Latest Pharma and Biotech News
Biotechnology
5 October 2026 Shares of Vaxcyte, a US clinical-stage vaccine innovation company, rocketed as much as 90% in pre-market activity today announced positive top-line results from the OPUS-1 pivotal adult Phase III trial evaluating the safety, tolerability and immunogenicity of VAX-31.
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Pharmaceutical
US pharma major Eli Lilly has expanded its partnership with US biotech company Gate Bioscience to develop oral medicines that eliminate disease-causing proteins, adding one target and an option to select a second. 6 October 2026
Pharmaceutical
An Expert View from Joel Stanley, CEO of AJNA BioSciences, a company developing botanical medicines from cannabis and psilocybin. 5 October 2026
Biotechnology
Australia’s CSL Limited and Swiss clinical-stage biotech Alentis Therapeutics today announced an exclusive global collaboration agreement to co-develop and co-promote lixudebart, which has the potential to become a first-in-class therapy targeting claudin-1 across a range of kidney, liver and other diseases. 5 October 2026
Biotechnology
US biotech Alector’s shares leapt more than 60% to $2.90 in pre-market activity today, on the news that it has entered into an exclusive global licensing agreement with Genentech, a Roche subsidiary. 5 October 2026
Biotechnology
Shares of Vaxcyte, a US clinical-stage vaccine innovation company, rocketed as much as 90% in pre-market activity today announced positive top-line results from the OPUS-1 pivotal adult Phase III trial evaluating the safety, tolerability and immunogenicity of VAX-31. 5 October 2026
Pharmaceutical
Danish pharma major Novo has reported results from REVEAL-1, which it describes as the largest UK real-world study of Wegovy (semaglutide injection) to date, covering 231,442 adults who started treatment through the private telehealth obesity provider MedExpress between May 2024 and January 2026. 5 October 2026
Biotechnology
Jiangsu Nhwa Pharmaceutical, the Chinese CNS-focused pharma company, has granted newly-formed US biotech Somnivera exclusive rights to develop, manufacture and commercialize a clinical-stage sleep disorder drug candidate outside Greater China, in a deal worth up to $517.5 million. 5 October 2026
Pharmaceutical
BioMarin Pharmaceutical announced new data evaluating the efficacy and safety of Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) in late-onset Pompe disease (LOPD) were presented at the 31st Annual Congress of the World Muscle Society (WMS), in Hiroshima, Japan. 5 October 2026
Biotechnology
On Saturday, Danish biotech Genmab announced results from Part C of the Phase I/II RAINFOL-01 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC). 5 October 2026
Pharmaceutical
Patients taking part in a clinical trial may be able to have blood drawn at home, speak to the study doctor by video and receive their medicine without visiting a hospital. These arrangements can reduce travel and make participation easier for people who live far from research centers. 5 October 2026
Pharmaceutical
Safety notices, revised product information and recalls accounted for much of the regulatory activity affecting human medicines between September 26 and October 5, 2026. Authorities in the USA, Europe, Japan, Switzerland and Australia also announced approvals, enforcement measures and changes to regulatory procedures, although new product decisions were less prominent. 5 October 2026
Pharmaceutical
Chinese drugmaker Hansoh Pharmaceutical plans to resubmit its lung cancer drug Aumseqa (aumolertinib) for European approval after its marketing authorization was revoked following a dispute over protected clinical data belonging to Anglo-Swedish pharma major AstraZeneca. 5 October 2026
Pharmaceutical
When a treatment moves from a clinical trial to the real-world post-marketing environment, the increased number of variables can lead to new or rare adverse events. Post-marketing pharmacovigilance (PV) is essential to manage patient safety and meet regulatory requirements. This phase also offers new insights into product safety in a broader patient population. 5 October 2026
Biotechnology
Pfizer has presented results from two Phase III trials evaluating the efficacy and safety of Litfulo (ritlecitinib) as a once-daily oral treatment across a wide range of disease extent. 5 October 2026
Biotechnology
Swedish immuno-oncology firm Alligator Bioscience has announced the appointment of Johan Giléus as Alligator’s new chief executive (CEO), effective 1 January 2027. 5 October 2026
Biotechnology
Significant research news last week included Mirum Pharmaceuticals releasing positive Phase III data for its hepatitis delta antibody brelovitug and Merck & Co Phase III results for its tulisokibart in hidradenitis suppurativa. Also of note, UK pharma major AstraZeneca said it will invest $2 billion in US biotech Summit Therapeutics, and France’s Sanofi announced an expanded global alliance with Regeneron in next-generation antibodies. 4 October 2026
Pharmaceutical
Germany’s Bayer announced on Friday that it plans to invest $2.2 bill in a new pharmaceutical manufacturing site in New Albany, Ohio, USA, adding to the string of major drugmakers announcing multibillion-dollar US projects in recent months. 3 October 2026
Biotechnology
Privately-held Italian drugmaker Italfarmaco and Japan’s JCR Pharmaceuticals have entered an exclusive license agreement to develop and commercialize JR-141 for the treatment of Hunter syndrome in the USA, Europe, and Latin America, pending regulatory approval. 3 October 2026
Pharmaceutical
The US Food and Drug Administration (FDA) approved Camzyos (mavacamten), from Bristol Myers Squibb for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms in adults and pediatric patients weighing 30 kg (66 lbs) or more. 2 October 2026
Pharmaceutical
US pharma major Johnson & Johnson has made no secret of its ambition to lead the oncology field. The Pharma Letter put that ambition to the company's own discovery leadership during a media site visit to J&J's Beerse campus in Belgium on September 29, 2026 — the company's largest R&D and supply chain site in Europe, and historically the home of Janssen Pharmaceutica, founded by Paul Janssen in the 1950s. 2 October 2026
All news
Biotechnology
Recipharm, the contract development and manufacturing organization (CDMO), and CanVirex, the biotech developing oncolytic virus immunotherapies, have signed a process development collaboration to scale up manufacturing of CanVirex's Vero cell/measles virus platform, supporting future clinical studies and long-term commercial production. 24 September 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved Elevar Therapeutics’ Lyrfigtu (lirafugratinib), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. 24 September 2026
Biotechnology
Flagship Pioneering, the US biotech venture creation company, has been awarded a contract worth up to $47 million over five years by the Department of War (DoW) under its ONTARGET program, to advance next-generation medical countermeasure technologies against biological threats, with initial projects run through two of its portfolio companies, Apriori Bio and Prologue Medicines. 24 September 2026
Biotechnology
Swiss clinical-stage biopharma AC Immune has announced positive safety and immunogenicity results through week-100 in Part 1 of VacSYn, its randomized, double-blind, placebo-controlled Phase II trial of ACI-7104 in patients with early-stage Parkinson’s disease (PD). 24 September 2026
Pharmaceutical
The global pharmaceutical industry has long grappled with the administrative weight of manufacturing changes. Before recent harmonization efforts, a single process optimization could trigger divergent regulatory demands worldwide. This fragmented landscape meant companies often hesitated to implement scientifically justified improvements, fearing unpredictable regulatory feedback. 24 September 2026
Pharmaceutical
Taiwanese biotech company Caliway Biopharmaceuticals has reported positive Phase II results for CBL-514, its investigational therapy for Dercum’s disease. The mid-stage trial met its primary and secondary endpoints, demonstrating clinically meaningful pain reduction in patients with this rare and chronic condition. 24 September 2026
Generics
UK-based generics and injectables major Hikma Pharmaceuticals has announced the appointment of Rebecca Hall as its new chief financial officer and executive director. Ms Hall is expected to officially join the leadership team in the first quarter of 2027, bringing extensive global pharmaceutical experience to the role. 24 September 2026
Pharmaceutical
South Korea’s Ministry of Food and Drug Safety has approved recoflavone (Latica/Recodu) for moderate to severe dry eye disease. 24 September 2026
Biotechnology
Enveda, the US biotech that uses AI to discover medicines from natural chemistry, has closed a $311 million Series E financing led by Catalio Capital Management, bringing its total capital raised since inception to more than $845 million. 23 September 2026
Biotechnology
Basecamp Research, the UK-headquartered AI company developing AI-designed medicines, has raised $140 million in an oversubscribed Series C financing to train a new generation of its EDEN foundation models and advance a pipeline of AI-designed therapeutics toward clinical development, starting with in vivo cell therapy. 23 September 2026
Biotechnology
Johnson & Johnson today announced new data from the Phase III MajesTEC-3 study showing sustained disease control and survival with Tecvayli (teclistamab) plus daratumumab in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. 23 September 2026
Pharmaceutical
Sydnexis, the US biopharma developing treatments for pediatric progressive myopia (PPM), has agreed to sell its royalty rights on net sales of Ryjunea (low-dose atropine 0.1 mg/ml) in Europe, the Middle East and Africa to Ligand Pharmaceuticals for a $23 million upfront payment. 23 September 2026
Pharmaceutical
UK pharma major AstraZeneca today revealed that its ’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate or BGF (320/28.8/10μg)) has been approved in the European Union (EU). 23 September 2026
Biotechnology
UK biotech Engitix, which is pioneering extracellular matrix (ECM)-driven drug discovery, today announced the appointment of Dr Sonia Quaratino in the newly created role of executive vice president, chief medical officer (CMO). 23 September 2026
Pharmaceutical
The Latin American Federation of the Pharmaceutical Industry (FIFARMA) announced its adhesion to the Alliance for the Elimination of HIV in the Americas, an initiative of the Pan American Health Organization (PAHO) presented during the 26th International AIDS Conference (AIDS 2026). 23 September 2026
Biotechnology
Roivant today announced top-line results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE). 23 September 2026
Pharmaceutical
US biopharma Viking Therapeutics has reported positive topline results from a maintenance dosing study of VK2735, its dual GLP-1/GIP receptor agonist, showing that less frequent dosing regimens preserved most of the weight loss achieved during an initial induction phase. 23 September 2026
Pharmaceutical
Swiss pharma giant Roche US subsidiary Genentech has announced positive prespecified interim results from the ongoing Phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN). 23 September 2026
Pharmaceutical
US biopharma Vertex Pharmaceuticals reported positive results from its Phase IIb AMPLIFIED study of inaxaplin in additional populations of people with APOL1-mediated kidney disease (AMKD), and said it has completed enrollment in the pivotal Phase II/III AMPLITUDE trial of the same candidate. 23 September 2026
Biosimilars
Contract development and manufacturing organizations (CDMOs) are ramping up their active pharmaceutical ingredient (API) investments in Europe. 23 September 2026
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