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Pharmaceutical
The US Food and Drug Administration (FDA) yesterday issued a final rule to amend its prescription drug advertising regulations, titled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format.” 21 November 2023
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) announced that the forthcoming International Recognition procedure (IRP) moved a step closer today, with the launch of the Agency’s new online ‘Eligibility Checker’ tool. 20 November 2023
Pharmaceutical
The US Food and Drug Administration’s pulmonary-allergy drugs advisory committee (PADAC) on Friday held an advisory committee (AdCom) meeting to discuss US pharma giant Merck & Co’s P2X3 inhibitor, gefapixant in chronic cough. 18 November 2023
Pharmaceutical
US clinical-stage biopharma Apollomics (Nasdaq: APLM) leapt on the announcement yesterday that its partner in China, Avistone Biotechnology, has received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC). 17 November 2023
Pharmaceutical
As part of UK Prime Minister Rishi Sunak’s Cabinet reshuffle today, Victoria Atkins has been named as Secretary of State for Health and Social Care, replacing Steve Barclay. 13 November 2023
Pharmaceutical
Eli Lilly's tirzepatide, which is already approved for the treatment of diabetes under the trade name Mounjaro, late Wednesday was also authorized by the US FDA for the treatment of chronic weight management. 8 November 2023
Pharmaceutical
Indian drugmaker Zydus Lifesciences, through its wholly-owned subsidiary Zydus Pharmaceuticals UK, announced the acquisition of the UK headquartered LiqMeds Group of companies. 31 October 2023
Pharmaceutical
A posting on the website of the German pharma trade group, the VFA, reveals a new report on evaluating the impact of the country’s SHI Financial Stabilization Act on patient access to medicines and on German business location. 30 October 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk on Friday announced that the sales and operating profit growth at constant exchange rates (CER) for the first nine months of 2023 and the full-year sales and operating profit outlook at CER have been raised. 14 October 2023
Pharmaceutical
India’s Sun Pharmaceutical Industries has presented Phase IV data on its Cequa (cyclosporine ophthalmic solution) showing sustained improvement in dry eye disease signs and symptoms in patients switched from AbbVie’s Restasis (cyclosporine ophthalmic emulsion) 0.05%. 12 October 2023
Pharmaceutical
French pharma major Sanofi is exploring a potential acquisition of cancer drugmaker Mirati Therapeutics, according to Bloomberg, citing people familiar with the matter, and other media reports. 6 October 2023
Pharmaceutical
Japan’s largest drugmaker Takeda revealed that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization has recommended the use of its Qdenga (dengue tetravalent vaccine [live, attenuated]; TAK-003). 5 October 2023
Pharmaceutical
Novo Nordisk’s American traded shares rose 1% after the Danish diabetes care giant won two patent challenges related to semaglutide, its best-selling weight-loss therapy, Wegovy, also marketed as Ozempic for diabetes. 3 October 2023
Pharmaceutical
With the threat of a federal government shutdown looming in America, the operations of the US Food and Drug Administration (FDA) may be impacted creating some potential application delays for pharmaceutical and medical device companies. 30 September 2023
Pharmaceutical
The US Food and Drug Administration announced it has awarded 10 new clinical trial studies, funded by Congress through the Orphan Products Grants Program, to support the development of medical products for rare diseases. 30 September 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Tetra Therapeutics, now a part of Japanese drugmaker Shionogi, Rare Pediatric Disease designation for zatolmilast (BPN14770). 29 September 2023
Pharmaceutical
A number of drugmakers are preparing to engage with administrators at Medicare to negotiate certain drug prices, as mandated by the Inflation Reduction Act (IRA), according to a report. 28 September 2023
Pharmaceutical
The first Rare Disease Research Landscape report has been published by the UK’s National Institute of Health Research (NIHR) in collaboration with the Medical Research Council (MRC), industry, charities and the devolved administrations. 23 September 2023
Pharmaceutical
Indian oncology company Venus Remedies has secured marketing authorization from Serbia for its chemotherapy drugs gemcitabine and docetaxel. 20 September 2023
Pharmaceutical
Germany’s Atriva Therapeutics and Canadian firm Biocure Technologies have entered into an exclusive letter agreement for a reverse takeover transaction. 18 September 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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