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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
Privately-held Isotope Technologies Munich (ITM) is not just the radiopharmaceutical company that can do it all - from manufacturing and supplying medical radioisotopes to developing a broad precision oncology pipeline, including two Phase III studies. 26 April 2024
Pharmaceutical
In a recent comment letter to US President Biden’s trade ambassador, Pharmaceutical Research and Manufacturers of America (PhRMA) encourages the Office of the US Trade Representative (USTR) to strengthen medical supply chains by negotiating meaningful trade agreements. 26 April 2024
Pharmaceutical
US pharma giant Merck & Co raised and narrowed its forecasts for profit and sales for 2024 in presenting its first-quarter financial results. 25 April 2024
Pharmaceutical
In its first quarter 2024 results statement, Bristol Myers Squibb beat expectations on revenues, which increased 5% to $11.9 billion, although it posted a loss per share of $5.89, due to charges from recently-closed deals. 25 April 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published its Final Draft Guidance (FDG) on a combination therapy from Swiss pharma giant Novartis. 25 April 2024
Pharmaceutical
A key Senate committee has launched an investigation into how Novo Nordisk prices its popular weight-loss drug semaglutide in the USA. 25 April 2024
Pharmaceutical
Sanofi shares were up by nearly 4% during Thursday’s early afternoon trading in Paris following its results presentation.. 25 April 2024
Pharmaceutical
Belgium’s largest drugmaker UCB today announced an update on its progress at its annual shareholder meeting (AGM), with the news edging its shares up 1.7% to 122.90 by midday. 25 April 2024
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
Pharmaceutical
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
Pharmaceutical
Swiss pharma giant Roche first-quarter 2024 sales figures this morning that were disappointing in some respects and saw the firm’s shares fall 3.5% to 221.70 francs. 24 April 2024
Pharmaceutical
Swiss pharma giant Novartis and the product development partnership Medicines for Malaria Venture (MMV) have announced positive data from their Phase II/III CALINA study. 24 April 2024
Pharmaceutical
A Takeda Pharmaceutical-partnered program has delivered strong mid-stage data, sending shares in Neurocrine Biosciences up 5%. 24 April 2024
Pharmaceutical
A single-line order from the US Supreme Court has scotched hopes on the part of Vanda Pharmaceuticals of resurrecting patents for Hetlioz (tasimelteon). 23 April 2024
Pharmaceutical
A manufacturing facility in Wisconsin, USA, has been purchased by Eli Lilly in order to support growing demand for its medicines. 23 April 2024
Pharmaceutical
San Diegan cancer company Kura Oncology has picked up Breakthrough Therapy designation for its menin inhibitor ziftomenib. 23 April 2024
Pharmaceutical
Swiss pharma giant Novartis today raised its full-year guidance after reporting better-than-expected first-quarter 2024 results, with the firm’s shares rising as much as 4.8% in early trading. 23 April 2024
Pharmaceutical
Despite the ongoing uncertainties surrounding macroeconomic activities, fluctuating interest rates, and changes in the US Medicare Drug Price Negotiation landscape, the top 20 global biopharmaceutical companies experienced a promising first quarter this year. 23 April 2024
Pharmaceutical
French drugmaker Sanofi has unveiled positive results from the Phase III LUNA 3 trial of rilzabrutinib. 23 April 2024
Pharmaceutical
Following a positive recommendation last month by the European Medicines Agency’s (EMA) human medicines committee (CHMP), today the European Commission (EC) granted marketing authorization for Emblaveo (aztreonam-avibactam) from Pfizer. 22 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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