Sun Pharma along with its wholly owned subsidiaries is a defendant in a multi-district litigation brought by various classes of plaintiffs, in the US District Court (District of Massachusetts), alleging a delay in the market entry for three generic drugs which are Valganciclovir, Valsartan and Esomeprazole.
Eminence Business Media’s “2nd Annual Pharma Manufacturing & Automation Convention 2019” concluded on October 17th & 18th, 2019 at Hotel Radisson Blu Plaza Banjara Hills, Hyderabad. The theme of the summit was “From Ideation to Innovation: Aligning with trending market demands”. The event was an outstanding success with 150+ delegates attending the conference with Honeywell, Zenith Technologies, Caliber Group, UL & Pharma Mantra partnering the event.
The Committee recommended granting a marketing authorisation for Isturisa* (osilodrostat) for the treatment of Cushing’s syndrome, a rare disorder that occurs when the body produces too much corticosteroid hormone. It leads to patients experiencing weight gain, fat build-up on the face and bruising.
The United States Food and Drug Administration (USFDA) issued Form 483 to Aurobindo Pharma over observation on it's two units of Hyderabad.
The CSIR-Central Drug Research Institute (CDRI), Lucknow, was seventh in the chain of CSIR labs that were established in India right after independence India with an aim for technological independence of the Nation. CSIR-CDRI was broadly mandated with the task to revolutionise the pharmaceutical sector, which was almost non-existent at that time for accessibility and affordability of drugs. Today, CSIR-CDRI has evolved into a unique institution possessing end-to-end expertise in the domain of new drug development - its human resource and infrastructure today is second to none. Besides being the breeding ground of huge highly trained human resource for the drug development and manufacturing, out of 20 new drugs discovered, developed and approved in the post-independent India, 11 (8 synthetic + 3 phytopharmaceuticals) are contributions of CSIR-CDRI, Lucknow. These include Centchroman, Arteether, Centbucridine, Gugulipid, Bacosides Enriched Standardized Extract of Bacopa, etc. Centchroman (Ormeloxifene), a non-steroidal contraceptive with almost no toxicity, is now part of the National Family Program, whereas a-(3 Arteether (antimalarial) is included in the National Malaria Program.
Researchers and innovators from universities, research organisations and enterprises from India can team up with European partners in the calls for proposals published by the European Commission (EC) under its Research and Innovation programme 'Horizon 2020' (2014-2020). Through participation in 'Horizon 2020'.
Proton Pump Inhibitors (PPIs) like Pantoprazole, Omeprazole, lansoperazole, Esomeprazole, Rabeprazole etc are having adverse drug effect which lead to acute kidney Injury. And due to that CDSCO requested the State Drugs Controllers to direct the manufacturers of Proton Pump Inhibitors to incorporate Acute Kidney Injury as an Adverse Drug Reaction in the package insert leaflet of the drugs.
Synthetic biology company, Camena Bioscience succeeded with significant breakthrough in DNA synthesis accuracy with the development of an innovative technology called gSynth™. With this pioneering enzymatic de novo synthesis and gene assembly method, gSynth is able to produce 300 nucleotide DNA molecules with an accuracy as high as 90%.
Johnson & Johnson Consumer Inc. (J&J) announced that 15 new tests from the same bottle of Johnson’s Baby Powder previously tested by the U.S. Food and Drug Administration (FDA) found no asbestos. An additional 48 new laboratory tests of samples from the single lot of Johnson’s Baby Powder that the Company voluntarily recalled on October 18 also confirmed that the product does not contain asbestos.
Sun Pharmaceutical Industries Ltd announced that one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S. CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.1 CEQUA is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar (NCELL™) technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration.