-
N-Nitrosamine Impurities and FDA’s Recommendations for Acceptable Intake Limits
04 Apr 2025 21:02 GMT
… for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of … impurities.
PharmTech: What are nitrosamine drug substance-related impurities (NDSRIs)?
…
References
FDA. FDA Statement on the FDA’s Ongoing Investigation into Valsartan and ARB …
-
The Changing Landscape of Heart Failure Drug Clinical Trials in China, 2013–2023
03 Apr 2025 11:17 GMT
… Drugs
The field of HF drug trials has focused predominantly on chemical drugs. Chinese pharmaceutical … sacubitril/valsartan. Chinese pharmaceutical enterprises have also … Medical Doctor Association; et al. Chinese guidelines for the diagnosis and treatment …
-
Medera Presented Updated Results from First-In-Human Gene Therapy Trial for Heart Failure with Preserved Ejection Fraction at 2025 HFpEF Summit
01 Apr 2025 12:00 GMT
… trial investigating SRD-002, a one-time gene therapy treatment … trials have had little success, except for the use of sacubitril-valsartan … and tissues. Global pharmaceutical and academic leaders are … Investigational New Drug (IND) clearances from the FDA for …
-
Medicare Negotiation for Heart Failure Drugs Could Save $5.83 Billion | ACC 2025
28 Mar 2025 23:35 GMT
… treatment: Jardiance (empagliflozin), Farxiga (dapagliflozin) and Entresto (sacubitril/valsartan). All three drugs … Releases Prices for Medicare Negotiated Drugs
In August 2024, … beneficiaries not taking these medications because of affordability issues …
-
Affordable healthcare: Koko Pimentel hails VAT-free move on 17 medicines
21 Mar 2025 10:39 GMT
… the Food and Drug Administration (FDA) in getting 17 medicine products free … senator.
The FDA said these new VAT-free medicines include treatments for high … , sitagliptin + metformin for diabetes, valsartan + amlodipine for hypertension, and sertraline …
-
Pimentel praises VAT-Free drugs, calls for wider coverage
20 Mar 2025 11:30 GMT
… financial burden of Filipinos needing medical treatment.
"Every peso … and Drug Administration (FDA), the newly VAT-free medicines include treatments for … sitagliptin + metformin for diabetes, valsartan + amlodipine for hypertension, and sertraline …
-
FDA Approves First Generics of Rivaroxaban Tablets
13 Mar 2025 00:33 GMT
… Johnson Innovative Medicine, formerly Janssen Pharmaceuticals. It is … the drug will provide more treatment options … dapagliflozin), Entresto (sacubitril/valsartan), Enbrel (etanercept), Imbruvica ( … Division of Drug Information. FDA Approves First …
-
Sacubitril/Valsartan Delivers Safer, Stronger Blood Pressure Control in CKD: Study Finds
13 Mar 2025 04:30 GMT
… BP control, necessitating alternative treatment strategies.
Against the above … Medicine, Yokohama, Japan, and colleagues assessed the impact of sacubitril/valsartan … of personalized treatment approaches. By integrating sacubitril/valsartan into …
-
FDA Approved Drug Products Approval List January 2025
11 Mar 2025 11:43 GMT
Approval Date Drug Name Submission … 47;2025 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEANDA #207299 ORIG … 1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN MACLEODS PHARMS LTD … 761036 SUPPL-51 DARATUMUMAB JANSSEN BIOTECH Approval 01/24 …
-
The Precedent: Federal Circuit Provides Further Clarity on Issues Surrounding Patent Validity in Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc.
22 Feb 2025 07:09 GMT
… claimed invention (a pharmaceutical composition combining valsartan and sacubitril) … by the FDA in 2015, becoming a treatment option … including MSN Pharmaceuticals, filed Abbreviated New Drug Applications (ANDA) … a three-day bench trial, the district court …