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. […]
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).
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. […]
It now costs $10,000 or more per person annually to treat someone with diabetes than someone who doesn’t have the chronic disease, according to a new analysis of large insurance company claims data. The Health Care Cost Institute, a Washington-based group backed by some of the nation’s largest insurance companies including UnitedHealth Group (UNH), Humana […]
(Reuters) – Celgene Corp on Thursday said the European Patent Office revoked a key patent on the company’s flagship multiple myeloma drug Revlimid, a move that could shave a year or two from the medicine’s exclusivity in Europe. The so-called polymorph patent in question would have kept cheaper versions of Revlimid off the European market […]
SAN DIEGO, May 7, 2015 /PRNewswire/ — Antiplatelet drug ticagrelor (Brilinta®) works faster and is more effective in blocking platelet activity in low-risk patients with acute coronary syndrome (ACS) than clopidogrel, according to a new study presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San […]
(Reuters) – A U.S. appeals court has blocked the sale of Novartis AG’s recently approved “biosimilar” form of Neupogen, Amgen Inc’s blockbuster drug used to prevent infections in cancer patients. A lower court judge rejected Amgen’s request for an injunction. The U.S. Court of Appeals for the Federal Circuit ruled on Tuesday, however, that the […]
MarketResearch.com: Asthma Therapeutics Market to Reach $21.7 Billion by 2020, Says New GBI Research Report
WASHINGTON and NEW YORK and LONDON, May 7, 2015 /PRNewswire/ — As a leading provider of market research reports and solutions, MarketResearch.com is pleased to highlight a recent report by GBI Research, forecasting the asthma therapeutics market to hit $21.7 billion by 2020, a CAGR 2.4% over $18.4 billion in 2013. To view this report by […]
(Reuters) – Johnson & Johnson will become the first pharmaceutical company to formally seek advice from outside medical ethicists on “compassionate use” requests, in which desperate patients ask drugmakers to let them take an experimental medication, the company announced on Thursday. The ethicists’ recommendations will be advisory, with J&J making the decision. But the drugmaker […]
(Reuters) – Venezuela is investigating whether drug companies including Germany’s Merck KGaA and Bayer AG have improperly profited from subsidized foreign exchange amid growing medicine shortages, the country’s health minister said. Those firms have received a favorable exchange rate through Venezuela’s currency controls to produce or import price-controlled medication to treat chronic ailments such as […]
(Reuters) – European regulators do not agree with the negative view expressed by one adviser about the efficacy of UniQure’s drug Glybera, the Western world’s first gene therapy. The Dutch company said it had received a final assessment report from the European Medicines Agency’s Committee for Advanced Therapies (CAT) following doubts raised by the adviser, […]
While some people visit primary care physicians when they’re in pain, others head to the emergency room. With emergency physicians wanting to provide pain relief to their patients, prescribing opioids to discharged patients may seem like the best option to some — but many physicians are refusing to jump the gun too soon. Published in the Annals of Emergency Medicine, a journal […]