Pharmafile PV Services’ Post

The US FDA has given the green light to adalimumab-ryvk (Simlandi), the first interchangeable, high-concentration, citrate-free adalimumab biosimilar. This marks a significant milestone as the 10th adalimumab biosimilar approved by the FDA and the inaugural approval for Alvotech, an Icelandic pharmaceutical company, in collaboration with Teva Pharmaceuticals. Robert Wessman, Chairman and CEO of Alvotech, highlighted the potential market impact of this interchangeable, citrate-free biosimilar in the evolving U.S. biosimilars environment. Adalimumab-ryvk, previously approved in the EU, Australia, and Canada, is indicated for various conditions, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Notably, it is the third Humira biosimilar granted interchangeability status, allowing pharmacists (subject to state law) to substitute it for the reference product without involving the prescribing clinician. This distinguishes it from other biosimilars, which are only interchangeable with the low-concentration formulation of Humira. The imminent launch of Adalimumab-ryvk in the U.S. is eagerly awaited, with details on pricing yet to be disclosed. The biosimilar market continues to evolve, offering new options and potential cost savings for patients. Stay tuned for further updates! LINK:https://lnkd.in/eaxnuMdF #FDAApproval #Biosimilars #HealthcareInnovation

The US FDA has given the green light to adalimumab-ryvk (Simlandi), the first interchangeable, high-concentration, citrate-free adalimumab biosimilar. This marks a significant milestone as the 10th adalimumab biosimilar approved by the FDA and the inaugural approval for Alvotech, an Icelandic pharmaceutical company, in collaboration with Teva Pharmaceuticals. Robert Wessman, Chairman and CEO of Alvotech, highlighted the potential market impact of this interchangeable, citrate-free biosimilar in the evolving U.S. biosimilars environment. Adalimumab-ryvk, previously approved in the EU, Australia, and Canada, is indicated for various conditions, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Notably, it is the third Humira biosimilar granted interchangeability status, allowing pharmacists (subject to state law) to substitute it for the reference product without involving the prescribing clinician. This distinguishes it from other biosimilars, which are only interchangeable with the low-concentration formulation of Humira. The imminent launch of Adalimumab-ryvk in the U.S. is eagerly awaited, with details on pricing yet to be disclosed. The biosimilar market continues to evolve, offering new options and potential cost savings for patients. Stay tuned for further updates! LINK:https://lnkd.in/eaxnuMdF #FDAApproval #Biosimilars #HealthcareInnovation

Orforglipron: the new kid on the GLP-1 block Orforglipron was originally discovered and developed by Chugai Pharmaceutical Co., Ltd. Eli Lilly licensed the worldwide development and commercialisation rights for Orforglipron from Chugai in 2018. Eli Lilly is currently running the clinical trials (phase 3) to see if Orforglipron is effective and safe for weight management and type 2 diabetes treatment. If successful, Eli Lilly would be responsible for bringing the drug to market. Type of drug: It's a non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a hormone that helps regulate blood sugar and appetite. Function: Orforglipron works by mimicking the effects of GLP-1, which can increase insulin production, slow digestion, and promote feelings of fullness, ultimately leading to weight loss and improved blood sugar control. Benefits: If approved, orforglipron could offer a convenient once-daily oral medication for weight management and type 2 diabetes compared to injectable GLP-1 drugs currently available. It's also expected to be cheaper to produce. Stage of development: Orforglipron is currently in phase 3 clinical trials, which are large-scale studies to assess its efficacy and safety before it can be submitted for regulatory approval. Side effects: Like other GLP-1 drugs, Orforglipron may cause gastrointestinal side effects, which are usually mild to moderate and tend to happen during the initial dose increase. Mergers, Acquisitions, Growth and Strategy for Healthcare Technology companies HealthTech M&A - Buy Side, Sell Side, Growth & Strategy services for companies in Europe, Middle East and Africa. Visit www.nelsonadvisors.co.uk HealthTech M&A Newsletter from Nelson Advisors - HealthTech, Health IT, Digital Health Insights and Analysis. Subscribe Today! https://lnkd.in/e5hTp_xb Healthcare Technology Buy Side, Sell Side, Growth & Strategy services for Founders, Owners and Investors. Email lloyd@nelsonadvisors.co.uk Healthcare Technology Thought Leadership from Nelson Advisors – Market Insights, Analysis & Predictions. Visit https://lnkd.in/ezyUh5i https://lnkd.in/dJG_G42J #HealthTech #HealthIT #DigitalHealth #lloydgprice #NelsonAdvisors

This week's @Pearce IP #BioBlast features the following (and more!):   - #ustekinumab: Alvotech announces settlement and launch dates for ustekinumab biosimilar in Europe, Japan and Canada  - #ustekinumab: Phase III study demonstrates biosimilarity of Celltrion Inc’s CT-P43 with The Janssen Pharmaceutical Companies of Johnson & Johnson’s #Stelara®  - #tocilizumab: Celltrion Inc submits application for tocilizumab biosimilar  - #aflibercept: Qilu Pharmaceuticals’s aflibercept biosimilar equivalent to #Regeneron’s Eylea® for nAMD   - #pembrolizumab / #trastuzumab: Health Canada approves Merck's #KEYTRUDA® in combination with trastuzumab and chemotherapy as treatment for adenocarcinoma patients     Read more: https://lnkd.in/g6PAG_m9    #bioblast #biosimilars #boutiquelawfirm #australia #patentlaw #awardwinning #pearceip #patents #biopharma #lifesciences #femalefounder  

Significant Progress in the Pharmaceutical Sector: FDA-Approved First Therapy for MASH! ✌ On 14th March 2024, FDA approved Madrigal Pharmaceuticals' Rezdiffra, the first treatment for steatohepatitis associated with metabolic dysfunction (MASH), signaling the end of the protracted search for a feasible remedy. Rezdiffra provides new hope for patients who were previously without targeted treatment options by treating patients with MASH, which is characterized by moderate to severe liver scarring. Rezdiffra approval establishes a ground-breaking precedent for future treatments in a field that is estimated to affect approximately 5% of adult Americans. Recently, potential competitors to Madrigal's (MDGL) treatment have also shown improvement. The news last week that Akero Therapeutics Inc.'s (AKRO) experimental treatment for MASH, efruxifermin, was showing encouraging results from a mid-stage trial caused its stock price to soar. Additionally, MASH patients will now be able to participate in 89bio Inc.'s (ET)(N)(B) phase 3 trial for Pegozafermin, an investigational medication. Rezdiffra is expected to have peak global sales of $5.5 billion, so this approval not only fills a significant gap in the MASH treatment market but also represents a sizable opportunity. #MadrigalPharmaceuticals #fdaapproval #Rezdiffra #mash #competitiveintelligence

Sun Pharma to introduce gastrointestinal drugs in India Day #92 of covering Pharma Developments. 💊News Buzz.!! Sun Pharma has entered into a non exclusive patent licensing agreement with Takeda Pharmaceutical Company to commercialise Voltapraz. 💊What is Voltapraz.? Voltapraz is a brand name for the medication Vonoprazan, a prescription drug used to treat acid-related stomach disorders 💊Who developed Voltapraz.? Discovered and developed by Takeda, Vonoprazan is a novel, orally active potassium competitive acid blocker, used to treat reflux esophagitis and other acid peptic disorders. 💊When did USFDA approve this.? The drug was approved by USFDA on Nov 2023. I will provide the source of the article in the comment section below. By the way today is the 92nd day of me deep diving into the pharmaceutical industry. I will be sharing insights from this industry on a regular basis. So please do follow me (Krishna Raj K) for such insights. #Finance #Linkedin #India

Eupraxia Pharmaceuticals (NASDAQ: EPRX) is a clinical-stage #biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. The Company strives to provide improved patient benefit and has developed technology designed to deliver targeted, long-lasting activity with fewer side effects. #DiffuSphere™, a proprietary, polymer-based micro-sphere #technology, is designed to facilitate targeted #drugdelivery, with extended duration of effect, and offers multiple, highly tuneable #pharmacokinetic (PK) profiles. This investigational technology can be engineered for use with multiple active pharmaceutical ingredients and delivery methods. On Aug. 7, Eupraxia announced its financial results for the second quarter of 2024. Dr. James Helliwell, CEO of Eupraxia stated, “Our #eosinophilic esophagitis (“EoE”) #clinicalprogram is making excellent progress, as additional safety and efficacy data from our ongoing RESOLVE study continues to suggest that EP-104GI could represent a significant improvement over currently approved therapies for this debilitating condition. In addition, during the second quarter, we presented data at two medical meetings highlighting the potential of our candidate for the treatment of knee #osteoarthritis (“OA”), EP-104IAR, which also holds the potential to advance the current standard of care in OA. “Looking ahead, we anticipate reporting new data from the fourth cohort of the RESOLVE study in the near term and we continue to engage prospective partners for possible licensing of the EP-10IAR program. We look forward to engaging with the U.S. Food and Drug Administration in the fourth quarter of 2024 on the EP-104GI program and potentially expanding our gastrointestinal trials into the U.S. With two clinical-stage assets each having the potential to represent a meaningful improvement over currently approved therapies, we believe Eupraxia remains well positioned to create shareholder value.” https://lnkd.in/gC9e38Rc. 

🌐 Elevating Respiratory Care Through Technological Advancements 🌐 Just came across a fascinating article titled "Mesh Nebulizers have become the first choice for new Nebulized Pharmaceutical Drug Developments" published in PubMed. This research sheds light on how mesh nebulizers offer increased portability, convenience, and energy efficiency compared to traditional jet nebulizers. Notably, they provide similar lung deposition and are favored in clinical trials sponsored by pharmaceutical companies, especially in high-cost and niche therapy areas. This shift underscores the importance of innovation in healthcare technology, paving the way for improved patient care and management. With built-in capabilities to optimize usage and disease management, mesh nebulizers are poised to revolutionize respiratory treatment. Check out the full summary here: https://lnkd.in/dEQynfFe Together, let's inspire innovation. #RespiratoryCare #HealthTechnology #MedicalAdvancements

Gland Pharma Bags USFDA Nod For Amyotrophic Lateral Sclerosis Injection Edaravone Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the FDA for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma America . According to IQVIA, the product had US sales of approximately USD 19 million for the twelve months ending January 2024. Gland Pharma has also announced the receipt of approval from the USFDA for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product). Srinivas Sadu IQVIA India IQVIA Italia IQVIA Biotech IQVIA Safety & Regulatory Compliance IQVIA Research & Development Solutions IQVIA Biotech IQVIA LATAM IQVIA MedTech #glandpharma #glandpharmanews #edaravoneinjection #USFDA #radicavainjection #mitsubishitanabepharma #amyotrophiclateralsclerosis

Basilea Pharmaceutica has announced the triggering of a US$1.25m milestone payment from Pfizer, triggered by sustained strong sales of Cresemba in the Asia-Pacific region and China. This is the second FY24 milestone payment for the region and is incremental to the payment received in March. Edison Group notes that, according to the latest available data, total in-market sales of Cresemba amounted to US$473m in the 12 months ending December 2023, representing a +26% year-on-year increase. Basilea is preparing to launch its Phase III programme for fosmanogepix, a broad-spectrum antifungal therapy, with the first of two Phase III trials expected to initiate in mid-2024. The company also made positive regulatory and operational strides with its lead antibiotic asset, Zevtera (following FDA approval in April 2024), and Edison eagerly await the announcement of a potential US commercial partner. #biopharmaceuticals #medical #sustainablegrowth https://lnkd.in/d7ATbkC4