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 […]
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
First Year After Launch: New molecular entities launched in the U.S. during 2015 that generated 2016 sales of at least $200 million
A listing of the the new molecular entities launched in the United States during 2015 that generated 2016 sales of at least $200 million
Lurking behind all the sound and fury in the political realm, 2017 is bringing new opportunities to marketers that have nothing at all to do with orange hair. A whole generation of technologies are growing to maturity together – predictive targeting, virtual reality, behavioral science, interactive video, big data, and more – all of which are transforming the ways in which brands can communicate with their audiences. But of course politics will matter too in this Year One of the Trump administration, as the continuing debate over drug pricing and the impact of the new president’s policies on the pharma industry remain very much up in the ai
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
“Failing to plan is planning to fail” states time management guru Alan Lakein. Nowhere does this axiom ring more true than in the tightly controlled world of Rx launches. Given the time and expense required to bring a prescription drug to market, coupled with its limited exclusive lifespan, we must maximize every moment from market conditioning to loss of exclusivity (LOE).
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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, […]
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. SPRITAM utilizes Aprecia’s […]
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 […]
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. […]
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 […]