European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. In conclusion, it is clear US and UK regulators are working to streamline guidelines to ensure the quality and thus safety of medical devices that are made available.

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Medical Manufacturing Food and Drug Administration Safety 104

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions.

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Manufacturing Food and Drug Administration Patients Pharma 104

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

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FDA Food and Drug Administration Patients Biopharma 207

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?

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Marketing Food and Drug Administration Medicine Prescription 103

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.

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Food and Drug Administration Medicine Food Government 119

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Food and Drug Administration Manufacturing Management Product Knowledge 98

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 105

Medical Food and Drug Administration Manufacturing Safety 105

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? This higher threshold, although not explicit, would also be expected to slow drug approvals.

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Food and Drug Administration Food FDA Safety 40

European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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Food and Drug Administration Manufacturing Food Medicine 98

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The vaccine showed an encouraging safety and tolerability profile in both trials.

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Food and Drug Administration FDA Engineering Food 105

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label.

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Food and Drug Administration Manufacturing FDA Medicine 52

Pharmaceutical Technology

NOVEMBER 7, 2022

Leveraging its cell expansion and activation technology as well as cell manufacturing capabilities, the company can extend NK cells while substantially boosting cytotoxicity across peripheral blood-derived products. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.

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Food and Drug Administration Food Networking Safety 98

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The approval is also accompanied by labelling with safety warnings.

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Food and Drug Administration Medicine FDA Food 98

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . In addition, the safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported.

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Food and Drug Administration Patients Safety Food 98

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

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Medicine Food and Drug Administration FDA Pharmaceutical 111

Pharmatutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 98

European Pharmaceutical Review

JUNE 29, 2023

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. Lonza and Vertex to partner to manufacture diabetes cell therapies The post First cell therapy approved for Type 1 diabetes appeared first on European Pharmaceutical Review.

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Food and Drug Administration FDA Food Education 98

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. These] data give us confidence to move forward with multiple programmes in parallel…and to expand manufacturing scale-up,” shared Imran. “We

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Food and Drug Administration Manufacturing Safety Pharmaceutical 105

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Pharmaceutical Food and Drug Administration Medicine Patients 96

pharmaphorum

DECEMBER 9, 2022

The achievement of the primary endpoint (PDF) milestone triggers a $35 million payment from Blackstone Life Sciences, Autolus also announcing an additional $35 million from Blackstone as a result of the completion of planned activities supporting the obe-cel manufacturing process. months) to the data observed in the prior ALLCAR19 study.

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Food and Drug Administration Safety Biopharma Patients 98

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Food and Drug Administration Pharmaceutical Food Side effects 98

Pharmaceutical Technology

MARCH 22, 2023

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs.

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Food and Drug Administration Electronics Pharma Pharmaceutical products 105

Evolve Your Success

APRIL 23, 2025

Most other civilized countries the government actually negotiates with pharma, drugs, medical equipment and so forth and get a discount as a result of all of their patients. This is an episode you don’t want to miss. Sure, and I would say insurance is more important in the United States than it probably is anywhere else in the world.

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Medical sales Sales Medical Healthcare 130

European Pharmaceutical Review

AUGUST 28, 2023

Potential of inclisiran for lowering LDL-C These findings “reconfirm and extend prior observations about the safety profile and efficacy of inclisiran for people with ASCVD and those at risk of cardiovascular disease, in whom cholesterol levels are not adequately controlled,” Dr Ray explained.

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Food and Drug Administration Patients Consulting Food 98

PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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Pharma Food and Drug Administration Medicine Government 105

European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. As a result of the rate of contamination events, simple and rapid detection of BCC in non-sterile pharmaceutical products is critical to ensure consumer safety. Daddy Gaoh et al.

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Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

pharmaphorum

JANUARY 30, 2023

The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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Food and Drug Administration Medicine Manufacturing Pharmaceutical 104

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. While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). The company stated that the Phase I/IIa trial will thoroughly evaluate the therapy’s clinical efficacy and safety.

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Food and Drug Administration FDA Food Safety 59

Pharma Leaders

MAY 1, 2023

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. The FDA also did not request for new preclinical or Phase III clinical trials for assessing efficacy or safety.

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Food and Drug Administration FDA Safety Food 52

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe.

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Medical FDA Food and Drug Administration Recruitment 98

European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing and supply of drug substance.

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Food and Drug Administration Medicine Distribution Food 59

Pharmaceutical Technology

JUNE 14, 2023

The agreement covers rights for the development, manufacture and commercialisation of NOV03 in the country. The therapy has shown efficacy and safety in trials for patients with a history of dry eye disease and clinical Meibomian gland dysfunction. to treat dry eye disease.

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Food and Drug Administration Pharmaceutical Safety Prescription 52