Japanese companies Chugai and TwoCells have announced the termination of their collaboration for the investigational regenerative cellular medicine for knee chondrogenesis gMSC 1. 13 April 2023
The US Food and Drug Administration issued a draft guidance, “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making 6 April 2023
The UK's National Institute for Health and Care Excellence (NICE) has issued preliminary guidance which does not recommend Cabometyx (cabozantinib) for a specific use in thyroid cancer. 5 April 2023
Gaetan Leblay has been named vice president, customer and digital strategy for Europe, the Middle East and Africa at the Johnson & Johnson subsidiary Janssen. 30 March 2023
Germany’s Evotec has extended and expanded a strategic partnership with US pharma major Bristol Myers Squibb in neurodegeneration that was originally signed in 2016. 28 March 2023
USA-based Cyclerion Therapeutics has announced corporate updates including advances in its zagociguat (formerly CY6463) mitochondrial disease program. 24 March 2023
A new immunology company, NImmune Biopharma, has been launched to develop omilancor, NIM-1324, and the entire LANCL portfolio, which it has bought from Landos Biopharma. 24 March 2023
Psychiatric and neurologic condition specialist Karuna Therapeutics has announced a public stock offering, with the goal of raising $400 million. 21 March 2023
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 20 March 2023
Danish drugmaker Pharmacosmos has announced the launch of its intravenous iron deficiency anemia medicine MonoVer (ferric derisomaltose) in Japan. 17 March 2023
UK-based Pharmanovia has expanded its endocrinology portfolio with a licensing agreement for Ghryvelin (macimorelin), a new medicine used for diagnosing adult growth hormone deficiency (AGHD) from US biopharma Aeterna Zentaris. 16 March 2023
Industry analyst Future Market Insights has forecast that the global market for psychedelic medicines, which it estimates to be currently worth $3.1 billion, will be worth over $14 billion by 2033. 14 March 2023
Japanese pharma majors Takeda and Shionogi will each receive about 130 million yen ($9.7 million) from the Japanese GHIT Fund to invest in malaria drugs development, according to a GHIT announcement issued on March 13. 14 March 2023
Spanish drugmaker PharmaMar says it has received the Temporary Authorization for the commercialization of Zepzelca (lurbinectedin) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy without central nervous system (CNS) metastases. 10 March 2023
The trade group for UK-based drugmakers, the Association of the British Pharmaceutical Industry (ABPI), has appointed vice president Susan Rienow to the role of president. 9 March 2023
The US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes. 8 March 2023
Japanese pharma company Alfresa has entered into a licensing deal with K Pharma to develop and commercialize ropinirole in Japan for the treatment of amyotrophic lateral sclerosis (ALS). 3 March 2023
The US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 2 March 2023
Pain is good. Or finding non-opioid ways to manage it is good, if Latigo Biotherapeutics’ $150 million March fundraise is anything to go by. 10 April 2025
The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 2025
At the recent American Academy of Neurology (AAN) 2025 annual meeting, Axsome Therapeutics presented promising data for AXS-05 (bupropion + dextromethorphan) in treating agitation associated with Alzheimer’s disease (AD). 10 April 2025
The first comprehensive analysis of clinical trials in the UK has found the country remains a global leader in medical research but highlights the need for broader disease focus and better trial representation. 10 April 2025
Danish pharma major Novo Nordisk has announced an investment of $1.1 billion to expand its production facility in Brazil’s Montes Claros, northern Minas Gerais, with the aim of increasing production capacity for injectable treatments for people with obesity, diabetes and other serious chronic diseases. 10 April 2025
US health technology assessor the Institute for Clinical and Economic Review (CER), in collaboration with researchers from Brown University, has published a new white paper that provides clear policy and market solutions to help manage affordable and equitable access to GLP-1 obesity medications. 10 April 2025
The All-Russian Union of Patients (VSP) has called on Russia’s Deputy Prime Minister, Tatyana Golikova, to expand the list of drugs that are the subject of public procurements in the country in order to avoid a shortage of certain categories of drugs in the domestic market, The Pharma Letter’s local correspondent reports.. 10 April 2025
The Russian pharmaceutical market grew by 10% in value terms to 2.85 trillion roubles ($85 billion) in 2024, which was mainly due to the growth of it commercial segment, where the growth of sales was equivalent to 13.8%. 9 April 2025
The European Commission (EC) has granted marketing authorization to Rinvoq (upadacitinib; 15mg, once daily), from US pharma major AbbVie , for the treatment of giant cell arteritis (GCA) in adult patients. 9 April 2025
US biotech Annovis Bio has reported encouraging findings for its experimental therapy buntanetap in a subgroup of patients with early-stage Parkinson’s disease and mild dementia. 9 April 2025
Swiss biopharma Idorsia has received approval from the US Food and Drug Administration for an updated label on its hypertension drug Tryvio (aprocitentan), removing the previous Risk Evaluation and Mitigation Strategy requirement. 9 April 2025
Shares of USA and UK-based KalVista Pharmaceuticals fell 4% to $11.04 yesterday, despite the company revealing it has signed a licensing deal for the commercialization rights in Japan to Kaken Pharmaceutical for sebetralstat, an investigational, oral on-demand treatment for hereditary angioedema (HAE). 9 April 2025
The uveitis treatment market across seven major markets—the USA, France, Germany, Italy, Spain, the UK, and Japan—is projected to grow from $522 million in 2023 to $1.5 billion by 2033, according to a report from data analytics firm GlobalData. This marks an annual growth rate of nearly 11%. 8 April 2025
In the USA, the layoffs at health agencies, proposed tariffs on imports and other disruptive policies under President Donald Trump have led some to express concern over a potential ‘brain drain’ impacting pharma and other industries. 8 April 2025
US biopharma Rhythm Pharmaceuticals has announced positive topline results from the pivotal Phase III TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, for the treatment of acquired hypothalamic obesity. 8 April 2025
Indian drugmaker Sun Pharmaceutical Industries revealed it has launched fexuprazan tablets 40mg in India under the brand name Fexuclue, which is a novel potassiumcompetitive acid blocker (PCAB) that is approved as a new treatment for adults with erosive esophagitis of all grades. 8 April 2025
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 April 2025
At the recent AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Disease (PD), Cerevance announced that solengepras, a first-in-class G-protein coupled receptor 6 (GPR6) antagonist in development for early PD, failed to meet its primary endpoint in the Phase II ASCEND trial as a monotherapy. 8 April 2025
US biotech company Vertex Pharmaceuticals has received European Commission approval to extend the use of its cystic fibrosis therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with ivacaftor. 8 April 2025
The USA’s Centers for Medicare & Medicaid Services (CMS) yesterday released the Calendar Year (CY) 2026 Rate Announcement for the Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs that finalizes the payment policies for these programs. 8 April 2025