Pharmaceutical Technology

FEBRUARY 21, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine via an Emergency Use Authorisation (EUA) on December 21, 2020. Since then, it has gained approval in 21 geographies, including the US, Japan and the European Union. Comirnaty is the first globally approved Covid-19 vaccine.

Sales 246

Sales Vaccination Vaccine Medicine 246

Fierce Pharma

APRIL 9, 2024

As part of the deal, Ascend has also agreed to a long-term partnership with Beacon to produce its ocular gene therapies for clinical and commercial use. . | Ascend, which bills itself as a “total solutions gene therapy development partner,” has picked up the manufacturing team and site of Beacon Therapeutics in Alachua, Florida.

Gene Therapy 92

Gene Therapy Gene Manufacturing Development 92

Rethinking Clinical Trials

MARCH 28, 2024

Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.

Trials 215

Trials Nurses Clinical Trials Clinical Trials 215

Rethinking Clinical Trials

APRIL 23, 2024

Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up. Read the full report.

Research 152

Research Clinical Trials Clinical Trials Trials 152

Pharma Mirror

JANUARY 2, 2024

The popularity of at-home DNA testing is soaring in popularity and uses. Selecting an at-home home DNA test kit is overwhelming, but it is reliable in terms of accuracy. When someone seeks information about paternity or genetic diseases without visiting a doctor’s chamber or laboratory, the best alternative is the at-home DNA test kit.

DNA 130

DNA Genetic Disease Genetics 130

Pharmaceutical Technology

FEBRUARY 10, 2023

4DMT is creating a gene therapy using an adeno-associated viral vector (AAV) and there is currently competition from several early-stage therapies in trial, such as Sangamo Therapeutics’s Fabry gene therapy that is currently at Phase III, which also uses AAV, and as of November 2022 has reported it is progressing to late-stage plans.

Gene Therapy 264

Gene Therapy Gene Trials Marketing 264

World of DTC Marketing

DECEMBER 29, 2021

There are also several physicians chiming in with their concerns over the long-term use of the drug. How many people will use the drug thinking they can eat what they want and not get exercise? Some were happy for any product that would help patients lose weight others were worried about the long-term use of the drug.

FDA Approval 191

FDA Approval Production Drugs 191

Pharma Mirror

SEPTEMBER 15, 2021

The use of opioids for pain relief in patients awaiting hip and knee replacement surgery increased dramatically during the pandemic according to new research from the University of Aberdeen. Opioids such as morphine and tramadol are often used as a last resort in pain management in osteoarthritis.

Research 130

Research 130

Pharmaceutical Technology

NOVEMBER 29, 2022

On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease. Since then, ketamine-assisted psychotherapy has become increasingly prominent, and is often used off label to treat certain kinds of depression.

Research 275

Research Trials Drugs Generic Drugs 275

Pharmaceutical Technology

OCTOBER 13, 2022

Oncotelic Therapeutics has received a contract from the US Biomedical Advanced Research and Development Authority (BARDA) to develop OT-101 to treat long-term effects of respiratory distress after Covid-19 infection. An antisense against TGF-?2,

Development 182

Development Clinical Trials Clinical Trials Trials 182

Fierce Pharma

SEPTEMBER 28, 2023

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

Drugs 108

Drugs 108

Camargo

SEPTEMBER 2, 2020

Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo.

Regulation 163

Regulation Production Drugs 163

Pharmaceutical Technology

MARCH 1, 2023

Developed using VelocImmune technology of Regeneron, Kevzara binds to the IL-6 receptor specifically and inhibits IL-6-mediated signalling. Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper.

FDA Approval 245

FDA Approval Clinical Trials Clinical Trials Trials 245

Pharmaceutical Technology

JANUARY 23, 2023

The term LN refers to a major predictor of poor prognosis in SLE patients, with inflammation of the kidney that encompasses diverse patterns of renal disease, including glomerular and vascular pathology. In previous years, Benlysta has managed to grow the lupus market in terms of value, having generated approximately $492.9m

Marketing 278

Marketing Production Drugs Trials 278

Drug Patent Watch

SEPTEMBER 12, 2023

In the world of patents, the right to exclude others from using or selling an invention is granted only during the patent’s validity. The post Understanding Patent Term Extensions: An Overview appeared first on DrugPatentWatch - Make Better Decisions. Once a patent expires, this exclusivity vanishes.…

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Rethinking Clinical Trials

AUGUST 3, 2023

Implementation science gives a heightened focus on how to get interventions to be as accessible, well used, and beneficial as possible to populations within the systems and communities in which people are seeking and receiving healthcare. Too often we think of sustainment in terms of fixing things in their original state.

Research 130

Research Trials Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Gene therapy delivery using viral vectors. Sanofi is one of the leading patent filers working with viral vectors.

Gene Therapy 246

Gene Therapy Gene Genome Genomics 246

Pharmaceutical Technology

MAY 2, 2023

The firms did not divulge the terms of the deal. They also used their standard colchicine regimen. Soligenix has signed an exclusive option agreement with Silk Road Therapeutics for the right to acquire Pentoxifylline (PTX) topical formulation intended to treat mucocutaneous ulcers in Behçet’s disease (BD) patients.

Trials 130

Trials 130

Pharmaceutical Technology

MAY 25, 2023

Clover Biopharmaceuticals will use Kyuan Trade’s extensive sales and distribution network to complement its in-house capabilities and increase access to its AdimFlu-S (QIS) across the country. The China National Medical Products Administration approved AdimFlu-S (QIS) in January 2022 for individuals aged three years and above.

Vaccination 262

Vaccination Vaccine Containment Sales 262

Pharmaceutical Technology

MARCH 14, 2023

The deal will also use the protein engineering and medicinal chemistry capabilities of Pfizer to advance Seagen’s ADC technology to unlock next-generation biologics and potential new target combinations. Pfizer has entered a definitive merger agreement to buy biotechnology firm Seagen in a deal valued at $43bn.

Antibody 130

Antibody Medicine Engineer Protein 130

Pharma Mirror

OCTOBER 28, 2021

The analysis foresees the use of automated cobots, AI, real-time release and rapid growth in new areas like mRNA vaccines, alongside the personalization of therapeutics (delivered at far larger scale). These new findings are released ahead of CPhI Worldwide (November 9-11, 2021), which is being held.

Manufacturing 130

Manufacturing Vaccination Vaccine Marketing 130

World of DTC Marketing

AUGUST 14, 2022

According to Healthcare Transformers, “ use of telehealth climbed more than 154% in late March 2020, compared with the year before, and a 2020 survey found 76% of patients would be interested in using it. The terms observation and inspection are often used interchangeably. There it is again. Why do patients lie?

Doctors 154

Doctors Doctor Medicine Research 154

Pharmaceutical Technology

MAY 9, 2023

At the annual European Heart Rhythm Association Congress, new real-world data was presented by researchers from Hong Kong, demonstrating that the risk of strokes was lower in atrial fibrillation (AF) patients who had been using statins within a year of their diagnosis.

Research 130

Research 130

Pharmaceutical Technology

MARCH 27, 2023

Technology-focused biomanufacturing company National Resilience has signed a $410m long-term loan financing deal to establish a resilient end-to-end biomanufacturing capacity. The company expects to manufacture a billion vaccines doses in its manufacturing network in the US, using the long-term financing deal.

Gene Therapy 130

Gene Therapy Manufacturing Vaccination Vaccine 130

Medical Xpress

MAY 12, 2023

Head and neck cancer (HNC) is an overarching term used for several types of cancer, including the most common form called head and neck squamous cell carcinoma (HNSCC). HNC patients can be treated with a combination of surgery, radiotherapy and/or chemotherapy. Nevertheless, treatment is not always effective.

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Rethinking Clinical Trials

JANUARY 9, 2024

Most of an analysis can proceed using complete data, so this isn’t an issue. Most of an analysis can proceed using complete data, so this isn’t an issue. Sometimes there is missingness in the outcome. In the presence of missing data, if data are MCAR, the standard GEE estimator based on complete data is consistent.

Trials 275

Trials Clinical Trials Clinical Trials Research 275

Medical Xpress

MARCH 27, 2023

The rising cost of cancer care puts patients and their caregivers at increased risk of experiencing financial toxicity, a term used to describe financial hardship caused by out-of-pocket treatment costs.

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Medical Xpress

MAY 5, 2023

Long-term indwelling urethral catheter (IUC) use is associated with a higher incidence of urinary tract infection (UTI) in people with spinal cord injury, according to a study published online March 27 in the Journal of Spinal Cord Medicine.

Medicine 96

Medicine 96

Medical Xpress

MAY 2, 2023

The accepted clinical practice of using beta blockers over the long term to curb the risk of further heart attacks or death doesn't seem to be warranted in patients who don't have heart failure, suggests a large study published in the journal Heart.

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Medical Xpress

NOVEMBER 30, 2022

A minimally invasive treatment for carpal tunnel syndrome provides complete and long-term relief to patients without the use of corticosteroids, according to research being presented today at the annual meeting of the Radiological Society of North America (RSNA).

Radiology 108

Radiology Research 108

Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1 (mRNA-1273.214) booster for usage in children aged six to 11 years. 5), mRNA-1273. 5), mRNA-1273. Free Whitepaper.

Gene Therapy 304

Gene Therapy Vaccination Vaccine Clinical Trials 304

Antidote

NOVEMBER 8, 2022

While there are many conditions that can cause memory loss , dementia and Alzheimer’s disease are probably two of the most well-known terms associated with cognitive decline. However, while these two terms are often used interchangeably, they actually refer to different kinds of memory loss diseases.

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Pharmaceutical Technology

JANUARY 2, 2023

Under the terms of the agreement, Sandoz will have the global rights to use Alteogen’s novel hyaluronidase, ALT-B4, for the development and commercialisation of a subcutaneous version of a biosimilar product. Developed using the Hybrozyme technology, ALT-B4 is Alteogen’s proprietary human recombinant human hyaluronidase enzyme.

Licensing 130

Licensing Licensing Production Sales 130

Pharmaceutical Technology

JANUARY 25, 2023

Spikevax is an mRNA vaccine that is approved in 20 geographies including the US, EU, and, the UK. The vaccine first gained Emergency Use Approval in December 2020 in response to the Covid-19 pandemic. It was an exceptional year for Moderna’s vaccine Spikevax, with forecast sales of $19.5bn in 2022.

Sales 147

Sales Vaccination Vaccine Marketing 147

Pharmaceutical Technology

DECEMBER 23, 2022

As per this deal, Lilly will obtain access to further targets in the central nervous system and peripheral nervous system using the Axiomer platform. By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy.

Genetics 328

Genetics Medicine Development Gene Therapy 328

Medical Xpress

MAY 16, 2023

Patients with rheumatic and musculoskeletal conditions are vulnerable to long term opioid use, with up to 1 in 3 of those with rheumatoid arthritis or fibromyalgia, who take these drugs for the first time, potentially at risk, suggest the findings of a research letter, published online in the Annals of the Rheumatic Diseases.

Drugs 96

Drugs Research 96

Pharmaceutical Technology

MARCH 21, 2023

Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives. Gladstone will use its expertise in immunology and virology to support the collaboration with InvisiShield. Tests of live virus can take place in its advanced Biosafety Level 3 (BSL-3) facility.

Development 288

Development Scientist Vaccination Vaccine 288