Privately-held metabolic health specialist Rivus Pharmaceuticals has announced new clinical data from the Phase IIa HuMAIN study of HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) 1 October 2024
US RNAi therapeutics company Alnylam Pharmaceuticals has released two new data sets from the HELIOS-B Phase III study of Amvuttra (vutrisiran), an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). 30 September 2024
Repair Biotechnologies, a company developing therapies to reverse atherosclerotic plaque, has entered into a collaboration with Genevant Sciences, a specialist in nucleic acid delivery technology. 27 September 2024
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
Cambridge, USA-based Korro Bio has entered a collaboration with Denmark’s Novo Nordisk to advance the discovery and development of new genetic medicines, with the initial target to treat cardiometabolic diseases. 17 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
The Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness of three medicines for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). 6 September 2024
Amid an explosion in investment and development milestones seen over the past decade, the age of radiopharmaceuticals as both diagnostics and as therapeutics is very much arriving. 5 September 2024
Lexicon Pharmaceuticals yesterday announced that a post-hoc analysis of Phase III data from the SCORED clinical trial demonstrated that Inpefa (sotagliflozin) reduced the risk of major adverse cardiovascular events. 4 September 2024
Anthos Therapeutics has reported a new analysis from the landmark AZALEA-TIMI 71 study, demonstrated that the investigational Factor XI inhibitor abelacimab was associated with remarkably low levels of periprocedural bleeding in patients with atrial fibrillation (AFib). 3 September 2024
Germany’s Bayer (BAYN: DE) has presented detailed results from its Phase III OCEANIC-AF trial for the blood thinner asundexian at the annual meeting of the European Society of Cardiology (ESC). 3 September 2024
Novo Nordisk’s semaglutide—marketed under the names Wegovy and Ozempic—have already shown their potential to treat diabetes, obesity, cardiovascular (CV) conditions and maybe even reduce aging, too. 2 September 2024
UK-based George Medicines has announced the presentation of results from its two pivotal Phase III trials at a Hot Line session of the European Society of Cardiology (ESC) Annual Meeting in London. 2 September 2024
Cytokinetics (Nasdaq: CYTK) has presented new data on aficamten, its experimental cardiac myosin inhibitor, at the European Society of Cardiology Congress 2024. 2 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
The European subsidiary of Japanese drugmaker Daiichi Sankyo announced its reinforced commitment to addressing key unmet needs and barriers in cardiovascular (CV) care, by shining a light on inequalities in treatment and outcomes experienced by various patient groups. 2 September 2024
Regulatory news last week included European Commission approval for Swiss drugmaker Basilea’s antibacterial Cresemba, triggering a milestone payment from partner Pfizer. On the research front, Neurocrine Biosciences released mixed results from a Phase II study of its NBI-1117568 as a treatment for schizophrenia. Also, Alnylam Pharmaceuticals reported new Phase III data on its vutrisiran in cardiomyopathy. Swiss pharma giant Novartis inked collaboration with Lindy Bioscience aiming to turn biologic drugs into at home injectables, US major Eli Lilly launched a single vial formulation of its fast selling obesity drug Zepbound at a price discount of around 50% compared with other GLP-1 medicines. 1 September 2024
After an active M&A year in 2022, UK pharma major AstraZeneca kicked off 2023 with an agreement to acquire USA-based clinical stage biotech CinCor Pharma. 9 January 2023
A growing number of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) coming into India have become 25% to 35% more expensive as reports of Covid infections spiral out of control in China, squeezing margins and increasing drug prices. The Indian government's production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates (DIs) and APIs is soon set to come to the aid of many domestic players, reports The Pharma Letter’s India correspondent. 29 December 2022
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
Switzerland-based Idorsia today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. 20 December 2022
In what could well be India's biggest pharma deal, China's Fosun Pharma-owned Gland Pharma is on the block. A number of private equity firms have been approached, including Baring Private Equity, Bain Capital, Blackstone, Carlyle, and KKR. 19 December 2022
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Drugmakers Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen have been named and shamed by the UK pharma trade group. 12 December 2022
Just a week after securing an historic US approval for its one-time hemophilia B treatment, Hemgenix (etranacogene dezaparvovec-drlb), Dutch gene therapy company uniQure has less positive news to announce. 30 November 2022
A Phase II miss for CinCor Pharma has sent the firm’s stock falling precipitously. Shares are now changing hands for around $14, 45% lower than last week. 29 November 2022
US pharma giant Merck & Co has recently presented positive top-line results from the Phase III STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein being evaluated as an add-on to stable background therapy for pulmonary arterial hypertension (PAH). 21 November 2022
Novartis has presented new data on Leqvio (inclisiran), an siRNA product approved in primary hyperlipidemia as an adjunct to diet and maximally tolerated statin therapy to reduce low-density lipoprotein cholesterol (LDL-C). 8 November 2022
Continued growth in the giant and growing market for heart failure treatments looks assured for British pharma major AstraZeneca, with more positive data for its glucose lowering blockbuster Farxiga (dapagliflozin). 8 November 2022
US drug developer Ionis Pharmaceuticals saw its shares close down 8.5% at $40.98 on Friday, after it revealed that its licensing partner, Germany’s Bayer, had pulled out of a deal for the development of fesomersen. 5 November 2022
Shares of French biotech Quantum Genomics were decimated on Friday after its revealed efficacy results for firibastat in its Phase III study FRESH in treatment-resistant hypertension (TRH), are non-significant versus placebo. The stock plunged 90% to 0.33 euros. 31 October 2022
Australia’s largest biotech CSL Limited today revealed it has entered into a strategic option and license agreement with Arizona, USA-based Translational Sciences for rights to its enhanced thrombus (blood clot) dissolving drug candidate, TS23. 26 October 2022
Sales and income were both down at Swiss pharma giant Novartis for the third quarter of 2022, with the company missing analyst estimates on both measures. 25 October 2022