European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105

FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 105

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

FDA 98

FDA Food and Drug Administration Medical Food 98

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?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The regulatory approval was based on the findings from the pivotal Phase III REST-ON clinical trial completed in March 2020.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical Specialization Food 98

Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

European Pharmaceutical Review

APRIL 12, 2024

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. Of note, between 2020 to 2022, there was a “remarkable surge” in deal worth.

Food and Drug Administration 104

Food and Drug Administration Medicine Food Pharmaceutical 104

pharmaphorum

NOVEMBER 2, 2022

The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. RelieVRx became the first FDA-authorised treatment for pain delivered at the patient’s home through virtual reality (VR) in November 2021.

Food and Drug Administration 135

Food and Drug Administration Food Patients FDA 135

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

Food and Drug Administration 141

Food and Drug Administration Pharmacology Side effects Physicians 141

Pharmaceutical Technology

JANUARY 16, 2023

In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.

Medicine 119

Medicine Food and Drug Administration Food Medical 119

European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA). Novartis continues to discuss the STAND results with the FDA and other health authorities.

Marketing 98

Marketing Food and Drug Administration Medicine FDA 98

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.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Food Medicine 98

European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

Food and Drug Administration 122

Food and Drug Administration Medical Medicine Engineering 122

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

JANUARY 29, 2024

In reviewing both the revised ISO standard and FDA study discussed, it is clear robust evaluation of toxicological substances such as extractables and leachables remain a key part of device-drug combination product and medical device safety assessments.

Food and Drug Administration 98

Food and Drug Administration Medical Safety Food 98

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Distribution 52

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

Pharmaceutical Technology

MAY 2, 2023

Avadel Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for LUMRYZ to treat cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. It has also secured orphan drug exclusivity from the FDA until 1 May 2030.

Food and Drug Administration 52

Food and Drug Administration FDA Food Pharmaceutical 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

Food and Drug Administration 52

Food and Drug Administration Biopharma FDA Food 52

Pharmaceutical Technology

MARCH 22, 2023

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. In recent times, various global administrators have issued regulatory standards. In 2020, Fresenius Kabi introduced their first RFID-enabled medication, Diprivan +RFID.

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma Pharmaceutical products 105

Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. It was also granted Orphan Drug Designation during the same time.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

MAY 24, 2023

Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). In July 2020, the US Food and Drug Administration (FDA) also granted orphan drug designation to INO-3107.

Food and Drug Administration 52

Food and Drug Administration Medicine Food Marketing 52

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 131

Medicine Food and Drug Administration Doctors Medical 131

European Pharmaceutical Review

JANUARY 19, 2023

Currently close to 80 percent of participants in clinical research trials are white, according to the Food and Drug Administration (FDA). To address this issue, the BMSF created the Winn Award Program in 2020 as part of its commitment to health equity, inclusion and diversity.

Food and Drug Administration 98

Food and Drug Administration Physicians Medicine Food 98

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.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

Food and Drug Administration 52

Food and Drug Administration Manufacturing Food FDA 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). US Food and Drug Administration. Available from: [link].

Food and Drug Administration 96

Food and Drug Administration Medicine Safety Food 96

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

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

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. NaviBot is subsidiary of MicroPort MedBot. About MicroPort MedBot Shanghai MicroPort MedBot (Group) Co.,

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 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

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). GlobalData is the parent company of Pharmaceutical Technology.

Patients 98

Patients Food and Drug Administration Sales Marketing 98

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

Food and Drug Administration 59

Food and Drug Administration Physicians Competition FDA 59

Pharmaceutical Technology

FEBRUARY 6, 2023

The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB.

Food and Drug Administration 59

Food and Drug Administration Food Medicine FDA 59

Pharmaceutical Technology

MAY 30, 2023

The US Food and Drug Administration (FDA) is currently reviewing a biologic licence application (BLA) for the vaccine candidate under priority review. The FDA awarded fast track designation for VLA1553 in 2018, and breakthrough therapy designation in 2021. Valneva plans to make further regulatory submissions.

Food and Drug Administration 52

Food and Drug Administration FDA Medicine Food 52

Pharma Leaders

JUNE 27, 2023

Jesduvroq (daprodustat) tablets received approval from the US Food and Drug Administration (FDA) in February this year to treat CKD-caused anaemia in adults on dialysis for a minimum of four months.

Food and Drug Administration 52

Food and Drug Administration Medicine Food Safety 52