Latest Pharma and Biotech News
Biotechnology
31 July 2025 Moderna has secured European clearance for its latest version of Spikevax (elasomeran) for individuals aged six months and older, after a positive recommendation from the European Medicines Agency's scientific panel.
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Biotechnology
US biotech BioMarin Pharmaceutical has presented new five-year data from its pivotal Phase III trial of Roctavian (valoctocogene roxaparvovec), showing sustained bleed control and a stable safety profile for adults with severe hemophilia A. 25 June 2025
Pharmaceutical
Nuvalent, a US biopharma developing precisely targeted therapies for clinically-proven kinase targets in cancer, has announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). 24 June 2025
Pharmaceutical
Sciwind Biosciences has shared late-stage trial data for its injectable GLP-1 therapy, signaling Chinese firms’ intensifying bid to challenge incumbents like Eli Lilly and Novo Nordisk in the global obesity drug market. 24 June 2025
Biotechnology
Revolution Medicines, a Californian oncology specialist developing targeted therapies for RAS-addicted cancers, has partnered with Royalty Pharma on $2 billion in flexible funding to support the former company’s independent global development and commercialization strategy and operations. 24 June 2025
Biotechnology
US biotech Nektar Therapeutics experienced a remarkable 130% increase in its share price, which reached $21.9, as it reported the successful outcome of a study related to atopic dermatitis. 24 June 2025
Pharmaceutical
See-sawing global tariffs, a US regulator in flux and a possible end to US drug price premia are not, apparently, enough to stymie pharmaceutical industry growth. 24 June 2025
Biotechnology
New York-based Formation Bio, an AI-native pharma company focused on accelerating drug development, revealed that its subsidiary Libertas Bio has licensed gusacitinib to Sanofi, expanding the partnership between the companies. 24 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan or Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. 24 June 2025
Generics
The revision of the European pharmaceutical legislation, the reform of the Supplementary Protection Certificate (SPC) system and the review of the SPC manufacturing waiver are now fundamental reforms to stimulate a strong off-patent pharmaceutical industry in Europe whose medicines account for the vast majority of those dispensed in Europe, trade group Medicines for Europe announced today. 24 June 2025
Biotechnology
Swiss pharma giant Roche has announced positive Phase I/II data on NXT007 in people with hemophilia A, supporting its progression into Phase III clinical development. 24 June 2025
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk yesterday announced that it will no longer be working with Hims & Hers Health on direct access to its blockbuster obesity drug Wegovy (semaglutide) that will no longer be available to Hims & Hers Health via NovoCare Pharmacy. 24 June 2025
Biotechnology
AI precision-medicine company Sonrai Analytics and German biotech Plectonic Biotech have entered a partnership to accelerate the development of next-generation immunotherapies using Plectonic’s LOGIBODY platform. 24 June 2025
Pharmaceutical
Obesity late-comer Amgen announced full results from Part 1 of the Phase II study of MariTide (maridebart cafraglutide, formerly AMG 133), a long-acting, peptide-antibody conjugate subcutaneously administered monthly or less frequently. 24 June 2025
Biotechnology
Licensing of innovator oligonucleotide drugs for central nervous system (CNS) indications surged 339% in 2024, jumping from $640 million to $2.81 billion, according to research from GlobalData. 24 June 2025
Biotechnology
New Jersey, USA-based clinical-stage biotech OnCusp Therapeutics has announced the appointment of Dr Dimitry Nuyten as chief medical officer (CMO). 24 June 2025
Pharmaceutical
Cidara Therapeutics, a US biotech leveraging its Cloudbreak platform for next‑generation antivirals, saw its stock more than double after announcing positive Phase IIb NAVIGATE results for its once‑per‑season influenza prevention therapy, CD388. 24 June 2025
Biotechnology
European biotech argenx has secured European Commission approval for Vyvgart (efgartigimod alfa) in chronic inflammatory demyelinating polyneuropathy (CIDP), marking the first regulatory green light for a novel mechanism in this condition in over three decades. 23 June 2025
Pharmaceutical
US pharma major Eli Lilly spotlighted new safety and efficacy data for its investigational oral GLP-1 therapy orforglipron at the American Diabetes Association meeting, revealing no liver toxicity and further bolstering its position in the growing diabetes and obesity treatment market. 23 June 2025
Biotechnology
Psychedelic medicines company Compass Pathways was trading 46% lower midday Monday. 23 June 2025
Biotechnology
Philadelphia, USA-based Medicus Pharma today announced the appointment of Andrew Smith as chief operating officer (COO). 23 June 2025
All news
Biotechnology
US mRNA specialist Moderna has announced that the UK Court of Appeal has upheld the validity of its EP'949 patent. 1 August 2025
Biotechnology
US Biotech Regeneron Pharmaceuticals today announced financial results for the second quarter of 2025 and provided a business update.
Revenue grew by 4% year-over-year to $3.68 billion, outpacing forecasts of $3.30 billion. 1 August 2025
Biotechnology
US biotech major Biogen reported a 7% rise in its second quarter revenue Friday, with sales of $2.45 billion. 1 August 2025
Pharmaceutical
For the first time in decades, the pharmaceutical industry has been directly affected by a geopolitical trade negotiation between the USA and the European Union. 1 August 2025
Biotechnology
US mRNA specialist Moderna has today reported financial results and provided business updates for the second quarter of 2025, sending the firm’s shares down almost 6% to $27.71 in pre-market trading. 1 August 2025
Pharmaceutical
US President Donald Trump has sent letters to leading pharmaceutical manufacturers outlining the steps they must take to bring down the prices of prescription drugs in the USA to match the lowest price offered in other developed nations. 1 August 2025
Biotechnology
Frazier Life Sciences (FLS), a US investment firm focused on innovative therapeutics, has announced the closing of its Frazier Life Sciences XII fund, with more than $1.3 billion in capital commitments. 1 August 2025
Biotechnology
CSL Behring, a part of Australia’s’ CSL Limited, today announced that the board of directors of the Italian Medicines Agency (AIFA) has approved reimbursement of Hemgenix (etranacogene dezaparvovec). 1 August 2025
Pharmaceutical
US pharma major Eli Lilly has announced top-line results from SURPASS-CVOT, a first-of-its-kind head-to-head Phase III cardiovascular outcomes trial comparing two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. 1 August 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. 1 August 2025
Pharmaceutical
Esteve CDMO (Esteve Química) - part of privately-held Spanish drugmaker Lab Esteve - has acquired Regis Technologies, a USA-based contract development and manufacturing organization (CDMO) headquartered in Chicago. 1 August 2025
Generics
Second quarter 2025 revenues at Teva Pharmaceutical Industries came in at $4.18 billion, flat in US dollars, or a decrease of 1% in local currency terms, compared to the same period of 2024. 31 July 2025
Pharmaceutical
Shares of Spanish plasma-derived medicines specialist Grifols rose 9% yesterday after it announced results for the first half of 2025, driven by a second quarter marked by continued improvements across key operational and financial metrics. These results reflect the ongoing execution of Grifols’ Value Creation Plan. 31 July 2025
Pharmaceutical
Bristol Myers Squibb has posted better-than-expected second-quarter 2025 results, driven by strong sales of its blood thinner Eliquis (apixaban) and cancer treatments Opdivo (nivolumab) and Revlimid (lenalidomide). 31 July 2025
Pharmaceutical
The US Food and Drug Administration has set prescription drug user fee rates for fiscal year 2026, with increases across all key categories under the Prescription Drug User Fee Act (PDUFA) VII. 31 July 2025
Pharmaceutical
Endometriosis remains a complex challenge for patients and drug developers, with GlobalData highlighting five major gaps holding back progress in the field. Limited disease awareness, diagnostic delays, and a lack of safe long-term treatment options continue to define the therapeutic landscape. 31 July 2025
Pharmaceutical
Shares in French pharma major Sanofi were 6% lower late Thursday after the presentation of the company’s second quarter financial results and latest guidance. 31 July 2025
Pharmaceutical
Shares of US pharma major AbbVie were up 6.1% at $200.96 in pre-market activity, as it announced second-quarter 2025 financial results. 31 July 2025
Biotechnology
The hidradenitis suppurativa (HS) market across the seven major pharmaceutical markets (7MM) is projected to grow from $1.84 billion in 2024 to $7.83 billion in 2034, registering a compound annual growth rate (CAGR) of 15.6%. 31 July 2025
Biotechnology
Japan’s Eisai and US biotech major Biogen have announced that the latest findings demonstrating the benefits of continuous treatment with Leqembi (lecanemab-irmb), an anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer's disease (AD) 31 July 2025
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