The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024
UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024
Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024
Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024
At the 65th American Society of Hematology (ASH) annual meeting, Gilead Sciences company Kite announced results from a three-year follow-up analysis of the ZUMA-12 trial. 12 December 2023
Protek, one of Russia's leading pharmaceutical distributors, will begin the supplies of an Ozempic (semaglutide) generic, originated by Danish diabetes care and obesity giant Novo Nordisk against diabetes mellitus to the Russian market by the end of this year, reports The Pharma Letter’s local correspondent. 12 December 2023
US pharma major Bristol Myers Squibb has announced the results of two early studies evaluating combinations of CELMoD agent golcadomide in non-Hodgkin lymphomas. 12 December 2023
Australian biotech CSL Limited has announced the three-year results from the pivotal HOPE-B study confirming continued long-term durability and safety of Hemgenix (etranacogene dezaparvovec-drlb) following a one-time infusion in people living with hemophilia B. 12 December 2023
Continuing a busy period of dealmaking, pharma major AstraZeneca has confirmed it will buy vaccine specialist Icosavax for around $800 million. 12 December 2023
Adding to the string of companies seeking to expand into the attractive antibody-drug conjugates (ADCs) space, Bristol Myers Squibb has announced an exclusive license and collaboration agreement for US clinical-stage biotech SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific ADC. 12 December 2023
Spanish dermatology specialist Almirall and etherna, a privately-held Belgian mRNA/lipid nanoparticle (LNP) technology platform company, have announced a collaboration. 12 December 2023
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 12 December 2023
The US Federal Trade Commission (FTC) is seeking to block French pharma major Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics therapy in development for treatment of Pompe disease. 12 December 2023
The Institute for Clinical and Economic Review (ICER) has published the report Unsupported Price Increases (UPI) of prescription drugs in the USA. 11 December 2023
Shares of USA-based Skye Bioscience rose 14% to $3.99 by mid-morning, after it revealed its intent to enter the huge and fast-growing obesity treatment sector. 11 December 2023
Cell therapy company AbelZeta Pharma has announced an agreement with AstraZeneca to co-develop a new CAR T-cell therapy in hepatocellular carcinoma (HCC). 11 December 2023
The European Commission (EC) has granted marketing authorization of a new indication Jemperli (dostarlimab), from UK pharma major GSK. 11 December 2023
Privately-held Swiss drugmaker Ferring Pharmaceuticals and Zürich-based microbiome translation company PharmaBiome have announced a research and development collaboration to drive forward new microbiome-based biotherapeutics in the field of gastroenterology. 11 December 2023
The Johnson & Johnson subsidiary Janssen has presented new long-term follow-up data at the 2023 American Society of Hematology (ASH) Annual Meeting from the Phase III GLOW and Phase II CAPTIVATE studies of first-line, fixed-duration treatment with Imbruvica (ibrutinib) plus AbbVie’s enclexta (venetoclax). 11 December 2023
Swiss pharm giant Novartis has announced positive results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta (iptacopan). 11 December 2023
Swiss pharma giant Roche has presented new data from its CD20xCD3 T-cell engaging bispecific antibody program at the 65th American Society of Hematology (ASH) Annual Meeting. 11 December 2023
Adding Sarclisa (isatuximab) to carfilzomib, lenalidomide and dexamethasone (KRd) caused a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly-diagnosed multiple myeloma (MM). 11 December 2023
The European Commission (EC) has authorized Japanese drugmaker Astellas Pharma’s Veoza (fezolinetant) 45mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 11 December 2023