FDAnews Drug Daily Bulletin
April 8, 2005 | Vol. 2 No. 70
The FDA has revamped its guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products to include specific timelines for application review milestones -- a change that should come as good news to drug manufacturers, many of which criticized the initial version of the document for being too vague.
Barr Laboratories is taking the plunge into the follow-on biologics market, announcing March 30 that it is partnering with Croatian biopharmaceutical firm PLIVA to develop its first biogeneric product.
Asthma inhalers using chlorofluorocarbon (CFC) propellants must be phased out by 2009, according to an FDA final rule that gives manufacturers significantly more time to make the transition to CFC-free products than some experts had recommended.
The manufacturers of multiple sclerosis (MS) drug Tysabri confirmed late March 30 that the drug has been linked to a third case of a deadly central nervous system disorder - news that analysts believe could close the door on the drug's potential return to the market.
Gov. Rod Blagojevich is awarding $15 million in grants and tax credits to Takeda Pharmaceuticals North America Inc. in return for adding 500 new jobs. The money will help Takeda build a 1.2 million-square-foot campus in Deerfield on a 70-acre property the company bought in December 2002.
Pharmaceutical giant Pfizer said yesterday it has no immediate plans to axe jobs in Ireland as part of its global cost-cutting program. The company, which employs 1,800 people in Ireland, is seeking to slash costs by 3.1 billion euros a year globally.
Takeda Pharmaceutical and Toray Industries announced today that the companies have concluded a joint development and marketing agreement on an investigational compound for frequent urination/urinary incontinence.
Swiss Medica (is pleased to announce its business relationship with two distinguished Massachusetts Institute of Technology scientists through its recent acquisition of Anti-Depression BioHealth Solutions Inc.
Carlsbad-based SkinMedica announced yesterday that it has closed a Series E preferred stock placement led by EuclidSR Partners.
Florida Attorney General Charlie Crist has sued three pharmaceutical companies for $25 million, charging them with illegally inflating prices on generic drugs used to treat depression, schizophrenia, seizures and angina.
Alliance Pharmaceutical, through its subsidiary PFC Therapeutics, and Beijing Double-Crane Pharmaceutical ("Double-Crane"), today announced that they have entered into a Memorandum of Understanding ("MOU") for the development of Oxygent in The People's Republic of China ("PRC").
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