European Pharmaceutical Review

FEBRUARY 4, 2025

This targeted approach has been shown to enhance the effectiveness of existing treatments, helping to improve patient outcomes while maintaining a manageable safety profile. Regulatory approval and NHS access The MHRAs decision follows similar approvals from the European Commission and the US Food and Drug Administration (FDA).

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

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Patients FDA Doctors Physicians 200

PharmExec

AUGUST 4, 2022

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

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Food Safety 88

Infuse Medical

JULY 4, 2024

Do you know the FDA is the Food and Drug Administration? Brief Introduction to Key FDA Regulatory Requirements The Food and Drug Administration plays an important role in ensuring the safety of medical devices in the United States. This is to ensure safety and effectiveness. They are Class I, Class II, and Class III.

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Training Medical FDA Food and Drug Administration 130

World of DTC Marketing

APRIL 12, 2021

We need a 21st-century approach that puts patient safety first. The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety.

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Food and Drug Administration Prescription Pharma Manufacturing 187

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

Pharmacy Times

MAY 15, 2024

Under the modification to the Food, Drug, & Cosmetics Act, individuals and health care providers can hopefully have more confidence in in vitro diagnostic devices.

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Safety Food FDA 57

World of DTC Marketing

NOVEMBER 27, 2020

Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases , which contained the highly promising news that both vaccines were 90 percent effective or more and have not presented any serious safety concerns. The results of trials were announced in press releases rather than peer-reviewed papers.

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World of DTC Marketing

APRIL 15, 2021

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. And while there’s concern that the Covid-19 vaccines were rushed and that that means they haven’t been properly vetted or that their safety is otherwise in question, it’s simply not the case.

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Food and Drug Administration Government Safety Manufacturing 203

European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

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Manufacturing Food and Drug Administration Engineering Safety 145

European Pharmaceutical Review

MAY 22, 2024

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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Medicine Leads Food and Drug Administration Safety 93

European Pharmaceutical Review

NOVEMBER 19, 2024

This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals. The US Food and Drug Administration (FDA) approved Novartis’ Pluvicto (lutetiumlutetium Lu 177 vipivotide tetraxetan) in 2022. “Radioligand therapies hold transformative potential for certain forms of cancer.”

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Food and Drug Administration Manufacturing Food Safety 52

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

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. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients. All but one patient in the trial received a single dose of Caldolor.

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Food and Drug Administration FDA Side effects Safety 98

World of DTC Marketing

FEBRUARY 4, 2021

The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

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Pharma Food and Drug Administration Side effects Safety 180

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

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European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. No unexpected safety findings were observed in PSMAfore. The data is consistent with the safety profile of Pluvicto.

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Food and Drug Administration Safety Food Medical 105

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. Additionally, patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate each product’s safety and effectiveness. This outcome was achieved by 93.5

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Food and Drug Administration FDA Safety Food 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. It also achieved non-inferiority of MACE compared to ESA control, in the primary safety analysis of the ITT population.

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Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

OCTOBER 25, 2022

The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. The safety profiles for both Imjudo added to Imfinzi and for Imfinzi on its own were consistent with previous data for the medications. No new safety precautions were identified.

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European Pharmaceutical Review

NOVEMBER 21, 2022

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). The first bioengineered HFpEF human heart models.

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Food and Drug Administration Food Safety Patients 139

Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

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Food and Drug Administration FDA Safety Medicine 98

Pharmaceutical Technology

JUNE 29, 2022

Safety observations were in line with Yescarta’s known safety profile. In April this year, the US Food and Drug Administration (FDA) granted approval for Yescarta for adult patients with large B-cell lymphoma. The median duration of response (DoR) was reported to be 38.6 In the trial, 6% of the subjects had Grade ?3

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Food and Drug Administration Safety Food Patients 111

Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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Food and Drug Administration FDA Safety Prescription 98

European Pharmaceutical Review

JULY 25, 2022

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

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European Pharmaceutical Review

APRIL 17, 2024

Roche explained that additional data offered further evidence on the safety profile of OCREVUS SC injection. It was consistent with the safety profile of OCREVUS IV infusion, the findings revealed. No new safety signals were identified for OCREVUS SC.

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Food and Drug Administration Safety Medicine Food 93

European Pharmaceutical Review

OCTOBER 24, 2023

PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides the broadest serogroup coverage of any meningococcal vaccine available in the US for meningococcal disease in individuals aged 10 to 25 years old, has been approved by the US Food and Drug Administration (FDA). About PENBRAYA?

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Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Eli Lilly and Company ’s tirzepatide to treat adults with obesity or overweight with weight-associated comorbidities. .

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Food and Drug Administration FDA Safety Food 104

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin.

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Food and Drug Administration FDA Safety Food 98

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.

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Food and Drug Administration FDA Safety Food 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. 7 The frequency of these issues prompts the question of why the Indian regulatory authorities are not policing this area of GMP and patient safety more effectively.

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Food and Drug Administration Manufacturing Safety Food 105

European Pharmaceutical Review

JANUARY 19, 2023

About the IMbrave050 study IMbrave050 is a Phase III global, multicentre, open-label, randomised study evaluating the efficacy and safety of adjuvant Tecentriq ® plus Avastin, compared with active surveillance, in people with hepatocellular carcinoma at high risk of recurrence after surgical resection or ablation with curative intent.

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Food and Drug Administration Safety Medicine Food 104

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. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally.

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Food and Drug Administration FDA Safety Food 105

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. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

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Food and Drug Administration FDA Safety Food 105

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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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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Food and Drug Administration Safety FDA Food 105

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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