmaceutical Technology

MARCH 30, 2023

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. The drug is approved in several indications, including advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and relapsed classical Hodgkin lymphoma (cHL). billion in 2028.

Food and Drug Administration 52

Food and Drug Administration FDA Sales Food 52

European Pharmaceutical Review

JULY 26, 2024

DURVEQTIX was approved by the US Food and Drug Administration (FDA) for haemophilia B as BEQVEZ TM in April this year. The pharmaceutical company licensed the gene therapy DURVEQTIX from Spark ® Therapeutics in December 2014.

Food and Drug Administration 52

Food and Drug Administration Engineering Food Patients 52

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. When the balloon reaches a sufficient pressure, this pushes the dissolvable needle into the intestinal wall, delivering the drug payload.”

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

Legacy MEDSearch

FEBRUARY 10, 2023

Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head. Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., Catalyst OrthoScience Inc. About Catalyst OrthoScience Inc. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. 1,2 The second occurrence of NDMA arising from degradation was in metformin drug product. FDA assigned a provisional AI of 26.5

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical FDA Medicine 98

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

Food and Drug Administration 119

Food and Drug Administration Medicine Food Government 119

Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. In an email to this news service, Dr.

Food and Drug Administration 52

Food and Drug Administration Prescription FDA Medical 52

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration approved Boehringer Ingelheim and Eli Lilly’s oral medicines Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) to manage blood sugar in children with type 2 diabetes (T2D) aged ten years or older. in the placebo group.

Medicine 59

Medicine FDA Food and Drug Administration Sales 59

World of DTC Marketing

MAY 6, 2021

Some say pharma should be allowed to make as much as they want because we live in a capitalist society but JAMA recently found out that price increases in branded drugs means that people will often go without their medications. But what about the costs to develop new drugs and the failure rates?

Pharma 185

Pharma Food and Drug Administration Government Insurance 185