FDAnews Drug Daily Bulletin

Although the FDA has made little headway on developing a formal approval pathway for follow-on biologics, drug developers aren't sitting on their hands waiting for the agency to act.

A federal appeals court has ruled against Teva Pharmaceutical in its attempt to force a district court to hear its patent challenge to Pfizer's antidepressant Zoloft -- a ruling that is a blow to generics seeking to use the declaratory judgment provision in the 2003 drug patent reforms to settle patent disputes.

All medically necessary drugs must be available under Medicare drug plans, according to the final rules implementing the massive Rx benefit -- a decision that addresses key concerns by drugmakers and lawmakers that some drugs could have been excluded under the proposed guidelines.

The agreement between the FDA and the Centers from Medicare & Medicaid Services (CMS) to conduct parallel reviews of products -- which would allow drugmakers to receive both a drug approval and reimbursement coverage simultaneously -- could speed some products to market, but it also raises concerns for the pharmaceutical industry, according to experts.

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.

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.

Cherie Booth QC has opened a facility at CCLRC Daresbury Laboratory which is designed to understand how genes make proteins.

Neose Technologies has signed an agreement giving BioGeneriX AG an option to license its GlycoPEGylation technology.

In a bid to shield more than $3 billion in sales of a high blood pressure drug, Pfizer is suing generic drug company Synthon Pharmaceuticals.

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.

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.

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.

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.