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Orexigen CEO Pledged To Keep Data Secret, But Not From Himself

In an interview two years ago, Orexigen Chief Executive Mike Narachi understood that data from the largest clinical trial of his company’s weight loss drug Contrave were to be kept secret except for “a small team” that would use it to file for approval with the Food and Drug Administration. However, Narachi differed from CEOs […]

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J&J Pegs Its Long-Term Growth Potential On Prevention

During Johnson & Johnson’s Pharmaceutical Business Review Wednesday, several executives from the healthcare-products giant made a case to Wall Street analysts that its pipeline of new drugs is strong enough to drive strong short-term sales and profit growth. But behind the scenes, the company is making a huge bet that focusing on disease prevention will […]

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Do R&D Costs Matter When It Comes To Drug Pricing?

Dr. Jerry Avorn, of Harvard Medical School and a long-time critic of the pharmaceutical industry, has published an opinion piece in the New England Journal of Medicine, challenging the costs of drug R&D as elucidated by the Tufts Center for the Study of Drug Development. Last November, the Tufts group published an analysis showing that […]

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Gilead patents on costly hepatitis C drug challenged in five countries

 A U.S. group is trying to block patents in five countries for Gilead Sciences Inc’s costly hepatitis C drug Sovaldi, in a bid to give almost 60 million afflicted people access to cheaper generic versions. In Argentina, Brazil, China, Russia and Ukraine, challenges have been filed against Gilead’s patents or patent applications, the New York-based […]

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U.S. FDA Approves INVEGA TRINZA, First and Only Four-Times-A-Year Treatment for Schizophrenia

93% of patients treated with INVEGA TRINZA remained relapse-free at the end of long-term maintenance trial   TITUSVILLE, N.J., May 19, 2015 / PR Newswire / — There’s a new treatment option for schizophrenia – INVEGA TRINZA™ (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the […]

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Twitter Attempts to Marry Gilead, Achillion, Finds Reality Instead

Biotech darling Gilead Sciences, Inc. (GILD) was almost the brand new owner of rival drugmaker Achillion Pharmaceuticals, Inc. (ACHN) yesterday—if only on Twitter. Rumors ran rampant on the social media site yesterday that Gilead had canceled an appearance at the same health conference Achillion had bowed out of because the two were in talks for […]

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Annual Healthcare Cost For Family Of Four Now At $24,671

Earlier today, the actuarial firm of Milliman, Inc. released their annual Medical Index for 2015 – an index that they’ve calculated and published since 2001. The Milliman Medical Index (MMI) is the total annual cost of healthcare as estimated by Milliman for a typical family of four with employer-provided PPO insurance coverage.  According to Milliman, this […]

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Cholesterol drugs may curb strokes among low-risk older adults

(Reuters Health) – Cholesterol-lowering drugs such as statins may reduce the risk of stroke in low-risk elderly patients, a French study suggests. People who took statins or fibrates, another type of cholesterol-lowering medicine, were 34 percent less likely to have a stroke than those who didn’t, researchers report. “If confirmed, these results are compatible with […]

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Novo Nordisk weighs diabetes drug’s use in fatty liver disease

Novo Nordisk is looking into recent clinical trial data that show its diabetes drug Victoza has potential as a treatment for fatty liver disease, a hot area for pharmaceutical development. Research from Britain’s University of Birmingham showed last month that the drug, also known as liraglutide, resolved fatty liver disease in more than a third […]

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U.S. FDA warns on newer class of type 2 diabetes drugs

The headquarters of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, in this file photo taken on November 4, 2009. Reuters/Jason Reed The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli […]

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U.S. FDA warns on newer class of type 2 diabetes drugs

The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization. The drugs belong to a class known as SGLT2 […]

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Indian court bars Glenmark from selling Merck drug copies

India’s Supreme Court has barred Glenmark Pharmaceuticals from making and selling copies of U.S. drugmaker Merck’s diabetes drugs Januvia and Janumet, according to a court document released on Friday. The court has, however, allowed Glenmark to continue to sell existing inventory, according to the document posted on the Supreme Court’s website after a hearing. The […]

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AbbVie Receives Orphan Drug Designation for HUMIRA from the U.S. Food and Drug Administration for the Investigational Treatment of Moderate-to-Severe Hidradenitis Suppurativa (HS)

NORTH CHICAGO, Ill., May 15, 2015 /PRNewswire/ — AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted HUMIRA® (adalimumab) orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS) (Hurley Stage II and Hurley Stage III disease), a painful, chronic inflammatory skin disease. AbbVie’s supplemental Biologic License Application seeking […]

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What The Travails Of The UK’s Largest Grocer Can Teach The Pharmaceutical Industry

In the five years since the first DrugBaron article was published, entitled “Hard Times, Harder Times,” it seems that in the business of drug discovery and development everything has changed – and at the same time nothing. On the one hand, the ubiquitous gloom that surrounded the industry has lifted, to be replaced with a febrile […]

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Did Orexigen Have The Right To File Its Controversial Patent?

Shares in Orexigen Therapeutics, the maker of a weight-loss drug called Contrave, have dropped 24%  to $5 since Tuesday, when news came out that data that the drug maker had originally presented as showing Contrave prevented heart attacks and strokes were part of a study that, in the end, showed no such thing. The news was […]

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Type of B vitamin shown to reduce risk of common skin cancers

A simple daily vitamin may help prevent the most common types of skin cancer in people at high risk of the disease, according to new research from Australia. A study conducted at the University of Sydney found that nicotinamide, a form of vitamin B3, reduced by 23 percent the incidence of new, non-melanoma skin cancers […]

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Roche immunotherapy improves lung cancer survival

A mid-stage trial of Roche Holding AG’s experimental immunotherapy showed that it doubled the likelihood of survival for lung cancer patients with the highest levels of a specific biomarker. The drug, known by the code name MPDL3280A, is part of a new class designed to help the body’s immune system fend off cancer by blocking […]

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LCS Group Announces Exclusive License from Lucerne Biosciences to Commercialize ‘813 Patent and ‘249 Application through Shire’s Marketing of Lisdexamfetamine Dimesylate for Binge Eating Disorder

NEW HAVEN, Conn., May 13, 2015 /PRNewswire/ — LCS Group, LLC announced today its exclusive license from Lucerne Biosciences, LLC to commercialize U.S. Patent No. 8,318,813 and U.S. Patent Application No. 14/464,249, both titled “Method of Treating Binge Eating Disorder” (“BED”).   LCS Group’s exclusive license is part of a unique strategic collaboration with the intellectual property’s […]

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A Top Cardiologist Says A Diet Drug Maker Misled Patients And Investors

Update 7:15: Click here for Orexigen’s comments on this situation. A top cardiologist is accusing a drug maker with whom he worked closely of making misleading statements about its weight loss medicine and refusing to release data that would undermine its previous claims. The pill, Contrave, was prescribed 117,000 times in its first three months on […]

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Drug Costs Top $50K A Year For Half Million Americans

With the drug industry launching more expensive targeted therapies, the number of Americans with annual medication costs of more than $50,000 has jumped more than 60% to nearly 600,000, a new analysis shows. The latest drug spending trend report from pharmacy benefit manager Express Scripts (ESRX) shows 576,000 Americans with annual medication costs of $50,000 […]

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