Dabur Pharma

ALSO NOTED: Bayer sues Watson over Yasmin; Zimmer weeds out doc conflicts

Mon, 21 Apr 2008 06:59:50 -0400

> Open another chapter in the Bayer fight to protect Yasmin patents: Watson Pharmaceuticals filed for FDA approval for its copycat version of the birth control pill, and Bayer sued to keep the drug off the market. Release

> Device maker Zimmer is working to cut "potential or perceived conflicts of interest" in any consulting deals with docs, by banning all gifts to healthcare professionals, pulling back on sponsoring doctor presentations at conferences, and reviewing royalty deals for potential conflicts--and in some cases, suspending payments. Report

> Alabama's Supreme Court ruled that GlaxoSmithKline and Novartis will have to face claims that they inflated Medicaid drug prices--together. The drugmakers had argued for separate trials. Report

> Shire has seen its share price drop by 22 percent over the past six months as investors worry that patients aren't switching to the ADHD treatment Vyvanse, its lead drug. Report

> India's Dabur Pharma said longtime shareholders the Burman family would sell its entire 65 percent stake in the company to a unit of Germany's Fresenius. Report

> Amylin Pharmaceuticals posted a larger first-quarter loss on higher marketing costs for diabetes meds Byetta and Symlin; the company lost $68.8 million last quarter versus $49.4 million during the same period last year. Report

> QLT said that its Visudyne eye treatment marketed by Novartis posted first-quarter sales of $36.5 million, a decline of 40 percent from first quarter of last year, because of increased competition from new macular degeneration meds. Report

> BrainCells is moving its lead program into a Phase IIa trial after boosting its second venture round with a second tranche. Report

> The FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. Report

> The war between Biogen Idec and Wall Street raider Carl Icahn is heating up. Report

> Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Report

> The U.K.'s Renovo has seen shares bounce back on the news that two more mid-stage studies have produced positive results. Report

And Finally... With a new safety threat reported almost every day, is this becoming the United States of Anxiety? Report

ALSO NOTED: Appeals court votes for FDA approval shield; Suicides rose as depression treatment fell;

Wed, 09 Apr 2008 06:59:50 -0400

> A federal appeals court backed the drug industry's arguments that it should be insulated from lawsuits over FDA-approved products, ruling 2-1 that antidepressant makers GlaxoSmithKline and Pfizer could not be held liable for the suicides of two patients using SSRIs. Report

> A new study shows rising suicide rates among children and teens in Canada, two years after drug regulators there warned of the safety risks of antidepressant use in children; the climbing suicide rate coincided with a 10 percent drop in the rate of doctor visits for depression treatment among children. Report

> Galderma Pharma has wrapped up its $420 million tender offer for fellow dermatology drug company CollaGenex Pharmaceuticals. Report

> Louisiana's new attorney general withdrew a multimillion-dollar antitrust lawsuit filed against Amgen by his predecessor. Report

> The healthcare and IT company McKesson has agreed to pay $190 million for McQueary Brothers Drug Co., a pharma and beauty products distributor based in Springfield, Mo. Report

> Novartis' plans to erect three wind turbines on its Grimsby, England, campus have drawn fire from environmentalists worried that the huge windmills might disturb birds. Report

> India's Dabur Pharma has agreed to supply Thailand with a copycat form of Sanofi-Aventis' Taxotere, which the Thai government is importing under a patent-busting compulsory license. Report

> Estrogen-only hormone replacement therapy has been linked to a benign breast-lump disease that's often a precursor to cancer. Report

> There's a shakeup under way at Inotek. The Beverly, MA-based developer says it is closing several international sites and a pilot manufacturing facility in Israel as it focuses all of its efforts on its two main programs and two preclinical programs. Report

> Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

And Finally... Russia has improbably emerged as a world leader in new cancer vaccines. The country's regulatory body approved the use of Antigenics' new kidney cancer vaccine, Oncophage--a world first. Report

ALSO NOTED: German Merck wants to make pharma buys; Novartis breast-cancer med prevents recurrence;

Tue, 11 Mar 2008 07:59:50 -0400

> Merck KGaA is on the prowl for pharma acquisitions, CEO Ludwig Kley told a German newspaper. Report

> Novartis' breast cancer med Femara can help prevent recurrence of the disease if it's administered after a preventive regimen of Tamoxifen--even if they start the Femara years later. Report

> In the case of a curious food-and-drug recall, Gorton's said that the pills a Pennsylvania family found last month in its fish filets were over-the-counter herbal supplements; the company subsequently took 1,000 cases of those filets off the market. Report

> Scotland's National Health Service can now use Cubicin to treat severe infections caused by the MRSA superbug. Report

> India's Dabur Pharma got regulatory approval to sell its copycat version of Pfizer's chemo drug Camptosar in Italy and Denmark; the company recently launched the generic in the U.S. Report

> Keryx Biopharmaceuticals' stock price wiped out on the rocky shores of a failed late-stage trial of its lead drug, Sulonex, for diabetes. Report

> India's Dr. Reddy's Laboratories is teaming up with 7TM on a drug discovery deal for metabolic disorders. Report

> The Translational Accelerator has opened its doors to all biotech companies in Arizona--or any life sciences company thinking about moving there. Report

> Wyeth has dumped a once-promising Curis collaboration. Report

> Japanese researchers have developed a new approach to make flu vaccines that are able to combat multiple strains of influenza, including strains of the bird flu virus, according to Japan's National Institute of Infectious Diseases. Report

And Finally... Shades of Barry Bonds or just a grown-up version of caffeine-fueled test-cramming? Academic researchers and scientists admit taking Adderall or Provigil to help them wrap up papers and studies. Report

SPOTLIGHT: Dabur gets nod for generic Camptosar

Thu, 01 Nov 2007 07:59:52 -0400

India's Dabur Pharma got the FDA's tentative OK to sell a generic version of Camptosar, Pfizer's colon cancer treatment. Report

ALSO NOTED: Strong euro hitting Merck KGaA's revenue; U.S. sales boost Lupin's Q3 profits;

Wed, 24 Oct 2007 06:59:50 -0400

> German pharma Merck KGaA says a strong euro will depress its year-end sales; it reported a 74.9 percent drop in third-quarter profits on a one-time charge from its acquisition of Serono. Report

> Strong U.S. sales boosted Indian drug maker Lupin in the third quarter, lifting profits by 46 percent to $19 million; sales grew by 35 percent. Report

> Dr. Reddy's Laboratories grew revenues by 20 percent this quarter, but profits fell slightly to $67 million. Release

> Indian pharma Wockhardt did end up acquiring U.S.-based Morton Grove Pharmaceuticals as expected--but at $38 million, the price was lower than rumored. Report

> India's Dabur Pharma inked a deal with Spain-based Combino Pharm to sell generic cancer drugs in that country. Report

> With Biogen Idec on the market, reporters are delving into the possibilities for the company and the potential fallout in the Boston biotech cluster that the company calls home. Report

And Finally... Apparently, the White House didn't like what its CDC chief was planning to tell Congress about global warming's effect on health. Report

SPOTLIGHT: Ellence knockoff OK'd

Fri, 24 Aug 2007 06:59:52 -0400

Indian generics maker Dabur Pharma got the FDA's nod for its version of the Pfizer breast-cancer treatment Ellence, a $60 million-per-year drug in the U.S. It's Dabur's third FDA approval in twelve months. Report