contraceptive news from FierceBiotech

Akzo Nobel's NV arm Organon and Schering have announced that they will discontinue their collaboration on the development of a male hormonal contraceptive. In a press release, Organon and Schering noted that while their work together was constructive, they "came to the conclusion that the administration route investigated in the trial, which combined an annual implant with three-monthly injections, would unlikely result in a product that would be acceptable for widespread everyday use." …

An FDA approval of any kind is often the trigger to a massive advertising blitz, but ad experts say that Barr Pharmaceuticals is likely to stay focused on a discreet, tailored campaign while talking directly with healthcare professionals. Barr notes that the agreement with the FDA also limits sales of the contraceptive to pharmacies and clinics, so a major branding campaign hardly makes sense.

- read the …

After three years of regulatory limbo, Barr Laboratories has won the right to market the Plan B contraceptive without a prescription. Women over 18 will be required to show proof of their age to buy the drug while under age girls will still need a prescription. Plan B has been a favorite cause on both sides of the political divide. Opponents say that OTC access of what it calls an "abortion pill" would encourage promiscuity and further spread sexually transmitted diseases while backers …

On Friday Barr Laboratories resubmitted its application to make Plan B available without a prescription. Given the FDA's sudden willingness to work out a marketing plan for the contraceptive, Barr has a good shot at finally obtaining an approval …

After a lengthy wait, the FDA and Barr Pharmaceuticals have come up with an agreement that clears the way for the over-the-counter sale of the contraceptive Plan B. Under the agreement, Barr will sell Plan B OTC to women over the age of 18 while women under that age will be required to have a prescription. The agency has been sitting on this decision for more than two years, leading several U.S. senators to vow to indefinitely hold up Dr. Andrew von Eschenbach's appointment to head the …

In what could mark a major breakthrough in the impasse over Plan B, the FDA has indicated that it may move ahead and make the controversial contraceptive available over-the-counter for women 18 and older. In a letter to Barr Pharmaceuticals, the agency asked what steps could be taken to ensure that underage girls don't obtain it and that a final decision was being sought in a matter of weeks. The morning-after pill has proved to be a major stumbling block at the FDA. A number of Democrats …

A study released by the Union of Concerned Scientists has found that about 15 percent of FDA staffers polled say they've been "asked to… inappropriately exclude or alter technical information or conclusions in an FDA scientific document." In addition, 39 percent of respondents stated that the FDA wasn't "acting effectively to protect public health." The questionnaire was sent to almost 6,000 FDA workers and 997 responded.

The survey underscores critics concerns that the …

Wyeth says it will hold off on an expected launch of the experimental depression drug DVS-233 until next year as it conducts more trials to "further define the profile" of the therapy. Patients in recent trials had complained of nausea, so Wyeth wants to see how volunteers respond to lower doses of the drug, which was derived from Effexor XR. Analysts say that DVS-233 is one of the more important drugs in Wyeth's pipeline. In addition, Wyeth announced that it expects to release its …

Duramed Pharmaceuticals has received FDA approval for Seasonique, an extended cycle contraceptive that should hit the markets in July. Seasonique's low-dose estrogen pills--which limit menstrual cycles to four times a year--replace a series of placebos in the monthly cycle that researchers say will help limit bloating and hormonal fluctuations.

- read the report from the Kaiser Network

Two Democratic senators--Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY)--said they met with newly nominated FDA chief Dr. Andrew von Eschenbach on Tuesday but failed to gain a timeline on a decision for Plan B. Both senators said they would continue to work to block his nomination until some decision was forthcoming on the controversial contraceptive.

- here's the article from ABC News