Novo Nordisk (NVO), the world’s largest maker of insulin for diabetics may expand its manufacturing operations to the United States, Bloomberg Business reported this morning. If a U.S. site is built, the facility will focus on manufacturing semaglutide, a medication for type 2 diabetes, Bloomberg said. During an interview with Lars Soerensen, Novo Nordisk’s […]
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.
Biogen’s Tecfidera And Other Orals Benefit As Increasingly Risk-Tolerant Neurologists Seek To Arrest Multiple Sclerosis (MS) Progression Sooner
ZUG, Switzerland, Aug. 13, 2015 /PRNewswire/ — Feedback gathered from 97 neurologists in June reveals that growing comfort with oral disease-modifying agents (DMAs) as well as multiple years of patient experience is driving neurologists to leave the injectables behind. While experience benefits oral agents moving forward in the treatment armamentarium, it is not the same story for […]
Genentech (RHHBY) has partnered with several pharmaceutical companies, including AbbVie (ABBV), Clovis Oncology (CLVS) and Immune Design Corp. (IMDZ), as it ramps up its oncology pipeline. On Wednesday, Genentech and its partner AbbVie announced its promising experimental leukemia drug Venetoclax yielded a positive result in reducing the number of cancer cells in patients with previously […]
GlaxoSmithKline is banking on a major clinical trial to revive its flagging respiratory medicine business, with billions of dollars of sales riding on a positive result. Data from the so-called SUMMIT study, designed to show GSK’s Breo can prolong lives of patients with chronic lung disease, are expected as early as next month, nine years […]
By David Beier, John Osborn and Merv Turner A familiar trope employed at the climax of movie thrillers is the zombie who returns from the dead to devour the brains of the living. The biopharmaceutical industry may feel as if it is living in its very own horror show as zombies take the form of […]
August 13, 2015By Mark Terry, BioSpace.com Breaking News Staff Bristol-Myers Squibb Company (BMY) announced yesterday that after delivering additional clinical trial data regarding expanded use of cancer drug Opdivo, the U.S. Food and Drug Administration (FDA) had delayed the decision date in order to evaluate the new data. Originally the supplemental Biologics License Application (sBLA) […]
The Food and Drug Administration pushed back the decision date on an expanded use of Bristol-Myers Squibb Co.’s cancer drug Opdivo to Nov. 27, Bristol-Myers said Wednesday. Bristol-Myers, which initially said a decision was expected by Aug. 27, said it had submitted additional clinical-trial data, which amounts to a “Major amendment” that requires additional time […]
Humira during 2014 remained the world’s best-selling prescription medicine; Sovaldi vaulted into second place in its first full year on the market; Harvoni is challenging Humira for the 2015 sales crown.
For a listing of the top 200 prescription medicines ranked by 2014 sales, please click on the link below: Top 200 Medicines Online 0815
Not your father’s launches The leading members of the pharmaceutical industry’s new compound class of 2013 have set a new standard for launch success. Remember when a drug that generated $100 million in sales in its first full year on the market was cause for wonder and surprise? Or, more recently, when a drug […]
For a listing of the new molecular entity U.S. launches during 2013, please click on the link below: NME 2013 Launches Online 0815
Hetlioz, a prescription pill designed to help blind people sleep at night and stay awake during the day, helped some achieve normal sleep rhythms in two company-funded studies. Vanda Pharmaceuticals Inc. won U.S. marketing approval for Hetlioz (tasimelteon) last year as a treatment for what’s known as non-24-hour sleep-wake disorder, or “non-24,” a chronic circadian […]
CVS Health Corp, the No 2 manager of drug benefit plans for U.S. employers and insurers, will wait until a second new cholesterol-lowering drug is approved by regulators before negotiating for price discounts or adding either of the much pricier new drugs to its list of covered medications. The U.S. Food and Drug Administration in […]
Chesterfield, UK-based Mallinckrodt plc (MNK) announced it will acquire Therakos Inc. for about $1.325 billion from Los Angeles-based The Gores Group, an investment firm. The Gores Group bought Therakos from Ortho Clinical Diagnostics, formerly a unit of Johnson & Johnson (JNJ), in December 2012. Mallinckrodt reported net sales of $2.54 billion in 2014, and […]
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 […]
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 […]