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Pharmaceutical
Licensing featured in the news last week, with Germany’s MorphoSys announcing a deal with USA-based Incyte to commercialize its B-cell malignancies candidate tafasitamab, and Biogen taking over an early-stage drug from Pfizer - PF-05251749 - which has potential for treating sleep disorders associated with Alzheimer’s and Parkinson’s disease. Also, UK-based Adaptimmune entered into a lucrative collaboration with Japan’s Astellas Pharma on cancer research. Elsewhere, Swiss giant Novartis’ novel arrangement with the UK’s National Health Service for access to its cardiovascular drug inclisiran attracted a fair amount of attention. On the M&A front, German biotech BioNTech said last Thursday it was buying USA-based Neon Therapeutics to boost its T-cell pipeline. 19 January 2020
Pharmaceutical
Novo Nordisk’s once-weekly drug Ozempic (semaglutide) has had its label expanded by the US Food and Drug Administration (FDA). 17 January 2020
Pharmaceutical
One deal skewed the picture in looking at the M&A activity by therapy area in the final quarter of 2019. 16 January 2020
Pharmaceutical
According to a new study, the global atherosclerosis drugs market was valued at ~$ 45.7 billion in 2018, and is expected to expand at a compound annual growth rate (CAGR0 of 2.5% during the forecast period of 2019 to 2027. 16 January 2020
Biotechnology
Swiss pharma giant Novartis has announced a deal with the National Health Service (NHS) that will bring English patients with atherosclerotic cardiovascular disease (ASCVD) access to inclisiran. 14 January 2020
Biotechnology
AstraZeneca and partner Merck & Co today announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the USA for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab. 13 January 2020
Pharmaceutical
London-based Exscientia has entered into a collaboration with Germany’s Bayer (BAYN: DE) with the goal of speeding up the discovery of small molecules focused on cardiovascular disease and oncology. 9 January 2020
Pharmaceutical
USA-headquartered contract research organization (CRO) QPS has formalized its relationship with G-CURE, a cardiovascular research organization originating from and closely linked to the Department of Cardiology at the University Medical Center Groningen (UMCG) in The Netherlands. 7 January 2020
Pharmaceutical
Canadian specialty pharma firm HLS Therapeutics yesterday announced that Vascepa (icosapent ethyl) was added to Health Canada's Register of Innovative Drugs and as a result it will benefit from data protection for a term of eight years from the date of the issuance of the notice of compliance. 7 January 2020
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca’s Farxiga (dapagliflozin) is closer to US approval in a new indication. 6 January 2020
Generics
The US Food and Drug Administration has approved two applications for the first generics of Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 24 December 2019
Pharmaceutical
Ahead of the regulator's expected action date of December 28, the US Food and Drug Administration on Friday approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 milligrams per deciliter or higher. 14 December 2019
Pharmaceutical
Following a negative US Food and Drug Administration advisory panel regarding its cardio drug Brinavess (vernakalant), US specialty pharma company Correvio Pharma today announced plans to explore strategic options to maximize stakeholder value. 11 December 2019
Pharmaceutical
A key advisory panel at the US Food and Drug Administration has recommended against approving heart med Brinavess (vernakalant hydrochloride), voting 11 against and two in favor. 11 December 2019
Pharmaceutical
French pharma major Sanofi was trading 5% higher as Tuesday’s activity entered its final hour, after the company announced a new strategy. 10 December 2019
Pharmaceutical
India's domestic drug market bounced back to growth in November. After clocking just 5.1% expansion in October, India's domestic pharma market registered 14.5% year-on-year growth in November. 9 December 2019
Pharmaceutical
Even after the approval of five new molecular entities (NME) in 2019, the drug launches and pipeline progress at Novartis show no sign of letting up. 5 December 2019
Generics
Bankrupt generic drugmaker Rising Pharmaceuticals has made admissions over charges that it conspired to fix prices and allocate customers for an off-patent hypertension drug. 4 December 2019
Pharmaceutical
The European Medicines Agency has begun its review of a marketing application for Vascepa (icosapent ethyl), from USA-based cardiovascular specialist Amarin. 3 December 2019
Pharmaceutical
Swiss pharma giant Novartis set the scene in M&A news, announcing a $9.7 billion acquisition of US biotech firm The Medicines Company and its cholesterol-lowerer inclisiran. Clinical trials news featured ChemoCentryx, which saw its shares triple on Tuesday after reporting strong Phase III results with its ANCA vasculitis drug candidate avacopan. Last week also saw a second sickle cell disease drug approval from the US Food and Drug Administration, this time Global Blood Therapeutics’ Oxbryta (voxelotor). Meanwhile, Hutchison China MediTech, also known as Chi-Med, gained approval and price listing for its Elunate for advanced colorectal cancer in China. 1 December 2019
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Anthos Therapeutics has presented data at the American Heart Association (AHA) Scientific Sessions from its landmark AZALEA-TIMI 71 study showing that abelacimab led to consistent and substantial reductions in bleeding for patients on or off antiplatelet (APT) therapy, compared to rivaroxaban. 18 November 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. 10 November 2024
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
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
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