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Biotechnology
The US Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. 22 December 2017
Biotechnology
Hot on the heels of an out-licensing deal for China, vTv Therapeutics has entered into a global agreement with Reneo Pharmaceuticals, a privately-held biotech company focused on developing treatments for orphan diseases. 22 December 2017
Pharmaceutical
Boehringer Ingelheim Pharmaceuticals Inc (BIPI) has agreed to distribute $13.5 million among all 50 US states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday. 21 December 2017
Biotechnology
CSL Limited and privately-held Canadian drug developer Vitaeris have entered into a strategic collaboration and purchase option agreement to expedite the development of clazakizumab (an anti-interleukin (IL)6 monoclonal antibody (MAb), formerly ALD518) as a therapeutic option for solid organ transplant rejection. 6 December 2017
Biotechnology
The US Food and Drug Administration has granted Amgen a label extension for Repatha, to include prevention of heart attacks and strokes. 4 December 2017
Pharmaceutical
AstraZeneca today announced a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China. 27 November 2017
Pharmaceutical
The Organization for Economic Cooperation and Development (OECD) continues to bring bad news about the health status of the Hungarian population. 20 November 2017
Pharmaceutical
New data showed that Jardiance (empagliflozin) reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease. 15 November 2017
Biotechnology
In addition to a wealth of previous data, Swiss pharma giant Novartis has now published a new analysts of a Phase III trial of its canakinumab and said that it expects to file for regulatory approval of the drug this year as a treatment for a group of heart attack survivors that are most likely to benefit. 14 November 2017
Pharmaceutical
Indian drugmaker Zydus Healthcare today announced that the Mexico regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval to commercialize Lipaglyn (saroglitazar magnesium) in Mexico. 10 November 2017
Pharmaceutical
The UK’s AstraZeneca has released third quarter results showing revenue of $6.2 billion, a 9% rise from the same period last year, amid continuing generic competition around big sellers such as cholesterol pill Crestor. 9 November 2017
Pharmaceutical
An application has been lodged with the European Medicines Agency to extend the label for Xarelto, in combination with aspirin, to treat coronary artery disease (CAD) or peripheral artery disease (PAD). 7 November 2017
Generics
Ireland-incorporated Endo International has revealed that two of its subsidiaries have filed suit in the US District Court for the District of Columbia against the Food and Drug Administration. 31 October 2017
Pharmaceutical
Bristol-Myers Squibb has posted profits from the latest quarter that missed analysts’ expectations. 26 October 2017
Biotechnology
Switzerland-based Idorsia today announced its financial results and an update on its research progress, which represent the business activity in the three and a half months since the demerger from Actelion on June 15, 2017, following the $30 billion acquisition by Johnson & Johnson. 24 October 2017
Pharmaceutical
On the politics scene, the biggest topic was US President Donald Trump’s executive order on the Affordable Care Act in his continuing attempt to rid the country of Obamacare. In terms of company news attracting attention, there were disappointing clinical trial results on Eli Lilly’s Verzenio; Good news for AstraZeneca’s Imfinzi and Tagrisso in lung cancer; and Merck & Co finally nailing the coffin on its cholesterol drug candidate anacetrapib. 15 October 2017
Pharmaceutical
Shares in Merck & Co were off 1% at $63.63 in after-hours trading, after the New Jerseyan giant revealed it would drop its experimental cholesterol drug anacetrapib. 12 October 2017
Pharmaceutical
Eliciting comment last week was news that a US judge had reversed an earlier ban on the marketing of cholesterol treatment Praluent in a long-running court battle between Amgen and the drug’s makers – Regeneron and Sanofi and ordering a re-trial. Also attracting attention was mid-stage data on Capricor Therapeutics’ Duchenne muscular dystrophy agent CAP-1002; strong Phase III results with Zogenix’ rare epilepsy drug candidate ZX008; and positive results for Ablynx’ rare blood disorder candidate caplacizumab. 8 October 2017
Biotechnology
In its patent infringement case against Sanofi’s new atopic dermatitis drug Dupixent, Amgen has secured a win courtesy of the US Patent and Trademark Office’s Patent Trial and Appeal Board, who refused an inter partes review of its patent on the grounds that not enough evidence had been brought to invalidate it. 6 October 2017
Biotechnology
Capricor Therapeutics saw its shares leap 21% to $3.97 pre-market today after it presented encouraging data on CAP-1002 in Duchenne muscular dystrophy (DMD). 4 October 2017
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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