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Largest Insulin Maker Novo Nordisk A/S May Build New Facility in the U.S.

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 […]

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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 […]

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Genentech Ramps Up Partnerships for Next-Gen Cancer Drugs

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 […]

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GSK hopes big clinical trial can breath new life into lung drug

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 […]

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Desperately Seeking Price Reform: The Pharmaceutical Industry Needs To Change Its Ways

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 […]

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FDA Pushes Back Review Date on Bristol-Myers Squibb’s Key Melanoma Drug Opdivo

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) […]

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FDA Decision on Bristol-Myers Squibb Drug Opdivo Is Pushed Back

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 […]

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2015 Annual Report: Top 200 Medicines

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.

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Top 200 Prescription Medicines Ranked By 2014 Sales

For a listing of the top 200 prescription medicines ranked by 2014 sales, please click on the link below: Top 200 Medicines Online 0815

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First Year After Launch – Special Feature

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 […]

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New Molecular Entity U.S. Launches During 2013

For a listing of the new molecular entity U.S. launches during 2013, please click on the link below: NME 2013 Launches Online 0815

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Hetlioz pill may ease sleep disorder for some blind people

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 […]

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CVS: All bets are off for new cholesterol drug contracts

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 […]

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Mallinckrodt Coughs Up $1.33 Billion for Therakos Inc.

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 […]

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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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