Genta sued over NDA withdrawal

Article Abstract:

A lawsuit was registered against the biopharmaceutical company Genta from New Jersey on 4th May 2004 for not clearly specifying the effect of Genasense drug utilized for recurring type of metastatic melanoma. After ten days when the Oncologic Drugs Advisory Committee (ODAC) did not approve the same, Genta withdrew this new drug application (NDA) which has led to a fall in the market value of Genta.

Legal issues & crime, Government regulation (cont), Government regulation, New Jersey, Legal/Government Regulation, Company legal issue, Cases, Laws, regulations and rules, Biological products industry, Genta Inc., Biopharmaceutics, Biopharmaceuticals, GNTA

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Maturing biotechs turn to pharma's markets

Article Abstract:

The foray into primary care, which is highly unusual for a small company, reflects maturation among biotechs, based on their ability to amass and efficiently use financial and commercial resources. Sepracor's focus on primary care market is an example of a shift in strategy at certain maturing biotech companies to target broader, highly competitive markets traditionally served by big pharma.

Market share, Company market share

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Redesigner drugs

Article Abstract:

Some biotech companies are placing drug redesign at the centers of their business plans with biotech steadily uncovering more drug targets and mechanisms, and finding new ways to exploit them. Also, several blockbuster drugs are losing patent protection in the next couple of years, which provides opportunities for companies to recast off-patent drugs into so-called second-generation drugs.

Manufacturing processes, Production processes, Remodeling and renovation

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