Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
Researchers at the University of Colorado Anschutz Medical Campus have officially identified a central conduit to obesity: fructose. While fructose’s contribution to obesity is well-known, a study published today in Philosophical Transactions aggregates a large amount of work to make a full argument for how fructose drives obesity and diseases such as diabetes and fatty liver disease. “This is an in-depth review on a hypothesis that puts nature at the center of weight gain, examining how fructose works differently than other nutrients by lowering active energy,” says Richard Johnson, MD, professor at the University of Colorado School of Medicine and study lead author. “We determine a recently discovered function of fructose in survival that stores fuel in case resources become scarce. This is known as the ‘survival switch,'” he says. Fructose is the source of sweetness in fruit, but is primarily consumed in Western society as table sugar and high ...
More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
With winnings from its arbitration battle against Johnson & Johnson in hand—alongside a jump in its own product sales—Alkermes seems to be feeling itself heading into the second half of 2023. After the Dublin-based drugmaker won a high-stakes case versus J&J last month, the company bumped up its 2023 sales forecast by $425 million to between $1.55 billion and $1.68 billion. In revealing second-quarter results, the company provided some details behind the new guidance. Alkermes expects J&J’s royalties and interest on late payments for 2022 to come in at around $197 million, while 2023 royalties should land between $265 to $280 million, the company said in an investor presentation (PDF). Those payments relate to J&J’s schizophrenia drug Invega, which uses Alkermes’ NanoCrystal technology and delivered sales of $4.1 billion last year. With the arbitration win in tow, Alkermes generated $617 million this quarter, including $248 million of back royalties and interest from ...
Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
Kenvue shares fell on Thursday even though the consumer health company beat second-quarter revenue and earnings expectations in the its first quarterly report since it spun out from Johnson & Johnson two months ago. The company, formerly J&J’s consumer health division, also issued an upbeat sales outlook for 2023. Kenvue CEO Thibaut Mongon said during an earnings call that the consumer landscape “continues to be uncertain” and the company expects “market volatility will continue.” But he noted that consumers are still willing to buy “trusted” and “efficacious” health products. Kenvue’s beat was driven by resilient demand for its wealth of widely known brands such as Band-Aid, Tylenol, Listerine, Neutrogena and Aveeno. “This quarter was yet another proof point, showcasing the power of our portfolio,” Mongon said during the call. J&J still owns a 90% stake in Kenvue, meaning it can generally control the direction ...
In 2017, when Genmab CEO Jan van de Winkel declared its multiple myeloma drug Darzalex—which is marketed by Johnson & Johnson—had the potential for peak sales of $13 billion, he relented that it was a best-case scenario.Six years later, that best-case scenario appears possible. On Thursday, J&J reported another quarter of strong sales for the monoclonal antibody. Darzalex generated $2.43 billion in the period, a 22% increase from the second quarter of last year. After realizing sales of $6 billion in 2021 and $8 billion last year, Darzalex is on track to approach revenue of $10 billion in 2023. The drug, which was approved in 2015, was boosted in 2020 with the development of Darzalex Faspro, a subcutaneous version of the treatment which allows patients to receive doses in minutes compared to hours for the previous intravenous administration. A year ago, J&J reported that 85% of patients receiving Darzalex were using Faspro. ...
Pictured: Johnson & Johnson Sign in Silicon Valley/Shutterstock, Michael Vi Johnson & Johnson exceeded Wall Street expectations in its second quarter performance. The healthcare products giant posted sales of $25.5 billion in its earnings report on Thursday. Worldwide sales numbers reflected a 6.3% growth for J&J with revenue close to $1 billion higher than analysts expected, thanks in particular to a nearly 10% increase in its medtech sales. Medtech has been on the rebound since patients have returned to non-emergent surgeries like knee and hip replacements, which saw a significant drop during the pandemic. Operational sales for the company’s pharma arm, suffering growth points due to dwindling COVID-19 vaccine sales, was up 3.9%. The second quarter posted no U.S. sales of J&J’s COVID vaccine, with no domestic revenue expected beyond the $747 million from outside the U.S. reported last quarter. Its government contracts are now complete. Primary growth drivers were J&J’s oncology and immunology ...
Dive Brief Abiomed’s Impella heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, the Food and Drug Administration said in a recall posted Friday. The company, which was acquired by Johnson & Johnson in December, began the recall of its Impella heart pumps in June, warning that the problem could result in low flow from the damaged pump or that the fractured material could block blood flow. Abiomed is not pulling the device from the market, but cautioned physicians to place it carefully in patients. Dive Insight The FDA marked the recall as Class I, its highest risk category. It did not specify whether any injuries or deaths had been reported. The recall includes Abiomed’s Impella CP with SmartAssist, Impella 5.5, Impella 5.0, Impella 2.5 and Impella LD pumps, totaling 9,252 units. ...
Pictured: Gavel on desk/Courtesy, iStock Astellas and Johnson & Johnson have filed lawsuits against the Medicare program, challenging the constitutionality of the Inflation Reduction Act’s drug pricing provisions. These legal actions add to a growing wave of litigation from drugmakers seeking to block the implementation of the Medicare Drug Price Negotiation Program. The IRA, designed to address rising healthcare costs and make medications more affordable for Americans, has faced significant opposition from the pharmaceutical industry. Friday, Astellas filed a lawsuit challenging the program, arguing that it violates the Fifth Amendment by unlawfully depriving them of their intellectual property rights. The pharma claimed that the IRA’s provisions, which allow Medicare to negotiate drug prices directly with manufacturers, amount to an unconstitutional confiscation of their patented drugs. Tuesday, J&J also filed a lawsuit against the Biden administration over the Medicare Drug Price Negotiation Program. The company asserted in its filing that the program is ...
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