SERB Pharmaceuticals’ Post

Congratulations to SFJ Pharmaceuticals, Inc. , sponsor of the bentracimab Biologics License Application (BLA), and SERB Pharmaceuticals! The companies announced that the US Food and Drug Administration has accepted the bentracimab BLA for filing and priority review with a target action date in Q1 of 2025. SERB Pharmaceuticals acquired exclusive US rights to bentracimab from SFJ and will commercialize bentracimab in the United States. Bentracimab is a human monoclonal antibody fragment being developed as a specific reversal agent for patients treated with ticagrelor (BRILINTA®) when reversal of antiplatelet effects of ticagrelor and its active metabolite is needed in patients requiring nondeferrable surgery/invasive procedure or in patients experiencing major bleeding. #mabs https://lnkd.in/ecUrFwYt

The US FDA New Drug Approvals in August 2024  PharmaShots, your go-to media platform for life science news, brings a condensed report highlighting new drug approvals in August 2024 by the US FDA.  Stay Tuned for more updates!   Servier Pharmaceuticals Citius Pharmaceuticals, Inc. Ascendis Pharma Galderma Gilead Sciences Incyte Johnson & Johnson #regulatory #usfda #pharma #healthcareindustry #approvals #newmolecularentities #biologic #pharmashots 

Grand Pharma Introduces a Global Innovative Product for the Treatment of Demodex Blepharitis and Meibomian Gland Disease with Demodex Mites Grand Pharmaceutical Group Limited (0512.HK, Grand Pharma, together with its subsidiaries, the Group) has entered into a strategic cooperation agreement for product introduction with LianBio Development (HK) Limited and Tarsus Pharmaceuticals, Inc.. After the relevant conditions are met, the Group will acquire the exclusive development, production and commercialization rights in Greater China Region (Mainland China, Hong Kong Special Administrative Region of China, Macau Special Administrative Region of China, and Taiwan Region) for TP-03, a global innovative ophthalmic preparation for the potential treatment of Demodex blepharitis and Meibomian Gland Disease (MGD) in patients with Demodex mites with an upfront payment of USD15 million and a certain amount of registration milestone fees. This strategic cooperation will deepen the strategic plan of the Group’s products in the field of ophthalmology. TP-03 was approved for commercialization by the United States Food and Drug Administration (FDA) in July 2023. It is the first and only drug approved by the FDA for Demodex blepharitis. There are positive topline results of TP-03 Phase II clinical research in the United States for the treatment of MGD patients with Demodex mites. In terms of registration in China, TP-03 has completed a Phase III clinical study. The results show that TP-03 has significant effectiveness in the treatment of Demodex blepharitis with tolerability and favorable safety. Read more here: https://lnkd.in/gsKDuR5A

Regeneron Pharmaceuticals recently received a complete response letter (CRL) from the FDA regarding the biologics license application (BLA) for linvoseltamab, a promising treatment for relapsed or refractory (R/R) multiple myeloma. The CRL was issued not due to concerns over the drug's safety or efficacy but rather because of issues identified during a pre-approval inspection at a third-party fill/finish manufacturer unrelated to linvoseltamab. Despite this setback, Regeneron remains committed to bringing this innovative therapy to patients as quickly as possible. Linvoseltamab has shown encouraging results in clinical trials, with a 71% objective response rate and a favorable safety profile. The company is working closely with the FDA and the third-party manufacturer to address the issues and is optimistic about the path forward. This decision highlights the complexities and challenges of the drug approval process, where external factors can delay the availability of potentially life-saving treatments. Regeneron is also continuing to explore linvoseltamab's potential in earlier stages of myeloma, including smoldering myeloma and MGUS, which could further expand its impact in the oncology field. Read more here: https://lnkd.in/ehhAqXDC #MultipleMyeloma #FDA #Regeneron #Oncology #Biopharma #DrugDevelopment

KORU today announced a collaboration with a global pharmaceutical company to initiate a feasibility study with the Freedom System for an FDA and EMA approved subcutaneous oncology biologic drug currently being delivered via manual syringe administration by healthcare professionals. The Freedom System is a purely mechanical ambulatory drug delivery device with 11 drugs approved on the label and over 40,000 patients globally. It’s designed to deliver large volumes of biologic medications subcutaneously and is capable of allowing patients to self-administer at home or by healthcare professionals in a clinic setting. Conversion of intravenous biologics to subcutaneous administration formulations is a growing trend in the oncology market. Evidence suggests subcutaneous administration of oncology therapy simplifies treatment, reduces pressure on hospitals, and improves quality of life. With the development of new subcutaneous drug therapies, there is an opportunity to develop drug delivery administration solutions which will optimize drug administration. “This collaboration presents an exciting, new opportunity to enter the growing oncology subcutaneous biologic market to solve significant unmet needs in the delivery of this life-saving therapy with our patient-centric solutions,” said Linda Tharby, KORU Medical’s President and CEO. “There are multiple subcutaneous oncology biologics currently approved using manual administration with an estimate of over one million global infusions. We anticipate progressing to commercialization of the Freedom System for this drug within 12 months.” Read full announcement here: https://hubs.la/Q02zL76s0 #KORU #FreedomInfusionSystem #FreedomInfusion #Milestone

📢Exciting News 📍 Today, Accord Biopharma, Inc. a subsidiary of Intas Pharmaceutical Ltd has gotten the acceptance of its #Biosimilar DMB-3115 which is proposed biosimilar to STELARA ® (ustekinumab) from #USFDA 📌Accord Biopharma, Inc. conducted multi-regional Phase-III clinical trail in patients with plaque psoriasis. The main focus of the study was the rate of change in the Psoriasis Area and Severity Index (PASI) to assess skin symptom improvement. 💊 STELARA®, a Janssen Biotech blockbuster, approved for psoriasis, psoriatic arthritis, Crohn's, and colitis. It raked in $13.9B in U.S. sales in 2022, ranking among top biologics. #Biosimilar #USFDA #ustekinumab #accordbiopharma #Intas https://lnkd.in/eQiVMPst

As 2023 featured major patent expirations, the rise of weight loss drugs and other new dynamics, seems like oncology and immunology continue to dominate the pharmaceutical landscape! Check out the top 20 drugs by worldwide sales of 2023! 💡 ⬇️

Through June 30, 2024, the FDA approved 27 novel pharmaceutical products for use in the United States. While 2023 was a record-breaking year with 72 novel approvals, this year is expected to approach that number. Of the novel approval’s year-to-date, 18 are specialty drugs. 13 have an Orphan Drug Designation and 11 are Breakthrough Therapies. In the second half of 2024, the FDA could approve an additional 37 novel drugs, which would bring the total novel approvals for the year to 65. Of the 37, 27 would be considered specialty while 10 are classified as traditional drugs. Although various drug classes are represented, the pipeline includes several new oncology treatments as well as medications to treat Alzheimer’s Disease. https://hubs.li/Q02KvK6m0

Jazz Pharmaceuticals' Suvecaltamide Falls Short in Essential Tremor Trial Jazz Pharmaceuticals' suvecaltamide has not met the primary or key secondary endpoints in a Phase IIb trial for essential tremor (ET). The trial, conducted across multiple centers, involved 420 patients receiving once-daily oral suvecaltamide. The high-dose cohort of 30mg did not show significant improvement on the Essential Tremor Rating Assessment Scale (TETRAS) or the Clinical Global Impression-Severity (CGI-S) scale at week 12. However, there were numeric improvements noted, and the placebo cohort showed more improvement than anticipated. Jazz Pharmaceuticals is now evaluating the trial data and awaiting results from a concurrent Parkinson's disease tremor trial to determine the future of suvecaltamide. The drug, which is a highly selective modulator of T-type calcium channels, was acquired by Jazz Pharmaceuticals in a $312.5 million deal with Cavion in 2019. Despite the recent setback, GlobalData forecasts global sales of suvecaltamide to reach $470 million by 2030. # Thank you Luca Bianchi for your submission!

PD-1 and PD-L1 Inhibitors Commpetitive Assessment, 2024 Updates | In-depth Insights into the Emerging Drugs, Latest FDA, EMA, and PMDA Approvals, Clinical Trials, and Treatment Outlook | Compass #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech