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Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s attempt to block the Medicare Drug Price Negotiation Program was rejected by a federal judge. 5 July 2024
Pharmaceutical
Mochida Pharmaceutical announced that it has submitted a New Drug Application to the China National Medical Products Administration (NMPA) for Epadel S (MND-21), a highly purified eicosapentaenoic acid (EPA). 4 July 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has concluded its review of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorization be revoked 29 June 2024
Pharmaceutical
Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6 have been made .... 24 June 2024
Pharmaceutical
US drugmaker Lexicon Pharmaceuticals today announced that, following multiple interactions with and recent feedback from the US Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). 21 June 2024
Pharmaceutical
The USA’s Biomedical Advanced Research and Development Authority (BARDA) has announced up to $500 million in Project NextGen funding to plan and execute multiple Phase IIb clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19. 15 June 2024
Pharmaceutical
Pfizer chief executive Albert Bourla said the pharma giant is pausing big acquisitions after spending $43 billion last year on buying Seagen, according to a Bloomberg report. 12 June 2024
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s new program to cap out-of-pocket costs at $35 per month for eligible patients for the company’s inhalers is now available. 1 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's Austedo XR (deutetrabenazine), as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for tardive dyskinesia (TD) and Huntington’s disease (HD) chorea. 30 May 2024
Pharmaceutical
Helsinn and Angelini Pharma have renewed their distribution and licence agreement for Aulin (nimesulide) and Mesulid (nimesulide). 28 May 2024
Pharmaceutical
Negotiators of a proposed World Health Organization (WHO) pandemic accord have been unable to reach consensus ahead of a self-imposed deadline of next week’s World Health Assembly. 25 May 2024
Pharmaceutical
Russia is experiencing a boom in demand and sales of antidepressants these days, according to recent statements by representatives of some leading local pharmacies and analysts. 21 May 2024
Pharmaceutical
A Delaware, USA, federal jury on Friday said that AstraZeneca should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, with its cancer drug Tagrisso (osimertinib), according to IP Law360. 20 May 2024
Pharmaceutical
This week, the US Centers for Medicare & Medicaid Services (CMS) announced it would hold off on a provision to rule RIN 0938-AU28 that would have required pharmaceutical manufacturers to stack discounts and rebates to report a best price for the Medicaid drug rebate program. 17 May 2024
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk is planning to test whether its weight loss drugs, including semaglutide, marketed as Wegovy, can impact alcohol use in patients with liver disease, according to Bloomberg. 15 May 2024
Pharmaceutical
Japanese drugmaker Eisai today announced it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older. 13 May 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has now approved Pfizer’s Oxbryta (voxelotor) to be recommended for use on the National Health Service NHS to treat people with hemolytic anemia caused by sickle cell disease (SCD). 6 May 2024
Pharmaceutical
Subsidies for Danish drugmaker giant Novo Nordisk’s diabetes drug Ozempic (semaglutide) will be restricted in its home country due to rising public spending on the blockbuster diabetes medicine, which is increasingly being used as a weight-loss treatment, according to a report from Bloomberg. 2 May 2024
Pharmaceutical
As of May 1, Johnson & Johnson is updating its brand and uniting both its two business segments under the Johnson & Johnson brand name in the UK. 1 May 2024
Pharmaceutical
US antivirals specialist Gilead Sciences announced that the US Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. 27 April 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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