Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller. By FRANK VINLUAN An experimental Cytokinetics drug has Phase 3 data showing it improved the ability of the heart to work during exercise. In addition to meeting this main goal of its pivotal test in a rare cardiovascular disease, the results look competitive with a Bristol Myers Squibb product already on the market. The Cytokinetics drug, aficamten, is a potential treatment for obstructive hypertrophic cardiomyopathy (oHCM), a condition that leads to thickening of heart muscle that makes it harder for the organ to pump blood. Patients experience fatigue and shortness of breath. The condition can progress to heart failure. Cytokinetics reported preliminary Phase 3 results on Wednesday showing that after 24 weeks, treatment with its once-daily ...
Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
Deerfield Agency has named its first chief creative officer. Sam Cannizzaro has ended a two-year stint at Elevate Healthcare Marketing to take up the position at a fast-growing agency that is carving out a niche serving small to midsize pharmaceutical companies. Pennsylvania-based Deerfield is a full-service agency specializing in healthcare. Last year, the acquisition of Verge Scientific, a company that supports brand strategy and public relations, helped the agency to grow its sales by 40% and increase its headcount from 88 to 141. Deerfield has navigated its rise without a chief creative officer. Now, Deerfield is filling that gap by hiring Cannizzaro, a person whose CV features highlights related to the initiation of omnichannel campaigns, work on telehealth solutions and immersive technologies, use of voice-based health assistants and launch of AstraZeneca’s first digital detailing solutions. In a statement, Frank Burrell, managing partner at Deerfield, said Cannizzaro will “lead creative visioning ...
GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024. By FRANK VINLUAN GSK’s cancer drug pipeline is getting bigger with the addition of another antibody drug conjugate, or ADC. It’s the second time in as many months that GSK has turned to Hansoh Pharma for one of the China-based biotech’s drugs. Per deal terms announced Wednesday, GSK is paying $185 million up front for rights to HS-20093, a Hansoh ADC that has been tested in lung cancer. GSK gains global rights to the drug candidate excluding mainland China, Hong Kong, Macau, and Taiwan. ADCs are made by chemically linking an antibody to a toxic drug payload. The targeting ability of the antibody is meant to provide a ...
Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition. By FRANK VINLUAN The rare inherited disorder epidermolysis bullosa, or EB, leads to skin so fragile that it tears like tissue paper. The resulting wounds and blisters are slow to heal and prone to infection. On Tuesday, the FDA approved a Chiesi Group drug developed to promote faster wound healing in EB patients. Privately held Chiesi will market its new drug as Filsuvez, the same brand name for the product in Europe, where it won its first regulatory approval last year. The FDA decision for this topical gel covers the treatment of patients age six months and older. EB stems from a mutation to the gene that codes ...
Illumina has decided against further appeals of U.S. and European antitrust litigation challenging its acquisition of liquid biopsy company Grail. Illumina expects to have terms of the divestiture set by the end of the second quarter of 2024. By FRANK VINLUAN Illumina is done fighting in the courts to keep cancer-detection company Grail. The gene-sequencing giant had previously pledged to divest Grail if it did not win either the U.S. or European appeals of anti-trust cases challenging the acquisition. A U.S. appeals court came down against the Federal Trade Commission’s case on Friday, but in a narrow way that hardly handed Illumina a clear victory. After reviewing the decision, Illumina said Sunday that it has decided against further litigation. The company will divest Grail. The planned divestiture is the latest step in a journey that started within Illumina. Grail began as research within the San Diego company. Grail spun out ...
Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point. By FRANK VINLUAN A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug, PNT2002, is also a radiopharmaceutical. It offers targeted delivery of a radioactive particle by linking it to a ligand that targets PSMA, a protein abundant on the surface of prostate cancer cells. The open-label Phase 3 study evaluated the Point radiopharmaceutical in patients with cases of prostate cancer that has ...
Dive Brief Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye. The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes. Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000. Dive Insight Glaukos expects to generate up to $310 million in ...
About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. Late Friday, Arcutis’ roflumilast—now approved in both cream and foam form under the brand name Zoryve—passed muster with U.S. regulators to treat seborrheic dermatitis in patients ages 9 and older. Arcutis has previously estimated there are more than 10 million people in the U.S. with seborrheic dermatitis, which causes red patches on the skin covered with large, flaking scales and a persistent itch. The disease most often affects parts of the body with oil-producing glands, such as the scalp, face, upper chest and back. Back in July 2022, roflumilast’s cream formulation won the company’s first approval in plaque psoriasis. In both its forms, roflumilast targets phosphodiesterase-4 (PDE4), an intracellular enzyme that boosts production of pro-inflammatory mediators and decreases production of ...
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