Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us    
Google
Web www.equitybulls.com
Union Budget
Budget 2011-2012 Home
Industry Expectations - Budget 2011-2012
Industry Reactions - Budget 2011-2012
Budget 2010-2011
Budget 2010-2011 Home
Industry Expectations - Budget 2010-2011
Industry Reactions - Budget 2010-2011
Contributor's Corner
Bonanza Portfolio
Hemant K Gupta
Krish Bhatt
S A A R T H I
Trinity Investments
Exchange Information
BSE 2009 Holidays
NSE 2009 Holidays
Investor Guide
Depository & Dematerialisation
Grievance Redressal
Investor Guide
SEBI
Trading of Securities
Transfer of Securities
Your Rights
Budget 2009-2010
Budget 2009-2010 Home
Industry Expectations - Budget 2009-2010
Industry Reactions - Budget 2009-2010
Interim Budget 2009-2010 Home
Industry Expectations - Interim Budget 2009
Budget 2008-2009
Railway Budget 2008-2009
Industry Expectations - Budget 2008
Union Budget 2008-2009
Highlights of Budget 2008-2009
Summary of Budget 2008-2009
Industry Reactions - Budget 2008
IPOs
Current IPOs
Past IPOs
IPO Subscription
Mutual Funds
Gold Exchange Traded Fund
MF Unique Holding
Forthcoming Dividends
ELSS Schemes Comparison
Tax Plans
New Fund Offers
Research
Arbitrages
Equity
Market Whispers
Tax Planning
Home
Equity Linked Savings Scheme
Post Office MIS
9% GOI Senior Citizens Savings Scheme
8% Savings (Taxable) Bonds
Kisan Vikas Patra
National Savings Certificate
Public Provident Fund
Stock Report

| More

U.S. FDA Accepts Biologies License Application for Mylan and Biocon's Proposed Biosimilar Pegfilgrastim for Review

Posted On: 2017-02-16 19:55:29

Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), for filing through the 351(k) pathway.

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017.

Mylan President Rajiv Malik commented: "We're proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product. Once approved, proposed biosimilar pegfilgrastim will complement Mylan's broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer."

Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: "We are extremely pleased with the regulatory progress of our biosimilars in the U.S. The FDA's acceptance for review of our second BLA for a proposed biosimilar developed by Biocon and Mylan is an outcome of our strong R&D and manufacturing capabilities. Once approved, our proposed biosimilar pegfilgrastim will provide a high quality alternative to branded pegfilgrastim (Neulasta®) for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer-care affordable and accessible for patients across the globe."

Shares of BIOCON LTD. was last trading in BSE at Rs.1094.75 as compared to the previous close of Rs. 1057. The total number of shares traded during the day was 39494 in over 2259 trades.

The stock hit an intraday high of Rs. 1098.85 and intraday low of 1053. The net turnover during the day was Rs. 42475635.


Source: Equity Bulls

Click here to send ur comments or to feedback@equitybulls.com





Other Headlines:

Orient Cement Ltd to announce Q3 results on Jan 29, 2018
The Ramco Cements Limited calls for Board Meeting on Feb 6, 2018
Pennar Industries Limited and its subsidiaries have received orders worth Rs. 242 crores
Laurus Labs certified as the 'Great Place to Work' in the large sized organizations category in India
Capital First Ltd to announce 3rd quarter results on Jan 24, 2018
Panama Petrochem Ltd calls for Board Meeting on Feb 5, 2018
Indraprashta Medical Corporation Ltd to consider 3rd quarter results on Feb 7, 2018
ICRA reaffirms rating of Indian Card Clothing Company Ltd
Victory Paper & Boards India Ltd calls for Board Meeting on Jan 25, 2018
Puravankara launches first affordable housing project Provident Park Square post RERA; invests Rs.600 crores
Wanbury Limited to consider Q3 results on Feb 8, 2018
Aksh Optifibre Ltd calls for Board Meeting on Feb 12, 2018
Rexnord Electronics and Controls Limited calls for Board Meeting on Jan 23, 2018
JK Paper Ltd to consider third quarter results on Jan 30, 2018
Fire accident at Linc Pen & Plastics Ltd's unit at Falta SEZ
Coromandel Engineering Company Ltd calls for Board Meeting on Jan 25, 2018
SSK Lifestyles Limited changes name
Bharat Forge sets up E- Mobility Research & Development Centre in UK
LGB Forge Ltd calls for Board Meeting on Feb 6, 2018
W H Brady & Company Limited calls for Board Meeting on Feb 10, 2018
Tokyo Plast International Ltd calls for Board Meeting on Jan 31, 2018
Brady & Morris Engineering Company Limited calls for Board Meeting on Feb 10, 2018
Reliance Nippon Life Asset Management Ltd Fixes Record Date for Interim Dividend
Ultramarine & Pigments Ltd to consider Q3 results on Feb 13, 2018
LTI Paves the way for Digital Transformation at MPPMCL
Mercator Limited wins dredging contract for Rs. 30.40 crores
MCX's total consolidated income decreased by 16.41% to Rs.76.52 crore for Q3 FY 2017-18
S H Kelkar and Company Ltd Q3 net profit up at Rs. 27.19 crores
Hatsun Agro Product Ltd Q3 net profit slumps to Rs. 14.97 crores
Agro Tech Foods Ltd Q3 PAT at Rs. 9.03 crores
Jay Bharat Maruti Ltd reports net profit of Rs. 14 crores in Q3
TV18 Broadcast Ltd Q3 net profit drops to Rs. 15.87 crores
Delta Corp Ltd Q3 net profit up at Rs. 44.42 crores
Gallantt Metal Ltd Q3 PAT at Rs. 7.57 crores
Frontline Securities Ltd Q2 PAT climbs to Rs. 2.54 crores
Federal Bank Ltd posts Q3 net profit of Rs. 260.01 crores
ABC Bearings Ltd Q2 net profit rises to Rs. 3.59 crores
Upsurge Investment & Finance Ltd appoints CFO
CLIO Infotech Ltd appoints company secretary
Hindustan Composites Ltd announces demise of Mr. Keith Marshall Robinson
Sun Pharma Announces Settlement of Patent Litigation for Generic LinzessŪ in US
Boston Leasing and Finance Ltd appoints additional directors
Upsurge Investment & Finance Ltd appoints additional director
Ashok Leyland Ltd calls for Board Meeting On February 1, 2018
Metal Coatings India Ltd announces sad demise of Director
Avantel Ltd calls for Board Meeting on Jan 27, 2018
Vedanta Limited to announce Q3 results on Jan 31, 2018
Valley Magnesite Company Ltd announces resignation of company secretary
Fortis Malar Hospitals Ltd calls for Board Meeting on Jan 23, 2018
Orient Paper & Industries Ltd to consider Q3 results on Feb 1, 2018


Website Created & Maintained by : Chennai Scripts
West Mambalam, Chennai - 600 033,
Tamil Nadu, India

disclaimer copyright © 2005 - 2018