Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. In 2019, Synlogic and Ginkgo Bioworks entered a platform collaboration to support a synthetic bionic medicines pipeline.

Food and Drug Administration 104

Food and Drug Administration FDA Engineering Medicine 104

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

MAY 19, 2023

This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).

Food and Drug Administration 105

Food and Drug Administration FDA Food Patients 105

European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.

Food and Drug Administration 97

Food and Drug Administration FDA Safety Food 97

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. thalassemia.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia thalassemia in adult and paediatric patients. Topic sponsors are not involved in the creation of editorial content.

Food and Drug Administration 98

Food and Drug Administration FDA Food Pharmaceutical 98

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings.

Food and Drug Administration 111

Food and Drug Administration FDA Medicine Government 111

Pharmaceutical Technology

OCTOBER 6, 2022

Oxbryta tablets received accelerated approval from the US Food and Drug Administration (FDA) in November 2019 to treat SCD in adults and children aged 12 years and above. The FDA has granted Orphan Drug and Rare Pediatric Disease designations for these two assets.

Food and Drug Administration 115

Food and Drug Administration FDA Food Pharmaceutical 115

European Pharmaceutical Review

AUGUST 25, 2023

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. In 2019, Sandoz entered into a global commercialisation agreement for Tyruko with Polpharma Biologics. Approval of Tyruko has been granted to Sandoz Inc.

Food and Drug Administration 98

Food and Drug Administration FDA Distribution Food 98

European Pharmaceutical Review

AUGUST 23, 2022

The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019. Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. The post Can Hepatitis C drugs reduce symptoms of PTSD?

Food and Drug Administration 94

Food and Drug Administration Pharmacology Prospecting Medical 94

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

Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Luye Pharma Group’s Rykindo (risperidone) as an extended-release injectable suspension to treat schizophrenia in adult patients. The company stated that the drug is currently being developed in Europe and planned to be launched in more countries and regions worldwide.

Food and Drug Administration 64

Food and Drug Administration FDA Pharma Food 64

European Pharmaceutical Review

JANUARY 26, 2023

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The draft ICH M10 guideline was published for comments in 2019.

Food and Drug Administration 98

Food and Drug Administration Medicine Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 97

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 97

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.

Food and Drug Administration 105

Food and Drug Administration FDA Medical Food 105

European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2019; 380(14):1347-1358. 2019; 16(9):1297-1299. 2023; 44(3):1384-1392.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Pharmaceutical Technology

JULY 26, 2022

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. Natalizumab is developed by Sandoz’s collaboration partner Polpharma Biologics.

Food and Drug Administration 64

Food and Drug Administration FDA Medicine Food 64

European Pharmaceutical Review

JULY 17, 2023

The $82 million project is funded by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. This $85 million programme ran between 2007 and 2019. Continuous manufacturing should also improve the quality of mRNA production through automation and in-line analytics, Braatz noted.

Manufacturing 98

Manufacturing Food and Drug Administration Engineering Biopharma 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

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Pharmacopoeia guidance on DEG and EG. The Lancet.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Food 105

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.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

Pharmaceutical Technology

APRIL 25, 2023

Cidara Therapeutics announced the receipt of a $20m milestone payment from Melinta Therapeutics following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA.

Food and Drug Administration 52

Food and Drug Administration FDA Food Medicine 52

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

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

MAY 19, 2023

The US Supreme Court has unanimously voted in favour of Sanofi and Regeneron in a years-long legal feud with Amgen over the potential patent infringement surrounding the companies’ anti-cholesterol drugs. This marks a milestone in the dispute nearly a decade after the first lawsuit filed by Amgen against the two companies.

Food and Drug Administration 59

Food and Drug Administration Food FDA Pharma 59

European Pharmaceutical Review

OCTOBER 19, 2023

One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. This is not an effective strategy.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Side effects Doctors 105

Pharmaceutical Technology

APRIL 12, 2023

The latest shipment is based on an exclusive licence agreement signed in 2019 between Pharming and Novartis. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients.

Food and Drug Administration 59

Food and Drug Administration Patients Food FDA 59

European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. Thus, LAMP assays, combined with DNA extraction by boiling, can be used as effective methods to detect BCC strains found in drug ingredients, pharmaceutical-grade water, and finished pharmaceutical products.”.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical products Pharmaceutical Pharmaceutical manufacturing 98

European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

FDA 52

FDA Food and Drug Administration Medicine Prospecting 52

MedCity News

JUNE 12, 2023

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence.

Food and Drug Administration 104

Food and Drug Administration Prescription Government FDA 104

Pharmaceutical Technology

MAY 12, 2023

In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year. The US FDA granted breakthrough therapy designation to bentracimab in 2019.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical FDA Specialization 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

NOVEMBER 1, 2022

In May 2022, the US Food and Drug Administration (FDA) granted orphan drug designation for selinexor in MF indication. In July 2019, the FDA approved Xpovio for treating relapsed or refractory multiple myeloma in adult patients. The therapy is commercialised in the US as Xpovio.

Food and Drug Administration 52

Food and Drug Administration FDA Medicine Food 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