Pharma News

The Indian pharmaceutical industry must consider the January 1, 2018 deadline issued by the Comptroller General of India Drugs (DCGI) as sacrosanct to improve the skills of people employed in their units, according to the Life Sciences Sector Skill Development Council (LSSSDC) set up under the auspices of the Ministry of Skills Development.

Timely action has stopped at least 1000kilos of fake cosmetics from coming on the market at a time when the demand for sunscreens are enormous. A Girgaum man has been prosecuted by the state Food and Drug Administration (FDA) for trying to sell spurious sunscreen tubes, filled with baby lotion, under the brand name of a reputed international cosmetics company.

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Small and medium-sized generic drug manufacturers in India say that the threat of stricter rules and higher barriers for foreigners in the US healthcare market will force a lot to find a niche or focus their expansion efforts on other countries.

The Ministry of Health is considering setting up an online portal to regulate and fill gaps in the sale of drugs in India across all platforms, including pharmacies. "The objective of such regulation would be to ensure the availability of drugs that meet quality standards to each person in need of medicines, to curb antimicrobial resistance and to regulate the supply of drugs online, "The ministry said.

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.