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Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Zerviate, 0.24% was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine, which is marketed under undeb Emadine brand name.
This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.
Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021. However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years.
Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases. Regulatory bodies governing clinical trials.
Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. Patient Grant.
Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company’s pipeline products include Busulipo which is under Phase II clinical trials and Nefecon for IgA Nephritis which is under Phase II clinical trials.
The Government recently announced the reclassification of fexofenadine 120mg, which will be available as General sale Medication (GSL), sold as branded products – Allevia 120mg tablets. Fexofenadine is known as generic product ‘fexofenadine’ and branded as Telfast. Summary of the post: What is fexofenadine?
Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial.
The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov. chief executive officer of Gamida Cell.
AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they reported top-line results last month – and a look at the full data set reveals why. billion upfront to license rights to Enhertu in a deal that could be worth up to $6.9
Licensed use. Modified-release metformin can be offered on a trial basis instead of standard release metformin to patients who experience gastrointestinal side effects (NICE, 2020). Popular brands of modified-release metformin: Sukkarto SR. Linagliptin (brand name: Trajenta). Alogliptin (brand name: Vipidia).
Conscious Greens is the first offering from Pairwise’s new brand, Conscious Foods. Pairwise teamed up with Performance Food Group (PFG) to co-brand its Purple Power Baby Greens Blend under PFG’s Peak Fresh Produce premium brand. Paul region, St. Louis and Springfield, Massachusetts.
Many branded products are sold, which are equivalent to co-codamol. Some branded products contain more than 8mg of codeine phosphate per tablet. Codeine linctus is licensed for adults 18 years of age and over. . Codeine lintus is a pharmacy-only medicine licensed for the management of dry coughs.
Kesimpta (ofatumumab) started life as an oncology drug and was first developed by Genmab and licensed to GlaxoSmithKline who marketed under the brand name Arzerra to treat chronic lymphocytic leukaemia.
Buscopan is a brand name for a drug called hyoscine butylbromide. Mebeverine, on the other hand, is a generic name of the drug, which is also known as Colofac (brand name). When recommending treatment, NICE looks at existing evidence from clinical trials to support prescribing decision making.
Escitalopram vs citalopram: licensed use. Escitalopram vs citalopram: licensed use. Escitalopram has a wider licensed used than citalopram: Depression. Escitalopram oral drops 20mg/ml (brand name Cipralex). Citalopram’s licensed range for depression in adults is 10mg-40mg per day (gradually increased if needed).
In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. The licensed use of Circadin is as follows: the short-term treatment of insomnia characterised by the poor quality of sleep in patients aged 55 or over. What is melatonin called in the UK?
In the UK, apixaban is known as a branded drug called Eliquis®. Apixaban vs warfarin: differences in licensed use. Warfarin is licensed for treatment/prevention of the following conditions: Prevention of clot formation in patients with rheumatic heart disease and atrial fibrillation (AF). Prevention of mini-strokes.
LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. Zebra Medical is anticipated to be run as a wholly-owned subsidiary under the Nanox brand. Finch will proffer ongoing technical support through the phase 1 trial of the treatment.
Novartis/Incyte’s Jakafi (ruxolitinib) looks unlikely to be added to the list of therapies that can be used against COVID-19, after it failed to cut complications or death in a phase 3 trial. Trials of the drug in other indications are not affected by the outcome, Novartis said.
Vibegron (brand name: Gemtesa) is the latest drug used to treat overactive bladder that has been approved by the FDA in the USA. Licensed use and legal status of vibegron (US). The effectiveness of vibegron: summary of clinical trial . The effectiveness of vibegron: summary of clinical trial . How does Vibegron work? .
AstraZeneca has taken the decision not to move a PCSK9-targeting antisense drug licensed from Ionis into a phase 3 programme, removing a competitor to Novartis’ rival therapy Leqvio. ” Leqvio reduced LDL-C by around 50% in its phase 3 trials, with the usual caveats about trying to draw comparisons from different studies.
Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. Some prescribers and pharmacists have been hesitant to give patients biosimilar forms of biologic drugs over concerns that they may not be as safe or effective as the branded product.
Cupelo chose to delay his retirement to work in clinical trials at a site specializing in Alzheimer’s research. The importance of clinical trials That hope is a motivator for many clinical trial participants. Donanemab was approved under the brand name Kisunla.
The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials.
“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565).
Analysis of clinical trial data for Novavax’s COVID-19 vaccine showed that the shot was over 90 percent effective in preventing all forms/severities of COVID-19, from mild to severe. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea. The vaccine was 78.6
The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. The Swiss pharma giant licensed ex-China rights to tislelizumab from BeiGene in February 2021 for $650 million upfront and up to $1.55
Celevac is a brand of tablets containing methylcellulose. Celevac tablets were licensed as general sale list medicines (GSL), which means they could be sold in any retail outlet, including pharmacies, over the counter without a prescription. . Licensed use of Celevac tablets: Constipation. What is Celevac? Zalewski et al.,
This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. However, even then, challenges could remain.
Crystacide cream is licensed for the treatment of skin infections caused by a microorganism, which are sensitive to hydrogen peroxide. Hydrogen peroxide cream (brand name: Crystacide) is a pharmacy-only medication, which means it can only be purchased from registered pharmacies, including online chemists.
Members can also benefit from mental health sessions with specialized therapists, personalized nutrition guidance from licensed nutritionists and dietitians and the convenience of a digital tracker for recording goals and side effects.
Fruquintinib has already been approved in China – under the Elunate brand name – becoming the country’s first home-grown therapy for a major form of cancer back in 2018. Shares in Hutchmed climbed as news of the Takeda licensing deal broke, up almost 4% at the time of writing. It is partnered in China with Eli Lilly.
The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. How Does Sibeprenlimab Work?
The evidence against the use of ibuprofen in children with chickenpox is taken from clinical trials, which took place in the USA. Calpol Infant, Six Plus is the or alternative brands of paracetamol ae suitable during chickenpox infection. The evidence-based guide is constructed from different clinical studies. £13.21.
The name Zeneca was invented by a branding consultancy who had been instructed to find a name which was memorable, had no associations with other companies, nor was offensive in any language”. The profits from these products funded the development of new drugs, such as gastroesophageal treatment Losec and cardiovascular treatment Aptin.
When prescribed, PPIs, including esomeprazole and omeprazole, have a wider licensed used. Brand name. As GSL product, esomeprazole has a wider presence online and in stores than omeprazole, which is only available as one branded GSL product. Available in the form of capsules and tablets as the generic and branded drug.
Clobetasone (brand name: Eumovate cream). Clobetasone (brand name: Eumovate) is the second steroid cream on the list, which is available over the counter. Clobetasone has a narrow licensed use. Dactacort has also antibacterial properties and is one of few over the counter creams licensed for bacterial infections.
Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).
Paracetamol: licensed use and limit on the sale . Paracetamol – licensed use . Ibuprofen: brands and products. Ibuprofen is sold in various brands. Supermarkets and pharmacies sell their brands of ibuprofen, which is usually the cheapest option for customers. . Ibuprofen gel is sold as various brands.
MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.
The FDA approved it under the brand name Gavreto on September 4. The company has an exclusive collaboration and license deal with CStone Pharmaceuticals for development and commercialization of pralsetinib and specific other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. On October 14, Liquidia announced the U.S.
Amorolfine 5% nail lacquer (brand name: Curanail 5% w/v Medicated Nail Lacquer) is available as general-sale medication, which can be purchased in most supermarkets and pharmacies. Additionally, oral antifungal tablets are not licensed for use in children. Amorolfine 5% nail lacquer is usually applied once or twice weekly.
Over the past year, we have witnessed first-hand how older, “less innovative” molecules have been integral for emergency treatment in hospitals, and also how they have been central to clinical trial research in identifying existing medicines that can be used to treat COVID-19.
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