Pharmaco - Today Stories

Thermo Fisher Scientific has reached an agreement to acquire Sanofi’s sterile drug product manufacturing facility in Ridgefield, New Jersey. The site, specializing in fill‑finish and packaging of aseptic injectable medications, currently employs over 200 staff who will transfer to Thermo Fisher upon deal completion. The acquisition is expected to close in late 2025 and aligns with both companies’ strategic initiatives to bolster U.S. pharmaceutical manufacturing. Sanofi is ramping up investments in U.S. manufacturing and research, targeting at least $20 billion by 2030. Thermo Fisher, which is committing roughly $2 billion to enhance its domestic production capacity, views the Ridgefield location as a key asset. CEO Marc Casper highlighted that the acquisition strengthens Thermo Fisher’s a…

Sun Pharmaceutical Industries has launched its novel oral treatment LEQSELVITM (deuruxolitinib) 8 mg tablets in the US for adults with severe alopecia areata. The debut follows an out‑of‑court settlement and licensing agreement with Incyte Corporation, resolving all pending patent disputes and clearing the path for the drug’s US rollout. LEQSELVITM, acquired through Sun Pharma’s $576 million purchase of Concert Pharmaceuticals, is a JAK1/JAK2 inhibitor that offers a much‑needed treatment for severe hair loss. In Phase III trials (THRIVE‑AA1/AA2), about one‑third of patients experienced at least 80 % scalp hair regrowth in 24 weeks. Analysts project annual US sales of $400 million by fiscal year 2030, with peak potential of $900 million. Stock market analysts expect the launch and legal cle…

LEO Pharma has struck a major deal to acquire exclusive global commercial rights for Spevigo (spesolimab) from Boehringer Ingelheim for US $105 million upfront, with milestone payments and royalties expected later. Spevigo is a humanized monoclonal antibody targeting the IL‑36 receptor, approved for generalized pustular psoriasis (GPP)—a rare, potentially life‑threatening skin disease characterized by painful pustular flares. Boehringer has already launched the therapy in more than 40 countries, including the US, Japan, China, and Europe. Under the agreement, LEO Pharma will lead global commercialization and further development of Spevigo, leveraging its deep expertise in dermatology. Both companies will explore expanding the therapy into other IL‑36–mediated skin conditions such as palmop…

Novo Nordisk is set to invest €2.34 billion in upgrading its pharmaceutical facility in Anagni, near Rome, aiming to enhance production of diabetes and weight loss medications. Acquired through Novo Holdings' 2024 takeover of Catalent, the Anagni site is central to Novo Nordisk's strategy to meet growing global demand for treatments like semaglutide-based therapies.  To expedite the project, Italian authorities have appointed Francesco Rocca, president of the Lazio region, as a special commissioner, granting him powers to streamline administrative processes. The initiative has been designated as a project of "pre-eminent strategic interest," facilitating faster approvals. Production is expected to commence between late 2026 and early 2027, with full completion anticipated by 2029.  The exp…

Merck (known as MSD outside of the US and Canada) has announced plans to acquire London-based Verona Pharma for approximately $10 billion, aiming to bolster its respiratory treatment offerings. The acquisition centers around Verona's flagship drug, Ohtuvayre, an inhaled, non-steroidal therapy for chronic obstructive pulmonary disease (COPD), approved by the U.S. FDA in June 2024. Since its U.S. launch in August 2024, Ohtuvayre has generated significant sales, contributing over 96% of Verona's Q1 2025 revenue of $76 million.  Merck will pay $107 per American Depository Share, representing a 23% premium over Verona's recent NASDAQ closing price. This move aligns with Merck's strategy to diversify its portfolio ahead of the anticipated 2028 patent expiration of its cancer drug, Keytruda. The…

AbbVie has announced a definitive agreement to acquire Capstan Therapeutics, a clinical-stage biotechnology company, for up to $2.1 billion in cash. This acquisition includes Capstan's lead asset, CPTX2309, a potential first-in-class in vivo CAR-T therapy currently in Phase 1 development for B cell-mediated autoimmune diseases. Unlike traditional ex vivo CAR-T therapies, CPTX2309 utilizes Capstan's proprietary targeted lipid nanoparticle (tLNP) platform to deliver mRNA encoding an anti-CD19 chimeric antigen receptor directly to CD8-expressing cytotoxic T cells within the body, eliminating the need for complex cell harvesting and manufacturing processes. The in vivo approach aims to reprogram T cells to target and deplete pathogenic B cells, potentially resetting the immune system and induc…

Novartis has concluded its tender offer to acquire Regulus Therapeutics, with approximately 74.49% of outstanding shares validly tendered and not withdrawn by the expiration deadline on June 24, 2025. The acquisition, executed through Novartis' subsidiary Redwood Merger Sub Inc., offered $7.00 in cash per share plus a contingent value right (CVR) of an additional $7.00 upon achieving a specified regulatory milestone.  The transaction is set to close promptly following the acceptance of the tendered shares. This move aligns with Novartis' strategic focus on expanding its renal disease portfolio, particularly through Regulus' lead asset, farabursen—a next-generation oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).  The acquisition un…

Fortrea and Emery Pharma have announced a strategic collaboration to conduct FDA-compliant drug-drug interaction (DDI) studies utilizing rifampin. This partnership aims to address the regulatory challenges posed by nitrosamine impurities, specifically 1-methyl-4-nitrosopiperazine (MNP), found in rifampin formulations. These impurities had previously led to the suspension of rifampin's use in healthy volunteer DDI studies due to safety concerns. Rifampin is a potent inducer of cytochrome P450 3A (CYP3A) enzymes and has been a cornerstone in evaluating the metabolic interactions of new drug candidates. However, the detection of MNP above acceptable intake limits necessitated the exploration of alternative inducers, such as phenytoin and carbamazepine. These alternatives, while viable, do not…

Eli Lilly has announced its intention to acquire Verve Therapeutics, a biotechnology company specializing in gene-editing therapies for cardiovascular diseases, in a deal valued at up to $1.3 billion. The agreement includes an upfront payment of approximately $1 billion, offering $10.50 per share—a 113% premium over Verve's 30-day average stock price. Additionally, shareholders may receive up to $3.00 per share through a non-tradeable contingent value right (CVR), contingent upon the advancement of Verve's lead therapy, VERVE-102, into a Phase 3 clinical trial within ten years . VERVE-102 is an innovative in vivo gene-editing therapy targeting the PCSK9 gene, which plays a crucial role in regulating cholesterol levels. Currently in Phase 1b clinical trials, the therapy has received Fast Tr…

Sanofi announced today that the U.S. FDA has granted orphan drug designation to rilzabrutinib for the treatment of sickle cell disease, marking its fourth orphan status for this investigational Bruton's tyrosine kinase (BTK) inhibitor. The oral, reversible BTK inhibitor targets immune system modulation and aims to reduce vaso-occlusive crises—a major source of pain and complications in sickle cell patients. Rilzabrutinib is also under regulatory review in the US, EU, and China for immune thrombocytopenia (ITP), with an FDA decision expected by August 29, 2025. Previous designations include approvals for ITP, warm autoimmune hemolytic anemia (wAIHA), and IgG4-related disease. Preclinical data presented at ASH 2024 demonstrated rilzabrutinib’s potential to reduce inflammation and blood vesse…

Sanofi announces the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company. The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline. DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis. Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B-cell depletion has the potential to reset the adaptive immune system, lead…

Paris, May 22, 2025. Sanofi announced today that it has entered into an agreement to acquire Vigil Neuroscience, Inc. (“Vigil”), a publicly traded clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases. This acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances Sanofi’s early-stage pipeline and includes VG-3927, which will be evaluated in a phase 2 clinical study in Alzheimer’s disease. VG-3927 is an oral small molecule TREM2 agonist. Activating TREM2 is expected to enhance the neuroprotective function of microglia in Alzheimer’s disease. Houman Ashrafian, MD, PhD Head of Research and Development, Sanofi “This acquisition is fully supporting Sanofi’s strategic focus on neurology and on advancing science and lever…

Researchers at the University of Turku, Finland, have taken a step towards more personalised and effective cancer treatments. A new study has identified the conditions under which the antibody drug bexmarilimab can activate the body's own defence system against cancer, and how to identify patients who will benefit from the drug. Bexmarilimab has the ability to “wake up” macrophages, a type of immune cell, to act against cancer. The study found that this activation occurs especially when the tumour microenvironment is immunologically silent. Moreover, in the healthy tissue adjacent to the tumour, bexmarilimab was shown to trigger B cell–mediated immune responses, regardless of how sensitive the neighbouring tumour was to the treatment. This suggests that the drug may have immunological effe…

London, 15 May 2025 – Hikma Pharmaceuticals PLC (Hikma, Group), the multinational pharmaceutical group, is today hosting sell-side analysts and investors at its US manufacturing and R&D facility in Columbus, Ohio. The senior leadership teams from our Generics and Injectables segments will present on their respective businesses, strategies, and plans to deliver long-term, sustainable growth. Attendees will tour the Group's state-of-the-art, 1,000,000 sq. ft. facility in Columbus, which produces oral, respiratory and other generic and specialty products. It is one of Hikma's four US manufacturing facilities producing a broad range of medicines for patients across the US, where Hikma is one of the largest suppliers of generic medicines. Attendees will also tour the Company's newly acquire…

GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD) GSK's acquisition of efimosfermin represents a significant strategic move for GSK in the hepatology space. The promising Phase II data and unique properties of efimosfermin, coupled with the substantial unmet medical need in SLD, position this asset as a potential new standard of care. The acquisition strengthens GSK's pipeline and offers opportunities for both monotherapy and combination approaches, with a potential launch in 2029. This investment underscores GSK's commitment to developing precision interventions for fibrotic liver diseases.

Lundbeck has reported a strong start to 2025, leading the company to raise its full-year financial guidance. This performance is primarily driven by significant growth in its strategic brands, particularly Rexulti® and Vyepti®, across all key geographical regions. The company is also making substantial investments in its R&D pipeline, with key late-stage assets like bexicaserin and amlenetug progressing according to plan. While overall profitability is strong, reflected in increased EBITDA margins, the company is facing higher administrative and R&D costs, as well as increased net financial expenses due to recent acquisition-related debt. Legal proceedings and environmental remediation efforts continue to be managed.

Roche has announced a $50 billion investment in the United States over the next five years, aiming to create over 12,000 jobs. This strategic move is in response to potential tariffs from the Trump administration targeting Swiss pharmaceutical imports. The investment will expand manufacturing and distribution centers in Kentucky, Indiana, New Jersey, and California. New facilities include a gene therapy plant in Pennsylvania, a continuous glucose monitoring site in Indiana, a weight loss drug factory at an undisclosed location, and a cardiovascular, renal, and metabolism research center in Massachusetts. CEO Thomas Schinecker emphasized that this initiative will position Roche to export more medicines from the U.S. than it imports, reinforcing the company's commitment to U.S. innovation an…

Research and development funding has increased: Biopharma funding increased for the second consecutive year in 2024. Total large-pharma R&D spending continued to increase. Clinical trial start volumes have stabilized: Trial starts have fully returned to pre-pandemic levels. Priorities have continued to shift. Clinical program productivity has increased: Improvement in productivity was driven by a success-rate increase in Phase III trials. Cycle times are stabilizing: Enrollment duration – the largest opportunity to improve trial cycle times – stabilized in 2024 after having increased between 2021 and 2023. Inter-trial intervals now typically account for 17 months of total development time across an R&D program; this figure has improved greatly since the 2022 peak of 32 m…

Partnership bolsters Boehringer’s autoimmune and inflammatory disease pipeline portfolio aiming to tackle areas of high unmet patient need. The agreement focuses on further research and development of a novel, first-in-class bispecific compound for T cell mediated targeted depletion of specific B cells to address autoimmune and inflammatory diseases. The candidate compound has the potential to reach patients with autoimmune diseases earlier in their treatment journey and achieve long-term disease control by reducing targeted B cell populations. Boehringer Ingelheim and Cue Biopharma, Inc. (Nasdaq: CUE) today announced a strategic research collaboration and license agreement to develop and commercialize Cue Biopharma’s CUE-501 product candidate, a differentiated B cell depletion therap…

Russell Abberley, Vice President and General Manager of Amgen UK and Ireland, has been confirmed as ABPI President-elect, having held the role on an interim basis. He will formally take up the Presidency on 13 May for a period of two years. Russell will lead the ABPI in its mission to make the UK the best place in the world to research, develop and launch the medicines and vaccines of the future. His immediate focus will remain on delivering a thriving UK life sciences ecosystem, where patients can access innovative medicines and vaccines and where the right conditions exist to attract global investment. He takes on the role at a pivotal moment, ahead of the publication of the NHS 10-Year Plan and the Life Sciences Sector Plan confident in the role that industry can play in delivering on t…