Pharma News

Lupin Limited (Lupin) has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 20 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 93rd Authority meeting dated 15.11.2021. The drug candidate Dapagliflozin and metformin extended release is included in 17 formulations out of 20 for which price fixation is applied. Dapagliflozin was patented by AstraZeneca and there are sixteen USA patents protecting this drug and one Paragraph IV challenge.

Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, becomes one of the first companies to launch a bioequivalent version of Tiotropium Bromide dry powder inhaler under the brand name - Tiogiva, in UK for the treatment of chronic obstructive pulmonary disease (COPD).

Novavax, Inc announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.

Natco Pharma Limited is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS), from the U.S. Food and Drug Administration (USFDA).

Masimo announced the findings of a study published in the Turkish Journal of Medical Sciences in which Dr. Ayten Saracoglu and colleagues at the Marmara University Pendik Training and Research Hospital in Istanbul evaluated the ability of ORi to guide oxygenation by measuring its impact on hyperoxemia-mediated morbidity during one-lung ventilation conducted as part of thoracic surgery. They concluded that ORi-guided oxygen titration may reduce hospital stay and increase patient safety.

The U.S. Food and Drug Administration approved Aduhelm for the treatment of Alzheimers, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

It is 2019 when Prof. Saptarshi Majumdar & Dr. Chandra Shekhar Sharma from the Department of Chemical Engineering has made a proven study about oral nanofibrous AMB to be effective for Kala Azar. This is a first-ever attempt to fabricate nanofibrous oral tablets of Amphotericin B for the potential cure of Leishmaniasis or Kala Azar. With the 2 years of advancement of examination, the researchers are now confident that the technology can be transferred to suitable pharma partners for large-scale production.

Researchers world-wide are focused on clearing the toxic mutant Huntingtin protein that leads to neuronal cell death and systemic dysfunction in Huntingtons disease (HD), a devastating, incurable, progressive neurodegenerative genetic disorder. Scientists in the Buck Institutes Ellerby lab have found that the targeting the protein called FK506-binding protein 51 or FKBP51 promotes the clearing of those toxic proteins via autophagy, a natural process whereby cells recycle damaged proteins and mitochondria and use them for nutrition.

Scientists have fabricated a device that can mimic human brain cognitive actions and is more efficient than conventional techniques in emulating artificial intelligence, thus enhancing the computational speed and power consumption efficiency.