Chronic Kidney Disease
Nov 30, 2023
Baird Medical’s Microwave Ablation System; BrainSpec’s AI-Backed Solution for Non-Invasive Brain Chemistry Measurement; AWAK’s AI-Enabled Kidney Disease Prediction Tool; Revvity’s EONIS Q System; FormaPath Announced Advancement in Cancer Pathology; Pramand Launched CraniSeal Dural Sealant
Baird Medical Received the US FDA Clearance for a Microwave Ablation System On November 22, 2023, Baird Medical announced the US Food and Drug Administration clearance of the company’s microwave ablation (MWA) system and disposable needles for use in the US. The clearance allows the use of the technology to a...
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Nov 07, 2023
New Asundexian Phase III Study Result; Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction Chronic Kidney Disease; Orphan Drug Designation to Rhenium Obisbemeda; FDA Approves Merck’s KEYTRUDA Plus Gemcitabine and Cisplatin for Biliary Tract Cancer; Orphan Drug Designation to Ayala’s AL102; GARDP Announces Successful Phase 3 Trial of of Uncomplicated Gonorrhea
Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea The Global Antibiotic Research & Development Partnership (GARDP), in partnership with Innoviva, Inc. (Nasdaq: INVA), had announced a significant milestone. They revealed that zolif...
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Oct 23, 2023
Ardelyx Overcomes Hurdles to Secure FDA Approval for Xphozah in Chronic Kidney Disease Treatment
Ardelyx has struck gold on its third attempt with Xphozah (tenapanor), the chronic kidney disease medication. Following two prior rejections, the FDA has granted its long-awaited approval. Xphozah, an innovative phosphate absorption inhibitor, is now officially sanctioned for the management of serum phosphate level...
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Oct 12, 2023
B. Braun’s Introcan Safety 2 IV Catheter; Everly Health’s At-Home Collection Kidney Health Test; FDA Clearance to Sanguina’s AnemoCheck Home; FDA Clearance for the DePuy’s TriALTIS™ Spine System; Biotronik’s Spinal Cord Stimulation Tech; Contego Medical’s Performance III Direct Transcarotid Access Stenting Trial
B. Braun Launched Introcan Safety® 2 IV Catheter with Multi-Access Blood Control Designed to Protect Clinicians Every Time the Hub is Accessed On October 11, 2023, B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy, announced the launch of its new Introcan Safety® 2 IV Catheter with Multi-Acces...
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Jun 12, 2023
Evolving Therapeutics in Chronic Kidney Disease (CKD) Treatment Market
Chronic kidney disease burden and diagnostic barriers Chronic kidney disease (CKD) is a progressive and irreversible ailment characterized by gradual loss of kidney function. It is clinically defined by a glomerular filtration rate of less than 60mL/min/1.73m2 or albuminuria of at least 30mg per 24 hours, or any...
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Feb 07, 2023
Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial
Merck Wins Another FDA Approval for Blockbuster Keytruda Merck & Co arrived just two months after GSK celebrated a positive phase III result with its checkpoint inhibitor Jemperli as a first-line therapy for endometrial cancer. Keytruda (pembrolizumab) from Merck improved progression-free survival (PFS) vers...
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Sep 13, 2022
Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial
Amgen Reveals the Top-line Result of its CodeBreak-200 trial of Lumakras in Lung Cancer The top-line result of Amgen's CodeBreak-200 trial of Lumakras in lung cancer was presented in abstract form at ESMO two weeks ago, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. The fu...
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Aug 30, 2022
Aktis’s Novel Targeted Alpha Radiopharmaceuticals; Koye Partners with Sonde Health; Novartis to Spin Off Sandoz Business; Alcon to Buy Aerie Pharma; Fast Track Designation to Merck’s MK-2060; FDA Approves Ibrutinib for Chronic GvHD; French Authorities Clears BrainVectis’s Clinical Trial; Takeda’s Dengue Vaccine TAK-003 Gets Approval in Indonesia
Aktis Oncology Raises USD 84 Million To Advance Novel Targeted Alpha Radiopharmaceuticals Aktis Oncology has raised an additional USD 84 million in its Series A round, adding to the USD 72 million raised last year to help bring its radiopharmaceuticals to market. The extension to the first round included Merck's...
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Jul 05, 2022
AstraZeneca’s Imfinzi Shows Positive Results; Novartis Announces Results of Tislelizumab; FDA Grants Orphan Drug Designation to Evorpacept; EU Approves Sanofi’s Xenpozyme; Bayer’s Kerendia Approves in China; FDA Breakthrough Therapy Designation to Talquetamab; FDA Puts Clinical Hold on Sanofi’s Tolebrutinib; FDA Rejects Spero’s Tebipenem
FDA Grants Orphan Drug Designation to Evorpacept for AML ALX Oncology Holdings announced that the U.S. Food and Drug Administration had granted orphan drug designation to Evorpacept, a next-generation CD47 blocker, for treating patients with acute myeloid leukemia (AML). Acute Myeloid Leukemia (AML) is an agg...
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Jun 21, 2022
Biogen terminates ALS Pact with Karyopharm; AbbVie’s Immunological Drug Skyrizi; NICE Backs Astellas’ Oral Therapy Evrenzo; Roche’s Crenezumab Fails in Clinical Trial; FDA Grants Fast Track Designation to Dianhydrogalactitol; Sierra Oncology Submits NDA for Momelotinib
Biogen terminates USD 217 Million ALS Pact with Karyopharm Biogen has backed out of the four-year-old partnership with Karyopharm on a drug candidate for the neurological disease amyotrophic lateral sclerosis, which could have cost the US biotech up to USD 217 million. The 2018 agreement that granted Biogen righ...
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