Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. The regulator accepted and gr anted priority review for the sNDA in January 2023.

Food and Drug Administration 59

Food and Drug Administration FDA Pharmacology Safety 59

European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 10 Evidence of safety, adherence to appropriate manufacturing standards and provision of appropriate product information to users is also required to gain registration under the scheme. 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

pharmaphorum

AUGUST 16, 2022

The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.

Pharmacology 52

Pharmacology Safety Networking Patients 52

Pharmaceutical Technology

FEBRUARY 8, 2023

The recent town hall, titled “Clinical Development of Gene Therapy Products for Rare Diseases”, was meant to further that dialogue with those in pharmaceutical industry developing new gene therapies for underserved patient groups. GlobalData is the parent company of Pharmaceutical Technology.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

European Pharmaceutical Review

DECEMBER 11, 2023

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.

Safety 98

Safety Pharmacology Engineering Medical 98

Impetus Digital

AUGUST 2, 2024

The pharmaceutical industry has numerous use cases for AI. AI can be used to improve the efficiency of pharmaceutical manufacturing processes through ongoing monitoring and predictive maintenance of equipment, optimization of production processes, and automated quality control, helping to reduce costs and improve yield.

Pharma 92

Pharma Manufacturing Medicine Marketing 92

Contrarian Sales Techniques

FEBRUARY 25, 2023

During my pharmacology class, I learned that there are no safe drugs, only safe patients. Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public. This includes potential side effects or adverse reactions to medications.

Side effects 52

Side effects Medical sales reps Insurance Medical sales 52

Pharmaceutical Technology

AUGUST 16, 2022

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. The post Q32 Bio and Horizon partner to develop autoimmune disease treatment appeared first on Pharmaceutical Technology.

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Safety 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development. Discover the top API protein and peptide companies in contract marketing.

Leads 40

Leads Marketing Pharmacology Retail 40

European Pharmaceutical Review

JULY 27, 2023

Pharmacological therapies mainly address symptoms and unfortunately a significant number of patients do not respond adequately, progressing to congestive heart failure and eventually needing a heart transplant. Despite these trials varying in design, they confirmed the feasibility and safety of the procedure. Frontiers in Pharmacology.

Pharmacology 98

Pharmacology Manufacturing Leads Patients 98

European Pharmaceutical Review

MAY 2, 2023

In 2019, the pharmaceutical industry spent $83 billion on R&D, which is about 10 times what the industry spent per year in the 1980s, 4 yet the average duration to develop a new medicine is still around 10-15 years. Available from: [link] Research and development in the pharmaceutical industry [Internet]. European Commission.

Patients 105

Patients Medicine Marketing Medical 105

European Pharmaceutical Review

SEPTEMBER 22, 2023

7 It is currently being evaluated in a Phase Ib/IIa clinical study, demonstrating to date a good safety profile. While favourable safety has been reported up to the Phase II, the relevance of targeting the C-terminal portion of Abeta still needs to be confirmed. CPT Pharmacometrics Syst Pharmacol. 2022;11(12):1578-91.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

European Pharmaceutical Review

MARCH 11, 2024

Reducing HIV treatment burden and stigma Decades of pharmaceutical advances and an array of treatment and prevention options mean that many people living with HIV can expect to live longer and fuller lives. Future innovation will be defined by ultra-long-acting options, self‑administration and, hopefully, concrete steps toward a cure.

Medicine 98

Medicine Pharmacology Healthcare Healthcare 98

European Pharmaceutical Review

JULY 18, 2024

How could this impact the pharmaceutical industry as a whole? This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. If we can continue to share and work together, we push further and deliver faster for patients.

Food and Drug Administration 59

Food and Drug Administration Engineering Pharmacology Side effects 59

Pharmaceutical Technology

FEBRUARY 13, 2023

However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.

Food and Drug Administration 52

Food and Drug Administration Leads Pharmaceutical Pharmaceutical research 52

European Pharmaceutical Review

JULY 25, 2024

Palframan received his BSc in pharmacology at King’s College London and his PhD in immunology at Imperial College London. The post The route to enhanced gene therapies appeared first on European Pharmaceutical Review. What should the industry prioritise to advance the gene therapy field?

Pharmacology 52

Pharmacology Manufacturing Medicine Training 52

pharmaphorum

DECEMBER 20, 2022

That’s impressive, as it has proved exceedingly difficult for pharmacological therapies to show an impact on fibrosis in prior studies. Similarly, a one-stage or greater improvement in liver fibrosis was seen in 24% and 26% of the resmetirom groups, respectively, versus 14% of patients taking placebo.

Pharmacology 52

Pharmacology Marketing Pharma Biopharma 52

Infuse Medical

DECEMBER 17, 2024

3D medical animation for healthcare breaks out these concepts into visually digestible bits whether you’re a surgeon outlining a difficult operation or a pharmaceutical company showing how a medicine operates at the cellular level. For more insights, visit our pharmaceutical animation section. Why choose Infuse Med?

Medical 52

Medical Healthcare Healthcare Education 52

Quantified

JUNE 28, 2022

Equally, certification can support compliance, fair balance and consistent inclusion of important safety information. Mark holds degrees in Medicine and Pharmacology from the University of Manchester and studied business at Manchester Business School.

Sales 52

Sales Pharma Training Management 52

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. Medical cannabis companies lack the resources of traditional pharmaceutical and biomedicine firms. Expert Review of Clinical Pharmacology.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

Pharmaceutical Technology

AUGUST 8, 2022

The digital pill, now marketed by Otsuka Pharmaceuticals, is forecasted to make $27 million in sales in 2022, as per GlobalData. GlobalData is the parent company of Pharmaceutical Technology. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.

Food and Drug Administration 122

Food and Drug Administration FDA Patients Medicine 122

European Pharmaceutical Review

JULY 19, 2023

The data “are compelling, particularly the significant improvements observed in both depressive and anhedonic symptoms,” stated Dr Roger S McIntyre, FRCPC, Professor of psychiatry and pharmacology, University of Toronto and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada.

Pharmacology 98

Pharmacology Patients Safety Medicine 98

Pharmaceutical Technology

OCTOBER 10, 2022

Despite the recognized need and demand for options to treat female sexual dysfunction, several safety and access issues associated with the use of available options. All this development comes in the backdrop of a wider sense of stigma against the use of pharmacologic options for female sexual function, says Kingsberg.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The clinical pharmacology knowledge also isn’t present at smaller companies, he adds.

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care.

Prescription 144

Prescription Ethics Safety Healthcare 144