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Regulus Therapeutics Announces RGLS4326 Program Hold
americanpharmaceuticalreview
July 25, 2019
Regulus Therapeutics announced a program update for RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The Company has been working with the United States Food and Drug Administration (FDA) since July 2018 ...
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Warning issued to company for using unfounded CBD treatment claims
europeanpharmaceuticalreview
July 25, 2019
FDA issues warning to a company that claimed its CBD products can be used to treat cancer and Alzheimer’s disease.
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Opiant Pharmaceuticals, Sanofi to Manufacture Acute Cannabinoid Overdose Treatment
contractpharma
July 25, 2019
Opiant’s drinabant, selective cannabinoid receptor antagonist, could be first approved treatment for ACO.
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La Jolla Pharma Receives Orphan Designation for Malaria Treatment
contractpharma
July 24, 2019
LJPC-0118, artesunate, demonstrated to be superior to quinine in reducing mortality in patients with falciparum malaria infection.
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APB-102 Receives Orphan Drug Designation for Genetic SOD1 ALS Treatment
americanpharmaceuticalreview
July 23, 2019
Apic Bio announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).
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Complete response letter given to ALS treatment for API concern
europeanpharmaceuticalreview
July 23, 2019
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
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FDA Approves Treatment for Complicated Urinary Tract, Complicated Intra-Abdominal Infections
americanpharmaceuticalreview
July 19, 2019
The U.S. Food and Drug Administration (FDA) has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
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Skyhawk, Genentech Enter Exclusive Multi-target RNA Alliance
contractpharma
July 17, 2019
Will leverage SkySTAR platform to discover and develop small molecule treatments for oncology and neurological disease targets.
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Company Reaches $1.4 Billion Settlement in Opioid Treatment Investigation
drugs
July 16, 2019
Company Reaches $1.4 Billion Settlement in Opioid Treatment Investigation.
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Syndax Pharma Gets IND Clearance for Leukemia Treatment
drugs
July 12, 2019
Will begin Phase 1/2 trial for targeted Menin inhibitor, SNDX-5613, in patients with relapsed/refractory acute leukemias.