Latest Pharma and Biotech News
Pharmaceutical
28 July 2025 For millions in low- and middle-income countries (LMICs), lifesaving medicines remain out of reach. While the pharmaceutical industry continues to deliver record-breaking innovation, access to those breakthroughs is often determined by cruel lotteries of geography and income.
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Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has entered a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group. 13 June 2025
Biotechnology
US immunology specialist Celldex was trading 5% higher midday Friday, following on from 10% gains on Thursday. 13 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Pharmaceutical
Germany’s Merck KGaA has presented detailed results from cohort B of the global Phase II WILLOW study of enpatoran, an investigational, oral, novel TLR7/8 inhibitor in systemic lupus erythematosus (SLE). 13 June 2025
Pharmaceutical
Symbiosis Pharmaceutical Services (Symbiosis), a global contract manufacturing organization (CMO) specializing in sterile manufacture of injectable drug products, has appointed Angelika Rublack as senior business development manager to support its expanding global client base and drive growth across several territories. 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Pharmaceutical
UK pharma major GSK today revealed that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to India’s Bharat Biotech International (BBIL). 13 June 2025
Pharmaceutical
Novo Nordisk late Thursday announced that it will advance subcutaneous (SC) and oral amycretin into Phase III development in weight management based on completed clinical studies and feedback received from regulatory authorities. 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Biotechnology
Belgium’s largest drugmaker UCB has announced plans for a significant investment in a new, state-of-the-art biologics manufacturing facility in the USA. 13 June 2025
Pharmaceutical
The Russian pharmaceutical market is showing positive dynamics these days, despite the ever-tightening sanctions regime and the growing isolation of Russia in the international arena, reports The Pharma Letter’s local correspondent. 13 June 2025
Pharmaceutical
Novartis has unveiled further data for Fabhalta (iptacopan), reinforcing its position in the paroxysmal nocturnal hemoglobinuria (PNH) market and adding momentum to the oral drug’s expanding presence across rare blood and kidney disorders. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Biotechnology
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Biotechnology
Sino-American oncology company BeOne Medicines is presenting new clinical data from cornerstone hematology assets at the European Hematology Association (EHA) Congress. 12 June 2025
Pharmaceutical
Research services company IQVIA has unveiled new AI agents built using NVIDIA technology that are designed to enhance workflows and accelerate insights for life sciences. 12 June 2025
Pharmaceutical
Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced new data from the pivotal AUGMENT-101 trial of Revuforj (revumenib), the company’s first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML). 12 June 2025
Biotechnology
US antivirals specialist Gilead Sciences’ Kite, unit today presented the latest results that demonstrate a 79% overall response rate (ORR) and 74% overall survival (OS) at six months follow-up, for Yescarta (axicabtagene ciloleucel) as second-line treatment for relapsed/refractory (R/R) large B-cell lymphoma (LBCL), from the largest real-world study in this patient population. 12 June 2025
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Pharmaceutical
A new real-world analysis from UK drugmaker Indivior suggests that patients with opioid use disorder (OUD) treated with its once-monthly injectable buprenorphine formulation, BUP-XR, made significantly fewer emergency department visits than those who received no medication-assisted treatment. 29 July 2025
Pharmaceutical
A major US trial has found that structured healthy lifestyle programs can slow memory loss in older adults, regardless of their genetic risk for Alzheimer’s. The findings were released at the Alzheimer’s Association International Conference (AAIC). 29 July 2025
Biotechnology
ReAlta Life Sciences, a US biopharma seeking to address life-threatening rare and acute inflammatory diseases by rebalancing the inflammatory response, has announced the appointment of Ellen Lubman as chief business officer (CBO). 29 July 2025
Biotechnology
Privately-held Italian pharma company Alfasigma has announced positive topline results from the OLINGUITO Phase III trial of filgotinib in active axial spondyloarthritis (axSpA). 29 July 2025
Pharmaceutical
Eli Lilly today announced positive top-line results from the Phase III BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). 29 July 2025
Pharmaceutical
Denmark’s diabetes and obesity giant Novo Nordisk saw its shares plummet more than 27% to 328.20 kroner this morning as it announced sales and operating profit growth at constant exchange rates (CER) for the first six months of 2025 and updated full-year sales and operating profit outlook at CER. 29 July 2025
Pharmaceutical
Novo Nordisk today announced that Maziar Mike Doustdar has been appointed as president and chief executive officer, effective August 7, 2025. Mr Doustdar succeeds Lars Fruergaard Jørgensen, who will step down as president and chief executive officer on the same date. The company also announced other executive-level changes, effective August 7. 29 July 2025
Pharmaceutical
US pharma giant Merck & Co was trading 4% lower in pre-market Tuesday after the group presented its second quarter 2025 financial results and guidance for the rest of the year. 29 July 2025
Generics
Russia is currently experiencing a strong increase in the sales of drugs against alcoholism, as the number of citizens, who suffer from alcohol addiction has significantly increased since 2022, reports The Pharma Letter’s local correspondent. 29 July 2025
Biotechnology
US pharma major Bristol Myers Squibb and Bain Capital announced the creation of a new independent biopharmaceutical company (NewCo) focused on developing new therapies for autoimmune diseases that address significant unmet needs of patients. 29 July 2025
Pharmaceutical
Family-owned Boehringer Ingelheim, now Germany’s largest drugmaker by revenue, has reported positive growth in the first half of 2025, with group net sales growing by 6.3% to 14.0 billion euros ($14.7 billion). 29 July 2025
Pharmaceutical
California’s MapLight Therapeutics has announced an oversubscribed $372.5 million Series D financing. 29 July 2025
Biotechnology
US biotech PTC Therapeutics’ shares trading up 4.8% to $46.48 in after-hours activity yesterday, as it announced that the US Food and Drug Administration (FDA) has approved Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). 29 July 2025
Pharmaceutical
AstraZeneca posted a robust second-quarter 2025 performance, lifted by record growth in its US business and solid momentum across its key therapy areas.
The UK pharma major reported revenue of $14.5 billion for the three months to June 30, up 12% from a year earlier and ahead of analysts’ forecasts. Pre-tax profit climbed 30% to $3.1 billion, while earnings per share rose 27% to $1.58. 29 July 2025
Biotechnology
The US Food & Drug Administration (FDA) has approved Danish biotech Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. 29 July 2025
Biotechnology
Sarepta Therapeutics has been cleared by the American medicines regulator to resume shipments of its gene therapy Elevidys (delandistrogene moxeparvovec-rokl) for ambulatory patients with Duchenne muscular dystrophy (DMD). 29 July 2025
Pharmaceutical
As many as 19 of the top 20 publicly-traded global biopharma companies reported revenue growth in 2024, with an overall 7.9% year-on-year (YoY) increase in aggregate revenue to $880.4 billion, reveals GlobalData. 29 July 2025
Pharmaceutical
Shares in CervoMed were up 6% Monday lunchtime after the US company announced positive 32-week data from the extension phase of the Phase IIb RewinD-LB trial showing that oral neflamapimod continues to slow disease progression and demonstrate an effect on a plasma marker of neurodegeneration in dementia with Lewy bodies (DLB). 28 July 2025
Pharmaceutical
Danish vaccine maker Bavarian Nordic today revealed that it has entered into an agreement to be acquired by a newly formed company controlled by Nordic Capital Fund XI and funds managed and advised by Permira Beteiligungsberatung GmbH, pursuant to which the offeror will make an all-cash recommended voluntary public takeover offer to acquire all issued and outstanding shares (excluding treasury shares) in Bavarian Nordic. 28 July 2025
Pharmaceutical
US clinical-stage oncology focused biotech Celcuity saw its shares skyrocket 180% to $38.59 in early trading as it announced positive trial data for its lead candidate gedatolisib. 28 July 2025
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