Pharma News

Scientists from the Florida campus of The Scripps Research Institute (TSRI) have developed a new drug delivery method that produces strong results in treating cancers in animal models, including some hard-to-treat solid and liquid tumors.

“Sun Pharma” and includes its subsidiaries or associate companies) was informed by the US FDA , that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.

Catalyst Pharmaceuticals Inc. a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare neuromuscular and neurological diseases, today announced positive top-line results from the investigator-sponsored trial evaluating Firdapse® (Amifampridine Phosphate) as a treatment for myasthenia gravis patients with anti-MuSK antibodies (MuSK-MG). MuSK-MG, is an ultra-rare sub-population of myasthenia Gravis (MG) patients which is a debilitating neuromuscular disease, and there are currently no FDA approved therapies for this specific form of MG.  Both of the co-primary efficacy endpoints of change from baseline (CFB) in total Quantitative Myasthenia Gravis (QMG) score (p=0.0003) and CFB in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score (p=0.0006) were statistically and clinically significant in this seven patient trial.  Several secondary efficacy measures also achieved statistical significance.  Amifampridine phosphate was well tolerated in this population of patients.

Arbutus Biopharma Corporation an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus (HBV) infection announced it has licensed to Alexion Pharmaceuticals, Inc.  its proprietary lipid nanoparticle (LNP) technology for exclusive use in one of Alexion’s rare disease programs. This transaction enables Alexion to address delivery for therapeutic application of messenger RNA (mRNA) and rapidly enter clinical development with its mRNA product candidate.

Both Johnson & Johnson and Danish partner Bavarian Nordic have induced a lasting immune response for a full year in 100% of vaccinated healthy volunteers, researchers reported. The world should be much better prepared for the next Ebola epidemic, with other promising results showing the potential of a long-lived lethal virus vaccine.

The policy, which had been pending for more than two years, also suggests raising public health spending to 2.5% of GDP, compared with 1.2% currently. EU Health Minister J P Nadda is expected to make a statement on the policy in Parliament.

The NPPA drug price regulator has capped the prices of four essential drugs and revised 14 others, including those used for the treatment of fungal infections and hypertension.

Since its inception, the National Pharmaceutical Pricing Authority (NPPA) has published 1,527 notices of demand to companies for surcharges on sales of formulations at prices above the notified ceiling price. Drug price regulator NPPA received Rs 672.28 fine crore up to date from pharmaceutical companies for overcharge, Parliament was informed.

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The main brands of some of the drugs used for the treatment of heart disease and diabetes are up to 10 times higher than generic drugs, the government said.

More than 20 medical devices that are notified as "drugs" must all carry the maximum retail price on packages, the NPPA drug price regulator said. These devices include cardiac valves, surgical dressings, condoms, stents, disposable hypodermic syringes and orthopedic implants.