Latest Pharma and Biotech News
Biotechnology
3 July 2025 The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody.
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Pharmaceutical
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. 4 July 2025
Pharmaceutical
Theratechnologies, a Canada-based biopharma, is to be acquired by CB Biotechnology, an affiliate of Future Pak, a privately-held contract manufacturer, packager and distributor of pharmaceutical and nutraceutical products. 4 July 2025
Pharmaceutical
Chinese biotech Brii Biosciences has licensed its experimental antibiotic BRII-693 to domestic pharma business Joincare Group for development and commercialization in China, as part of a technology transfer and exclusive licensing agreement announced on Wednesday. 4 July 2025
Pharmaceutical
US pharma major Eli Lilly today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase III clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. 4 July 2025
Pharmaceutical
Pharmaceutical companies are heading toward a steep patent cliff that could strip more than $230 billion in US drug sales between 2025 and 2030, according to a new report from analytics firm GlobalData. The industry is preparing for a wave of revenue loss as leading drugs lose exclusivity and face generic and biosimilar competition. 4 July 2025
Pharmaceutical
A new company is responsible for Japanese promotional activities for Actair, Stallergenes Greer’s sublingual immunotherapy tablet for the treatment of patients suffering from house dust mite induced allergic rhinitis. 4 July 2025
Pharmaceutical
Multinational pharmaceutical companies (MNCs) are facing significant challenges in China's vaccine market, as regulatory scrutiny, domestic competition, and changing consumer behaviors disrupt a once-thriving sector. 4 July 2025
Pharmaceutical
In the high-stakes world of drug development, a pill is never just a pill. Every oral drug that reaches the market has passed through a tightly managed series of steps—none more critical, or more vulnerable, than tech transfer. 4 July 2025
Pharmaceutical
A new European Commission strategy promises to lift life sciences in the region out of a two-decade slump by tackling regulatory barriers, boosting clinical trials and supporting biotech innovation. The plan was unveiled in Brussels on July 2 and is being described by industry as a long-overdue course correction. 3 July 2025
Pharmaceutical
The UK government today launched its 10 Year Health Plan for the National Health Service (NHS), promising a "new era." A new network of neighborhood health hubs will be set up to shift care out of hospitals and into the community. 3 July 2025
Pharmaceutical
US-Japan venture capital firm AN Venture Partners has wrapped up its first fund at $200 million, marking one of the largest biotech funds focused on Japan to date. The new vehicle, called AN Venture Partners I, is backed by over 20 limited partners, including Japanese drugmakers Shionogi and Otsuka Pharmaceutical. 3 July 2025
Pharmaceutical
US women’s health focused drugmaker Organon yesterday revealed disappointing results from the Phase II ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. 3 July 2025
Pharmaceutical
The chronic kidney disease (CKD) anemia market across the seven major markets (7MM) is forecast to grow at a compound annual growth rate (CAGR) of 1.7% from $4.4 billion in 2024 to $5.3 billion in 2034. 3 July 2025
Pharmaceutical
Australian neurodegenerative diseases specialist Neurizon Therapeutics has agreed an exclusive global license agreement with Elanco Animal Health and affiliates for monepantel, the active pharmaceutical ingredient in NUZ-001. 2 July 2025
Pharmaceutical
A federal judge has blocked the US Department of Health and Human Services from moving forward with a major workforce reduction and agency overhaul, finding that the changes may violate federal law and cause lasting disruption. 2 July 2025
Pharmaceutical
Alnylam Pharmaceuticals has won European Commission approval for Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM), positioning the drug as a likely challenger to entrenched therapies in a market expected to see rapid evolution. 2 July 2025
Pharmaceutical
Mitsubishi Tanabe Pharma Corporation is now under the ownership of US private investment firm Bain Capital Private Equity. 2 July 2025
Pharmaceutical
Artificial Intelligence (AI) is reshaping pharmacovigilance, promising faster detection of safety signals hidden within mountains of adverse event (AE) data. However, as the US Food and Drug Administration (FDA) sharpens its focus on transparency, credibility, and real-world monitoring, the days of relying on opaque algorithms are numbered. In this article, we explore why sponsors and safety teams must rethink their approach to AE prediction to ensure the very tools designed to protect patients don’t become risks themselves. 2 July 2025
Pharmaceutical
Vertex Pharmaceuticals today announced that the European Commission has granted approval for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) ages six years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 1 July 2025
Pharmaceutical
Mental health company atai Life Sciences was trading more than 31% higher during Tuesday morning’s trading in New York. 1 July 2025
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Pharmaceutical
Denmark, oncology-based Pharmacosmos today announced that it has assumed the worldwide rights, excluding select Asia-Pacific territories, to the investigational oncology asset lerociclib. 12 May 2025
Pharmaceutical
US President Donald Trump sent shivers through the pharmaceutical industry as he vowed to dramatically reduce the high drug prices that have long been a feature of the US market. 12 May 2025
Pharmaceutical
US pharma major Eli Lilly announced a significant expansion of its long-standing alliance with Purdue University, with Lilly's planned investment of up to $250 million in the collaboration over the next eight years. 12 May 2025
Pharmaceutical
Shine Technologies, a private nuclear fusion corporation based in Wisconsin, USA, has entered into a definitive agreement to acquire the SPECT business from Lantheus, a radiopharmaceutical-focused company. 12 May 2025
Pharmaceutical
Novo Nordisk today presented data from the Phase III REAL8 basket, which showed that once-weekly Sogroya (somapacitan) was non-inferior to its own once-daily growth hormone Norditropin (somatropin). 12 May 2025
Pharmaceutical
Sylentis, a wholly-owned subsidiary of Spanish drugmaker PharmaMar, announced top-line results from the SYL1801-II study, a Phase IIa dose-ranging trial evaluating SYL1801. 12 May 2025
Pharmaceutical
A sustainable healthcare system requires holistic approaches. However, the counterproposal to the cost-control initiative, which was rejected by the people, demonstrates once again that the Swiss healthcare system is still characterized by silo thinking: Although Parliament deliberately removed separate cost targets for each cost block from the proposal, the Federal Department of Home Affairs (FDH) and Federal Office of Public Health (FOPH) blatantly disregarded this decision and reinstated the silo mentality, according to a posting on the website of Interpharma, the association of the research-based pharmaceutical industry in Switzerland. 12 May 2025
Pharmaceutical
UK-based pharma major AstraZeneca has started construction on a new manufacturing site for small molecule drugs in Wuxi, a city in East China's Jiangsu province, underscoring its deepening investment in the country. 12 May 2025
Pharmaceutical
New figures from European industry group EFPIA paint a stark picture of the growing divide in access to innovative medicines across the EU, with patients in some countries waiting more than seven times longer than others for the same treatment. 12 May 2025
Pharmaceutical
A Feature on M&A, VC investment, licensing and partnerships in the radiopharmaceuticals arena. 9 May 2025
Pharmaceutical
The UK government has announced a trade agreement with the USA. The UK-US Economic Prosperity Deal was agreed on Thursday May 8 with further details released on Friday May 9. 9 May 2025
Pharmaceutical
Oculis Holding reported a net loss of $36 million for the first quarter of 2025, more than double the loss in the same period last year, as the Swiss biopharma stepped up investment in its late-stage pipeline. 9 May 2025
Pharmaceutical
The human immunodeficiency virus (HIV) market across the seven major markets (7MM: the USA, France, Germany, Italy, Spain, the UK and Japan) is forecast to grow at a compound annual growth rate (CAGR) of 1.9% from $26.5 billion in 2023 to $32.1 billion in 2033, pharma analytics company GlobalData forecasts. 9 May 2025
Pharmaceutical
US pharma major Eli Lilly yesterday announced executive leadership transitions that will further enhance the company's ability to drive sustained, long-term growth and ensure that its medicines continue to reach millions of people worldwide. 9 May 2025
Pharmaceutical
UK pharma major AstraZeneca has suffered a setback in its legal fight to block the US government's efforts to lower prescription drug prices, after a federal appeals court dismissed its challenge to Medicare’s negotiation powers. 9 May 2025
Pharmaceutical
UK pharma major GSK has unveiled full Phase III data showing its experimental drug linerixibat significantly reduced itching in people with primary biliary cholangitis (PBC), a rare autoimmune liver disorder. The results were presented at this year’s European Association for the Study of the Liver (EASL) meeting. 9 May 2025
Pharmaceutical
US non-profit the Gates Foundation has pledged to spend more than $200 billion over the next two decades, doubling its giving to date, and bringing forward its planned closure to 2045. The decision marks a seismic shift in the organization’s philanthropic approach. 8 May 2025
Pharmaceutical
Merck KGaA led the way in pharmaceutical M&A in April. The German company announced a $3.9 billion deal to buy the US drug developer SpringWorks Therapeutics in the month's biggest buy, with Swiss firm Novartis the only other established big pharma name to acquire a company, though a host of further deals were done. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
Pharmaceutical
Japanese drugmaker Takeda posted revenue of 4.58 trillion yen ($31.7 billion) for the fiscal year ended March 31, up 7.5% on a reported basis, while core operating profit rose 10% to $8 billion. Earnings per share slipped 26% to $0.45 as net profit fell to $748 million. 8 May 2025
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