ALSO NOTED: New warning added to Aptivus; Novartis increases NeuTec control; and much more...

> The warning on the AIDS drug Aptivus is being updated to include a warning that the drug has been linked to sometimes fatal cases of bleeding in the brain. Report

> Novartis has acquired 8.3 percent of NeuTec, bringing its total to 52 percent as it pursues plans to buy the British biotech. …

Siemens to buy Bayer's diagnostics business

Siemens has agreed to buy the diagnostics division of Bayer Healthcare for $5.3 billion. The move is expected to help Bayer complete the acquisition of Schering . Siemens bought Diagnostics Products in the U.S. for $1.86 billion and paid about a billion dollars for CTI Molecular Imaging.

"The acquisition of Bayer Diagnostics is part of our targeted strategy to create the health-care industry's first integrated diagnostics company," said Siemens CEO.

- here's The

Cephalon shares jump on Fentora decision

Shares of Cephalon surged this morning after the FDA issued an approvable letter for its cancer pain drug Fentora. Cephalon officials said they would respond to the FDA within 60 days. One analyst noted that a 90-day delay in marketing Fentora would actually be to Cephalon's advantage, giving it more time to maximize sales of Actiq before a generic competitor hit the market.

- here's the AP report on …

Vertex inks rich pact with J&J

Shares of Vertex soared on the news that it has inked a collaboration deal with Johnson & Johnson to develop VX-950 for hepatitis C. Vertex gains $165 million and up to $380 million in milestone payments. Vertex retains North American development rights to the drug.

- read the AP report

Actavis renews bidding war for Pliva

Ignoring Pliva's endorsement of a buyout offer from Barr Pharmaceuticals, the Actavis Group has upped its bid to $2.3 billion and insists it will win in the end. Actavis has acquired more than 20 percent of Pliva's shares and says that it believes the board will be happy to accept the highest offer for the Croatian generic drug company. If Actavis prevails, it will create the world's third largest generic drug maker, behind Teva and Novartis.

- here's the report on Actavis from the International Herald Tribune

New warnings added to controversial antibiotic

Sanofi-Aventis has added new warnings to its antibiotic Ketek after talks with the FDA. The drug company says the warnings are intended to update doctors and patients on potential adverse events. But the warning is unlikely to quell the controversy around the drug, which has been linked to 12 cases of liver damage. Sanofi-Aventis says the rewards still outweigh any risks associated with Ketek.

- read the AFX report on Ketek

SPOTLIGHT: Viread program mired in controversy

The case of Gilead's Viread program for poor countries is becoming a case-study in how the best of intentions by a drug company can become entangled in a series of bureaucratic snafus. The AIDS drug is being provided at cost, but dealing with a myriad of governments and the WHO has limited the flow of medicines to a trickle. Report (WSJ sub. req.)

ALSO NOTED: Group backs Gardasil; Astellas halts program; and much more...

> A key federal advisory group has endorsed Merck's cervical cancer vaccine, Gardasil. The vote by the Advisory Committee for Immunization Practices makes it likely that the government will covering the cost of the shot. Insurers like Wellpoint have already begun to issue coverage approvals, setting up Gardasil as a blockbuster with an estimated potential of $3 billion a year. …

Alexion heart failure drug flunks trial (again)

Alexion's heart failure drug, pexelizumab, has suffered a second pivotal trial failure. Researchers say the drug failed to deliver a better outcome than a placebo in reducing death at 30 days after heart bypass surgery. Alexion had trimmed down its study early this year after analyzing negative data for coronary artery bypass graft surgery patients. But Alexion CEO Dr. Leonard Bell says he's already turned his attention to other drug candidates in the pipeline. Chief among them is …

BMS gains FDA approval for dasatinib

Bristol-Myers Squibb has won FDA approval to market dasatinib for certain forms of leukemia. BMS won accelerated approval of the drug--to be marketed as Sprycel--from the agency for all phases of chronic myeloid leukemia in patients resistant to Gleevec. The FDA also approved the drug for patients resistant to therapies for Philadelphia chromosome-positive acute lymphoblastic leukemia.

- here's the AP report on the approval

Europeans OK Tysabri's return to MS market

Elan and Biogen have gained another regulatory victory in their effort to return Tysabri to the market, winning European approval for use of the drug to delay progression and reduce the frequency of relapses. The FDA recently allowed the use of Tysabri as a second-line therapy for patients who hadn't responded to other therapies. When Tysabri was introduced, researchers believed that it represented a major advance for MS patients, but the drug was quickly pulled after it was linked two …

Doctors balancing effects, costs of Lucentis and Avastin

With Genentech's Lucentis expected to gain FDA approval soon for wet macular degeneration--a common cause of blindness among the elderly--a new debate is emerging comparing the steep cost of the therapy with off-label Avastin, which can be just as effective and much less expensive. Lucentis is an offshoot of Avastin and is likely to cost $1,500 to more than $2,000 per injection. It will be the only therapy that has delivered data that clearly demonstrates its value for the ailment. But …

France's Diatos prepares its IPO

France's Diatos, a 2004 Fierce 15 company, is going public with an IPO designed to raise €25 million. Diatos CEO John Tchelingerian said the company is braving difficult market conditions in mounting the offering, but that institutional investors backed the move. Diatos has specialized in developing its own cancer therapies.

- here's the Dow Jones report on the IPO

SPOTLIGHT: Generic competition heats up

In what is rapidly developing as a new trend that could have a major impact on generic manufacturers, Pfizer says it will introduce a copycat version of the antidepressant Zoloft that will be priced below generics. The move follows Merck's announcement that it plans to roll out a cheap copycat of the blockbuster cholesterol drug Zoloft. Drug makers have become increasingly aggressive in their response to the onslaught of generic competition. In Pfizer's case, the company has a subsidiary …

VC: VLST lands $55M second round

VLST lands $55M second round

ALSO NOTED: Auxilium enrolling patients; Wyeth wins conditional approval; and much more...

> Auxilium Pharmaceuticals of Malvern, PA has begun enrolling patients for a Phase III trial of AA2600, an experimental therapy for hypogodanism, testosterone deficiency. "Delivering testosterone replacement therapy through an oral transmucosal film may provide men efficacy results equivalent to approved transdermal treatments but with quicker release of testosterone and lower dosing," said Dr. Jyrki Mattila, Auxilium's EVP for R&D. …

Eli Lilly to shutter European facilities

Eli Lilly plans to shutter two research sites and a manufacturing facility in Europe, including one R&D center in Belgium that employs 330 staffers. Altogether, most of the 900 workers employed at the facilities will be affected by the restructuring. The manufacturing center is at Basingstoke. Lilly said the move was prompted by what it called an increasingly difficult global environment hampered by price pressures.

- here's the AFX report on Lilly

Roche CEO outlines acquisition plans

Roche Holding CEO Franz Humer has ruled out any big takeover moves, but signaled the European drug giant was very interested in acquiring new products, technologies and smaller developers. Noting that none of Roche's biggest drug producers are facing the loss of patent protection in the near future, Humer said he was bullish about the company's prospects. "We are at the start of a wave of new product launches...(with) significant development possibilities, thanks to new applications and …

FDA OKs Novartis' Exelon for dementia

The FDA has approved Novartis' Exelon for Parkinson's patients with mild to moderate dementia. This is the first approval for a drug that treats this condition. Exelon has also been approved for Alzheimer's and was approved for Parkinson's in Europe last March. The approval was based on data from a pivotal study involving 541 patients which demonstrated significant improvements in overall functioning with less deterioration in daily functions.

- here's the AFX report on Exelon

Vectura announces successful trial, share offering

The UK's Vectura Group and Sosei say their joint Phase IIb trial for an experimental therapy to treat COPD finished successfully, laying the groundwork for a share offering by Vectura. The trial of 335 subjects tested four doses of NVA237 inhaled once daily for 28 days. NVA237 is being developed and commercialized by Novartis both as a monotherapy and in combination with their once daily bronchodilator indacaterol under a global license agreement signed in April 2005. Vectura separately …