The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Injectafer (ferric carboxymaltose injection), Japanese drugmaker Daiichi Sankyo and its US subsidiary, American Regent, have announced. 7 June 2023
The US Federal Trade Commission and the US Department of Justice, Antitrust Division released a summary of a two-day workshop that explored new approaches to enforcement of the antitrust laws in the pharmaceutical industry. 2 June 2023
The British business of Pfizer has announced a positive reimbursement decision for Vydura (rimegepant), unlocking the migraine med’s routine use in England and Wales. 31 May 2023
Atea Pharmaceuticals today announced that its board of directors unanimously rejected the unsolicited proposal from Tang Capital Partners, on behalf of Concentra Biosciences, to acquire all outstanding common shares of Atea for $5.75 per share in cash, plus a contingent value right representing the right to receive 80% of the net proceeds payable from any license or disposition of Atea’s programs. 30 May 2023
Japanese drug major Astellas Pharma said today that its Dutch subsidiaries have made an intended decision to sell and transfer its manufacturing plant, located in Meppel, Netherlands, to Delpharm Industrie SAS. 25 May 2023
Boston, USA-based Verastem Oncology will present updated interim results from Part A of the Phase II RAMP 201 study of avutometinib and defactinib at this year’s annual meeting of the American Society of Clinical Oncology (ASCO). 19 May 2023
Privately-held, San Diego-based Nielsen BioSciences has granted Japanese dermatology specialist Maruho exclusive rights to market CANDIN (Candida albicans skin test antigen for cellular immunity) in Japan for the treatment of Verruca vulgaris (common warts). 16 May 2023
Swiss financial group Cedrus is to collaborate with Chinese pharma giant Xiuzheng Pharmaceutical to identify investment opportunities in China. 16 May 2023
Ireland’s health technology assessor, the National Centre for Pharmacoeconomics (NCPE), has confirmed a positive reimbursement decision for the oral anti-seizure med Ontozry (cenobamate). 15 May 2023
Spanish plasma-derived drugmaker Grifols says that its board of directors has approved the realignment of the company’s management team to accelerate Grifols’ performance and simplify its corporate governance, ensuring a sharper focus on delivering results. 13 May 2023
UK pharma major GSK has sold 240 million shares in its consumer healthcare spinoff business Haleon at 335 pence per share, raising about £804 million ($1 billion), the company said. 12 May 2023
UK-based small molecule specialist Tay Therapeutics has entered into an exclusive license agreement with VYNE Therapeutics for its oral BET inhibitor, TAY-B2. 2 May 2023
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of Lynparza (olaparib) plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). 29 April 2023
Johnson & Johnson has secured a positive reimbursement decision in the UK for Imbruvica (ibrutinib), in the first-line treatment of chronic lymphocytic leukemia (CLL). 21 April 2023
The USA’s Biomedical Advanced Research and Development Authority (BARDA) is seeking proposals for advanced research and development activities for COVID-19 therapeutics for both pre-exposure prophylaxis (PrEP) and treatment. 21 April 2023
Veru saw its share rise 15% to $1.19 by mid-morning after it announced the sale of its Entadfi (finasteride and tadalafil) capsules business for benign prostatic hyperplasia (BPH) to Blue Water Vaccines for $20 million and up to an additional $80 million from sales milestones. 20 April 2023
US pharma major Eli Lilly plans to invest an additional $1.6 billion and add another 200 new jobs at its two new manufacturing sites within LEAP Innovation Park in Boone County, bringing the company's total commitment to $3.7 billion and up to 700 new jobs. 18 April 2023
Privately-held Swiss firm Ferring Pharmaceuticals has entered into a new strategic collaboration in women’s health with the BioInnovation Institute (BII). 18 April 2023
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
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