USFDA issued Form 483 to Aurobindo Pharma
The United States Food and Drug Administration (USFDA) issued Form 483 to Aurobindo Pharma over observation on it's two units of Hyderabad.
Industry News
Invitation for Nominations / Applications for CDRI AWARDS for Excellence in Drug Research 2020
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.
Call for proposal INDIA-EU co-funding on Health, Bioeconomy, Clean Energy and Biotechnology
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'.
Mention Acute Kidney Injury as ADR in the package insert of PPIs: CDSCO
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.
Breakthrough in the accuracy of synthetic DNA production by Camena Bioscience
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%.
New Tests from the same bottle of J&J Baby Powder previously tested by FDA find no Asbestos
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 Pharma Launches CEQUA for the Treatment of Dry Eye Disease in the U.S.
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.
Mylan to invest 1bn USD in India
US based, Myaln reported that they will invest one billion USD in the next 5 to 6 years on capex in India by understanding importance of the India's position in world pharma supply-chain, and pitched for the government incentivising research and development activities. Mylan had been investing close to about 400 to 450 mn USD towards Capex every year and half of it in India.
Roche presents positive Phase III results for Tecentriq® (atezolizumab)
Roche presented positive results from the Phase III IMvigor130 study evaluating Tecentriq® (atezolizumab) plus platinum-based chemotherapy versus chemotherapy alone for the first-line (initial) treatment of people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) eligible and ineligible for cisplatin chemotherapy. In the study, Tecentriq plus chemotherapy showed a statistically significant improvement in progression-free survival (PFS) compared with platinum-based chemotherapy alone (median PFS=8.2 versus 6.3 months; hazard ratio (HR)=0.82, 95% CI: 0.70-0.96; p=0.007).
Torrent Pharma expanding its recall for Losartan Potassium Tablets
Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis.
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