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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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The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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
Pharmaceutical
The new $2,000 cap on out-of-pocket costs for prescription drugs went into effect as of January 1, 2025, the US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced. 2 January 2025
Pharmaceutical
The market for artificial intelligence (AI) in cancer care is projected to grow from $2.2 billion in 2024 to $6.3 billion by 2029, reflecting a growth rate of 23.1%, according to a recent study by BCC Research. 31 December 2024
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Pharmaceutical
Just as MDMA looked to be leading the charge of psychedelics and related compounds towards market for mental health conditions, a dose of jeopardy has been thrown into the mix. 28 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 28 March 2024
Pharmaceutical
US biopharma Altimmune has claimed that it could have something special on its hands in the highly lucrative obesity field. 28 March 2024
Pharmaceutical
Swedish biotech Oncopeptides yesterday announced a collaboration with Vector Pharma FZCO to commercialize its flagship drug Pepaxti (melphalan flufenamide in the Middle East and North Africa (MENA) region. 28 March 2024
Pharmaceutical
An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024
Pharmaceutical
A South Korean company, AriBio, has announced the signing of exclusive marketing rights for its investigational Alzheimer’s disease drug, AR1001. 27 March 2024
Pharmaceutical
In what is seen as an important win for Merck & Co, the US pharma giant late yesterday announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk injection (which will be marketed in the USA as Winrevair). 27 March 2024
Pharmaceutical
A $20 million series A fundraise will propel Edgewood Oncology out of stealth mode and through early stage research for BTX-A51. 27 March 2024
Pharmaceutical
Israel’s Teva Pharmaceutical Industries and Japanese drugmaker Daiichi Sankyo have been called out for breaches of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. 27 March 2024
Pharmaceutical
Building on positive Phase I/IIa data for its Dravet syndrome candidate, Stoke Therapeutics now hopes to jump towards pivotal research. 27 March 2024
Pharmaceutical
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical have secured European approval for a new formulation of Abilify Maintena (aripiprazole). 27 March 2024
Pharmaceutical
The European Medicines Agency (EMA) has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. 27 March 2024
Pharmaceutical
Veeda Clinical Research Limited, a full-service contract research organization (CRO) with a proven record of drug development success, announced that it has acquired Heads, a privately held European CRO, which specializes in conducting clinical trials in oncology. 27 March 2024
Pharmaceutical
Not-for-profit research partnership TB Alliance has won a A$17 million grant from the Australian government to continue its work combating tuberculosis. 26 March 2024
Pharmaceutical
German pain specialist Grünenthal has released its 2023 full-year results, announcing a double-digit revenue growth. 26 March 2024
Pharmaceutical
Cohance Lifesciences and Suven Pharma are to merge, creating one of India's largest integrated contract development and manufacturing organization (CDMO) players. 26 March 2024
Pharmaceutical
New York-based Nuvation Bio, a biopharma tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, is to buy AnHeart Therapeutics. 26 March 2024
Pharmaceutical
US privately-held biopharma Pharmazz and Dr Reddy's Laboratories have enter into licensing agreement to market first-in-class centhaquine (trade name Lyfaquin) for hypovolemic shock in India. 26 March 2024
Pharmaceutical
New York-based Axsome Therapeutics has announced positive results from the Phase III SYMPHONY trial of reboxetine. 26 March 2024
Pharmaceutical
Drug sales in the Russian market are steadily growing, while last year the overall retail sales increased by 8% year-on-year basis to 1.5 trillion roubles $16.2 billion), according to latest data, provided by the Russian pharmaceutical analytics agency RNC Pharma, reports The Pharma Letter’s local correspondent. 26 March 2024
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