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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
USA-based Perosphere and Japanese drug major Daiichi Sankyo(TYO: 4568) have entered into a clinical trial agreement under which Daiichi Sankyo will support and co-sponsor a Phase I clinical study testing the safety, tolerability and effectiveness of PER977 to reverse the anticoagulant activity of edoxaban, Daiichi Sankyo's investigational oral, once-daily, direct factor Xa-inhibitor. 25 April 2013
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) has entered into a non-exclusive agreement with drug major Bristol-Myers Squibb (NYSE: BMY) to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of B-MS' investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus (HCV) infection, genotype 1. 23 April 2013
Pharmaceutical
US Pharma giant Merck & Co (NYSE: MRK) has opened its new pharmaceutical manufacturing facility in Hangzhou, China, which will package Merck medicines for China and the Asia Pacific region and will become a critical part of the group's global supply chain, and involved an investment of nearly $120 million. 19 April 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) this morning (April 19) issued final draft guidance recommending German drugmaker Bayer's (BAYN: DE) Xarelto (rivaroxaban) as a clinically and cost-effective option for treating pulmonary embolism (PE) and preventing recurrent deep vein thrombosis (DVT) and PE after acute PE in adults. The draft guidance has been issued to consultees for appeal and published on the NICE web site for information. 19 April 2013
Pharmaceutical
Japanese mid-sized drugmaker Otsuka Pharmaceutical (TYO: 4578) says that the US Food and Drug Administration has accepted for priority review the company's New Drug Application for the potential use of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The drug is already approved for the treatment of hyponatremia. 12 April 2013
Pharmaceutical
Canadian specialty pharma firm Pivotal Therapeutics (CNSX: PVO), with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, has announce that Vascazen met its primary endpoint in the REVEAL trial. Vascazen is the second to market prescription only Omega-3 therapy available in the USA and is available by prescription nationwide. 9 April 2013
Pharmaceutical
One of the most widely used drugs to treat arrhythmias, amiodarone, may increase the risk of developing cancer, especially in men and people exposed to high amounts of the drug. That is the conclusion of a new retrospective study published early on-line in CANCER, a peer-reviewed journal of the American Cancer Society, released by Wiley Science today. The study's results indicate that a potential link between amiodarone and cancer warrants further investigation. 8 April 2013
Pharmaceutical
Privately-held Japanese drugmaker Kowa and pharma major Daiichi Sankyo (TYO: 4568) say they will be ending their joint marketing partnership for sales of Livalo (pitavastatin calcium) tablets, a cholesterol-lowering agent, and Olmetec (olmesartan medoxomil) tablets, an antihypertensive agent, as of June 30, 2013. 7 April 2013
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) examined the added benefit of apixaban, US drug majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer's (NYSE: PFE) Eliquis, which has been approved in Germany since November 2012 for the prevention of embolism and stroke in adults with non-valvular atrial fibrillation. 5 April 2013
Generics
Australian drug developer Alchemia (ASX: ACL) says its commercialization partner, India's Dr Reddy's Laboratories (NYSE: RDY) has launched Alchemia's US Food and Drug Administration-approved generic anti-coagulant fondaparinux in India. This is the first time fondaparinux has been made available outside the USA since the product was launched in July 2011. 4 April 2013
Generics
People who regularly take statins to reduce high cholesterol will see lower hospitalization rates according to a new study presented at the Academy of Managed Care Pharmacy (AMCP)'s 25th Annual Meeting & Expo in San Diego, USA. The study was conducted by pharmacy benefit manager Prime Therapeutics (Prime) and Blue Cross and Blue Shield Minnesota. 4 April 2013
Pharmaceutical
Clinical data and the opinions of interviewed thought leaders indicate that there is little to distinguish between current regimens utilized for the treatment and secondary prophylaxis of deep vein thrombosis (DVT)/pulmonary embolism (PE), as these regimens are initiated with use of a short-term injectable anticoagulant prior to long-term anticoagulation with warfarin, according to a new report from health care advisory firm Decision Resources. 28 March 2013
Biotechnology
US cardiovascular drug developer Aastrom Biosciences (NasdaqCM: ASTM) has announced a strategic change in its R&D programs to focus on the clinical development of its lead product, ixmyelocel-T, for the treatment of dilated cardiomyopathy (DCM). 28 March 2013
Pharmaceutical
New Zealand's Pharmaceutical Management Agency, PHARMAC, is seeking feedback on a proposal to fund the antiplatelet agent ticagrelor (Brilinta) through a provisional agreement with its maker, Anglo-Swedish drug major AstraZeneca (LSE: AZN). In summary, this proposal would result in ticagrelor being fully funded from June 1, 2013, for patients diagnosed with acute coronary syndromes who meet the Special Authority criteria. 26 March 2013
Generics
Anglo-Swedish drug major AstraZeneca (LSE: AZN) has entered into a settlement agreement in its US patent infringement litigation against USA-based Watson Laboratories, Actavis (NYSE: ACT; formerly known as Watson Pharmaceuticals but changed its trading name after acquiring Actavis), and Hungarian drugmaker EGIS Pharmaceuticals regarding Watson's proposed rosuvastatin zinc product. 25 March 2013
Biotechnology
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said on Friday that it is recommending a marketing authorization be granted for US biotech firm Biogen Idec's (Nasdaq: BIIB) Tecfidera (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP, on the basis of quality, safety and efficacy data submitted by Biogen Idec, considers there to be a favorable benefit-to-risk balance for the drug. 25 March 2013
Pharmaceutical
The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication - a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk - should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks. 22 March 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN), ahead of its Investor Day briefing in New York later today, announced two major alliances to bolster its research productivity. The firm's new chief executive, Pascal Soriot, who just a few days ago revealed plans for a major overhaul of its research sites including 1,600 job cuts (The Pharma Letter March 19), said: "Our vision is clear - to be a global biopharmaceutical company with a focused portfolio in core therapy areas, underpinned by distinctive science and a growing late-stage pipeline, with sound financials offering attractive returns for investors." 21 March 2013
Pharmaceutical
Patients taking high potency statins for high blood pressure are at a 34% higher risk of being hospitalized for acute kidney injury (AKI), compared with those taking low potency statins, a paper published today (March 20) on bmj.com suggests. 20 March 2013
Pharmaceutical
A new perspective from the US Food and Drug Administration states the agency has not changed its recommendations regarding German family-owned drug major Boehringer Ingelheim's Pradaxa (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations. 19 March 2013
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