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Among last week’s news of note, Alnylam seems to have had a windfall in terms of a deal with Blackstone that, in exchange for royalty rights on inclisiran, a potential treatment for heterozygous familial hypercholesterolemia, it will get $2 billion funding. On the regulatory front, AstraZeneca gained US Food and Drug Administration approval for its rare disease drug Koselugo (selumetinib). Standing out among a significant amount of novel coronavirus news, was the planned collaboration of two ‘Big Pharmas’ – GlaxoSmithKline and Sanofi – to work on a potential COVID-19 vaccine. Also, although reports from Chinese trials on Gilead Sciences’ candidate remdesivir were disappointing, the company’s own studies, which have yet to report officially, anecdotally, show more promise. 19 April 2020
Biotechnology
The USA’s Blackstone revealed today that it will provide up to $2 billion to support Alnylam’s advancement of innovative RNA interference (RNAi) medicines that have the potential to transform the lives of patients suffering from a range of debilitating diseases. 14 April 2020
Pharmaceutical
The European Commission has approved both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) for use in adults with primary hypercholesterolemia or mixed dyslipidemia in Europe. 6 April 2020
Pharmaceutical
Much as COVID-19 was the focus of news last week, other things were happening too. Among these, Danish CNS specialist Lundbeck suffered a couple of signification setbacks, first with Tourette syndrome candidate Lu AG06466, and then even worse, with Parkinson’s hopeful foliglurax. There was better news for Bayer and Merck & Co, whose heart failure drug vericiguat saw positive results presented at the American College of Cardiology’s meeting. On the legal front, there was a major disappointment for Amarin, when a US court declared that the company’s patents on its fish oil-based cardiovascular drug Vascepa were not valid. Deal-making news included Daiichi Sankyo acquiring gene therapy manufacturing technology from Ultragenyx, signalling an interest in expanding the company’s focus. Also, Fate Therapeutics agreed a deal with Johnson & Johnson for rights to its iPSC platform. 5 April 2020
Pharmaceutical
Fish oil-based drug Vascepa (icosapent ethyl) could make a smaller splash than Amarin had hoped, after a US court nixed part of its patent estate. 31 March 2020
Pharmaceutical
A new sub-analysis of the landmark Phase III DAPA-HF trial has showed positive efficacy for Farxiga (dapagliflozin) in treating cardiovascular conditions. 30 March 2020
Pharmaceutical
New data has been presented on vericiguat, an orally-administered soluble guanylate cyclase (sGC) stimulator being developed to treat patients with heart failure with reduced ejection fraction and following a worsening event. 30 March 2020
Biotechnology
Novartis has announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. 30 March 2020
Pharmaceutical
Deal-making news last week featured Bayer’s announcement on Monday that it is teaming up with India’s Curadev to use the latter’s STING antagonists to develop therapies across a range of indications. Also, Silence Therapeutics has inked a deal with AstraZeneca worth up to $400 million on siRNA therapeutics, including SLB360. Among research news, Novavax presented new data on its flu vaccine candidate NanoFlu that compared it with Sanofi’s Fluzone. Regulatory news included Food and Drug Administration approval for Bristol-Myers Squibb’s multiple sclerosis drug Zeposia. Also, in an unusual move, Gilead Sciences asked the FDA to rescind Orphan Drug designation for its anti-viral candidate remdesivir, which is now been investigating as a possible COVID-19 treatment. 29 March 2020
Pharmaceutical
Following the March 23-26 meetings of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), outcomes of reviews on three groups of medicines have been announced. These are as follows: 28 March 2020
Pharmaceutical
Japan has become the latest country to approve AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) for hyperkalemia. 26 March 2020
Biotechnology
UK novel RNA therapeutics specialist Silence Therapeutics saw its sales rocket 32% to 535.00 pence as markets opened today, as it announced a strategic collaboration with AstraZeneca to discover, develop and commercialize small interfering RNA (siRNA) therapeutics for cardiovascular, renal, metabolic and respiratory diseases. 25 March 2020
Pharmaceutical
Shares of Canadian drug developer Milestone Pharmaceuticals (Nasdaq: MIST) were down a massive 75% at $10.51 in pre-market trading today, after its announcement on Monday of disappointing top-line results from its Phase III, multicenter, randomized, double-blind, placebo-controlled NODE-301 trial of its investigational new drug, etripamil nasal spray. 24 March 2020
Biotechnology
Germany’s Bayer and Indian drug discovery firm Curadev Pvt Ltd today announced a research collaboration and license agreement for Curadev’s Stimulator of Interferon Genes (STING) antagonist program. 23 March 2020
Pharmaceutical
Advanz Pharma has reached agreement to acquire all of the issued and outstanding shares of fellow Canada-based Correvio Pharma. 16 March 2020
Biotechnology
UK company George Health has announced £27 million ($35 million) in new financing to accelerate the commercialization of drugs and technologies for some of the world’s most destructive diseases. 10 March 2020
Biotechnology
Data and analytics firm GlobalData suggest that, out of all the drugs that are currently in the pre-registration phase and are expected to launch in 2020, 10 have the potential to reach blockbuster status over the next six years. 9 March 2020
Pharmaceutical
US regulatory approvals featured significantly in last week’s news, with Esperion Therapeutics receiving Food and Drug Administration clearance for its cholesterol lowering drug Nexletol, marking the company’s first approval. Baudax Bio received FDA approval for its non-opioid pain drug Anjeso and the agency granted approval for Lundbeck’s Vyepti, the first intravenous treatment for migraine. In M&A news, Takeda exercized its option to acquire PvP Biologics, while deals included Sangamo’s collaboration with Biogen for its zinc finger protein technology and Alzheimer’s and Parkinson’s disease. 1 March 2020
Pharmaceutical
A 19% jump in Bayer’s annual sales was still not enough to lift investor anxiety around the mounting Roundup (glyphosate) lawsuits that the company is facing. 27 February 2020
Pharmaceutical
USA-based Esperion Therapeutics last week received its first-ever product approval and yesterday announced another, with the US Food and Drug Administration approving Nexlizet (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C), lowering medicine. 27 February 2020
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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