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Biotechnology
Global biotech leader Amgen (Nasdaq: AMGN) has announced positive results from the AMG 145 Phase II GAUSS study, in patients with high cholesterol who cannot tolerate statins, such as all-time blockbuster Pfizer's Lipitor (atorvastatin) which is now off patent in the USA. 7 November 2012
Pharmaceutical
Life Science Entrepreneurs, a Spanish company dedicated to the early-stage development of high-risk/very high return ventures, has announced the conclusion of a first investment for an antiplatelet drug candidate code-named NmC. 6 November 2012
Pharmaceutical
In a follow up to a 2011 safety communication, the US Food and Drug Administration has evaluated new information about the risk of serious bleeding associated with use of German family-owned drug major Boehringer Ingelheim's anticoagulant Pradaxa (dabigatran etexilate), concluding that rates of gastrointestinal bleeding and intracranial hemorrhage were no higher in Pradaxa patients than in those using the older drug, warfarin, that it was designed to replace. 6 November 2012
Biotechnology
French drug major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN) say that the ODYSSEY OUTCOMES trial, a Phase III cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. The drug candidate is part of a new class of medicines to treat patients who cannot lower their low density lipoprotein (LDL) cholesterol through widely used statin, and has been forecast as having blockbuster status. 5 November 2012
Biotechnology
The US Food and Drug Administration (FDA) late Friday approved German drug major Bayer's (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), ie, leg and lung blood clots, and to reduce the risk of recurrent DVT and PE. 5 November 2012
Pharmaceutical
Portola Pharmaceuticals, Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) last week announced a clinical collaboration to conduct a proof-of-concept study of PRT4445 and the investigational oral Factor Xa inhibitor Eliquis (apixaban). PRT4445 is a universal Factor Xa inhibitor antidote in clinical development designed to reverse the anticoagulant activity of any Factor Xa inhibitor. No agents are approved to reverse the activity of Factor Xa inhibitors. 5 November 2012
Generics
In the USA, the cost paid for statins (drugs to lower cholesterol) in people under the age of 65 who have private insurance continues to exceed comparable costs paid by the government in the UK by more than three fold. These results from Boston University's Boston Collaborative Drug Surveillance Program are a follow up of an ongoing comparison of prescription drug costs between the USA and UK. The initial results reported on relative drug costs in 2005. The current updated results for 2009 appear this week in the journal Pharmacotherapy. 4 November 2012
Pharmaceutical
Among a batch of news for drugmakers released last Friday, the European Medicines Agency's Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Japanese drug major Astellas (TYO: 4503) Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. 22 October 2012
Biotechnology
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory yesterday voted by nine to six that Kynamro (mipomersen sodium) should be approved for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), though expressing some safety concerns. The drug is being developed by Sanofi (Euronext: SAN) subsidiary Genzyme in partnership with Isis Pharmaceuticals (Nasdaq: ISIS). 19 October 2012
Pharmaceutical
Belgian drugmaker ThromboGenics NV (Euronext Brussels: THR) yesterday received US Food and Drug Administration approval for Jetrea (ocriplasmin) USA for the treatment of symptomatic vitreomacular adhesion (VMA), a progressive sight threatening condition. Jetrea is the first pharmacological agent to be approved for this indication. 19 October 2012
Pharmaceutical
The Indian subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday launched its patented antiplatelet drug Brilinta (ticagrelor), used to prevent heart attack, after receiving approval from the Drug Controller General of India (DCGI). 18 October 2012
Pharmaceutical
Drug developer Theravance (Nasdaq: THRX) has signed a collaboration agreement with pharma giant Merck & CO (NYSE: MRK) to discover, develop and commercialize novel small molecule therapeutics directed towards a target being investigated for the treatment of hypertension and heart failure, worth a potential $153 million. 17 October 2012
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has received approval from the US Food and Drug Administration of its Abbreviated New Drug Application for trospium chloride extended-release capsules, the generic equivalent to Allergan's (NYSE: AGN) Sanctura XR. 14 October 2012
Biotechnology
A study published in The Lancet found that participants in a Phase I clinical trial saw their level of low density lipoprotein (LDL) cholesterol, or “bad” cholesterol, fall by up to 57% as a result of taking ALN-PCS. 3 October 2012
Biotechnology
In what turns out to be a very busy couple of days for French drug major Sanofi (Euronext: SAN), the company announced an acquisition, revised terms for an off patent best-seller and presented strong clinical data on two of its drugs. 3 October 2012
Pharmaceutical
There was a flurry of announcements from Japan's Ministry of Health, Labor and Welfare (MHLW) on Friday, the first of which was good news for German drug major Bayer (BAYN: DE) and US partner Regeneron (Nasdaq: REGN), with the news that the regulator has approved the companies' Eylea (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). 1 October 2012
Pharmaceutical
The US Food and Drug Administration has acknowledged receipt of the New Drug Application resubmission for pharma major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of March 17, 2013. 28 September 2012
Pharmaceutical
Canada-based Cardiome Pharma (Nasdaq: CRME) saw its shares go into free-fall, dropping 54.4% to close at $0.88, after the company revealed that its partner, drug giant Merck & Co (NYSE: MRK), will return the global marketing and development rights for both the intravenous (IV) and oral formulations for vernakalant, a treatment for chronic atrial fibrillation, to Cardiome. 27 September 2012
Pharmaceutical
In final guidance issued this morning (September 26), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended National Health Service use of German family-owned drug major Boehringer Ingelheim's Actilyse (alteplase) for the treatment of acute ischemic stroke. 25 September 2012
Pharmaceutical
Phase III study results released by Swiss drug major Novartis (NOVN: VX) yesterday show that its investigational drug RLX030 (serelaxin; trade name Relaxin) reduced all-cause mortality in patients with acute heart failure (AHF). The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases. 25 September 2012
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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