Jumping into the multibillion-dollar market for biosimilar insulin products seemed like a no-brainer for Merck & Co., which is one of the world’s leaders in diabetes.
But the company’s Lantus biosim partnership with Korea’s Samsung Bioepis has faced its share of challenges, not the least of which is a patent fight that has stymied its launch despite a tentative FDA approval last summer
Now Merck is ditching the biosimilar Lantus market altogether and shelling out cash to Samsung Bioepis for its costs, too. That leaves Mylan and its partner Biocon as the only major biosimilar players in a strong position to challenge Eli Lilly and Boehringer Ingelheim’s biosim Basaglar—and Sanofi’s Lantus brand itself, when its last patents expire in 2020.
Merck continues to work with Samsung Bioepis on other biosimilars in oncology and immunology, according to the statement. “We believe that biosimilars can present significant opportunities for cost savings through competition and improved patient access to therapies,” the company said. (See more details on FiercePharma)
In the case, plaintiff Carla Allen sued J&J alleging the company’s Johnson’s Baby Powder caused her to develop mesothelioma. Her legal team asked for $40 million in compensatory damages and more in punitive damages, but the jury unanimously ruled for the drugmaker.
After several setbacks this year in its long-running talc litigation, Johnson & Johnson has scored a second straight win in a mesothelioma case in California.
A J&J spokesperson said the company is “pleased” with the jury’s finding. “While we deeply sympathize with anyone suffering from any form of cancer, the science and facts show that her disease was not caused by her use of our talcum-based products,” she added.
In the trial, Allen’s legal team presented five experts, a treating physician and hours of video testimony from a J&J corporate representative. After the testimony, the jury determined that she failed to prove that the product causes cancer.
South Korean stock regulators have ruled that Samsung BioLogics intentionally violated accounting rules to inflate its value tied to its Biogen-partnered affiliate Samsung Bioepis before going public in 2016. Based on that, the country’s Securities and Futures Commission (SFC) has halted trading of the company on Wednesday, fined it 8 billion Korean won ($7.1 million), recommended dismissal of its chief executive Kim Tae-han and referred the case to prosecutors.
To make it worse, a review is underway that could eventually end in enforced delisting, which could be a serious blow to the fast-growing contract biologics manufacturer and to its parent Samsung Group.
In a Wednesday statement, Samsung BioLogics defended its practice, saying it followed related guidelines and that it will file an administrative lawsuit. (see more details on FiercePharma)
Under the heat of an addiction epidemic is perhaps the worst of times to approve a new opioid in the U.S. But the FDA granted AcelRx’s sufentanil-based Dsuvia—ten times the strength of the already high-powered fentanyl—a green light anyway.
A 30 microgram sufentanil tablet that’s put under the tongue, Dsuvia is now approved to manage acute pain in adults, despite an outpouring of concerns over the drug’s potential role in the U.S. fight against the opioid crisis and even doubts about its efficacy and safety profile.
It was no ordinary FDA review, and not only because its Anesthetic and Analgesic Drug Products Advisory Committee chair, Raeford Brown, wrote a letter pleading with the agency to reject it. Commissioner Scott Gottlieb also made a rare separate statement to explain. But the noise around the approval didn’t stop AcelRx from planning a launch early next year or Jefferies analyst Roger Song from projecting more than $500 million in peak U.S. sales.
Here’s the twist: The opioid won’t be available at retail pharmacies for patients to take home. It must be administered by a healthcare professional in a medically supervised setting, such as hospitals and emergency rooms, under a restrictive risk-management plan mandated by the FDA.
That restriction could turn out to be a double-edged sword. On the one hand, it limits the drug’s uptake and hence sales, but on the other, as executives pointed out on the call, the drug poses low risk for potential abuse—a feature that could ease some public anxiety over yet another opioid option.
All eyes are on Eli Lilly’s Trulicity as it faces down some hefty new competition from diabetes rival Novo Nordisk. But the Indianapolis drugmaker just notched an important trial win that shows it can hang with its rival.
Monday, the pharma giant said that in a cardiovascular outcomes trial, Trulicity showed it could significantly cut down the combined rate of heart attack, stroke and cardiovascular death. It’s not the first drug to gain that distinction; fellow Lilly drug, SGLT2 Jardiance, grabbed that title in 2015, and since then plenty of other diabetes products—including Novo’s blockbuster GLP-1 Victoza and newer entrant semaglutide—have done the same.
Trulicity, though, is the first to demonstrate a reduction in a trial that included a majority of participants—about 69%—without already established cardiovascular disease, which “could help Trulicity differentiate” from other drugs’ outcomes studies, Credit Suisse analyst Vamil Divan wrote to clients. (see more details on FiercePharma)
Midterm elections are underway, pharma watchers are keeping a close eye on the results, well aware that the industry has a lot at stake. Drug pricing has become a central issue in the election, and just who wins and loses in the Congressional races will determine how the industry fares for years to come. One favorable outcome for drugmakers, which many experts predict, is that Democrats will flip the House of Representatives, while Republicans will retain control of the Senate.
Anything can happen in elections, of course. But that scenario would be a positive for healthcare companies because it “likely means gridlock,” Cowen Washington Research Group healthcare and pharma managing director Rick Weissenstein wrote in a note to investors.
But while the drug pricing hearings would make “good theater,” like big tobacco hearings in the 1990s, Weisseinstein believes they wouldn’t bring about tangible change to pharma pricing dynamics. (see more details on FiercePharma)
Pfizer acknowledged Tuesday that it continues to struggle with manufacturing at some Hospira plants, an issue that bodes ill not just for investors but also for U.S. hospitals. The manufacturing problems at Hospira that dented earnings and led it to lower its forecast mean ongoing drug shortages for healthcare providers.
Manufacturing problems at Pfizer’s plant in McPherson, Kansas, are at the heart of some of the most troubling shortages for the the FDA and the healthcare system. Its Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.
The FDA pointed out in a report that shortages of these particular drugs were caused by production delays tied to changes and upgrades made at a Pfizer facility in Kansas after the agency slapped it with a warning letter. It was then “exacerbated by recent issues related to manufacturing quality at the same facility.” The FDA has been working with Pfizer and other drugmakers to deal with the shortages.