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BIO Urges Governor to Sign interchangeable biologic medicine bill.

2015-04-07 14:31:09| Industrial Newsroom - All News for Today

BIO is calling upon Governor Deal to sign legislation to create pathway for substitution of interchangeable biologic medicines. Policies outlined in Bill 51, which passed Georgia Senate with 43-3 vote following unanimous vote in the House, align with BIO's principles on biologic substitution. BIO President and CEO Jim Greenwood called this legislation, "a significant step forward," citing transparency and communication between patients and their treatment teams.

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Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection

2015-03-13 21:02:00| Merck.com - Research & Development News

Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection, Mercks investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Manufacturer Of Tylenol Pleads Guilty To Selling Liquid Medicine...

2015-03-12 04:27:09| Biotech - Topix.net

McNeil Consumer Healthcare, the Johnson & Johnson subsidiary that makes Tylenol, filed a guilty plea to a federal district court in Philadelphia of selling liquid medicine contaminated with metal. The drug maker also agreed to pay a fine of $25 million to the US Department of Justice for selling adulterated medication for children and infants.

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McNeil pleads guilty to selling children's medicine containing metal particles

2015-03-11 07:04:06| Biotech - Topix.net

McNeil Consumer Healthcare has agreed to plead guilty to federal criminal charges and pay $25 million to resolve allegations regarding manufacturing problems that led to the 2010 recall of its over-the-counter infants and children's medicines. Under the settlement announced by the U.S. Attorney's Office, the Fort Washington, Pa.

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KEYTRUDA (pembrolizumab) is First Medicine to be Made Available to Patients Through U.K. Early Access to Medicines Scheme (EAMS) for Advanced Melanoma

2015-03-11 01:01:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. EAMS Aims to Give U.K. Patients Access to Promising, Innovative Treatments Prior to European License KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the companys anti-PD-1 therapy, pembrolizumab, which is marketed in the U.S. under the name KEYTRUDA, is the first treatment to be accepted under the U.K.s new Early Access to Medicines Scheme (EAMS). Pembrolizumab was accepted under the scheme for the treatment of advanced melanoma based on the significance of the early study findings and unmet medical need. Language: English Contact: MerckMedia Contacts:Pam Eisele, 267-305-3558Claire Mulhearn, 908-236-1118orInvestor Contacts:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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