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Generics
US drugmaker Forest Laboratories saw its share drop 8.7%, to $29.63 in late trading yesterday, after reports from Reuters and other news services that a Food and Drug Administration panel of external experts had voted against approval of its new drug Daxas (roflumilast). The drug was licensed for US development from Swiss pharmaceutical firm Nycomed in a deal which included an upfront payment of $100 million, plus milestones and royalties (The Pharma Letter August 11, 2009). 8 April 2010
Pharmaceutical
Italian drugmaker Recordati has signed a license agreement with Esteve, a leading Spanish pharmaceutical company, for the marketing and sales in Spain of pitavastatin, a novel statin for the treatment of hypercholesterolemia. 8 April 2010
Pharmaceutical
Swiss drugmaker Nycomed and its partner, USA-based Baxter International, have received the approval for TachoSil, a surgical patch, from the US Food and Drug Administration. TachoSil has been approved as an adjunct to hemostasis (control of bleeding) in cardiovascular surgery. 7 April 2010
Pharmaceutical
Japanese drug major Daiichi Sankyo has submitted a New Drug Application to the domestic Ministry of Health, Labor and Welfare seeking approval of the anticoagulant edoxaban, for the prevention of venous thromboembolism (VTE) after major orthopedic surgery. 7 April 2010
Pharmaceutical
The launches and widespread uptake of novel oral anticoagulants will drive the venous thromboembolism drug market to nearly double from $2.9 billion in 2008 to more than $5 billion in 2018 in the USA, France, Germany, Italy, Spain, the UK and Japan, suggests advisory firm Decision Resources. 1 April 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca and the USA's Abbott Laboratories announced yesterday that the US Food and Drug Administration issued a complete response letter for the New Drug Application for Certriad (rosuvastatin/fenofibric) acid delayed release capsules for the treatment of elevated cholesterol levels. The news sent out worrying signals, and the UK-headquartered firm saw its share price dip 1.3% to 29.42 shortly after the news. 31 March 2010
Biotechnology
The USA's pharmaceutical research and biotechnology companies are developing 234 medicines for the special health care needs of children, according to a new report released by the trade group Pharmaceutical Research and Manufacturers of America (PhRMA). 31 March 2010
Pharmaceutical
There was some positive news for French drug major Sanofi-Aventis late yesterday, when the UK's National Institute for Health and Clinical Excellence (NICE) in England and Wales published a new appraisal consultation document for Multaq (dronedarone) indicating its intention to recommend use of the drug for the management of patients with atrial fibrillation (AF). 30 March 2010
Pharmaceutical
According to Progenericos, the Brazilian Association of the Generic Drug Industry, more than 7 million pills of US drug behemoth Pfizer's Viagra (sildenafil) were sold in Brazil in 2007, representing a market value of around $210 million reals ($116.8 million). It is estimated that, with the end of patent protection of Viagra, its current price will decrease from between 35% and 50%, notes a blogger on the IP Tango web site. 29 March 2010
Generics
US drug behemoth Pfizer has been found by a jury yesterday to have committed racketeering fraud in the marketing of its epilepsy drug Neurontin ((gabapentin) and must pay $142.1 million in damages, according to multiple media reports. "The message, if there was a message, is that they acted in a fraudulent manner," said Hank Pierotti, foreman of the eight-person federal jury in Boston, after the verdict. "If you're fraudulent, you deserve to be punished,' he stated, noted Bloomberg. 26 March 2010
Generics
European Medicines Agency (EMEA) yesterday afternoon recommended a precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH and has revealed that an application for a copy version of a diabetes drug has been withdrawn. 26 March 2010
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) has outlined the most effective drugs that health care professionals in general and community settings should prescribe adults with neuropathic pain, a potentially debilitating condition that affects thousands in the UK. This is the first time that a clinical guideline has been published in this area. 25 March 2010
Pharmaceutical
The French Transparency Commission, which recommends medicines' reimbursement prices under the country's health system, has given a low rating to domestic drug major Sanofi-Aventis' cardiovascular drug Multaq (dronedarone), according to a report by the local newspaper La Tribune, causing the company's shares to drop as much as 3% before recovering for a dip of 0.4% to 56.33 euros yesterday, as investors reassessed their views on the drug's potential. 24 March 2010
Pharmaceutical
French drug major Sanofi-Aventis and marketing partner USA-based Bristol-Myers Squibb received good news this morning with European approval of their dual antiplatelet combination tablet DuoPlavin/DuoCover (clopidogrel 75mg and acetylsalicylic acid 100mg or 75 mg) by the European Commission. 24 March 2010
Generics
The Canadian pharmaceutical market is expected to continue on an upward compound annual growth rate (CAGR) of 2.55% in US dollar terms and 4.3% in local currency terms, according to Business Monitor International. Growth will be driven by the ageing population which will increase demand for chronic diseases medicines. BMI also expects pricing reforms to influence this outlook, although until patented and generic drug prices are more aligned across provinces and territories we will maintain our current view on spending. 23 March 2010
Pharmaceutical
US patients and health care providers were warned by the Food and Drug Administration last Friday about the potential for increased risk of muscle injury from the now off-patent but once blockbuster cholesterol-lowerer simvastatin at the top approved dosage of 80mg. 22 March 2010
Generics
Following three days of meetings last week, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) reviewed further results from clinical studies and post-marketing experience for all three centrally-authorized pandemic influenza vaccines, gave a positive opinion on Hospira's filgrastim and gave a positive opinion on Tarceva (erlotinib) in non-small cell lung cancer. 22 March 2010
Generics
India-based Ranbaxy and its US subsidiary have reached an agreement with Japan's largest drugmaker, Takeda, resolving outstanding patent litigation related to Ranbaxy's generic version of the diabetes drug Actos (pioglitazone) 15mg, 30mg and 45mg tablets. 16 March 2010
Pharmaceutical
The US Food and Drug Administration last Friday called for a new boxed warning to the blockbuster anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the compound to convert it to its active form. It also said it is seeking input on how to increase transparency in its interactions with regulated industry. 15 March 2010
Biotechnology
UK drug giant GlaxoSmithKline as been granted marketing authorization from the European Commission for Revolade (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). 15 March 2010
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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