This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
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.
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.
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?
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.
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).
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.
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?
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.
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.
Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.
In fact, one branded combination products, which contain paracetamol and ibuprofen, is available in the UK. Branded versions of ibuprofen 200mg and 400mg are available in form of liquid capsules (Nurofen Express), which may provide for faster pain relieve as compared to a standard formulation of ibuprofen tablets.
The best evidence for or against the effectiveness of medicines comes from well designed clinical trials. Different brands of cough syrups contain very often the same active ingredients. Guaifenesin syrup is available under different brands. Another popular brand of guaifenesin syrup is Benelin 3.
The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was significantly more effective than placebo at clearing up skin lesions in patients with moderate to severe plaque psoriasis. billion in sales last year.
The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. “The value of the selective M 1 agonists was enhanced with a signal observed in early clinical trials of HTL0018318, and in addition we have been advancing the development of such agonists with novel chemistry. .
iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate. Download this exclusive report here.
The two partners have since started a clinical trial with the first drug from that collaboration – a cancer therapy – and last year 23andMe also licensed a bispecific antibody that blocks IL-36 to Spain’s Almirall. What Virgin has done spectacularly well, is change things like travel.
Themes and Branding: Salesforce allows you to customize the look and feel of your org with custom themes and branding. You can change colors, add a logo, and create a consistent brand experience. Chatter Free Users: Chatter Free licenses allow users to access Chatter without having a full Salesforce license.
About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19. today announced that the U.S. Actemra/RoActemra is not U.S. Both studies were published in the New England Journal of Medicine.
and in Asia and for our R&D pipeline, including the Phase 1 trial of EYP-1901 in wet age-related macular degeneration that is expected to commence in the coming months.”. “We “We are excited about the significant potential of these products in both the U.S.
The company expects to release the interim results of this trial in the second half of 2021 and is also seeking commercialization partners to reach out to patients directly, using consumer advertising and branding in the US, which will help them to expand their market at a larger scale as the patients will have a direct reach to the medicine. .
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.
We are excited to bring such a promising brand under the BetterLife umbrella, especially in such a fast-growing and exciting sector,’’ said Dr. Ahmad Doroudian, CEO of BetterLife. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.
When it comes to the approval of new drugs, brand and generic, the systems of the U.S. For each drug regulatory authority, before a drug is approved, three phases of clinical trials of increasing complexity and scope in human subjects and proof that a drug will be manufactured correctly under Current Good Manufacturing Practices are required.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content