Scientists find unique anti-diabetes compound using powerful new drug-discovery method

Scientists from The Scripps Research Institute (TSRI) have deployed a powerful new drug discovery technique to identify an anti-diabetes compound with a novel mechanism of action. The finding, which appeared online ahead of print in Nature Communications, may lead to a new type of diabetes treatment. Just as importantly, it demonstrates the potential of the new technique, which enables researchers to quickly find drug candidates that activate cellular receptors in desired ways.

Follow below link:
https://www.worldpharmanews.com/research/3295-scientists-find-unique-anti-diabetes-compound-using-powerful-new-drug-discovery-method

FDA’s History of Withdrawing Warning Letters

Follow the link given below for more details :

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/10/warning-letter-what-warning-letter-latest-developments-in-pacira-and-a-look-at-fdas-history-of-withd.html

India woos Italian bulk drug makers to cut dependency on Chinese APIs

HYDERABAD: The government is looking to promote, domestic pharma companies' tieups with bulk drug makers in Italy to cut dependence on China for pharmaceutical ingredients. 

India sources over 70 per cent of its requirement of bulk drugs (ingredients) from Chinese pharmaceutical companies. 

Pls click below link :

http://m.economictimes.com/industry/healthcare/biotech/pharmaceuticals/India-woos-Italian-bulk-drug-makers-to-cut-dependency-on-Chinese-APIs/articleshow/48446172.cms

Indian Government Initiatives For The Development of Pharma Industry

The Addendum 2015 of the Indian Pharmacopoeia (IP) 2014, published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, is expected to play a significant role in enhancing the quality of medicines that would in turn promote public health and accelerate the growth and development of pharmaceutical sector.

China luring Indian pharma scientists with 3 times higher pay to boost formulations segment

Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength

AUDIENCE: Pharmacy, Consumer

ISSUE: On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. See the firm Press Release for further details.

Government to set up R&D centre for bulk drugs at NIPER

Link :

http://www.business-standard.com/content/b2b-pharma/government-to-set-up-r-d-centre-for-bulk-drugs-at-niper-114071500616_1.html

Merck, BD Face Issues With Drug Container Closures

Merck is recalling thousands of bottles of Temodar and temozolomide capsules because cracks in the caps have rendered the child-resistant closure ineffective.

 

The recall affects roughly 276,000 five- and 14-count bottles of the oral chemotherapy drugs, which were distributed nationwide between July 2013 and August of this year. No adverse events have been reported, according to Merck.

In a similar incident, the FDA is alerting healthcare providers not to use compounded or repackaged drugs that have been stored in 3 ml and 5 ml syringes manufactured by Becton-Dickinson, unless there is no alternative. Drugs stored in these syringes may lose potency over time due to a possible interaction with the rubber stopper in the syringe, the agency says.

Providers who use a substitute product may need to adjust the dosage in case patients have been receiving a subpotent product to avoid adverse events, the agency adds.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA's interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.

Judge Says Marketing Exclusivity Begins With FDA Sign-Off on Drug

A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs.




Click below link : 

http://www.fdanews.com/DID1007152?hittrk=DID15O1