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

MHRA, CDSCO Sign Agreement to Increase Regulatory Collaborations

Click below link :

http://www.raps.org/Regulatory-Focus/News/2015/10/05/23328/MHRA-CDSCO-Sign-Agreement-to-Increase-Regulatory-Collaborations/

Upcoming bulk drug policy could trigger investments worth Rs 40,000 cr

Link : http://www.business-standard.com/article/companies/upcoming-bulk-drug-policy-could-trigger-investments-worth-rs-40-000-cr-115062900720_1.html

India Must Reduce Reliance On China For Bulk Drugs: Indian Drug Manufacturers Association

Link : http://www.medindia.net/news/india-must-reduce-reliance-on-china-for-bulk-drugs-indian-drug-manufacturers-association-153049-1.htm

FDA revokes approval for Sun Pharma's seizure drug over compliance issues

The US Food and Drug Administration has revoked an approval issued in March to Sun Pharma Advanced Research Company (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site.

The move comes as a setback to SPARC, the research arm of India's largest drugmaker, Sun Pharmaceutical Industries Ltd. The drug, Elepsia XR, was its first to receive an FDA approval.

The company said in June it had been working "very aggressively" to find partners for the product. It had had "some advanced discussions" and aimed to launch the drug by the second half of fiscal 2016.

Analysts estimated modest sales of about $50 million annually from Elepsia XR.

SPARC had said it would produce the drug at Sun Pharma's Halol plant, in Gujarat, as an adjunct treatment for partial onset seizures in epilepsy patients of 12 years and older.

Most analysts saw the approval as positive mainly because it came despite the FDA having expressed concerns a year ago about manufacturing processes at the Halol plant.

Sun Pharma had been working on fixing the issues the FDA outlined and some analysts said the approval allayed fears of a possible adverse FDA action at Halol.

On Saturday, SPARC said the FDA issued it a "Complete Response Letter" in which it said "the compliance status of the manufacturing facility was not acceptable on the date of approval".

It said Sun Pharma "has taken several corrective measures" to fix problems at the plant.

Source : http://www.businesstoday.in/sectors/pharma/fda-revokes-approval-for-sun-pharma-seizure-drug-over-compliance-issues/story/224139.html

India Seeks to Amend Pharma Manufacturing Laws to meet Export Standards

FDA Shows Flexibility in Rare Disease Drug Development

Companies developing drugs for rare diseases that lack alternative treatments may be able to start clinical trials without the standard toxicology studies, provided they justify the approach, the FDA says.

The agency urges sponsors to meet with it early in the drug development process — before animal studies are begun — to see if such flexibility is appropriate.
The advice, outlined in guidance released Aug. 14, acknowledges the fact that patients with rare diseases may be willing to take greater risks than those with common, often less serious diseases.

The FDA also advises pre-IND meetings to discuss the availability of appropriate endpoints.
Well-characterized efficacy endpoints may not always be available for rare diseases, the agency points out. In such cases, drugmakers should develop new patient assessment tools, taking into consideration their validity, reliability, feasibility, resistance to bias, ability to detect change and clinical interpretability.

The FDA notes, for instance, that a Phase 3 study with a primary efficacy endpoint that is clinically meaningful but prone to bias may benefit from having secondary endpoints, such as laboratory measurements, that are bias-resistant. In early-stage trials, the ability to detect change may be more important than clinical meaningfulness to establish proof of concept.
Sponsors should also take advantage of pre-IND and other meetings to discuss their knowledge of the disease pathophysiology and the proposed drug’s mechanism for treatment, the agency says.

Lack of detail about a rare disease’s pathophysiology can be overcome by examining its natural history before setting out to develop a drug. This will help the company define the disease population, design and implement clinical studies and develop outcome measures and biomarkers.

Design features for a rare disease clinical trial are the same as for other drug trials: a clear statement of objectives, a design that permits valid comparison with a control, appropriate patient selection, methods to minimize bias and assess patients’ response and ability to analyze effects of treatment. With rare disease trials, however, the minimum number of patients required to establish safety and efficacy will be considered case by case, the FDA says.

Comments on the guidance are due Oct. 16.

Source :http://www.fdanews.com/CTA091715?hittrk=CTA1591