PharmaTech

SEPTEMBER 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Safety 98

Safety Patients Consulting FDA 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.

FDA 165

FDA Doctors Prescription Pharma 165

MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

FDA 95

FDA Patients Safety Biopharma 95

European Pharmaceutical Review

JANUARY 7, 2025

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines.

Food and Drug Administration 105

Food and Drug Administration FDA Medical Food 105

World of DTC Marketing

OCTOBER 29, 2020

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. While the product safety information page is among the top five pages visited what alarmed me was that time on the page was measured in seconds not minutes for most online visitors. It doesn’t happen, and the FDA should know this by now.

Side effects 181

Side effects Safety FDA Pharma 181

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. ” Patients want to understand how the drug works and the potential side effects before starting therapy.

Marketing 285

Marketing Prescription Side effects Doctors 285

World of DTC Marketing

JUNE 3, 2022

The continued emphasis on digital health is overrated but digital health will become an integral part of total patient care. To become a vital part of patient care, digital health providers need to provide the medical community with studies that show their value to patient outcomes. The FDA defines digital health this way.

Doctors 291

Doctors Insurance Medical Patients 291

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.

Safety 98

Safety Food and Drug Administration Prospecting Food 98

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. .

Food and Drug Administration 98

Food and Drug Administration Patients FDA Food 98

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.

Food and Drug Administration 119

Food and Drug Administration FDA Food Patients 119

World of DTC Marketing

NOVEMBER 10, 2020

Biogen shot up when an initial review of their Alzheimer’s drug was positive, but then analysts torpedoed the company when another FDA panel said there wasn’t enough data. When a vaccine is available, you can also bet that people will form long lines to get vaccinated even though there is skepticism about vaccine safety.

Media 286

Media Retail FDA Safety 286

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.

Food and Drug Administration 119

Food and Drug Administration FDA Safety Food 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.

FDA 98

FDA Food and Drug Administration Safety Medicine 98

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

World of DTC Marketing

DECEMBER 23, 2020

DTC marketers who believe that DTC is essentially the same as before the pandemic are failing to recognize significant shifts in patient behavior regarding prescription drugs. In an era of a pandemic, are psoriasis patients really going to ask for a drug that may compromise their immune system? What are other patients saying about it?

Prescription 249

Prescription Doctors Side effects Marketing 249

World of DTC Marketing

JANUARY 8, 2021

Can the FDA really control the quality of vaccine orders this big? However, in vaccines, cut corners could compromise patient safety. I wonder why the FDA has not hired or dispatched more safety inspectors to plants making Covid-19 doses. Supply Issues? Right now, the biggest challenge is just getting vaccinated.

Government 266

Government Safety FDA Pharma 266

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).

Food and Drug Administration 111

Food and Drug Administration Patients Safety Physicians 111

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

Food and Drug Administration 105

Food and Drug Administration FDA Safety Engineering 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. In these subjects, the median progression-free survival (PFS) following Enhertu treatment was 9.9

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. Clinical trials of the FDA approved Rykindo ®.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

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.

Food and Drug Administration 116

Food and Drug Administration Patients Side effects Safety 116

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

Food and Drug Administration 105

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

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

FDA 128

FDA Food and Drug Administration Biopharma Food 128

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.

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. The company noted that satisfactory patient response may need Opzelura application for over 24 weeks.

Food and Drug Administration 116

Food and Drug Administration FDA Food Patients 116

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).

FDA 104

FDA Food and Drug Administration Safety Medicine 104

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.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

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.

Food and Drug Administration 105

Food and Drug Administration Pharmaceutical FDA Food 105

World of DTC Marketing

DECEMBER 29, 2020

All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. It’s estimated that the COVID 19 vaccine market could be worth almost $100 billion. That’s a hell of an incentive.

Pharma 307

Pharma Food and Drug Administration Media Food 307

pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

FDA 111

FDA Food and Drug Administration Patients Food 111

European Pharmaceutical Review

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours. Clinical study of Adstiladrin.

FDA 110

FDA Food and Drug Administration Food Patients 110

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.

FDA 105

FDA Food and Drug Administration Medicine Food 105

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.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

AUGUST 30, 2022

Based on the results, Pfizer said it intends to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF “in fall 2022”. However, there are currently no prophylactic or therapeutic options for this group of patients. Approximately 37,000 patients have been enrolled to date, receiving 120?g

Patients 98

Patients Food and Drug Administration Safety FDA 98

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.

FDA 98

FDA Food and Drug Administration Food Patients 98

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.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98