Pharma News

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients.

The Drug Control Administration (DCA) has stopped 11 pharmaceutical manufacturing firms located in the pharmaceutical hub of Baddi, Barotiwala, Nalagarh, Sirmaur and Kangra districts after significant observations were detected in its functioning during risk-based inspections conducted recently.

State Drugs Controller Navneet Marwaha said, "In the last two months, 29 firms were inspected in the second phase of the joint inspection by the state DCA and the Central Drugs Standard Control Organisation."

The U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.

Johnson & Johnson has settled its lawsuit over Amgen's proposed biosimilar version of J&J's top-selling treatment Stelara for psoriasis and other autoimmune conditions, according to a filing in Delaware federal court.

Amgen said in a statement on Tuesday that the settlement terms are confidential, but it will allow the company to sell its biosimilar of Stelara "no later than January 1st, 2025."

SSUHS, a state university of the government of Assam, announced that a common entrance examination will be held for admission into D.Pharm and B.Pharm courses in the institutes of Assam affiliated to SSUHS for session 2023 including institutes run under private sector.

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.