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
Swiss drugmaker Novartis has announced that the US Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) trials for spinal muscular atrophy (SMA) patients can go ahead. 3 August 2021
ParaPRO, a specialty pharma company focused on innovative anti-parasitic treatments, has announced the availability of Natroba (spinosad) Topical Suspension, 0.9%, the first product for scabies to be approved by the US Food and Drug Administration (FDA) in more than 30 years. 3 August 2021
Following a successful financial year 2020, German family-owned pharma major Boehringer Ingelheim says it has continued its positive trend in the first half of 2021. 3 August 2021
South Korea’s Celltrion Healthcare today announced that it has signed a contract to supply its two anticancer therapeutics – Herzuma (trastuzumab) and Truxima (rituximab) to the Brazilian market. 3 August 2021
Finnish drugmaker Orion Corp has entered into an agreement to distribute US biopharma firm Marinus Pharmaceuticals’ CNS-selective GABAA modulator, ganaxolone, as a treatment for orphan, genetic disorders ganaxolone, across Europe. 3 August 2021
The share of domestic drugs in public procurements in Russia grew to a record figure of 87% this year, according to recent studies conducted by some leading local analysts in the field of pharmaceutics and Russian media, reports The Pharma Letter’s local correspondent. 3 August 2021
Independent French pharma major Servier today announced the global Phase III double blinded placebo controlled AGILE study of Tibsovo (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) met its primary endpoint of event-free survival (EFS). 3 August 2021
USA-based cell and gene therapy specialist Mustang Biotech’s shares edged up 1.4% to $2.83 in after-hours trading, following the0 announcement that the European Medicines Agency has granted Priority Medicines (PRIME) designation to MB-107, its lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID) in newly diagnosed infants, also known as bubble boy disease. 3 August 2021
Ukraine may become one of the European centers for clinical trials and studies of original Western drugs in years to come, according to recent statements by some leading local state officials and the Ukraine media reports. 3 August 2021
The Federal Trade Commission (FTC) has expressed its disappointment at a Supreme Court decision relating to AndroGel (testosterone gel), a prescription medicine used to treat the symptoms of testosterone deficiency. 2 August 2021
Anglo-Swedish pharma major AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the USA for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. 2 August 2021
French drugmaker Ipsen and US biotech Exicure have signed an exclusive collaboration agreement to research, develop, and commercialize spherical nucleic acids (SNAs) as potential investigational treatments for Huntington’s disease and Angelman syndrome. 2 August 2021
A new medicine that helps reduce unacceptably high ‘bad cholesterol’ and the risk of cardiovascular events like heart attack and stroke has gained long-awaited listing on Australia’s Pharmaceutical Benefits Scheme (PBS). 2 August 2021
Privately-held FluGen, a clinical-stage US vaccine developer, today announced the publication of results from its Phase II human challenge study of Bris2007 M2SR, the company’s investigational, supra-seasonal, live, single-replication, intranasal influenza (flu) vaccine. 2 August 2021
Shares of Autolus Therapeutics were up 12.8% at $6.00 in pre-market trading, after the UK-headquartered cancer immunotherapy company announced an agreement with Moderna. 2 August 2021
Japanese pharma major Eisai closed up 1.2% at 9,092 yen today, as it announced that its anti-epileptic drug (AED) Fycompa (perampanel) has obtained two additional approvals in China. 2 August 2021
Indian pharmaceutical companies are set to gain from the US Food and Drug Administration's changed stance on biosimilar versions of biological medicines. With the US FDA approving a biosimilar interchangeable insulin product for the treatment of diabetes for the first time in the country, the doors appear to have been opened for generic players, with many considering it a shot in the arm, reports The Pharma Letter’s India correspondent. 2 August 2021
Minovia Therapeutics and Japan’s Astellas Pharma on Friday announced a worldwide strategic collaboration and license agreement for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction. 2 August 2021
The European Medicines Agency’s human medicines committee (CHMP) has approved a scale-up of the active substance production process at US mRNA-based biotech Moderna's COVID-19 vaccine manufacturing sites in the USA. 2 August 2021