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6 January 2025 Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market.
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Shares in USA-based NRx Pharmaceuticals have fallen by around a fifth, after the firm announced disappointing results from a trial of NRX-101. 1 May 2024
Pharmaceutical
UK pharma major GSK today reported first quarter 2024 financial results, showing that total sales were £7.4 billion ($9.26 billion) +10% and +13% ex COVID revenues. 1 May 2024
Pharmaceutical
Neurocrine Biosciences has secured US Food and Drug Administration approval for Ingrezza Sprinkle (valbenazine). 1 May 2024
Pharmaceutical
The USA’s Federal Trade Commission yesterday revealed it has expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration’s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma and COPD drugs. 1 May 2024
Pharmaceutical
US pharma giant Merck & Co has announced results from STRIDE-10, a Phase III trial of V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine (PCV), at the European Society of Clinical Microbiology and Infectious Diseases event in Barcelona, Spain. 30 April 2024
Pharmaceutical
Shares of US developer of rare neurological drugs Harmony Biosciences (Nasdaq: HRMY) rose more than 10% to $32.30 today, after it announced the acquisition of Epygenix Therapeutics. 30 April 2024
Pharmaceutical
Oncotelic Therapeutics has agreed to sell to Mosaic ImmunoEngineering rights to its clinical-stage necroptosis cancer therapies. 30 April 2024
Pharmaceutical
US pharma major Eli Lilly today announced its financial results for the first quarter of 2024 and raised it guidance, with the news pushing the firm’s share up 5.6% to $778.19. 30 April 2024
Pharmaceutical
X4 Pharmaceuticals has secured US approval for Xolremdi (mavorixafor), for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). 30 April 2024
Pharmaceutical
A full cycle of production of a drug for the treatment of Fabry disease will be launched in Russia this year, reports The Pharma Letter’s local correspondent. 30 April 2024
Pharmaceutical
A once-weekly insulin product developed by Novo Nordisk will be reviewed by an advisory panel, convened by the US regulator, on 24 May. 30 April 2024
Pharmaceutical
Italy-based biopharma Newron Pharmaceuticals was trading 14% higher at lunchtime on Tuesday. 30 April 2024
Pharmaceutical
USA-based neurodegenerative disorders specialist Annovis Bio saw its shares plunge 60% to $7.28 by close of trading, despite what it said were positive results for its Alzheimer’s disease (AD) candidate. 30 April 2024
Pharmaceutical
More prominent warnings are to be added to the package insert of montelukast (Singulair) in the UK, reminding patients and healthcare professionals that they should be alert to serious behavior and mood-related changes (neuropsychiatric reactions) associated with the treatment, said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 30 April 2024
Pharmaceutical
The world’s top 20 pharma companies spent $145 billion between them on R&D investments in 2022-23 - compared to the prior year’s $139 million - according to research from the professional services firm Deloitte. 29 April 2024
Pharmaceutical
Osaka, Japan-based drugmaker Ono Pharmaceutical has entered into a drug discovery collaboration agreement with fellow Japanese firm PRISM BioLab. 29 April 2024
Pharmaceutical
Interpharma, the association of research-based pharmaceutical companies in Switzerland, has called on lawmakers to reconsider a cost containment package which it says “is putting patient access at risk.” 29 April 2024
Pharmaceutical
Family-controlled Spanish pharma company Esteve has signed a binding offer with USA-based Perrigo Company to acquire the latter’s HRA Pharma Rare Diseases, a specialist in rare and ultra-rare diseases. 29 April 2024
Pharmaceutical
The fact that the government has exempted the parallel importers from the obligation to contribute to the critical medicine stocks creates an extremely competitive situation, says Ida Sofie Jensen, chief executive of Lif, the Danish Association of the Pharmaceutical Industry. 29 April 2024
Pharmaceutical
US pharma major AbbVie announced financial results for the first quarter of 2024, showing that worldwide net revenues were $12.310 billion, an increase of 0.7% on a reported basis, or 1.6% on an operational basis. 26 April 2024
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Pharmaceutical
A late-stage trial failure has dented Denali Therapeutics stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. 7 January 2025
Pharmaceutical
Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all. 7 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. 7 January 2025
Pharmaceutical
Sentynl Therapeutics, wholly owned by Zydus Lifesciences, has announced that the US Food and Drug Administration has accepted its New Drug Application for CUTX-101, a potential first treatment for Menkes disease. The application has been granted priority review, with a target action date set for June 30, 2025. 7 January 2025
Pharmaceutical
rug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical revealed in a Security and Exchange Commission (SEC) notice. 7 January 2025
Pharmaceutical
A team of Chinese researchers has identified a promising candidate for glaucoma treatment using artificial intelligence tools. 6 January 2025
Pharmaceutical
Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market. 6 January 2025
Pharmaceutical
Immedica Pharma, a Swedish company specializing in rare diseases, has announced its acquisition of Marinus Pharmaceuticals in a deal valued at $151 million. The agreement, finalized through a cash tender offer, marks a significant expansion of Immedica’s presence in the US market. 6 January 2025
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca has announced that new, positive, long-term results from the pivotal ALPHA Phase III trial have appeared in the journal Blood, which is published by the American Society of Hematology. 6 January 2025
Pharmaceutical
Alon Natanson, a business leader and alumnus of the Hebrew University of Jerusalem, has been appointed chief executive officer (CEO) of Yissum, the Israeli Hebrew University Tech Transfer company. 6 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
Pharmaceutical
Switzerland’s Santhera Pharmaceuticals has entered an exclusive deal with Clinigen Group to manage the supply and distribution of Agamree (vamorolone) in regions where the drug is not yet commercially available. 6 January 2025
Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
Pharmaceutical
Hutchmed has announced agreements to divest its 45% equity stake in Shanghai Hutchison Pharmaceuticals Limited (SHPL) for $608 million in cash. The buyers are GP Health Service Capital and Shanghai Pharmaceuticals. 2 January 2025
Pharmaceutical
Kazia Therapeutics, an oncology-focused Australian drug developer, has been advised by the US Food and Drug Administration (FDA) that accelerated approval for its brain cancer drug, paxalisib, is unlikely. 2 January 2025
Pharmaceutical
The type 1 diabetes (T1D) market across the seven major markets (7MM: USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow at a compound annual growth rate (CAGR) of 13.3% from $2.2 billion in 2023 to $9.9 billion in 2033. 2 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib. 2 January 2025
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