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April 13, 2005

Vol. 2 No. 73

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DDMAC Director Says Quality of DTC Ads Has Decreased

The overall quality of direct-to-consumer (DTC) advertising has been declining, according to the head of the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), which last year issued a record number of warning letters for violations of the agency's ad requirements.

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PhRMA to Promote Low-Cost Medicines Through National Coalition

A national coalition led by PhRMA will spend roughly $30 million through June to develop and promote a program that would help low-income Americans gain access to the medicines they need.

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FDA Names Former Deputy Assistant Attorney General As Chief Counsel

The FDA has appointed former Justice Department official Sheldon Bradshaw as its chief counsel, effective April 1.

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AaiPharma May Seek Chapter 11 Bankruptcy

North Carolina-based drug developer aaiPharma is on the verge of seeking Chapter 11 bankruptcy protection after missing a recent interest payment.

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Drugmaker Plans $125 Million Note Offering

Nabi Biopharmaceuticals said it intends to offer $125 million in notes to raise money for, among other things, clinical trials.

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Pharmexa A/S to Acquire GemVax AS

Pharmexa has entered into an agreement to acquire GemVax AS, a private Norwegian biotech company focusing on cancer vaccines. The purchase price will be paid in newly issued Pharmexa shares and by issuance of a convertible debt instrument.

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OnSource Executes Definitive Merger Agreement With Osmotics

OnSource announced that it executed a definitive agreement to merge (the "Merger Agreement") with Osmotics Pharma (OPI). OPI is an emerging specialty pharmaceutical company focused on developing prescription products for the treatment of various dermatological disorders, antibiotic-resistant strains of bacteria and certain cancers.

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DiObex Licenses Worldwide Rights to Cortisol Inhibitors

DiObex, a biotechnology company developing therapeutics for the treatment of metabolic diseases, announced the conclusion of a worldwide exclusive license agreement with Cortendo Invest AB of Gothenburg, Sweden.

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Janus Pharmaceuticals Raises Series A Funding of More Than $2 Million

Janus Pharmaceuticals Inc. (Janus) announced the closing of the company's Series A financing round for a total of over $2 million. Lead investor was Private Equity Japan Co., Ltd (PEJ). of Tokyo, Japan. Commensurate with this funding, Mr. Shinji Kimura Managing Director, PEJ, joins the Janus Board of Directors.

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Costello Takes on Big Drug Groups

Drug companies could face restrictions on advertising medicines under a Federal Government Budget push to prevent a blowout in Australia's pharmaceutical benefits scheme (PBS).

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Cellegy Pharmaceuticals Announces Settlement of PDI Litigation

Cellegy Pharmaceuticals announced that it has entered into a settlement agreement with PDI, Inc. resolving the lawsuits that the companies had filed against each other relating to an exclusive license agreement for Cellegy's Fortigel (testosterone gel) product candidate in North American markets.

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Botaniex Purchases Major Parcel of Land in Guangdong, China

CortDev announced that Botaniex has purchased a 16.5-acre parcel of land in Zhaoqing High Technology Industry Development Zone, Guangdong Province, China.

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