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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
Two months ago, the biotechnology company Orexigen filed a patent claiming its weight-loss drug Contrave might prevent heart attacks based on the first 25% of data from an ongoing study. But the disclosure was improper, yielding protests from Steven Nissen, the Cleveland Clinic scientist running the study, Orexigen’s marketing partner, the Japanese drug giant Takeda, […]
Deerfield, Ill.-based Baxter International (BAX) said Tuesday it would buy a promising leukemia treatment, Oncaspar, from Italian company Sigma-Tau Finanziaria S.p.A. for $900 million, as it bolsters its oncology pipeline in an increasingly lucrative and competitive field. Baxter estimated oncology alone could bring in $10 billion once its pipeline is established, with Oncaspar already raking […]
A U.S. Food and Drug Administration advisory committee on Tuesday recommended approval of Vertex Pharmaceuticals Inc’s combination cystic fibrosis therapy, finding it to be safe and effective for patients ages 12 and up. The recommendation, which came in a 12-1 vote, will now be considered by FDA officials who are expected to decide by July […]
A person holds pharmaceutical tablets and capsules in this picture illustration taken in Ljubljana September 18, 2013. Reuters/Srdjan Zivulovic Almost two-thirds of the drug combinations widely sold in India to fight pain, depression, and psychotic conditions lack the necessary regulatory approvals, despite some of the pills being banned internationally, a study published on Tuesday shows. […]
Orexigen Therapeutics Inc and its partner Takeda Pharmaceutical Co said they were terminating a trial assessing the cardiovascular safety of obesity drug, Contrave. Orexigen Therapeutics shares were down 12.5 percent in after market trading after falling 13.6 percent in regular trading on the Nasdaq on Tuesday. The study was not being terminated due to the […]
A trial assessing the cardiovascular safety of obesity drug Contrave, made by Orexigen Therapeutics Inc and Takeda Pharmaceutical Co Ltd, was terminated on Tuesday due to unauthorized release of study data. A statement from Cleveland Clinic, which was conducting the trial, said the study was being halted as unauthorized release of trial data by Orexigen […]
More than a half-million U.S. patients had medication costs in excess of $50,000 in 2014, an increase of 63 percent from the prior year, as doctors prescribed more expensive specialty drugs for diseases such as cancer and hepatitis C, according to an Express Scripts report released on Wednesday. Of the estimated 575,000 Americans who used […]
The U.S. government said health insurers must cover all FDA-approved methods of birth control without co-pays or charges to the patient, as it issued a paper on Monday looking to clarify coverage guidelines under the Affordable Care Act. Recent published reports found that some payers were ignoring federal requirements for covering birth control, a benefit […]
Endo Pharmaceuticals Shells Out $130 Million for Nearly 70 Pipeline Programs From Aspen Pharmacare Holdings
DUBLIN — Endo International (ENDP) has continued its trend of expanding its portfolio through acquisitions, announcing a $130 million deal to acquire a large portfolio of anti-pain anti-infectives, cardiovascular and other therapeutics areas from Aspen Pharmacare Holdings, the company said this morning. The deal includes products that are currently on the market, as well as […]
Horizon Pharma plc Announces Settlement of PENNSAID(R) 2% Patent Litigation With Perrigo Company plc
DUBLIN, IRELAND–(Marketwired – May 8, 2015) – Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that its affiliates have entered into a settlement and license agreement with Perrigo Company plc and its […]
Amarin Pharmaceuticals, which was rebuffed by the Food and Drug Administration in its effort to market its fish oil pill Vascepa to treat high triglycerides, is suing the agency, saying its First Amendment rights are being violated. To make its case, the small drugmaker has hired one of the nation’s top free speech lawyers, Floyd […]
The World Health Organization has added new curative treatments for hepatitis C to its essential medicines list, but the U.N. agency said prices needed to fall to make them accessible to patients in poorer countries. The treatment of hepatitis C, which affects about 150 million people globally and kills around half a million each year, […]
Swiss drugmaker Novartis said European health regulators have approved a drug for advanced lung cancer that is intended to treat patients with a specific genetic mutation. Zykadia, or ceritinib, is from a new class of medicines known as ALK inhibitors. It was approved in April 2014 in the United States. It is designed for use […]
Vertex Pharmaceuticals Inc’s combination of an experimental compound and an approved drug significantly improved lung function in cystic fibrosis patients with the most common genetic mutation underlying the disease, FDA staff said. The U.S. Food and Drug Administration staff reviewers, however, were not sure whether Vertex’s already approved therapy, Kalydeco, had a positive effect alone. […]