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Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Biotechnology
Ascendis Pharma has granted fellow Denmark-based Novo Nordisk an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases. 4 November 2024
Pharmaceutical
Swiss pharma giant Novartis revealed rising sales and earnings in its third-quarter financial results on Tuesday. 29 October 2024
Pharmaceutical
Denmark-based Novo Nordisk’s oral semaglutide, marketed as Rybelsus for type 2 diabetes, has not gained much presence in the GLP-1 receptor agonists (GLP-1RAs) market despite its approval in 2019, as its injectable alternatives prove to have higher efficacy and results both in diabetes and obesity patients. 28 October 2024
Pharmaceutical
Germany’s Bayer has entered into an exclusive licensing agreement with privately-held Dewpoint Therapeutics for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. 25 October 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 23 October 2024
Pharmaceutical
Philadelphia, USA-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn (iloprost), the only FDA-approved treatment for severe frostbite in the USA. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
Pharmaceutical
Johnson & Johnson has reported revenue of $22.5 billion for the third quarter of 2024, a 5.2% increase year-over-year. 15 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Pharmaceutical
AstraZeneca has entered into an exclusive license agreement with China’s CSPC Pharmaceutical to advance the development of an early stage, novel small molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia. 7 October 2024
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
Canada-based Cardiome Pharma (TSX: COM) has signed an agreement with Austrian firm AOP Orphan Pharmaceuticals to commercialize Brinavess (vernakalant intravenous) in select European markets. 4 July 2013
Pharmaceutical
German pharma major Bayer (BAYN: DE) has today (July 2) revealed results of an open-label, single-center, parallel-group Phase I study showing that three- and four-factor prothrombin complex concentrates (PCCs) can reverse the anticoagulant effect measured by coagulation assays in study participants treated with the oral anticoagulant Xarelto (rivaroxaban). 2 July 2013
Biotechnology
Dutch biotech company Pharming Group (NYSE Euronext: PHARM) and Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Group company, have entered into a strategic collaboration for the development, manufacture and commercialization of new products based on the Pharming technology platform. 2 July 2013
Pharmaceutical
Janssen Research & Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ) revealed on Friday (June 28) that US Food and Drug Administration has issued a complete response letter for the supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) - partnered with German drug major Bayer (BAYN: DE) - to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS). 1 July 2013
Pharmaceutical
Canada's Resverlogix (TSX:RVX) saw its share go into free fall on June 27, when the company announced that its Phase IIb ASSURE clinical trial evaluating its lead drug candidate RVX-208 in high-risk cardiovascular patients with low high-density lipoprotein (HDL) did not meet its primary endpoint of a -0.6% change in percent atheroma volume as determined by intravascular ultrasound (IVUS). 28 June 2013
Pharmaceutical
US drugmaker Forest Laboratories (NYSE:FRX) has announced positive top-line results from an eight-week pivotal Phase III clinical trial evaluating the efficacy and safety of investigational fixed dose combination (FDC) of nebivolol and valsartan (Novartis' now off patent blockbuster Diovan) for the treatment of hypertension. 28 June 2013
Pharmaceutical
Canada-based Cardiome Pharma (TSX: COM) has announced adoption of the decision by the European Commission of the transfer of the centrally-approved marketing authorization for Brinavess (vernakalant intravenous) from Merck & Co (NYSE: MRK), which announced last year that it would return rights to the drug (The Pharma Letter September 27, 2012). 27 June 2013
Pharmaceutical
USA-based SciClone Pharmaceuticals (Nasdaq: SCLN) yesterday (June 25) has announced an agreement with biopharmaceutical company Taiwan Liposome (TLC), which grants the US firm a license and the exclusive rights to promote, market, distribute and sell ProFlow, intended for the treatment of peripheral arterial disease (PAD), in China, Hong Kong and Macau. 26 June 2013
Biotechnology
US biotech firm Isis Pharmaceuticals (Nasdaq: ISIS) saw its shares leap as much as 22% to $26.89 on Monday, after the company revealed that it investigation drug reduced triglycerides in blood and increased the level of "good" cholesterol. 25 June 2013
Pharmaceutical
Family-owned German drug major Boehringer Ingelheim has submitted an application to the European Medicines Agency) for use of Pradaxa (dabigatran etexilate) for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE. Rival drug Xarelto (rivaroxaban), from Germany's Bayer, gained European approval for DVT and PE last year (The Pharma Letter November 21, 2012). 25 June 2013
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation status to RLX030 (serelaxin), an investigational drug for patients with acute heart failure (AHF), Swiss pharma major Novartis (NOVN: VX) announced this morning (June 21). 21 June 2013
Pharmaceutical
Following a launch scheduled for 2015 for the treatment of chronic heart failure (CHF), Swiss drug major Novartis' (NOVN: VX) novel combination drug LCZ-696 will rapidly dominate the global CHF therapeutics sector and mark a drug development paradigm shift, says research and consulting firm GlobalData. 21 June 2013
Biotechnology
Sweden-based Athera Biotechnologies, which is 65% owned by Karolinska Development, has entered into an option agreement with Boehringer Ingelheim on a novel preclinical antibody program, whereby Athera grants the family-owned German drug major an exclusive option to acquire the entire program. Athera's fully-human monoclonal antibody is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death. 19 June 2013
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday (June 18) that it has received an offer for its thrombosis brands and Notre-Dame de Bondeville (NDB) site from Aspen Global and Aspen Pharmacare (JSE: APN), South Africa's largest drugmaker. A period of exclusivity has been agreed with Aspen and GSK will respond to the offer subject to consultation with employees and the relevant works councils. 19 June 2013
Pharmaceutical
Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for the antiplatelet agent prasugrel for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI). Analysts at Credit Suisse have a net present value for prasugrel of 78.19 yen per share (4% of total) for Daiichi Sankyo. 18 June 2013
Biotechnology
US drugmaker Santarus (Nasdaq: SNTS) and Netherlands-based Pharming Group (NYSE Euronext: PHARM) say that the US Food and Drug Administration has accepted for filing the Biologics License Application for the investigational drug Ruconest (recombinant human C1 esterase inhibitor) 50IU/kg. Ruconest is approved in Europe for the treatment of acute angioedema attacks in patients with HAE. 18 June 2013
Pharmaceutical
In India, some key cancer drugs, antibiotics and medicines to treat cardiovascular diseases and tuberculosis are set to become cheaper by up to 50% within the next 45 days. The National Pharmaceutical Pricing Authority (NPPA) will shortly notify prices of as many as 150 packs of essential medicines in line with the new pharma pricing policy, according to official sources quoted by the Indian newspaper the Business Standard. 17 June 2013
Pharmaceutical
America's biopharmaceutical research companies are developing 215 medicines for two of the leading causes of death of Americans - heart disease and stroke, according to a new report and overview released yesterday (June 12) by the Pharmaceutical Research and Manufacturers of America (PhRMA). 13 June 2013
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