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Exploring the Potential of Novel Pharmaceutical Drugs: A Review of Recent Research Findings Introduction to Novel Pharmaceutical Drugs The world of pharmaceuticals is con... Read More - https://lnkd.in/dYGmXkMm

On Thursday, Biocon announced a patent settlement with Janssen Inc. for its Stelara biosimilar. With this deal, Biocon will be launching its Bmab 1200, a biosimilar referencing Stelara, in February 2025, subject to FDA approval. Biocon's BLA for Bmab 1200 has already been accepted by the FDA for review under the 351(k) pathway. With this agreement, Biocon joins a list of other biosimilar competitors including Amgen, Alvotech/Teva Pharmaceuticals, Samsung Bioepis/Sandoz, Celltrion Inc, Formycon AG/Fresenius Kabi, and Dong-A Pharmaceutical Co.,Ltd/Accord Healthcare, all of whom have launch dates for their respective biosimilar products slated for the first half of 2025. Stelara, introduced in 2009, has been Janssen Inc.'s top-selling drug since 2019, with sales reaching $7 billion in 2023 and is expected to contribute significantly to the company's projected $57 billion revenue by 2025. https://lnkd.in/ddQwnNpq

For distribution of biosimilars Trastuzumab and Bevacizumab in Australia Biocon Biologics (subsidiary of Biocon) announced a five-year partnership with Sandoz AG (Sandoz) which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia. Under the agreement, Sandoz will distribute the Biocon Biologics’ brands, OGIVRI (bTrastuzumab) and ABEVMY (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia. Trastuzumab is a biosimilar of Herceptin and Bevacizumab is a biosimilar of Avastin3 – both biosimilars are available on the PBS and utilised for the treatment of various cancers. The agreement is effective from 01 January 2024 and commercialisation commenced on 01 February 2024. Powered by Capital Market – Live News Disclaimer: No Business Standard Journalist was involved in creation of this content First Published: <!-- -->Feb 09 2024 | 9:15 AM<!-- --> <!-- -->IST Source link

Interesting overview on the top 20 drugs in 2023 - In recent years, COVID-19 vaccines from Pfizer and Moderna dominated pharmaceutical sales, but 2023 brought changes due to major patent expirations and the emergence of new drugs, leading to unexpected shifts in the top 20 drugs by global sales. MSD cancer drug Keytruda became the top seller, with $25 billion in global sales, representing 40% of MSD revenue and expected to reach $30 billion this year. Keytruda overtook AbbVie's Humira, which was the bestselling drug for nine years until displaced by Pfizer and BioNTech’s Comirnaty in 2021. Despite facing biosimilar competition, Humira remains second on the list, unlike Bristol Myers Squibb’s Revlimid, which struggled against copycat competition. https://lnkd.in/eEtjK_T3

China's new trend in strategic placement of PROTAC drugs To date, more than 20 PROTACs have entered clinical trials worldwide. The following table lists some domestic pharmaceutical companies, such as Beigene, Haisco, Hinova Pharmaceuticals and Pioneer Pharmaceuticals, which are involved in the field of PROTAC. According to the public information, there are now 16 domestically produced PROTACs in the clinical stage, but not yet any PROTAC entered the pivotal or phase 3 clinic. In terms of clinical stage, 3 companies including Hinova Pharmaceuticals, Beigene and Haisco, initiated clinical trials in 2021, and another 3 companies, namely Pioneering Pharmaceuticals, Beigene and Accutar Biotech, initiated clinical trials in 2022. Clinical development accelerated in 2023, with as many as 11 trials initiated, suggesting that with the gradual validation of PROTAC technology, domestic pharmaceutical companies are gradually increasing their investment in the field of protein degradation.

Finland to exchange Biologics for cheaper biosimilars at pharmacies >Fimea (Finnish Medical Agency) on 18th Jan has stated that from April 2024, Biologics drugs can be exchanged for cheaper alternatives like biosimilars in pharmacies. However, biologics prescribed for patients under 18 years cannot be exchanged. >The first drug to be included is Enoxaparin – Used to treat Deep vein thrombosis and venous thromboembolism. >Starting January 2025 all other biologics will be eligible for exchange in pharmacies, except for insulin. Glargine Insulin exchange will begin in April 2025 and for long-acting insulins in January 2026. >Short-acting insulins are not included in the drug exchange program. To curb the high cost of biological drugs, the Finnish government is planning to increase price competition in biologics to achieve cost savings. >With the wider introduction of biosimilars, it is estimated to save millions of euros in state’s drug reimbursement program. #marketaccess #hta #biologics

Exciting news for the pharmaceutical industry! Learn about the latest developments in the pipeline for treating bronchiectasis. #PharmaNews #BronchiectasisResearch

Exciting news for the pharmaceutical industry! Learn about the latest developments in the pipeline for treating bronchiectasis. #PharmaNews #BronchiectasisResearch

The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #GlobalTargetedDrugs #ColorectalCancer #PharmaceuticalMarket #CancerTreatment #TargetedTherapies #HospitalCare #SpecialtyClinics #CancerResearch #MedicalAdvancements #PatientCare

$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Publishes Shareholder Update Letter - Jun 10, 2024 The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) focused heavily on increasing use of intravenous ketamine and intranasal S-ketamine as the emerging standard of care for treating severe depression and suicidality Presenters from 3 open label studies at the ASCP suggested that intravenous ketamine is at least equivalent and may have advantages over intranasal S-ketamine NRx Pharmaceuticals has now reached the 9-month stability point with its ketamine formulation (NRX-100) and has initiated 3 manufacturing lots for future drug release. Nonclinical safety for short term use of NRX-100 has recently been published and submitted to FDA FDA leadership, in public comments at ASCP, focused on the need for nonclinical safety data for intravenous ketamine as a condition of ketamine approval The short-term need for intravenous ketamine as an already-approved, schedule 3 drug, is heightened by recent regulatory decisions that may delay the path of potent, schedule 1 psychedelic drugs that may require more complicated clinical trial designs. RADNOR, Pa., June 10, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company's progress here: NRx Email Alerts. Today's update highlights potential implications of the Company's recent activities at the annual meeting of the American Society of Clinical Psychopharmacology. The key points include: Intravenous and intranasal ketamine were highlighted as emerging standards of care for severe depression and suicidality Planned NDA filing for NRX-100, our preservative free IV ketamine, for Suicidal Depression in 2024, is based on well controlled trials against both placebo and active comparator. Fast Track Designation was previously granted An independent FDA advisory panel recently voted against MDMA, a potent, class I psychedelic, refocusing attention on already-approved Schedule 3 drugs such as ketamine for treatment of suicidal depression. The FDA panel and emerging guidance highlights the complexity of clinical trials of DEA Schedule 1 hallucinogens that do not have already-approved human uses NRx anticipates that an important issue for longer term use of ketamine in depression will be the current multidose vial presentation that contains potentially toxic preservatives previously acceptable for one time use but less suitable for repeated use. NRX-100 is planned as a single-dose, preservative-free medication. https://lnkd.in/eNCx9puY