European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Safety Food and Drug Administration FDA Side effects 59

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts.

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Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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European Pharmaceutical Review

DECEMBER 12, 2023

The US Food and Drug Administration (FDA) has approved two landmark cell-based gene therapies for treatment of inherited blood disorder sickle cell disease. Developed by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first FDA-approved therapy to use CRISPR/Cas9 genome editing technology.

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Food and Drug Administration FDA Safety Food 105

World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. The issue continues to be “do patients, and caregivers understand the risk?”

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European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Overall, the data showed that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.

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Food and Drug Administration FDA Food Patients 119

European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

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MedCity News

JUNE 22, 2022

The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning of medical device remanufacturing and empower the FDA to educate company technicians so they know if they’ve crossed the line into a regulated activity. .

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European Pharmaceutical Review

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel; beti-cel), the first cell-based gene therapy for the treatment of adult and paediatric patients with beta-thalassemia who require regular red blood cell transfusions. .

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European Pharmaceutical Review

DECEMBER 18, 2023

After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 A second study led by Yvan Beaussant from the Dana-Farber Cancer Institute that gathered input from patients in the trial during exit interviews. Participants involved in the trial had moderate to severe depression scores at baseline.

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Food and Drug Administration Patients Side effects Safety 116

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.” Like Stelara, the most serious known side effect of Wezlana is infection.

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Food and Drug Administration FDA Side effects Safety 98

World of DTC Marketing

JUNE 24, 2021

Safety pages on Pharma product websites continue to have high utility. Patient behavior has changed during the pandemic as Google has shown that more are going online for health information. Patient behavior has changed during the pandemic as Google has shown that more are going online for health information.

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Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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Food and Drug Administration FDA Side effects Safety 98

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. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? Nowhere to be seen.

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FDA Food and Drug Administration Patients Biopharma 207

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. the patient population, product being studied, therapeutic area, and trial phase. home health visits).

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FDA Food and Drug Administration Safety Medicine 104

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. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”

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Food and Drug Administration FDA Safety Food 105

pharmaphorum

JUNE 27, 2022

The safety of Astellas’ gene therapy portfolio has been thrust into the spotlight once again, after the FDA placed a clinical hold on a trial of its Pompe disease candidate AT845. The post Another Astellas gene therapy hits a safety hurdle appeared first on.

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European Pharmaceutical Review

MARCH 20, 2024

The US Food and Drug Administration (FDA) has approved gene therapy Lenmeldy (atidarsagene autotemcel) as the first treatment for children with early-onset metachromatic leukodystrophy (MLD). Deficiency of the enzyme arylsulfatase A (ARSA) and subsequent buildup of sulfatides in the cells is considered to cause MLD, FDA elucidated.

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PharmExec

JULY 26, 2024

The study is expected to evaluate the safety of Iomab-ACT in sickle cell disease patients who are undergoing allogeneic bone marrow transplants.

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Pharmaceutical Technology

JUNE 6, 2023

American Regent and Daiichi Sankyo have announced that the INJECTAFER (ferric carboxymaltose injection) has received approval from the US Food and Drug Administration (FDA) to treat iron deficiency in adult patients with heart failure. It is also indicated for IDA adult patients with non-dialysis-dependent chronic kidney disease.

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Food and Drug Administration Patients FDA Food 52

European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The study involves patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods.

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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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. The median OS in patients on quizartinib was 31.9

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Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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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. In these subjects, the median progression-free survival (PFS) following Enhertu treatment was 9.9

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Food and Drug Administration FDA Safety Food 105

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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European Pharmaceutical Review

OCTOBER 25, 2022

AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combination therapy has been approved in the US for adult patients with unresectable hepatocellular carcinoma (HCC). Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. p=0.0035).

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy. to treat the signs and symptoms of dry eye disease.

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European Pharmaceutical Review

JANUARY 30, 2023

Jaypirca (pirtobrutinib) has been approved by the US Food and Drug Administration (FDA), making it the first and only FDA-approved non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor. The safety of Jaypirca was evaluated in 128 patients with MCL: 36 percent were exposed for six months or longer.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). Furthermore, the favourable pharmacokinetic, safety and tolerability profile of REL-1017 was in line with data reported in prior Phase I trials.

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Food and Drug Administration FDA Safety Food 119

Infuse Medical

JULY 4, 2024

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. Let’s see FDA regulations for medical device training. This is to ensure safety and effectiveness.

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Training Medical FDA Food and Drug Administration 52

Pharmacy Times

MAY 2, 2024

Currently, the treatment is being evaluated in the phase 3 CALYPSO study to further prove the safety and efficacy in patients with hypoparathyroidism.

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Pharmaceutical Technology

JULY 1, 2022

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. We look forward to working with the FDA toward full regulatory approval for Paxlovid.”. “We

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Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

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European Pharmaceutical Review

DECEMBER 2, 2022

has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Clinical safety data of Rezlidhia for AML. Rigel Pharmaceuticals, Inc.

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