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Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements. Across the industry, recent innovations in drug delivery signal a creative shift towards ease of administration and expanded treatment options.
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The regulator will announce its decision during the fourth quarter of 2023.
The 'life-extending' drug combination is recommended for usage in adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received hormone therapy. It acts by hindering proteins in cancer cells to avert cell division and growth.
The UK National Institute for Health and Care Excellence (NICE) has recommended Novartis Pharmaceuticals UK’s Piqray (alpelisib) along with hormonal therapy fulvestrant to treat hormone receptor+, HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer.
Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. billion in backloaded milestone payments.
Recombinant therapeutic proteins. Fusion proteins. They may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system.
Alnylam Pharmaceuticals, a leading RNA interference (RNAi) therapeutics biopharmaceutical company, announced it received approval from the US Food and Drug Administration (FDA) for its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis in adults.
Drug discovery company Veneno Technologies has signed a joint research agreement with Japanese pharmaceutical company Astellas Pharma. Veneno will carry out a programme to generate functional peptides (DRPs) for G protein-coupled receptors (GPCRs), which will be targeted by Astellas.
Standard treatment strategies include combinations of antibiotics, hormonal therapies and biologic agents most notably adalimumab (Humira), the only FDA-approved biologic for moderate to severe cases while surgery remains an option for advanced disease.
In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Lerner researchers developed a novel artificial intelligence platform to identify potential drugs for COVID-19, finding melatonin to be a promising candidate.
Proteins are the chains of amino acids linked together in different combinations and perform a wide variety of functions. However, continuous regulation of the cellular proteome is essential for maintaining the right balance of different proteins necessary for normal cellular function, survival, and proliferation.
Over the years, pharmaceutical companies have shifted their priorities from traditional interventions towards more advanced pharmacological strategies, such as protein therapeutics. Further, $400 billion is the anticipated sales of protein-based therapeutics in 2023. The mRNA is then translated into to form functional proteins.
Renegade Creamery makes plant-based cheese but adds milk proteins produced in strains of yeast and bacteria and uses an “artisan fermentation process.” Like Renegade Creamery, the company also uses transgenic bacteria and yeast to make the protein because they have a history of being a safe and reliable way of producing animal proteins.
Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development. This venture also led me to identify a gap in the market for contract manufacturing of recombinant proteins.
According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sym-021’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes ) bacterium that is often found in acne lesions, could be the first ever vaccine for the condition. C acnes is implicated in moderate to severe acne, which is difficult to treat.
a clinical-stage biotech company focused on pioneering therapies based on G protein-coupled receptors (GPCRs), recently completed its initial public offering (IPO), marking a significant milestone for the South San Francisco-based firm. SEP-786, an oral parathyroid hormone 1 receptor (PTH1R) agonist, aims to restore essential mineral balance.
Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.
NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. ER is the primary driver of hormone receptor (HR) positive breast cancer, which is the most common breast cancer subtype. Terms of the Collaboration.
Although studies have associated some diets with lower levels of the Alzheimer’s disease biomarker tau protein, such as the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets, this study suggests that high sodium intake contributes to the formation of tau tangles (clusters of tau proteins) in the brain.
In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.
Merck & Co has signed a multi-billion cancer drug development deal, which will see it investing $1 billion in partner Seattle Genetics. US-based Merck, known as MSD outside North America, will globally develop and market Seattle’s investigational antibody-drug conjugate (ladiratuzumab vedotin). billion equity investment in 5.0
2, 2020 — An experimental antibody drug that targets one of the body’s key metabolism regulators may help obese people lose weight — at least briefly. That’s one finding from an early study that tested the injection drug, which mimics the effects of a natural hormone called fibroblast growth factor 21 (FGF21).
Alkaloids, natural dyes, drugs, proteins, and enzymes are some of the important classes of natural heterocyclic compounds essential for human life. The company filed heterocyclic composition patents in areas such as PAD4 inhibitors, factor Xa inhibitors, and nuclear hormone receptor modulators.
Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. For example, studies of heart attack prevention medications use the surrogate endpoint of low-density lipoprotein cholesterol (LDL-C) to assess the effectiveness of new drugs. What Is a Surrogate Endpoint?
Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. AUTHORIZED USE. anti-infectives).
FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).
The trial, conducted in nine countries, found that adding chemotherapy to hormone-blocking drugs brought no added benefit to a particular group of patients. Those were postmenopausal women with hormone-sensitive breast cancer that had spread to only one to three lymph nodes, and who had a low risk of recurrence. WEDNESDAY, Dec.
The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE.
Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).
In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.
Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases. The growing popularity of peptide-based drugs can be attributed to its high specificity, minimal drug-drug interactions, affinity, proven pharmacological value and favorable safety profiles.
Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.
Adrenoleukodystrophy (ALD/ X-ALD) is a rare, X-linked disorder secondary to a mutation in the ABCD1 gene, which encodes for a peroxisomal membrane protein, resulting in an excessive accumulation of very-long-chain fatty acids (VLCFAs) in the brain and adrenal glands. The disorder can occur at any stage of life and vary with severity.
FDA’s Green Flag to Ascendis’s Once-Weekly SKYTROFA for Treatment of Pediatric Growth Hormone Deficiency. Growth Hormone Deficiency , commonly known as dwarfism, can constitute short stature and complications with metabolism, which arise due to inadequate production of growth hormones by the pituitary gland inside the body.
Current treatments for HR+ breast cancer patients include hormonal therapies, chemotherapies for those that do not respond to hormonal therapy alone and targeted therapies, either stand-alone or in combination with hormonal therapies. Trodelvy is a Targeted Therapy Trodelvy is a Trop -2 directed antibody-drug conjugate therapy.
With eight drugs awaiting regulatory approval and 26 projects in Phase III studies, Sanofi is on the cusp of a transformative year during 2021. He also noted innovations are occurring with protein degraders, antibody conjugates, nanobodies and multi-specific antibodies, specifically bi- and tri-specific. ricochet64/Shutterstock.
Drugs and therapies under study are our hope for the future of healthcare, so taking the time to learn more about them is an investment in your future health as well as the background education you need to make informed decisions about your treatment. CDK4/6 inhibitors are used alongside hormone therapy.
Therapeutic Developments Related to Glaucoma The introduction of new classes of glaucoma medications, such as prostaglandin analogs, nitric oxide-donating drugs and Rho kinase inhibitors, has added to the pharmacological options available for managing IOP.
One of the reasons behind this gap is the US Food and Drug Administration’s (FDA) “ generally recognized as safe ” — or GRAS — designation. rBST/rBGH The compound rBST, also referred to as rBGH or bovine somatotropin, is a human-made variant of a hormone naturally produced by cows for managing metabolic activities.
In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.
The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5
However, several drug delivery devices that enable patients to self-administer their respective medications are now available. Subcutaneous drug delivery systems – the helping hand for patients. Over the past few years, the pharmaceutical industry has witnessed significant advances and innovation in the field of drug delivery systems.
Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion in 2022.
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