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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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Pharmaceutical
Available evidence does not support a link between GLP-1 receptor agonists with suicidal and self-injurious thoughts and actions. 12 April 2024
Pharmaceutical
USA-based Nectero Medical has raised $96 million in a Series D financing round led by Norwest Venture Partners, with significant investments also from Boston Scientific, BioStar Capital and others. 12 April 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending Aquipta (atogepant). 11 April 2024
Pharmaceutical
Data from the RESMAIN study of Kinselby (resminostat) have been presented at the 5th World Congress of Cutaneous Lymphomas (5WCCL), at the City of Hope, Pasadena, California, USA. 11 April 2024
Pharmaceutical
The European Parliament has formally adopted new pharmaceutical legislation, including proposals for a new directive and a new regulation. 11 April 2024
Pharmaceutical
Affecting one in 19 women, polycystic ovary syndrome (PCOS) remains understudied, with no dedicated treatments. Surprisingly, new diabetes and weight loss drugs may help. 10 April 2024
Pharmaceutical
A private share placement is set to land Massachusetts, USA-based Acrivon Therapeutics with an additional $130 million to fund its oncology research. 10 April 2024
Pharmaceutical
Keen to take French pharm major Sanofi head-on, the Serum Institute of India (SII) is to scale up supplies to fulfil India's entire annual demand for injectable inactivated poliomyelitis vaccines (IPV). 10 April 2024
Pharmaceutical
Cell programming specialist Ginkgo Bioworks today announced the expansion of its strategic partnership with Denmark’s Novo Nordisk under a framework agreement that initially is contemplated to run over five years. 10 April 2024
Pharmaceutical
Japan-based Teijin Group’s healthcare business, Teijin Pharma, has entered into an exclusive global licensing agreement with French drugmaker Bioprojet Pharma. 10 April 2024
Pharmaceutical
British specialty medicines firm Essential Pharma has announced the completion of the acquisition of the entire issued share capital of fellow UK-based Renaissance Pharma. 10 April 2024
Pharmaceutical
The segment of public procurement of medicines in Russia is facing a serious crisis due to the ever-growing number of failed tenders, caused by a low interest of suppliers and drugmakers for them, The Pharma Letter’s local correspondent reports. 10 April 2024
Pharmaceutical
Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH). 9 April 2024
Pharmaceutical
Nearly eight years after the UK voted to leave the European Union (EU), the government is still delaying on introducing certain new rules that impact the life sciences industry. 9 April 2024
Pharmaceutical
Results from the Phase III clinical trial MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of Abrysvo versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD), were released today by Pfizer. 9 April 2024
Pharmaceutical
Sino Biopharmaceutical revealed it has entered into a strategic partnership with Boehringer Ingelheim to bring the German family-owned company’s innovative cancer therapies to the market in mainland China. 9 April 2024
Pharmaceutical
The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals to register its Parkinson’s disease candidate SPN-830. 9 April 2024
Pharmaceutical
UK health technology assessor the National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending use of remdesivir for treating COVID-19 in eligible adults and children. 9 April 2024
Pharmaceutical
Of the 46 cancer drugs for which the US Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study presented at the American Association for Cancer Research (AACR) 2024 annual meeting. 9 April 2024
Pharmaceutical
An FXR agonist developed by Ascletis Pharma has not performed well in mid-stage trials, leading the Hangzhou, China-based firm to dial down its investment in the drug. 8 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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