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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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UK-based specialty pharma group Essential Pharma has bought the Reminyl (galantamine hydrobromide) product line from Johnson & Johnson. 17 April 2024
Pharmaceutical
California, USA-based Terns Pharmaceuticals has appointed Melita Sun Jung as chief business officer. 17 April 2024
Pharmaceutical
Shares in US CNS specialist Intra-Cellular Therapies closed 23% higher on Tuesday. 17 April 2024
Pharmaceutical
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 17 April 2024
Pharmaceutical
Medicare beneficiaries in the USA are facing greater access restrictions on their lifesaving medicines, according to a study by the Schaeffer Center at the University of Southern California. 17 April 2024
Pharmaceutical
France-based Medincell, a biopharma developing long-acting injectable drugs in many therapeutic areas, has announced a collaboration with US drugmaker AbbVie. 16 April 2024
Pharmaceutical
US healthcare giant Johnson & Johnson has announced its financial results for the first quarter of 2024. 16 April 2024
Pharmaceutical
German family-owned drugmaker Boehringer Ingelheim today announced a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned, along with its full-year 2023 financial results. 16 April 2024
Pharmaceutical
Having recently gained US regulatory approval for its Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), Swiss pharma giant Novartis is now arming itself with clinical data for a new indication. 16 April 2024
Pharmaceutical
USA-based rare seizure specialist Marinus Pharmaceuticals saw its shares crash, falling nearly 83% to $1.36, after it revealed that a trial failed to meet early stopping criteria. 16 April 2024
Pharmaceutical
The US medicines regulator has established a new Center for Clinical Trial Innovation (C3TI). 16 April 2024
Pharmaceutical
In a significant stride towards addressing the challenge of meningococcal-B disease, Serum Institute of India (SII) and the University of Oxford, UK, have formalized a technology license agreement negotiated by Oxford University Innovation. 16 April 2024
Pharmaceutical
Italian family-owned drugmaker Chiesi Farmaceutici has appointed Richard Smith as vice president and business unit leader of the US AIR at Chiesi USA. 16 April 2024
Pharmaceutical
Bulgaria’s Supreme Administrative Court has cancelled the mechanism guaranteeing the predictability and sustainability of the National Health Insurance Fund (NHIF) budget for drugs for 2021. 15 April 2024
Pharmaceutical
A US judge has dismissed a legal claim from pharma major Eli Lilly alleging that an online pharmacy illegally sold an unauthorized compounded version of the company's dual GIP and GLP-1 receptor agonist tirzepatide. 15 April 2024
Pharmaceutical
Japanese drugmaker Nxera Pharma has entered into an exclusive supply and distribution agreement with Handok to commercialize Pivlaz (clazosentan sodium) 150mg in South Korea. 15 April 2024
Pharmaceutical
A new modelling analysis by UK pharma major AstraZeneca, IMPACT CKD, forecasts up to 16.5% of the population across eight countries will suffer from chronic kidney disease (CKD) by 2032, including a staggering rise of up to 59.3% in advanced-stage. 15 April 2024
Pharmaceutical
How the regions should handle the rising costs of medicine was a central theme at the Danish Regions' summit last week, where it was agreed to work for the re-introduction of a state guarantee scheme to finance medicine subsidies 15 April 2024
Pharmaceutical
As the first drug to reach the US market for the treatment of Staphylococcus aureus bacteremia (SAB) in over 15 years, Swiss drugmaker Basilea Pharmaceutica's (SIX: BSLN) Zevtera (ceftobiprole medocaril), will play a unique and critical role in the future management of this serious, and commonly fatal infection. 12 April 2024
Pharmaceutical
Under the US Biden administration’s Inflation Reduction Act (IRA), government bureaucrats will unilaterally decide how much a treatment selected for price setting is worth. 12 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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