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
The Russian Ministry of Health has approved the use of Zolgensma (onasemnogene abeparvovec), the world’s most expensive drug against spinal muscular atrophy (SMA) in the domestic market, reports The Pharma Letter’s local correspondent. 22 December 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, has announced that Apretude (cabotegravir), the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually-acquired HIV-1, has been approved in the USA. 21 December 2021
Some 55 Indian pharmaceutical manufacturing companies may be fulfilling the technical requirements and quality standards needed to produce mRNA COVID-19 vaccines, according to a global report. 21 December 2021
US biotech Moderna has announced preliminary neutralizing antibody data against the Omicron variant following the company’s booster candidates at 50 µg and 100 µg dose levels. 21 December 2021
Clearly French pharma major Sanofi’s appetite for M&A has not been satisfied yet, as the company today announced its sixth acquisition this year. 21 December 2021
Topical dermatology specialist DermBiont has raised $28 million in a series A financing, at the same time as acquiring clinical-stage biotech Chromaderm. 21 December 2021
The European Commission (EC) has granted US biotech Novavax conditional marketing authorization (CMA) for its Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults. 21 December 2021
AstraZeneca has announced that a supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US Food and Drug Administration. 21 December 2021
Shares of bluebird bio closed down 18% at $10.03 yesterday, after it announced that the FDA has placed its clinical program for lovotibeglogene autotemcel (lovo-cel) - previously known as LentiGlobin - as a gene therapy for sickle cell disease (SCD) on partial clinical hold for patients under the age of 18. 21 December 2021
The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021
US biotech Lineage Cell Therapeutics and its subsidiary, Cell Cure Neurosciences, have entered into an exclusive worldwide collaboration and license agreement with Swiss pharma giant Roche and its Genentech affiliate for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA). 21 December 2021
In March 2021, the US Food and Drug Administration (FDA) announced its continued support for rare disease programs.1 So far, giant strides have been made in the search to find cures for diseases that affect a small percentage of the population, but are devastating in effect. 21 December 2021
Swiss pharma giant Novartis has announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU). 20 December 2021
US biotech Moderna has taken a more conciliatory approach in a row with the National Institutes of Health (NIH) over who is responsible for the creation of the Spikevax coronavirus vaccine. 20 December 2021
In a bid to rescue its controversially approved Alzheimer’s drug that has failed to produce significant sales, US biotech Biogen today announced that, effective January 1, 2022, it will reduce the wholesale acquisition cost (WAC) of Aduhelm (aducanumab-avwa) 100mg/mL injection for intravenous use in the USA by around 50%. 20 December 2021
Swiss pharma giant Novartis has signed an option, collaboration and license agreement with Chinese biotech BeiGene for ociperlimab (BGB-A1217), expanding the company’s R&D activities in immuno-oncology. 20 December 2021
US pharma giant Pfizer and Germany’s BioNTech will amend the clinical study evaluating the safety, tolerability, and immunogenicity of their Comirnaty COVID-19 vaccine in children six months to under five years of age. 20 December 2021
Japanese drug major Eisai today announced an agreement with US biotech Gilead Sciences for the commercialization and distribution of Jyseleca (filgotinib), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn's disease in Asia (South Korea, Taiwan, Hong Kong and Singapore). 20 December 2021
German pharma and life sciences group Merck KGaA today announced a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine (marketed as Mavenclad for multiple sclerosis) for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 20 December 2021