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U.S. jury clears Eli Lilly in first Cymbalta withdrawal trial

Eli Lilly on Friday was cleared of liability in the first trial involving claims that its antidepressant Cymbalta caused severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations, the company said. Eli Lily has been sued by roughly 250 plaintiffs who say that the company downplayed warnings about symptoms that can occur when patients […]

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Amarin Wins Off-Label Case Against FDA

A federal court in New York delivered a setback to the Food and Drug Administration, ruling the agency can’t bar a drug company from marketing a pill for off-label use as long as the claims are truthful. The decision by the federal district court in the Southern District of New York, is the latest of […]

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Amarin scores early victory in fish oil drug marketing lawsuit

A U.S. judge on Friday barred the U.S. Food and Drug Administration from stopping Irish drugmaker Amarin Corp from promoting its fish oil drug for off-label uses, saying the company is protected by the First Amendment. The pharmaceutical industry has been watching this case because it is one of the first to raise a First […]

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Pfizer, Bristol revive cancer drugs that rev up immune system

Some of the most heralded new cancer drugs fight the disease by removing brakes on the immune system. Now a few leading drugmakers are paying attention to a second, opposing force: medicines that accelerate the immune system’s attack. Pfizer Inc, which is lagging rivals in the lucrative field of cancer immunotherapies, has been the first […]

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Biogen Sinks Some More After Doctors Fear More Brain Infections Will Occur in Patients Taking Drugs Like Tecfidera

Biogen Inc. shares sank after doctors in a top medical journal said more instances of brain infections may occur in people taking a type of medication that includes the drugmaker’s top-selling multiple sclerosis treatment. The shares fell 5.6 percent to $316.60 at the close in New York following the publication of the letter in the […]

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Britain raps Pfizer over huge jump in epilepsy drug price

Britain’s competition watchdog has accused Pfizer and Flynn Pharma of breaching UK and European law by ramping up the cost of an epilepsy drug, given to more than 50,000 British patients, by as much as 2,600 percent. The Competition and Markets Authority (CMA) said its provisional view was that Pfizer and Flynn Pharma each abused […]

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Allergan reports better-than-expected revenue

Irish drugmaker Allergan Plc (AGN.N) reported better-than-expected revenue for the first full quarter since the merger of Actavis and Allergan. Allergan, which changed its name from Actavis after the deal closed, said adding signature drugs like Botox and eye drops Restasis boosted branded products sales five-fold to $3.71 billion in the second quarter ended June […]

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Eli Lilly Accused of Hiding Cymbalta Brain Risk

Eli Lilly and Co. was accused of misleading consumers about the frequency of “brain zaps” and other withdrawal symptoms tied to its antidepressant Cymbalta in the first court trial targeting the drug. Lilly officials failed to provide proper warnings that Cymbalta, once the company’s top-selling drug, carried with it severe withdrawal risks, said T. Matthew […]

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FDA to revise Novartis’ Gilenya label to reflect brain infection risk

The U.S. Food and Drug Administration said it will update the label of Novartis AG’s multiple sclerosis drug, Gilenya, after cases of serious brain infections were linked with its use. A case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported with the use of the drug, a first […]

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Mallinckrodt Profit Surges as Acquisitions Drive Sales

Pharmaceutical company Mallinckrodt PLC said its profit soared in the latest quarter as the company’s specialty brand sales continue to benefit from recent acquisitions. But overall sales missed analysts’ lofty expectations, and shares slid 10.4% in midday trading—hitting a six-month low and giving up nearly half of the stock’s gain this year. In March, the […]

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Regeneron raises Eylea sales forecast, shares at record

Regeneron Inc’s blockbuster eye drug, Eylea, showed no signs of a slowdown as the drugmaker raised the full-year sales forecast for its flagship product above at least four analysts’ expectation. The company’s shares rose to a record of $605.93 in early trading on Tuesday. U.S. sales of Eylea surged 58 percent to $655 million in […]

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Akorn Inc’s Hi-Tech Pharmacal infringes Allergan glaucoma drug patents

Akorn Inc’s Hi-Tech Pharmacal Co, Inc infringed three Allergan Inc patents on its Lumigan topical glaucoma treatment, a U.S. appeals court ruled on Tuesday. The U.S. Court of Appeals for the Federal Circuit also said five of Allergan’s Lumigan patents were valid. The case stems from lawsuits Allergan filed in 2011 against Hi-Tech, Novartis AG, […]

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New analysis underscores improving pharma R&D productivity

Drug industry productivity is continuing to improve, with a bumper haul of new products being launched and companies proving more successful in the final stages of clinical testing, according to a new analysis. Data from Thomson Reuters published on Tuesday showed the number of innovative medicines, or new molecular entities, launched globally in 2014 hit […]

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Pharma Sales to Grow Beyond $1 Trillion

PHILADELPHIA, Aug. 4, 2015 /PRNewswire/ — The Intellectual Property and Science business of Thomson Reuters, the world’s leading provider of intelligent information for businesses and professionals announced the release of the 2015 CMR Pharmaceutical R&D Factbook, the biopharmaceutical industry’s leading resource of global R&D trends. Despite concerns around declines in R&D, the analysis identifies a surge […]

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Eli Lilly faces first U.S. trials over Cymbalta withdrawal

Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations. Plaintiff Claudia Herrera is one of about 250 people who have sued Lilly over Cymbalta, and the […]

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In a first, drug using 3D printing technology gets FDA nod

The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3D printing technology, paving the way for potential customization of drugs to suit patients’ needs. The drug, made by privately held Aprecia Pharmaceuticals Co, was approved for oral use as a prescription adjunctive therapy in the treatment of epilepsy, […]

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FDA Approves The First 3D Printed Drug Product

BLUE ASH, Ohio, Aug. 3, 2015 /PRNewswire/ — Aprecia Pharmaceuticals Company today announced that the U.S. Food and Drug Administration (FDA) has approved SPRITAM® levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.[1] SPRITAM utilizes Aprecia’s […]

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New cocktails to test limits of cancer drug pricing

New cancer drug cocktails set to reach the market in the next few years will test the limits of premium pricing for life-saving medicines, forcing company executives to consider fresh market strategies. The growing reluctance of governments and private insurers to fund very expensive drugs – even remarkably effective ones – points to a showdown […]

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Why Pharma Must Change Its Model

A difficult feat to accomplish in business is to make dramatic change in the midst of current success. History is littered with companies that were once on top of the world and today are non-existent or merely footnotes because they were unable to make sustainable changes when times were good and yet change was required. […]

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AstraZeneca Halts Three Clinical Trial Programs, Reports Six Quarters of Top-line Growth

At the very end of its 2015 half-year financial report, on page 49, AstraZeneca PLC (AZN) noted the termination of three projects between April 1 and June 30. They were a program for selumetinib for uveal melanoma, tenapanor for ESRD-pi/CKD with T2DM and Nexium for refractory reflux esophagitis. The selumetinib and tenapanor programs were halted […]

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