News and Trends 3 Feb 2023 Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug Genoscience Pharma has announced that its lead candidate, ezurpimtrostat, a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor, has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC). ODD qualifies ezurpimtrostat for a potential seven years of market exclusivity after approval. The FDA’s ODD program provides […] February 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Jan 2023 Stemline Therapeutics’ breast cancer treatment approved The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics, a wholly-owned subsidiary […] January 31, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Jan 2023 Stargardt disease treatment gets FDA fast track Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) for MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to […] January 31, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Jan 2023 Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. The designation approval is based on results from the phase Ib clinical trial of TGCT cohort for Pimicotinib. […] January 31, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jan 2023 FDA clearance for ‘revolutionary’ approach to J-Pouch issue ExeGi Pharma LLC, which develops live biotherapeutic drugs and probiotics, says the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. The clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or J-Pouch) who experience excessive stool frequency. “Excessive stool frequency […] January 27, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 11 Jan 2023 Renexxion goes to FDA with cystic fibrosis drug Renexxion Ireland Limited has opened an investigational new drug (IND) application with the U.S Food and Drug Administration (FDA) for naronapride for the treatment of GI motility disorders in patients with cystic fibrosis (CF). This is a first step towards conducting clinical trials of the drug candidate in CF patients. Naronapride, post approval, could be […] January 11, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 11 Jan 2023 AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra, (albuterol/budesonide, formerly known as PT027) is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication […] January 11, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 9 Jan 2023 BD and CerTest Biotec receive emergency use authorization for mpox test BD (Becton, Dickinson and Company), and CerTest Biotec have announced emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a molecular polymerase chain reaction (PCR) assay for mpox virus detection. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System is now available for BD MAX System users. “The […] January 9, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 9 Jan 2023 Rani Therapeutics provides pipeline update Rani Therapeutics Holdings, Inc. has completed a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) with respect to RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update. Following feedback from the meeting with […] January 9, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 4 Jan 2023 Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation Infex Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) designation to MET-X, the company’s broad spectrum metallo-beta-lactamase (MBL) inhibitor. Infex Therapeutics’ MET-X is a resistance bypass treatment that targets Gram-negative Enterobacterales. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics and evade antibiotic clearance of […] January 4, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 20 Dec 2022 F2G looks for FDA new drug application approval for invasive fungal infections treatment F2G Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its new drug application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options. F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal […] December 20, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 14 Dec 2022 NMD Pharma cleared for spinal muscular atrophy trial NMD Pharma A/S has received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to advance NMD670 into a phase II clinical study in patients of spinal muscular atrophy (SMA) type 3. NMD Pharma is a Danish clinical stage biotech company developing first-in-class, small molecule ClC-1 inhibitors for […] December 14, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email