ROCKVILLE, Md., Feb. 2, 2010 - The FDA today posted on its website a letter sent to Eli Lilly & Co. regarding a web page and two patient videos for PAH drug Adcirca. [more]
ROCKVILLE, Md., Feb. 2, 2010 - The FDA today posted on its website a letter sent to Meda Pharmaceuticals regarding a waiting room sign promoting allergy medication Astelin. [more]
ROCKVILLE, Md., Feb. 2, 2010 - The FDA today posted on its website a letter sent to Sanofi Aventis regarding a patient brochure for acne medication BenzaClin. [more]
ROCKVILLE, Md., Feb. 2, 2010 - The FDA today posted on its website a letter sent to Novalar Pharmaceuticals regarding a patient brochure for OraVerse injection. [more]
DUBLIN--(BUSINESS WIRE)--Dec 4, 2009 - ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209), today announced it has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding clinical study management services provided by the company to one of its clients in relation to two studies conducted between 2004 and 2006. These studies related to the development of an antibiotic for the treatment of complicated skin and skin-structure infections. [more]
ROCKVILLE, Md., Dec. 3, 2009-GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy. [more]
ROCKVILLE, Md., Nov. 16,2009--The FDA has posted on its website warning letters it sent to Eisai, Inc. for Dacogen and to Shire Development Inc. for Fosrenol. Both letters mention misleading information regarding the marketing of the two drugs. [more]
ROCKVILLE, Md., Oct. 21, 2009--The Food and Drug Administration today posted on its website a warning letter send to King Pharmaceuticals over two Embeda video news releases. [more]
ROCKVILLE, Md., Oct. 13, 2009--The U.S. Food and Drug Administration today warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain. [more]
ROCKVILLE, Md., Sept. 16, 2009--The FDA today posted on its website a warning letter sent to Bioniche Pharma over two internet web pages for Sotradecol.
[more]
ROCKVILLE, Md., Sept. 16, 2009--The FDA has posted on its website a warning letter sent to Allergan, Inc.. The agency said in its letter that a consumer website and a launch display timeline for eyelash drug Latisse are misleading "because they omit and minimize risks associated with Latisse." [more]
ROCKVILLE, Md., Aug. 31, 2009--[Original Posting 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. [more]
ROCKVILLE, Md., Aug. 27, 2009--The FDA has posted on its web site warning letters it sent to Johnson & Johnson and Pedinol Pharmacal. The agency reviewed a journal advertisement for Johnson & Johnson's Ertaczo Cream. [more]
ROCKVILLE, Md., Aug. 27, 2009--The FDA has posted on its web site a warning letter sent to Johnson & Johnson. The agency reviewed a journal advertisement for Johnson & Johnson's Ertaczo Cream. According to the FDA, "This journal advertisement broadens the approved indication, contains unsubstantiated efficacy claims about the product, and omits important risk information." [more]
EAST RUTHERFORD, N.J., Aug. 24 /PRNewswire-FirstCall/ -- Cambrex Corporation (the "Company") announced that it has received a warning letter from the U.S. Food and Drug Administration ("FDA") relating to an inspection of the Company's generic active pharmaceutical ingredient ("API") manufacturing facility located in Milan, Italy in March 2009. The observations noted in the warning letter are primarily related to the collection and maintenance of certain laboratory data. [more]
ROCKVILLE, Md., Aug. 21, 2009--The FDA has posted to its website warning letters it sent to companies and individuals regarding either misleading information about their marketed products or objectionable conditions. [more]
ROCKVILLE, Md., Aug. 18, 2009--The FDA today posted on its website a warning letter sent to Johnson & Johnson Pharmaceutical Research & Development regarding "objectionable conditions" found during an FDA investigation into one of J&J's studies. [more]
ROCKVILLE, Md., July 22, 2009--The FDA has posted on its website a warning letter sent to Abbott Laboratories about a consumer-directed patient testimonial DVD in which Earvin “Magic” Johnson (Magic Johnson) is being interviewed about his experience with HIV disease and Kaletra(lopinavir/ritonavir) (Kaletra) treatment. [more]
ROCVKILLE, Md., July 22, 2009--The FDA has posted to its website a warning letter it sent to Alaven Pharmaceutical LLC regarding a Holiday Promotion Postcard 2008 (postcard) for Rowasa Enema (Rowasa). [more]
Mergers & Acquisitions, Partnerships, & Collaborations 2010 – Review and Outlook
This PharmaLive Special Report analyzes the healthcare industry’s M&As of 2009, providing a comprehensive listing of companies’ M&A activity and detailing the top 20 deals within each of the Pharmaceutical, Biotechnology, Specialty, and Medical Device sectors, and previews potential M&A activity within the healthcare arena for 2010.
The introductory rate of $395 expires February 17, 2010.
