Article Listing - R&D Spending Up 300% At Powderject
Positive Ph III results for Novo Nordisk's FIX derivative for hemophilia B
20 May 2013
Danish insulin giant Novo Nordisk (NOV: N) says it has completed paradigm 2, the first Phase III trial with a long-acting FIX derivative, N9-GP (glycopegylated recombinant factor IX), for hemophilia B patients, with successful results. Paradigm 2 is a multicenter, blinded trial evaluating the safety and efficacy of N9-GP when used for on-demand or prophylactic treatment in patients with haemophilia B.
CIS countries prepare for the introduction of drug reimbursement schemes
20 May 2013
Russia, Ukraine and Kazakhstan have recently taken steps to introduce drug reimbursement schemes similar to those functioning in other countries. If introduced, these could completely change the operating environment on both the generic and innovative drug markets in these countries.
Stallergenes and DBV Technologies partner on developing novel respiratory allergies treatments
20 May 2013
French biotech firms DBV Technologies (Euronext: DBV), creator of Viaskin, a new standard in the treatment of allergies, and Stallergenes (Euronext Paris CAC small), worldwide leader in allergen immunotherapy, have entered into a strategic research partnership.
Lundbeck and Takeda's Brintellix shows positive results in Ph III major depression study
20 May 2013
Danish CNS specialist Lundbeck (LUND: DC) and partner Takeda Pharmaceutical (TYO: 4502), Japan's largest drugmaker, are presenting new data on four pivotal studies on Brintellix (vortioxetine), a novel investigational drug, at the 2013 Annual Meeting of the American Psychiatric Association (APA) in San Francisco, taking place May 18-22, demonstrating efficacy at doses of 15mg and 20mg per day including an improvement of overall functioning.
Access to medicines in Europe: the EU cannot save banks while sacrificing people's health
20 May 2013
In a seminar hosted last week by the Group of the Progressive Alliance of Socialists & Democrats (S&D) in the European Parliament and the Member of the European Parliament (MEP), Alejandro Cercas (S&D, Spain), six MEPs from various political groups, along with representatives of governments, leading academics, researches and public health organizations met to raise awareness about one of the most alarming issues that European health care systems face - the increasingly inadequate public access to medicines and its dire consequences, according to a web posting by the European Public Health Alliance.
Greek research-based drugmaker group AIFD challenges generics assumptions in Draft Patent Law
20 May 2013
One of the most important preconditions for Turkey to reach a reformist, sustainable economic growth with high-added-value and to attract more direct foreign investment is to create an effective patent system at international standards, protecting intellectual property rights, comments the research-based Turkish pharma industry group, the AIFD.
HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst
20 May 2013
While the risks involved in HIV vaccine development have turned Big Pharma away from pursuing a preventative vaccine, government-funded organizations and smaller biotech firms may provide the answer, a GlobalData analyst has said in a research note as World AIDS Vaccine Day approaches.
Elan makes "transformational" acquisitions and a divestment
20 May 2013
Ireland-headquartered Elan Corp (NYSE: ELN) (Elan) this morning announced a series of transactions designed to decisively transform and advance the company. Upon shareholder approval, the totality of these strategically driven decisions, in addition to the $1 billion Theravance royalty participation agreement and dividend pass through announced last week (The Pharma Letter May 13) and the previously completed $3.23 billion Tysabri (natalizumab) transaction with Biogen Idec, will form a dynamic and unique business foundation for Elan in the years ahead. Elan is at the same time fighting off a hostile takeover approach from Royalty Pharma (TPLs passim).
Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines
20 May 2013
India's National Pharmaceutical Pricing Authority (NPPA) last week announced plans that will bring down the prices of essential medicines, increase the number of drugs under price control, and alter the way the government regulates prices in the 720 billion-rupee ($13.17 billion) domestic market.
SciClone gains China rights to Zensun's Neucardin
20 May 2013
USA-based SciClone Pharmaceuticals (Nasdaq: SCLN) today announced that the Company has entered into an agreement with Zensun (Shanghai) Science & Technology granting SciClone a license and the exclusive rights in China, Hong Kong and Macau to promote, market, distribute and sell Neucardin, a genetically engineered recombinant peptide fragment of neuregulin-1 and a novel, first-in-class therapeutic drug for the treatment of patients with intermediate to advanced chronic heart failure (CHF).
- Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- US FDA advisory panel backs approval of Merck & Co's suvorexant, but only at lower doses
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- Positive new data on Novartis' Galvus in elderly type 2 diabetes patients
