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The FDA has released a draft guidance providing recommendations on nonclinical
safety evaluations to support the clinical study and approval of drug combinations,
including fixed-dose combination products, co-packaged products and adjunctive
therapies.
In an effort to promote university-led biotech venture companies, the Osaka
prefectural government will begin subsidizing researchers who are planning to
establish biotechnology-based businesses related to medical products and food.
New River Pharmaceuticals announced today a drug-development agreement that
positions the small Radford company to receive a share of the U.S. profits of
its planned treatment for attention-deficit/hyperactivity disorder and up to
$500 million from partner Shire Pharmaceuticals Group if the product sells well.
Flamel Technologies has entered into an agreement with Bristol-Myers Squibb,
which resolves all outstanding matters with respect to the former licensing
agreement dated Aug. 26, 2003, between the companies for Flamel's formulation
of long-acting human insulin, Basulin.
Regulators have denied petitions to prevent or delay approval of certain generic
versions of Johnson & Johnson's Duragesic, a chronic pain patch. Noven Pharmaceuticals,
which disclosed the decision by the FDA, said the denied petitions were from
Alza; Brookoff and Voth; London & Mead; and Steven Shafer.
A move by Arena Pharmaceuticals to issue up to 6.9 million shares of company
stock to the public has met stiff opposition from a key shareholder worried
that the sale will dilute the value of the stock.
Medicis Pharmaceutical has said under an amendment
to its dermatology products development joint venture with aaiPharma, it will
assume management and development of the project.