CTI Life Sciences Fund’s Post

Is capivasertib the first of many AKT inhibitors to reach the market? 👀 Last November, capivasertib, the collaborative asset of Astex Pharmaceuticals and AstraZeneca, was granted approval by the U.S. FDA. Last week the AKT inhibitor reached another milestone as it received approval from the U.K. Medicine and Healthcare products Regulatory Agency (MHRA). ✅ As capivasertib increases its presence on the global market it makes you wonder about similar candidates. While a few ATK drugs were dropped early after showing mixed results there are still candidates out there progressing through the pipelines. Although, capivasertib clearly appears as the frontrunner in this area. 🥇 Find out more in our article! ⬇️ https://lnkd.in/dFZJFt5z #biotechinnovation #cancertreatment #drugdevelopment #pharmanews #biotechtrends #healthcareadvances #medicalresearch #oncology GSK | Novartis | Laekna Therapeutics | Janssen Inc.

AbbVie Inc. has announced its acquisition of Landos Biopharma, Inc., a clinical stage biopharmaceutical company specializing in developing novel, oral therapeutics for autoimmune diseases. This acquisition is expected to advance the clinical development of Landos' lead investigational asset, NX-13, a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action. NLRX1 is known to regulate immunometabolism and inflammation, impacting multiple mechanisms of inflammatory bowel disease (IBD) pathogenesis. NX-13 is currently being evaluated in a Phase 2 clinical trial for ulcerative colitis (UC), with promising potential for the treatment of UC and Crohn's disease. AbbVie's acquisition of Landos represents a significant step forward in addressing the therapeutic gap in current treatment options for autoimmune diseases. By leveraging AbbVie's expertise in global development and therapeutic area leadership, NX-13 could potentially provide a novel and effective approach to treating UC and Crohn's disease, ultimately benefiting patients worldwide Source : https://lnkd.in/e8DPfXpq #AbbVie #LandosBiopharma #AutoimmuneDiseases #NX13 #UlcerativeColitis #CrohnsDisease #ClinicalTrial #InnovationInHealthcare #HealthcareAdvancements #Immunometabolism #InflammatoryBowelDisease #IBDResearch #Biopharmaceuticals #HealthcareInnovation #GlobalHealthcare #PatientCare #TherapeuticAdvances #ClinicalDevelopment #HealthcareNews

$100B Vertex Pharma Working to create a new generation of non-addictive painkillers as the most promising in its pipeline. Vertex Pharmaceuticals Inc‘s (NASDAQ:VRTX) blockbuster drug Trikafta for cystic fibrosis (CF) has shown remarkable efficacy, potentially extending the lives of some patients by up to 45 years.  Despite its high cost of $300,000 per patient annually in the U.S., sales remain robust. Since its launch in 2019, Trikafta has amassed $26 billion in revenues and is expected to reach $10 billion in annual sales next year.  Additionally, Vertex anticipates regulatory approval for its fifth CF treatment, the vanza triple, this year, with projected annual sales matching Trikafta’s success. Vertex is poised for substantial growth and will emerge as a top contender among pharmaceutical companies. Now, the same research team at Vertex’s San Diego lab is nearing the culmination of another extensive project: developing non-opioid painkillers, presenting a new avenue for substantial market expansion. Vertex’s challenge lies in replicating its success in cystic fibrosis (CF) treatment across other diseases.  Recently, it gained regulatory approval for a groundbreaking CRISPR gene editing-based therapy for sickle cell disease and beta-thalassemia.  Moreover, Vertex acquired Alpine Immune Sciences Inc (NASDAQ:ALPN) for $4.9 billion, a move aimed at developing a treatment for autoimmune kidney disease.  However, analysts highlight a new generation of non-addictive painkillers as the most promising in Vertex’s pipeline.  VX-548, a non-opioid painkiller, is undergoing late-stage clinical trials and shows potential for FDA approval this year.  It promises reduced pain with fewer side effects and no risk of addiction compared to traditional opioids.

Stories making headlines today in the biopharma industry: I am excited to share some key updates with you from the biotech and pharmaceutical industry this week. Leading the pack, we have Novo Nordisk, the Danish pharmaceutical giant, joining forces with Swiss biotech EraCal Therapeutics. The duo is set to develop an experimental obesity drug with a potentially game-changing mechanism that moderates appetite and body weight. The interesting part of the deal being the possible achievement of €235 million (~$255 million) in milestone payments! Moving on, in a significant step towards increased pharmaceutical safety, the U.S. Food and Drug Administration (FDA) has called for mandated boxed warning for six Chimeric Antigen Receptor T cell (CAR-T) therapies developed by Novartis, Gilead, Bristol Myers Squibb, and Johnson & Johnson, about the risk of secondary cancers. In acquisition news, Sanofi has purchased Inhibrx for a substantial $1.7 billion with plans to incorporate its potentially superior therapy for Alpha-1 Antitrypsin Deficiency (AATD) into their rare disease pipeline. The fascinating part is that Sanofi will hold only Inhibrx's lead drug INBRX-101 and separate all other programs into a spinoff named New Inhibrx, increasing Sanofi's stake in New Inhibrx to 8%. There are also big moves in cancer medicine. Merck has struck a deal with Unnatural Products, worth $220 million, to develop macrocyclic therapies for cancer. Simultaneously, CG Oncology is gearing to increase its Initial Public Offering from 11.8 million to 17 million shares, planning to raise around $262.8 million from their NASDAQ debut. Finally, Accent Therapeutics, a cancer biotech, has secured $75 million from Series C funding round backed by three major pharmaceutical companies, among other investors. The fund will be used to launch their first two precision oncology small molecules into early clinical trials. Stay tuned for more exciting updates from the world of biotech and pharma! #pharma #biotech #topstories #biodatastudio

Big news, Gilead Sciences announces its acquisition of CymaBay Therapeutics for its lead candidate seladelpar, as it hits a significant milestone with FDA Here's what you need to know: 1️⃣ Strategic Acquisition: Gilead will acquire CymaBay for $4.3 billion (27% Stock Premium), bolstering its liver disease portfolio with seladelpar, an investigational treatment for primary biliary cholangitis (PBC) With strong Phase III results, seladelpar offers an avenue for patients with PBC, addressing an unmet medical need in the field 2️⃣ FDA Acceptance and Priority Review: The FDA has accepted CymaBay's New Drug Application (NDA) for seladelpar, granting it a priority review with a PDUFA date of Aug. 14, 2024 Seladelpar is the only investigational agent to have demonstrated significant improvements in biochemical markers of disease progression and PBC-related pruritus 3️⃣ Strategic Fit and Market Potential: This acquisition aligns with Gilead's already transformative pipeline for liver diseases, leveraging its expertise and commercial experience Following the recent collaboration with Arcus Biosciences, Gilead continues to strengthen its pipeline and expand its forward-looking revenue in biotech #acquisitions #liverdisease #biopharma https://lnkd.in/gg72V5BY

Featured highlights from today's Efortless Update: [Clinical Trials] 07/18 「AVEO Oncology's phase 3 Trial of TiNivo-2 Fails Primary Endpoint in Advanced RCC, Provides Efficacy at Standard Monotherapy Dose 」 07/18 「Alkeus Pharmaceuticals, Inc. shares interim TEASE-3 study data at the 42nd American Society of Retina Specialists Meeting」 07/18 「Abliva AB's FALCON Study Continues with KL1333 for Primary Mitochondrial Disease; Market Advancement Expected in 2024」 [Deals] 07/18 「Meitheal Pharmaceuticals, Inc. Pharmaceuticals Acquires North American Rights for CONTEPO from Nabriva Therapeutics plc, Gearing Towards Antibiotic Development」 07/18 「ME Therapeutics and NanoVation Therapeutics™ collaborate on mRNA-based drug trials using LNP technologies under a new material transfer agreement」 [Regulatory] 07/19 「EMA accepts marketing authorisation application for GSK's Blenrep for relapsed or refractory multiple myeloma treatment based on DREAMM-7 and DREAMM-8 trial results」 07/19 「Bristol Myers Squibb's Opdivo and Yervoy treatment for hepatocellular carcinoma validated by EMA for review based on CheckMate - 9DW trial results」 same day : ( ↑ NYSE: BMY | +0.5% ) 07/19 「ONO PHARMACEUTICAL CO., LTD. submits marketing authorization application to EMA for cancer therapy vimseltinib after MOTION phase 3 study results」 View the full newsletter contents for free via the link in the comments.

Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational claudin (CLDN) 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy approved for this patient population in the U.S. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a new target action date of November 9, 2024. In the U.S., it was estimated that 26,890 people will be diagnosed with gastric cancer and 10,880 will die from the disease in 2024. Since early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, gastric cancer is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor's origin to other body tissues or organs. The five-year relative survival rate for patients at the metastatic stage is 7%. Moitreyee Chatterjee-Kishore, Ph.D., MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas: "Astellas is committed to introducing new targeted therapies for hard-to-treat cancers. Those living with advanced gastric or GEJ cancer often face great unmet needs, and the FDA acknowledgment of the zolbetuximab BLA resubmission brings us one step closer to offering this important treatment option to eligible patients in the U.S. facing this deadly disease." #gastriccancer #GEJ #targetedtherapy #zolbetuximab #Astellas #ScienceFirstForPatients #ChangingTomorrow

The U.S. FDA's Center for Drug Evaluation and Research (CDER) has licensed 56 novel treatments in 2023, marking a 51% increase from 2022 when the CDER cleared 37 drugs, the lowest since 2016. This year, oncology was the most common therapeutic area to win CDER approvals, accounting for 31% of total authorizations. Notable cancer drugs to receive FDA approval this year include Jaypirca, Epkinly, multiple myeloma drugs, Elrexfio and Talvey from Johnson & Johnson, and Pfizer. Drugs targeted at neurological and autoimmune conditions comprised 11% of total approvals each. Biogen and Eisai's became the first to receive an FDA nod this year when the agency cleared their anti-amyloid antibody Leqembi for Alzheimer's disease under its accelerated pathway. Acadia Pharma's Rett syndrome therapy Daybue and Sage and Biogen's depression therapy Zurzuvae were greenlighted. Pfizer and Eli Lilly won FDA approvals for their ulcerative colitis therapies Velsipity and Omvoh. Pfizer led CDER approvals this year with six approvals, while Biogen and AstraZeneca came in second and third with four and three approvals, respectively. Other leading drugmakers to receive FDA approvals this year include GSK, Bristol Myers Squibb, Regeneron, Roche, Novo Nordisk, Sanofi, and Novartis. Asian drugmakers Astellas Pharma, Daiichi Sankyo, Inc. and Takeda were also notable winners. #fdaapproval #pharmaceuticals #regulatoryaffairs #medicalinnovation #oncology

Sanofi and Denali Therapeutics' setback in the HIMALAYA trial for ALS treatment with SAR443820 highlights key points for the pharmaceutical sector: 1️⃣ Persistence in Innovation - Despite not meeting the primary endpoint in ALS treatment, Sanofi's continued exploration in a multiple sclerosis trial with SAR443820 exemplifies the relentless pursuit of breakthroughs. 2️⃣ Challenges in Collaboration - The ups and downs in the Sanofi-Denali RIPK1 collaboration reflect the complex nature of drug development partnerships, emphasizing the need for adaptability and resilience. 3️⃣ RIPK1 Inhibitors' Potential - The broader industry's engagement with RIPK1 inhibitors, despite varied successes, underscores the ongoing quest to unlock new therapeutic avenues. Key Questions: 🔷 How will these developments shape future strategies in tackling complex diseases? 🔷 What can we learn from the resilience and adaptability required in pharmaceutical R&D? This moment serves as a reminder of the critical need for continuous learning and innovation in our journey to address unmet medical needs. Let's discuss how setbacks can pave the way for future successes. #HealthcareInnovation #Pharmaceuticals #DrugDevelopment #ALSResearch

AbbVie submits Biologics license application to US FDA for Telisotuzumab Vedotin Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer @NSCLC) with c-Met protein overexpression AbbVie announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. Approximately 85% of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world.2 The c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25% of advanced EGFR wild type, nonsquamous NSCLC patients3 and is associated with a poor prognosis.4,5,6 Teliso-V is being evaluated within this patient population who currently have very limited treatment options. #Healthcare #Pharma #LinkdInpost #Dailyupdates #Abbvie #BLA #Discovery #Science