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
Amyloidosis-focused biopharma Attralus and Ossianix, an antibody engineering company developing a single domain antibody platform (VNARs) to deliver molecules across the blood-brain barrier (BBB), have agreed a deal. 18 November 2022
A seven-member panel has been formed by India's Ministry of Health and Family Welfare to prepare the country's first-ever national drug database, which will be used to monitor the quality of drugs in circulation, reports The Pharma Letter’s local correspondent. 18 November 2022
French drugmaker Sanofi has added a European approval to those in the USA and Japan for Enjaymo (sutimlimab) to treat hemolytic anemia in adults with cold agglutinin disease (CAD). 18 November 2022
Shares of US biotech Inovio were down almost 7% at $2.30, after the company disclosed it was halting development of two vaccine programs because of disappointing clinical trial results. 18 November 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Exkivity (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD). 18 November 2022
While excitement about the potential of CRISPR/Cas9 gene editing remains high, a setback for a leading company using this technique shows it is no golden ticket to success. 18 November 2022
Today, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) – the expert committee that evaluates the value of medicines in in the country – published advice recommending Australia’s discount rate could be lowered between 3.5% - 4% to bring the country closer to other recommended international standards. This is down from the current 5%. 18 November 2022
The US Food and Drug Administration late yesterday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes. 18 November 2022
The US Food and Drug Administration has approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr). 17 November 2022
The European Commission today granted marketing authorization for Sino-American biotech BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 17 November 2022
Japanese drug major Takeda today revealed that the Phase III PhALLCON trial of Iclusig (ponatinib) for adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) met its primary efficacy endpoint in the frontline setting. 17 November 2022
French specialty vaccine company Valneva today announced the appointment of Dipal Patel as chief commercial officer (CCO) and management board member. 17 November 2022
The unexpected news of a positive Food and Drug Administration advisory committee vote yesterday sent US cardiorenal-focussed drugmaker Ardelyx’ shares surging 84.4% to $2.25 in pre-market trading this morning. 17 November 2022
Research from industry analyst GlobalData has identified challenges in the development of new CAR-T cell therapies for chronic lymphocytic leukemia (CLL). 17 November 2022
Japanese drug major Astellas Pharma today announced positive top-line results from the Phase III SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). 17 November 2022
Germany’s Merck KGaA has announced an investment of more than 290 million euros ($302 million) in its biosafety testing capacity at Rockville, Maryland, USA. 16 November 2022
Due to the high-risk nature of drugs being developed for neurology diseases, most product launches in the recent history of Parkinson’s disease have been the result of strategic partnerships for marketing and sales, with few exceptions. 16 November 2022