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Pharmaceutical
Australian medicines regulator the Therapeutic Goods Administration (TGA) has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information- external site. 26 April 2024
Pharmaceutical
With peptides, oligos and peptide conjugates continuing to attract drug developer interest and industry capacity in short supply, China’s WuXi AppTec says its Changzhou site has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). 19 April 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. 17 April 2024
Pharmaceutical
Japanese pharma major Shionogi has received approval of a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment and post-exposure prophylaxis for influenza virus infection for pediatrics aged 5 to 15 April 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved the medicine Nulibry (fosdenopterin) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A. 9 April 2024
Pharmaceutical
French pharma major Sanofi today announced the UK launch of Verorab (Sanofi Inactivated Rabies Vaccine) an inactivated rabies vaccine indicated for pre-exposure and post-exposure prophylaxis of rabies in all age groups. 5 April 2024
Pharmaceutical
Japan’s Asahi Kasei Pharma has concluded an agreement with Swedish Orphan Biovitrum Japan Co regarding exclusive distribution rights in Japan for the additional indication of idiopathic thrombocytopenic purpura (immune thrombocytopenia) for Doptelet (avatrombopag maleate), a thrombopoietin receptor agonist. 2 April 2024
Pharmaceutical
Earlier this week Merck & Co gained much awaited approval from the Food and Drug Administration for its pulmonary arterial hypertension (PAH) treatment Winrevair (sotatercept-csrk) injection. 30 March 2024
Pharmaceutical
Germany’s Merck KGaA says it has expanded its M Lab Collaboration Center in Shanghai, the company’s largest in its global network of 10 interconnected labs. 29 March 2024
Pharmaceutical
Eisai today announced that it has entered into an agreement to divest its Japanese rights for vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate) and muscle relaxant Myonal (eperisone hydrochloride) to fellow Japan based Kaken Pharmaceutical. 29 March 2024
Pharmaceutical
Swedish company InDex Pharmaceuticals have announced the departure of chief executive (CEO) Jenny Sundqvist and chief financial officer and deputy CEO Johan Giléus. 27 March 2024
Pharmaceutical
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) today announced the new Quantitative Medicine (QM) Center of Excellence (CoE). 25 March 2024
Pharmaceutical
Pfizer intends to sell around 630 million Haleon ordinary shares, taking its interest down to 22.6% from 32%. 19 March 2024
Pharmaceutical
Privately-held Austrian firm pharmaand (pharma&) has announced the presentation of new data from the randomized, Phase III company-sponsored ATHENA trial. 18 March 2024
Pharmaceutical
Eris Lifesciences has announced the acquisition of fellow Indian company Biocon Biologics’ India branded formulation business for a consideration of rupees 1,242 crore (~$149 million). 16 March 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today (March 7) approved US drugmaker Marinus Pharmaceuticals’ Ztalmy (ganaxolone) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD). 7 March 2024
Pharmaceutical
US pharma company CymaBay Therapeutics today announced that the Marketing Authorization Application (MAA) for seladelpar, for the treatment of primary biliary cholangitis (PBC), has been validated and will be reviewed by the European Medicines Agency (EMA). 4 March 2024
Pharmaceutical
Serum Institute of India (SII) aims to significantly boost supply of its human papillomavirus (HPV) vaccine as it gears up to provide its jabs to the government at cheaper rates for an immunization campaign this year against the cancer-causing virus, according to a Reuters report. 4 March 2024
Pharmaceutical
Viking Therapeutics’ shares surged more than 80% pre-market on Monday, after it announced positive top-line results from the company's Phase II clinical trial of VK2735 as an obesity treatment. 27 February 2024
Pharmaceutical
Japanese drugmaker Daiichi Sankyo said on Friday that it would invest about 1 billion euros ($1.07 billion) to expand a manufacturing site near Munich, Germany, to boost its work on precision cancer drugs, according to media reports. 20 February 2024
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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