Industry Buzz

FDA advisory panel considers cardiovascular and teratogenic risks of Vivus’ weight-loss drug Qnexa. ...

Continuously increasing regulatory requirements, operational needs and financial pressures are forcing the Academic Medical Centers (AMCs) to re-evaluate and transform the way clinical research is managed. Many pharmaceutical and medical device companies are cutting back on their R&D budgets and industry has begun to look for new and hopefully less expensive sources of innovation. AMCs seem to be a perfect fit and they are quickly becoming a deal-making hot spot. ...

FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations ...

Gorsky is chosen to succeed Weldon as J&J's CEO ...

FDA issues guidance on notifying agency about drug shortages - Enanta Pharmaceuticals gives Novartis exclusive license to its Phase-I ready protease inhibitor - Supreme Court denies Janssen petiton for review of patent infringment case against Abbott, takes no action on ACLU petition in Myriad gene patent case - FDA questions durability of effect and long-term safety of droxidopa treatment ...

NICE seeks more data on cost-effectiveness of Roche's Tarceva - EU science advisory panel warns about boceprievir in HIV and aliskiren in diabetes - Gilead has setback in its "Nuc" hepatitis C trial - FDA says Qnexa weight-loss drug needs CV outcome trial - Corcept's Korlym (RU-486) will not require REMS - Takeda accelerated pursuit of Nycomed as alogliptin faltered ...

Business & Finance Pfizer and Zhejiang agree on $545M branded-generics partnership InPharm.com Feb. 20, 2012 Tetraphase secures $67M BARDA contract for antibiotic development Genetic Engineering & Biotechnology News Feb. 16, 2012, Pharmaceutical Business Review Online Feb. 17, 2012 Sun spinoff... ...

Gilead's reports viral relapse in study patients taking its hepatitis C candidate - FDA says long-term cardiovascular outcome trial is necessary for Vivus' Qnexa ...

PowerPoint presentations have become a vital part of both internal and external communications at pharmaceutical and medical device companies. Whether you are from regulatory affairs, charged with presenting information on how to comply with new requirements to the manufacturing team or you are from a small medical device company presenting your product to possible investors, your presentation could mean the lifeblood of your organization. Not only do executives use presentation slides to make pitches to stakeholders, but doctors also use them to present information at meetings and conferences too. ...

Teva's U.S. generic sales rebound with late-year launches and Lipitor deal - AztraZeneca to partner with Express Scripts to provide Arimidex directly to patients - Regeneron forecasts Eylea sales of $250 million to $300 million for 2012 - Acorda expands pipeline with Nueuronex and new Ampyra indications ...

In a surprise move, an FDA panel this afternoon voted overwhelmingly 20-to-2 in favor of recommending that the Qnexa diet pill developed by Vivus should be approved by the FDA. The endorsement marks the first time that an FDA panel had taken such a step during a two-year period in which a trio of new [...] ...

Once again, the Plan B birth control pill is in the news. This time, a federal judge has ruled that the state of Washington may not force pharmacies to sell the pill or other emergency contraceptives, because the purpose of a contoversial law was to suppress religious objections by pharmacists, not to promote access to [...] ...

A bit of drama unfolds this morning at an FDA conference center in Silver Spring, Maryland, where an advisory panel is meeting once again to review the Qnexa diet pill - one of three forthcoming obesity drugs that have preoccupied regulators, investors and overweight patients for the past couple of years. Why? The FDA has [...] ...

The common wisdom over the past few years is that biotechs are having a rough time attracting venture capital financing thanks to changing priorities for exit strategies and the vagaries in successful drug development and approval. A new analysis, though, suggests that perhaps a shift may be under way - biopharma VC financing totaled [...] ...

Yet another drugmaker has agreed to settle a large backload of product liability lawsuits. In the latest instance, Teva Pharmaceutical will pay more than $250 million to settle more than 80 lawsuits alleging the drugmaker intentionally sold its Propofol anesthetic in vials that were large enough to be reused by doctors, but led some colonoscopy [...] ...

Top of the morning to you. And a fine one, it is. Sunny skies are unfolding over the Pharmalot corporate campus, where the birds are chirping and the official mascots are fertilizing the official weeds. What better way to start the day? Of course, there is much to do, so we now turn our attention [...] ...

After more than two years of controversy over manufacturing gaffes and product recalls, Bill Weldon is retiring as Johnson & Johnson ceo in April, ending a 10-year reign at the top of one of the most venerable, but now tarnished names, in corporate America. The 63-year-old Weldon will be replaced by Alex Gorsky, 51, who [...] ...

More than two dozen people who suffered medication shortages have filed a lawsuit against the US Department of Health and Human Services, the FDA and the National Institutes of Health, arguing their rights were violated because the federal government failed to take adequate enforcement actions against such drugmakers and allow for alternative means to protect [...] ...

We all know about the placebo effect. But a Harvard Medical School professor has applied the same theory to antidepressants and his findings are likely to rile drugmakers. Why? He filed Freedom of Information Act requests to obtain unpublished clinical trial data and found that, when combining results with published data, the various antidepressants were [...] ...

Last October, the FDA wrote drugmakers to remind them they are required to report any life-savings meds that are discontinued and encourage them to voluntarily report any supply disruptions that could lead to a shortage (read the letter). Now, the agency has issued a draft guidance that instructs drugmakers on the specific procedures for notifying [...] ...

Some experts caution that the devil is in the details -- and in how they are implemented. ...

Researchers wanted to investigate whether boosting fructose consumption actually leads to weight gain in humans, as opposed to rats or hamsters ...

Also: age and gender differences in heart-attack symptoms; Supreme Court won't hear J&J's patent plea against Abbott; a study of raw milk and food-borne illness outbreaks. ...

Gorsky and Sherilyn McCoy were in late 2010 appointed to an expanded "office of the chairman" and given new duties as part of a succession race. ...

Short supplies of both drugs can be traced back to the closing of a Ben Venue Laboratories plant in Ohio. ...

Catching more high-risk patients would mean doctors could better steer preventive care that could avert heart attacks. ...

Also: rules coming for food sold in school vending machines and stores; hospitals are retooling menus; hepatitis C deaths largely among baby boomers. ...

Meeting participants were in agreement that the full studies should eventually be published for the benefit of science and of public health. ...

No adverse events associated with the problem have been reported, the company says. ...

"We could improve dismal health outcomes on both ends of the socioeconomic spectrum if we were simply faithful to science, if we provided and practiced care that we know to be effective." ...