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.

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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.

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Food and Drug Administration Engineering Food Patients 52

European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The organisation considers collaboration will advance scientific discovery, clinical advances and training.

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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. .

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Pharmaceutical Technology

APRIL 18, 2023

The company has launched 19 new medicines since 2014, including Jaypirca, which was approved by the US Food and Drug Administration in January 2023 to treat mantle cell lymphoma. The new facilities will also support the company’s efforts to manufacture new therapeutic modalities, including genetic medicines.

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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”. References Smoking, Drinking and Drug Use among Young People in England, 2021. The harmful effects of smoking are well known, causing more avoidable deaths than any other single cause.

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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.

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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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

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.

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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.”

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European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

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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.”

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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.

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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.

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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. Available from: [link] 4. J Pharm Sci.

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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.

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Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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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?

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