Shares of Biocon continue to fall on US FDA observations

Policy & Regulatory |  News | 0 Comment | 12 May, 2017

Shares of Biocon, India's largest and fully-integrated, innovation-led biopharmaceutical company, continue to fall for the third day today from May 10 after it received observatio...Read more

Intel to provide health care support to parents of its employees in India

Policy & Regulatory |  News | 0 Comment | 11 May, 2017

Intel has introduced Elder Care Program in India under which healthcare support will be given to its employees’ parents.Through the Elder Care Program, the US-based hardware and semic...Read more

FDA studies for OncAlert® cancer test commences

Policy & Regulatory |  News | 0 Comment | 10 May, 2017

Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of oral/oropharyngeal cancer, announced the launch and first pati...Read more

Medrobotics receives FDA approval

Policy & Regulatory |  News | 0 Comment | 09 May, 2017

Medrobotics has received FDA regulatory clearance to market the Flex® Robotic System for colorectal procedures in the United States. Medrobotics is the first and only company to offer m...Read more

Karnataka State Pollution Control Board directs Pall to close down its centre in Bengaluru

Policy & Regulatory |  News | 0 Comment | 08 May, 2017

Pall India Pvt. Ltd, a fully owned subsidiary of Pall Corporation, is one of the 16 companies (under red category) which was asked by the Karnataka State Pollution Control Board (KSPCB) to ...Read more

Eris Lifesciences gets SEBI nod for IPO

Policy & Regulatory |  News | 0 Comment | 08 May, 2017

Private equity firm ChrysCapital-backed Eris Lifesciences Ltd has received the Securities and Exchange Board of India’s (SEBI) approval for an initial public offering. The capital ma...Read more

India and Japan intensify cooperation in medical device regulations

Policy & Regulatory |  News | 0 Comment | 05 May, 2017

India and Japan will intensify their joint cooperation for the development of a world-class medical device regulatory ecosystem in India, which will facilitate and expedite building up of a...Read more

TPG, General Atlantic to bid for Fortis Healthcare, SRL

Policy & Regulatory |  News | 0 Comment | 04 May, 2017

Private equity firms TPG Capital Inc and General Atlantic Pvt. Ltd have formed a consortium to acquire a controlling stake in Fortis Healthcare Ltd and its subsidiary SRL Diagnostics Pvt. L...Read more

Immediate reporting of coronary stent shortage

Policy & Regulatory |  News | 0 Comment | 03 May, 2017

Hardening its stand against pharmaceutical giants Abbott, Medtronic and Boston Scientific, the National Pharmaceutical Pricing Authority has asked hospitals, doctors and patients at large t...Read more

Foamix Pharmaceuticals Ltd. completed Phase 3 trials for FMX101

Policy & Regulatory |  News | 0 Comment | 02 May, 2017

Foamix Pharmaceuticals Ltd., a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, ann...Read more

MPEG LA invites CRISPR-Cas9 patents to be pooled in a one-stop license

Policy & Regulatory |  News | 0 Comment | 02 May, 2017

World licensing leader MPEG LA, LLC invited holders of CRISPR-Cas9 patents to participate in the creation of a global CRISPR-Cas9 Joint Licensing Platform that will make their groundbreakin...Read more

60 medicines declared 'substandard' by drug regulator

Policy & Regulatory |  News | 0 Comment | 01 May, 2017

Some of the most common pills like Combiflam and D-Cold consumed in India has been recently decalared as sub-standard by Indian drug regulator, CDSCO.  Specific batches of 60 drugs ha...Read more

Bayer Receives FDA Approval for Stivarga

Policy & Regulatory |  News | 0 Comment | 28 Apr, 2017

Bayer announced that the U.S. Food and Drug Administration (FDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) w...Read more

FDA warning to 14 companies for false claims

Policy & Regulatory |  News | 0 Comment | 27 Apr, 2017

The U.S. Food and Drug Administration has issued warning letters to 14 companies based out of U.S., who are selling more than 65 products illegally making false claims to prevent, diagnose,...Read more

CPhI expert calls for ANDA approvals to be reduced by two-thirds in order to lower drug costs

Policy & Regulatory |  News | 0 Comment | 27 Apr, 2017

Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, discusses the necessity of time reduction for ANDA approvals, arguing that&nbs...Read more

Lok Sabha passes HIV and AIDS Prevention and Control Bill, 2017

Policy & Regulatory |  News | By BioSpectrum Bureau | 0 Comment | 20 Apr, 2017

The Lok Sabha on recently passed a crucial bill that ensures equal rights to the people affected by HIV and AIDS in terms of getting treatment, jobs or admissions to educational institution...Read more