Pharma News

the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.

The Director General of foreign Trade made an amendment in the export policy of cough syrup. Now, it is required to test export samples from government labs before exporting cough syrup.

As per revised export policy, cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis issued by government laboratories.

Antiretroviral cocktails can make human immunodeficiency virus, or HIV, undetectable and untransmittable, but both the virus and its treatment can also accelerate aging of bone and muscle.

Now Medical College of Georgia scientists are looking at drugs already being studied in clinical trials for cancer to help put the brakes on these classic indicators of aging that can lead to falls, fractures and early frailty.

For the first time, researchers described the structure of a special type of amyloid beta plaque protein associated with Alzheimer’s disease (AD) progression. In a report published May 10 in the journal Neuron, scientists showed the small aggregates of the amyloid beta protein could float through the brain tissue fluid, reaching many brain regions and disrupting local neuron functioning.  The research also provided evidence that a newly approved AD treatment could neutralize these small, diffusible aggregates.

Dr. Reddy’s Lab gets subject expert committee (SEC- Oncology & Haematology) recommendation for Lenalidomide Capsule. The 148th meeting was held on 11.05.2023 at CDSCO (HQ) New Delhi.

Dr. Reddy’s Lab presented the proposal for manufacturing and marketing permission of Lenalidomide Capsule 25mg (using Lenalidomide povidone premix) along with the results of the BE study before the committee.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz® Injection).

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

As per new amendment of New Drugs and Clinical Trials, Clinical Research Organisations cannot conduct any clinical trial or bioavailability studies without permission from Central Licencing Authority.

As per new amendment, application for registration of Clinical Research Organisation for the purpose of conducting clinical trial or bioavailability or bioequivalence study with the Central Licencing Authority shall be made to the said authority in Form CT-07B.

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.