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Pharmaceutical
The global antithrombotic drug market will reach a value of $24.3 billion in 2015, compared with $22.7 billion in 2011, according to a new report for business information provider Visiongain. 18 February 2013
Pharmaceutical
Swedish Orphan Biovitrum (STO: SOBI) says that it has entered into a distribution agreement with privately-held PharmaSwiss to market four products approved for the treatment of indications within the oncology, cardiovascular and anti-infective therapy areas. Financial terms of the deal were not disclosed. 13 February 2013
Pharmaceutical
Rapidscan Pharma Solutions (RPS) EU has entered into an agreement with Mallinckrodt Medical BV for the exclusive right to promote and distribute Rapiscan (regadenoson) in France, Italy, Belgium and Spain. RPS' US parent acquired rights to the product (excluding the USA, Canada and Mexico) from Gilead Sciences in 2010. Financial terms of the accord were not disclosed. 11 February 2013
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) has received a favorable ruling from the US Court of Appeals for the Federal Circuit (Washington) in its patent dispute with Mylan (Nasdaq: MYL) over its cholesterol lowerers Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), according to reports by Bloomberg and Reuters. 8 February 2013
Pharmaceutical
Germany's Bayer (BAYN: DE) and Janssen Pharmaceuticals, a part of US health care giant Johnson & Johnson (NYSE: JNJ), have entered into a clinical collaboration with USA-based Portola Pharmaceuticals to evaluate the safety of PRT4445, an investigational antidote for Factor Xa inhibitors, in healthy volunteers who have been administered their oral anticoagulant Xarelto (rivaroxaban). 6 February 2013
Biotechnology
USA-based The Medicines Company (Nasdaq: MDCO) has formed an exclusive global alliance with RNAi therapeutics company Alnylam Pharmaceuticals (Nasdaq: ALNY) for the development and commercialization of the latter's ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia. 5 February 2013
Biotechnology
The European Medicines Agency has launched a six-month public consultation on the revised guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (LMWHs). 3 February 2013
Generics
The introduction of generic statins has kick-started a decline that will see the global statins market lose over $7 billion in revenue by 2018, states the latest report by business intelligence providers GBI Research. 30 January 2013
Biotechnology
The US Food and Drug Administration yesterday approved Sanofi (Euronext: SAN) subsidiary Genzyme's orphan drug Kynamro (mipomersen sodium) injection as an addition to lipid-lowerers and diet to treat patients with a rare type of inherited high cholesterol called homozygous familial hypercholesterolemia (HoFH). 30 January 2013
Pharmaceutical
Negative NICE final guidance for Pierre Fabre's Javlor in bladder cancer; fast-track FAD for Eliquis
In final guidance published (January 23, 2013), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has not recommended National Health Service use of French independent drugmaker Pierre Fabre's Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract which has progressed following prior treatment with platinum-containing chemotherapy. This confirms a previous negative draft final guidance on the drug (The Pharma Letter March 11, 2011). 23 January 2013
Pharmaceutical
The Brazilian market for atrial fibrillation will increase at a rate of 31% per year from 2011 to 2016, according to advisory firm Decision Resources new Emerging Markets report titled Atrial Fibrillation in Brazil, which finds that this dramatic growth will be fueled by an increased drug-treated population and the proliferation of treatment alternatives for stroke prophylaxis in atrial fibrillation. 22 January 2013
Biotechnology
Netherlands-based biotech firm Dezima Pharma says it has in-licensed a cholesteryl ester transfer protein (CETP) inhibitor DEZ-001 (formerly TA-8995) from Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508). Financial terms of the deal were not disclosed. 22 January 2013
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech firm, announced top-line results of the Phase III Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, showing the study did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, 95% CI 0.90, 1.13). 18 January 2013
Pharmaceutical
At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) assessed available data related to safety concerns over Merck & Co's (NYSE: MRK) cholesterol drug Tredaptive, Pelzont and Trevaclyn - identical medicines containing the active ingredients nicotinic acid and laropiprant - and recommended that the marketing, supply and authorizations of these medicines be suspended across the European Union. 13 January 2013
Generics
China, abundant in heparin raw materials, has become one of the world's largest heparin API producers and exporters, owing to the quality of heparin active pharmaceutical ingredient (API) having won international recognition gradually, according to a new report added to the offering of Reportlinker.com. 13 January 2013
Pharmaceutical
Norway's Pronova BioPharma (OSE: PRON.OL), recently the subject of a $845 million takeover bid from Germany's BASF (The Pharma Letter November 22, 2012), and partner Takeda Pharmaceutical (TYO: 5402) announced yesterday that Lotriga (omega-3-acid ethyl esters 90) granular capsule 2g is now available for the treatment of hyperlipidemia in Japan. 11 January 2013
Biotechnology
South Korean drugmaker Shin Poong Pharmaceutical (KOSPI: 019170) and France's Laboratoire francais du Fractionnement et des Biotechnologies (LFB) have signed a term sheet for the establishment of a joint venture for the production and supply of biotechnology medicinal products. 11 January 2013
Generics
US drugmaker Forest Laboratories (NYSE: FRX) has entered into a settlement agreement with US subsidiaries of India's Glenmark in patent infringement litigation brought by Forest in response to Glenmark's Abbreviated New Drug Application seeking approval to market generic versions of Forest's Bystolic (nebivolol) tablets. 3 January 2013
Pharmaceutical
The US Food and Drug Administration on December 28 finally approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem which is co-marketing by Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE), leading the shares of the companies to rise 1.9% to $31.90 and just under 1% to $24.99, respectively. 31 December 2012
Biotechnology
The US Food and Drug Administration has recently approved emerging US biotech firm Aegerion Pharmaceuticals' (Nasdaq: AEGR) Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). 28 December 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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