Meitheal Pharmaceuticals, Inc.’s Post

$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

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

Skyrizi Leads Ad Spending Amidst Tough Pharmaceutical Market In July, AbbVie's Skyrizi remained the top pharmaceutical drug ad spender for the second consecutive month, but overall ad spending on pharmaceutical drugs witnessed a sharp decline. Skyrizi's ad spending dropped by $3.4 million to $23.2 million. Sanofi and Regeneron's Dupixent secured the second spot with $20 million in ad spending. GSK's Trelegy rose to fourth place, while Eli Lilly's Mounjaro maintained its position in the eighth spot. The total spending on the top pharmaceutical drug ads in July was only $126.3 million, reflecting possible shifts in marketing strategies amidst competition and challenges in the industry. The future of pharmaceutical ad spending remains uncertain. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit "Pharmtales". #pharma #pharmaceutical #pharmatles #latestnews #pharmanews #pharmaceuticalindustry #pharmaceuticalcompanies #skyrizi https://lnkd.in/dCnC3mXs

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

Anebulo Pharmaceuticals Receives Positive Feedback from FDA on Path to Advance Phase 3 Clinical Development of ANEB-001 and Completes Dosing of Phase 2 The lead candidate is ANEB-001, a potent, small molecule cannabinoid receptor antagonist, under development to address the unmet medical need for a specific antidote for ACI. ANEB-001 is an orally bioavailable, readily absorbed treatment candidate that we anticipate will rapidly reverse key symptoms of ACI. ANEB-001 is protected by one issued patent and rights to one patent application covering various methods of use of the compound and delivery systems. The Phase 2 proof-of-concept trial for ANEB-001 in December 2021 in the Netherlands and announced positive Phase 2 Part A proof-of-concept topline data on July 5, 2022, positive Part B data on September 26, 2022, completed dosing of all subjects in mid-December 2022, and announced preliminary Phase 2 Part B data on January 9, 2023.

🔍 Pharmaceutical Industry Updates: Key Developments from July 2024 1. Bristol Myers Squibb Expands with Prothena: BMS has secured a global license for Prothena’s neurodegenerative treatment candidate, PRX019, with a deal potentially reaching $617.5 million in milestone payment [[❞]](https://lnkd.in/eCfdib4i. 2. Abbott's Innovative Marketing Strategy: Abbott is adopting a "guerrilla marketing" approach for its continuous glucose monitoring systems, aiming to increase outreach and engagemen [[❞]](https://lnkd.in/ePcCDfmz. 3. Tirzepatide's Chinese Approval: Eli Lilly's tirzepatide has been approved for weight loss in China, marking a major milestone in its global expansio [[❞]](https://lnkd.in/ePcCDfmz. 4. Pfizer vs. AstraZeneca Patent Battle**: Pfizer triumphed in a patent infringement case against AstraZeneca over the cancer drug Tagrisso, with AstraZeneca ordered to pay $107.5 millio [[❞]](https://lnkd.in/eCfdib4i. 5. Bernie Sanders Targets Drug Pricing: U.S. Senator Bernie Sanders is intensifying scrutiny of Novo Nordisk's pricing for GLP-1 agonists, warning of potential financial strains on the U.S. healthcare syste [[❞]](https://lnkd.in/eCfdib4i. 6. Innovative Antibiotic Funding in the UK**: The UK launches a Netflix-style subscription model for antibiotic funding, promoting new drug development to combat resistanc [[❞]](https://lnkd.in/eNg-BvJw. 7. FDA Criticizes Jiangsu Hengrui**: The FDA has flagged issues with cleanliness and quality controls at Jiangsu Hengrui's manufacturing site in China, demanding improvement [[❞]](https://lnkd.in/eCfdib4i. These updates reflect ongoing changes and challenges in the pharmaceutical sector, highlighting innovation, legal dynamics, and regulatory actions.

The global Actinic Keratosis Therapeutics market was valued at US$ 3313 million in 2023 and is anticipated to reach US$ 4791.7 million by 2030 witnessing a CAGR of 5.3% during the forecast period 20242030. 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. #GlobalActinicKeratosisTherapeuticsMarket #SkinHealth #TopicalMedications #PhotodynamicTherapy #DestructiveTreatment #Hospitals #Clinics #HealthcareSettings #PharmaceuticalMarket #MarketGrowth

Hemogenyx Pharmaceuticals PLC Announces Half-Year Report https://lnkd.in/gBJjSErt Key Highlights 1. Applied for Investigational New Drug ("IND") status for the Company's lead product HEMO-CAR-T with the U.S. Food and Drug Administration ("FDA"). 2. The IND application was placed on clinical hold, with the FDA later accepting the Company's plan for resolving outstanding issues. 3. Continuing development of Chimeric Bait Receptor ("CBR") antiviral/biodefence platform. 4. Following the period's end, the Company received a strategic investment of US$833,000 from Prevail Partners, LLC ("Prevail Partners") at a large premium to share price. 5. Entered into an agreement with Prevail InfoWorks Inc. ("Prevail InfoWorks") to provide clinical services and technologies for the Company's upcoming Phase I clinical trial of HEMO CAR-T.