Latest Pharma and Biotech News
Pharmaceutical
2 April 2025 Freed from their former obligations to remain loyal to agency and state, a number of high-profile figures from the US Food and Drug Administration (FDA) have sounded the alarm about its direction of travel under Robert Francis Kennedy Jr (RFK Jr), the new Secretary of Health and Human Services.
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Biotechnology
CordenPharma has unveiled plans for a strategic investment exceeding 1 billion euros ($1.1 billion) to enhance its peptide development and manufacturing capabilities. 6 March 2025
Biotechnology
Israel-based Pluri, a biotech using its platform for cell-based solutions to create a collaborative network of ventures, was trading 4% higher Wednesday lunchtime. 5 March 2025
Biotechnology
UK-based Trimtech Therapeutics, a biotech harnessing targeted protein degradation (TPD) for neurodegenerative diseases, has announced the closing of its $31 million seed funding round. 5 March 2025
Pharmaceutical
Ireland-headquartered Jazz Pharmaceuticals has entered into a definitive agreement to acquire US biopharma company Chimerix for $8.55 per share in cash, representing a total consideration of around $935 million. The news sent Chimerix’ shares rocketing almost 70% to $8.40. 5 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis submitted by Swiss pharma giant Roche. 5 March 2025
Biotechnology
The board of directors at immunology-focused biopharma Acelyrin has found that an unsolicited takeover bid from Concentra Biosciences is an inferior proposal to the planned merger with Alumis. 5 March 2025
Pharmaceutical
Pliant Therapeutics has scrapped its Phase IIb Beacon-IPF trial for bexotegrast in idiopathic pulmonary fibrosis (IPF), after data monitors noted higher adverse events for the treatment group. 5 March 2025
Pharmaceutical
The Department of Government Efficiency (DOGE), led by Tesla chief executive Elon Musk, has terminated leases for 30 US Food and Drug Administration facilities across the USA. 5 March 2025
Biotechnology
IN8bio has unveiled a new T cell engager (TCE) platform, marking its first major push into autoimmune disease. 5 March 2025
Pharmaceutical
German life science giant Bayer has reported 2024 group revenue of 47.6 billion euros ($51.5 billion), down 2.2% from the previous year. Core earnings per share fell 21% to 5.05 euros, while EBITDA before special items declined 13.5% to 10.1 billion euros. 5 March 2025
Pharmaceutical
The combined use of two well-known active substances can fight leukemic cells and limit their spread. This is the result of a study conducted by the Karl Landsteiner University of Health Sciences (KL Krems) and recently published in the journal Cancer Letters. 5 March 2025
Pharmaceutical
Leading pharmaceutical associations in Russia have called on the government to postpone the introduction of new procurement rules that will give preference to drugs completely produced in Russia in state tenders. 5 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). 5 March 2025
Biosimilars
Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). 5 March 2025
Biotechnology
San Francisco-based 3T Biosciences, an immunotherapy company in the field of solid tumors and other immune-mediated diseases, has announced the promotion of Marvin Gee to chief research officer and the appointment of Barbara Sennino as senior vice president and head of early development. 4 March 2025
Pharmaceutical
Russia plans to increase procurements of drugs against rare diseases despite the current tough business environment and maintaining sanctions pressure, reports The Pharma Letter’s local correspondent. 4 March 2025
Generics
Czech Republic-based Zentiva Pharma, a generics and over-the-counter medicines company that is wholly-owned by private equity firm Advent International and was formerly a subsidiary of Sanofi , has announced a major UK launch. 4 March 2025
Biosimilars
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s Prolia and Xgeva brands respectively for all indications of the reference products. 4 March 2025
Biotechnology
Privately-held Cambridge, USA-based biotech Gensaic announced a potentially lucrative license and discovery collaboration with Denmark’s Novo Nordisk . 4 March 2025
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published a special report on chronic obstructive pulmonary disease (COPD) therapies as part of the Centers for Medicare & Medicaid Services (CMS) public comment process on Medicare drug price negotiations. 4 March 2025
All news
Pharmaceutical
US pharma major Eli Lilly’s brand value has surged by 108% since entering the weight loss market in 2023, according to a new report from Brand Finance. 3 April 2025
Biotechnology
US biotech BioMarin Pharmaceutical yesterday revealed that the Phase III PEGASUS trial evaluating Palynziq (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically-significant lowering in blood phenylalanine( Phe) levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone. 3 April 2025
Biotechnology
Sino-American biotech BeiGene today revealed it intends to discontinue its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. 3 April 2025
Biotechnology
Australian biotech major CSL Limited subsidiary CSL Behring today announced that it has successfully concluded negotiations in Germany with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) resulting in national reimbursement of Hemgenix (etranacogene dezaparvovec). 3 April 2025
Pharmaceutical
Colorado, USA-based Edgewise Therapeutics, a muscle disease-focused biopharma company, closed 23% lower after Wednesday’s trading. 3 April 2025
Pharmaceutical
With two new lawsuits, Eli Lilly has escalated its legal campaign against the makers of unauthorized versions of its diabetes and weight-loss drugs, Mounjaro (tirzepatide) and Zepbound (tirzepatide), challenging inroads made by drug compounders in what has become a highly lucrative market. 3 April 2025
Generics
US generic manufacturer Padagis has received clearance to extend the shelf life of its over-the-counter naloxone nasal spray to 36 months, as the company looks to bolster value and accessibility in a crowded but critical public health market. 3 April 2025
Pharmaceutical
Pharmaceuticals will be exempt from the tariffs on imports to the USA that were announced by US President Donald Trump Wednesday, according to a White House fact sheet. 3 April 2025
Pharmaceutical
Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. 3 April 2025
Biotechnology
US clinical-stage biotech Nurix Therapeutics announced that Sanofi has exclusively licensed an undisclosed Nurix program targeting a previously undruggable transcription factor for autoimmune diseases. 3 April 2025
Biotechnology
North Carolina, USA-based clinical-stage gene therapy company Atsena Therapeutics has announced the successful closing of an oversubscribed $150 million Series C financing. 3 April 2025
Biotechnology
Swiss clinical-stage biotech AC Immune’s shares closed up 5.9% at $1.90 yesterday, after it announced additional interim safety and positive immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson’s disease (PD). 3 April 2025
Biotechnology
The European Medicines Agency has temporarily suspended enrollment and dosing in a Phase II trial of Sarepta Therapeutics' gene therapy, Elevidys (delandistrogene moxeparvovec-rokl), for Duchenne muscular dystrophy (DMD). 3 April 2025
Pharmaceutical
CNS specialist Axsome Therapeutics has announced results from the PARADIGM Phase III proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS). 3 April 2025
Biotechnology
Swiss pharma major Roche said a higher-dose version of its top-selling multiple sclerosis drug Ocrevus (ocrelizumab) failed to deliver additional benefit in slowing disability progression, compared to the currently approved dose, in a Phase III trial. 3 April 2025
Biotechnology
US biotech Inhibrx Biosciences has announced a leadership shake-up following the departure of co-founder Brendan Eckelman, who is leaving to establish a new privately-held biotech company. 2 April 2025
Biotechnology
Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi, has announced that the National Institute for Health and Care Excellence (NICE) has issued its final guidance in England and Wales recommending the use of Altuvoct (efanesoctocog alfa). 2 April 2025
Biotechnology
US biotech Artis BioSolutions has officially launched with the acquisition of Landmark Bio, a translational development and manufacturing group formed through an alliance of academic and industry stakeholders. 2 April 2025
Biotechnology
The UK’s health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended brentuximab vedotin in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with untreated stage 3 or 4 CD30+ Hodgkin lymphoma (HL), within final draft guidance (FDG). 2 April 2025
Generics
German tech conglomerate Siemens has signed an agreement with Miko Pharma to develop facilities for the local production of generic pharmaceuticals in Ghana. 2 April 2025
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