Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.Novo Holdings’ planned acquisition of Catalent is facing another delay. Just weeks after Novo Holdings decided to resubmit its application to the Federal Trade Commission, the agency is seeking more information about the deal. The transaction was originally expected to close by the end of this year, but this timeline may not be as solid given the repeated delays in the FTC’s review process. The acquisition was announced in early February when Novo Holdings — the investment arm of the foundation that owns a controlling stake in Danish pharma giant Novo Nordisk — disclosed its plans to acquire New Jersey-based contract development manufacturing organization Catalent ...
Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
On Wednesday, 3 April, 2024, a letter from the House’s Select Committee on the Chinese Communist Party recommended more companies to add to the Pentagon’s list of firms that are allegedly working with the Chinese military. The letter identifies several companies, including two headquartered in California—Innomics (Sunnyvale, CA, US) and Axbio (Santa Clara, CA, US)—as potentially Chinese military-backed companies, and implied the companies may have tried to hide their affiliation with Chinese-headquartered BGI Genomics (Shenzhen, China), which has been on the security risk list since 2022. Other Chinese companies recommended for the list are Origincell (Shanghai, China), Vazyme Biotech (Nanjing, China), and STOmics (Shenzhen, China). The letter states that Innomics recently registered to conduct business operations in Kentucky under BGI. Innomics provides sequencing services to institutional and corporate clients for research purposes and STOmics sells lab kits and reagents. BGI asserts that both Innomics and STOmics belong to BGI but ...
Two Japanese pharmaceutical companies and a bank are teaming up to form a joint venture to advance therapeutic discoveries from academia. The focus will be innovation from universities in Japan. By Frank Vinluan Academic labs are starting points for many biopharmaceutical industry innovations, and Japan’s universities are no exception. But academic scientists often struggle to find the financing and support to turn their discoveries into new companies, leaving the research to languish in what is sometimes referred to as “the valley of death.” Now Takeda Pharmaceutical, Astellas Pharma, and Sumitomo Mitsui Banking Corporation are teaming up to form a joint venture intended to advance academic discoveries, primarily innovation from Japan. All three are sharing ownership in the joint venture, whose name has not yet been determined. The joint venture’s founders say the valley of death has become more pronounced in recent years. In response to this challenge, the companies said they engaged ...
The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease. By Frank VinluanThe liver is the only organ in the human body capable of regenerating itself. Boehringer Ingelheim has begun a research alliance with a startup to see if its technology can produce new therapies that tap into the liver’s capacity for regeneration and repair. Boehringer is committing to pay Ochre Bio to up to $35 million to begin the partnership, which is focused on identifying, characterizing, and validating multiple novel regenerative targets for chronic liver diseases. Specific targets were not disclosed, but Monday’s announcement describes the deal as a multi-target, multi-year collaboration. Ochre develops RNA medicines for chronic liver diseases. The Oxford, U.K.-based startup hasn’t disclosed details about its internal pipeline, but the company ...
Upcoming weekly insulin candidates can reduce the injection burden on patients with diabetes and ease the load on healthcare resources, said Anna Hodgkinson, a specialist diabetes pharmacist at an ongoing diabetes conference in London. Hodgkinson, who works at at the Lambeth Diabetes Intermediate Care Team, called particular attention to Novo Nordisk’s Awiqli (insulin icodec) and Eli Lilly’s LY3209590 (insulin efsitora alfa), both of which are weekly insulin candidates that may be available on the market shortly. She was speaking at a talk at the Diabetes UK conference on 17 April. The conference closes on 19 April. Despite the benefits, Hodgkinson raised questions about whether Awiqli’s long half-life may prolong the time required for insulin clearance. The therapy is still yet to be tested in chronic kidney disease patients, Hodgkinson added. Awiqli is a long-acting basal insulin analogue with a half-life of 196 hours (8.1 days). Its treatment regimen involves three ...
Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
Boehringer Ingelheim reported robust sales in 2023, with a 10.3% increase in human pharma sales that was strongly driven by Jardiance (empagliflozin) and Ofev (nintedanib). The German company announced that it had reached €20.8bn ($22.1bn) in human pharma sales in 2023, also achieving a 14.2% boost in research and development (R&D) investments that reached €5.8bn. Boehringer’s R&D investments accounted for 22.5% of net sales, as per a 16 April press release. In the press release, Michael Schmelmer, a member of Boehringer’s board of managing directors with responsibility for finance and group functions, said, “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives.” Last year, Jardiance propelled the company’s growth with a 31% sales jump, ...
Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year. By FRANK VINLUAN Targeted therapies and immunotherapies offer new treatment options for more types of cancer, but these drugs are less helpful when tumors produce multiple copies of a gene. This gene amplification contributes to drug resistance. Boundless Bio’s research into the what drives this phenomenon has yielded new understanding of cancer biology. The company now has $100 million in IPO cash to support two programs in early clinical development and more in its pipeline. Boundless Bio late Wednesday priced its offering of 6.25 million shares at $16 each, which was the midpoint of the preliminary $15 to $17 price range the San Diego-based company set last week. Those shares will trade on the Nasdaq under ...
Don Tracy, Associate Editor Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile. Today, Viking Therapeutics announced promising results from a Phase I trial of VK2735, an investigational oral tablet targeting both GLP-1 and GIP receptors for the treatment of metabolic disorders, such as obesity. Results from the 28-day trial show that patients administered VK2735 experienced up to 5.3% weight loss, Additionally, 57% achieved more than 5% in weight loss resulting from treatment with VK2735, a major difference compared to those treated with a placebo. The tablet’s safety profile was reported to be well tolerated, with most adverse effects (AEs) being mild and no serious AEs reported.1 “These Phase I results highlight VK2735’s promising early weight loss and tolerability profile when dosed as an oral tablet,” said Brian Lian, PhD, CEO, Viking, in a press release. “We believe these data indicate that ...
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