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Pharmaceutical
Swiss contract development and manufacturing organization (CDMO) Lonza announced today that its chief executive, Pierre-Alain Ruffieux, will leave the company at the end of September by mutual agreement. 18 September 2023
Pharmaceutical
Final guidance from the UK’s health technology assessor recommends that the country’s national healthcare provider fund Jakavi (ruxolitinib) in polycythaemia vera (PV). 14 September 2023
Pharmaceutical
British nephrology start-up Mironid has extended its series A financing round, bringing the total amount raised to $44 million. 13 September 2023
Pharmaceutical
The Johnson & Johnson subsidiary Janssen has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of erdafitinib for the treatment of patients with locally-advanced or metastatic urothelial cancer with susceptible pan-fibroblast growth factor receptor (FGFR) alterations. 8 September 2023
Pharmaceutical
Cardiology specialist Corteria Pharmaceuticals has raised $71 million in a series A financing co-led by American investor OrbiMed and EU-based Jeito Capital. 7 September 2023
Pharmaceutical
Women’s health company Organon has appointed Juan Camilo Arjona Ferreira as chief medical officer and Charlotte Owens as head of medical affairs and outcomes research. 6 September 2023
Pharmaceutical
Swiss rare disease specialist Relief Therapeutics has entered into a new exclusive licensing agreement with Acer Therapeutics for Olpruva (sodium phenylbutyrate). 31 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a final guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. 31 August 2023
Pharmaceutical
German infectious disease specialist AiCuris Anti-infective Cures has received a milestone payment of around $32.5 million from partner Merck & Co after a new US approval for Prevymis (letermovir). 23 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted Swedish firm Calliditas Therapeutics’ submission for the supplemental New Drug Application (sNDA) and granted Priority Review for the full approval of Tarpeyo (budesonide) for the treatment of IgA nephropathy (IgAN). 18 August 2023
Pharmaceutical
US legislators have proposed two new bills that aim to bolster the Vaccine Injury Compensation Program and help vaccines gain the general public's acceptance, the first being the Vaccine Injury Compensation Modernization Act and the second The Vaccine Access Improvement Act. 15 August 2023
Pharmaceutical
Germany’s Ketabon GmbH, a joint venture between HMNC Brain Health and Develco Pharma, today announced today top-line results from its Phase II KET01-02 Ketabon study with lead asset KET01. 14 August 2023
Pharmaceutical
Shares of Japanese drugmaker Daiichi Sankyo (TYO: 4568) moved up almost 2% to 4,279 yen today, as it revealed a decision to close its Japanese research and development (R&D) subsidiary, Daiichi Sankyo RD Novare, headquartered in Edogawa-ku, Tokyo. 7 August 2023
Pharmaceutical
Danish vaccine developer Bavarian Nordic says that the US Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services, has placed a new order valued at $120 million, primarily covering the manufacturing of new bulk product for the company’s Imvanex (marketed as Jynneos in the USA) smallpox/monkeypox vaccine. 4 August 2023
Pharmaceutical
Taiho Pharmaceutical, a subsidiary of Japanese drugmaker Otsuka, says that its partner, privately-held French drugmaker Servier, has received approval from the European Commission, of Lonsurf (trifluridine/tipiracil) in combination with bevacizumab. 2 August 2023
Pharmaceutical
The German economic development agency, Germany Trade and Invest (GTAI), has released a new podcast looking at recent developments in the life sciences industry in the country. 1 August 2023
Pharmaceutical
C4X Discovery (C4XD) has sold its remaining rights to the oral Orexin-1 receptor antagonist, C4X_3256, to fellow British firm Indivior, for $20 million. 1 August 2023
Pharmaceutical
Last Thursday, the US Food and Drug Administration (FDA) approved Ervebo, a vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus in individuals 12 months through 17 years of age. 29 July 2023
Pharmaceutical
Syros Pharmaceuticals shares fell 5.7% after-hours trading on Friday, after it revealed that US pharma giant Pfizer will terminate a license deal between the companies related to the development of novel therapies for two blood disorders. 25 July 2023
Pharmaceutical
The World Health Organization (WHO) is seeking to align its biowaiver policy with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guide. 21 July 2023
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
US biotech start-up RayThera has secured $110 million in series A financing to fund the early clinical development of its small molecule drug candidates in immunology. 8 April 2025
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