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Biotechnology
The Japanese business of Swiss biotech Idorsia has launched Pivlaz (clazosentan), a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm. 20 April 2022
Biotechnology
Acoramidis, an orally-administered small molecule transthyretin from US biotech BridgeBio Pharma that is currently being assessed in Phase II and Phase III trials, could compete with Pfizer’s Vyndaqel (tafamidis) in the transthyretin amyloidosis cardiomyopathy (ATTR-CM) and ATTR-polyneuropathy (ATTR-PN) market. 13 April 2022
Biotechnology
Japan’s largest drugmaker Takeda today announced that the Phase III SHP643-301 study evaluating the safety profile and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients aged two to 13 April 2022
Biotechnology
Among regulatory news last week, the US Food and Drug Administration on Monday advised Alnylam Pharmaceuticals of a three-month delay to its review of the New Drug Application for amyloidosis drug vutrisiran. AstraZeneca released strong results from a Phase IIb trial of its cholesterol lowerer AZD8233. Troubled US biotech bluebird bio last Tuesday announced a significant restructuring program, which would involve a 30% reduction in its workforce. US pharma giant Pfizer announced its first M&A deal this year, agreeing a $525 million bid for RSV vaccine developer ReViral. Also, Biogen reacted angrily to the US Centers for Medicare & Medicaid Services’ (CMS) decision to limit coverage of its Alzheimer’s disease drug Aduhelm. 10 April 2022
Pharmaceutical
AstraZeneca has announced Phase IIb results from the ETESIAN trial that showed AZD8233 reached a statistically-significant and clinically-meaningful reduction (of 73% change) from baseline in low-density lipoprotein cholesterol (LDL-C) levels. 5 April 2022
Pharmaceutical
A new joint guideline published today from the American College of Cardiology, the American Heart Association, and the Heart Failure Society of America, increases the focus on preventing heart failure (HF) in people who are showing early signs of “pre-heart failure,” and updates treatment strategies for people with symptomatic heart failure to include SGLT-2 inhibitor (SGLT2i) medicines 4 April 2022
Pharmaceutical
US pharma major Bristol Myers Squibb has announced impressive results from the Phase III VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT. 4 April 2022
Biotechnology
German life sciences major Bayer underlined its determination to drive breakthrough innovations during an event on Friday. 2 April 2022
article
The Ministry of Health has begun collecting data on drugs that are not produced in Russia as well as a number of “friendly” countries as part of its efforts to prevention their shortage in the domestic market, according to recent statements by an official spokesman of the Ministry and local media, reports The Pharma Letter’s local correspondent. 30 March 2022
Pharmaceutical
Through the Institute of Drug Technology (Farmanguinhos) and independent French laboratory Servier, Fiocruz has signed a Memorandum of Understanding for technical cooperation to develop new drugs against chronic diseases, from a new pharmaceutical platform. 21 March 2022
Pharmaceutical
A post hoc sub-analysis of the REDUCE-IT Study, published in the Journal of the American Heart Association (JAHA), has found that Vascepa (icosapent ethyl) significantly cut the risk of cardiovascular (CV) death, strokes, heart attacks, coronary revascularization, and unstable angina by 34% in those with a history of percutaneous coronary intervention (PCI). 11 March 2022
Biotechnology
Adeno-associated virus (AAV) specialist Voyager Therapeutics has sold options on some of its novel capsids to Novartis. 8 March 2022
Pharmaceutical
Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) has been granted a marketing authorization by the European Commission (EC) for the treatment of adults with symptomatic chronic heart failure. 7 March 2022
Pharmaceutical
German pharma and crop sciences major Bayer shared successful fourth-quarter and full-year 2021 financial results on Tuesday. 1 March 2022
Pharmaceutical
A new broader label for heart med Jardiance (empagliflozin) will help developers Eli Lilly and Boehringer Ingelheim extend the increasingly lucrative franchise. 25 February 2022
Biotechnology
Swiss pharma giant Novartis regained control of the cholesterol lowering drug Leqvio (inclisiran) in July 2021, cutting contractor Corden Pharma out of the loop in a bid to get the regulatory process back on the road, following a regulatory delay, and by December gained US Food and Drug Administration approval of the drug. 23 February 2022
Generics
The High Court in London has ruled against attempts by Servier to limit damages it owes for infringements of competition law in the sale and supply of a widely-prescribed blood pressure drug. 22 February 2022
Biotechnology
Dutch thrombotic diseases specialist TargED Biopharmaceuticals has raised 39 million euros ($44 million) in a Series A financing to accelerate development of its lead compound, Microlyse. 22 February 2022
Biotechnology
Chinese biopharma firm Innovent Biologics has announced that its experimental anti-PCSK9 antibody, named IBI306, has come up trumps in two Phase III trials in China. 18 February 2022
Pharmaceutical
California’s Cytokinetics has announced top-line results from the METEORIC-HF Phase III trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). 16 February 2022
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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