Article Listing - US FDA VITAMINS REGS THIS WEEK
US FDA Benefit-Risk Assessment Plan viewed by PhRMA
10 May 2013
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) says it shares the Food and Drug Administration's belief that a structured approach to benefit-risk assessment can improve and facilitate greater understanding of FDA's regulatory decisions by public stakeholders including patients, consumers, health care professionals and biopharmaceutical companies.
Shire prevails in US Lialda patent dispute with Watson
10 May 2013
Ireland-headquartered drugmaker Shire's (LSE: SHP) subsidiary Shire Development has prevailed in its US litigation against three companies (now trading as Actavis: NYSE: ACT) in connection with their Abbreviated New Drug Application for a generic version of Shire's Lialda (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Launch of Biotie/Lundbeck's Selincro will see a paradigm shift in alcohol addiction market
10 May 2013
US and European psychiatrists and US managed care organization (MCO) pharmacy directors surveyed by advisory firm Decision Resources agree that a therapy's ability to support abstinence is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in the treatment of alcohol addiction.
India's NPPA says drugmakers cannot raise prices of imported products
10 May 2013
At a meeting earlier this month, India's drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has denied a price rise for some imported products from French drug major Sanofi (Euronext: SAN), Lantus (insulin glargine), Switzerland's Novartis (NOVN: VX), Vitalux Plus TR (a multivitamin and minerals supplement for vision & the eye care), and USA-based Allergan (NYSE: AGN), Pred Forte (prednisolone), according to a Business Standard report posted on the NPPA's web site.
ScinoPharm Taiwan and Coland in strategic alliance for generic oncology injectables
10 May 2013
ScinoPharm Taiwan (TSE: 1789.TW) and Coland Holdings (TSE: 4144.TW) have formed a strategic alliance to develop a series of generic oncological drugs for Mainland China. Several active pharmaceutical ingredients (APIs) have been initially selected for development and future sales as injectable formulation products from the list of ScinoPharm-developed APIs. This will allow the companies to compete within the anti-cancer drug market in China and tap into this large and growing business potential.
Novartis' Ilaris gets new indication of childhood arthritis from US FDA
10 May 2013
Swiss pharmaceutical major Novartis (NIVN: VX) said this morning (May 10) that the US Food and Drug Administration has approved its Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older.
Trevena and Forest Labs collaborate on TRV027 for acute heart failure
10 May 2013
US GPCR ligand drug developer Trevena and Forest Laboratories (NYSE: FRX) have entered into a collaborative licensing option agreement for the development of TRV027, an AT1R biased-ligand that recently completed Phase IIa clinical trials. Trevena expects to commence a 500-patient multicenter Phase IIb clinical trial in acute decompensated heart failure (ADHF) by year end.
Unigene and Nordic Bioscience amend JDV accord; Amgen Vectibix China deal
10 May 2013
USA-based Unigene Laboratories (PINK: UGNE) has entered into an equity transfer and exclusive license agreement with Nordic Bioscience, involving three proprietary metabolic peptide analogs for type 2 diabetes, osteoarthritis and osteoporosis developed as part of a joint development vehicle (JDV) established by both companies in October 2011.
Eisai's Fycompa shows clear therapeutic benefit in hard-to-treat epilepsy
10 May 2013
Japanese drug major Eisai's (TYO: 4523) antiepileptic drug (AED) Fycompa (perampanel), shows a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to the investigators of two new analyses on early clinical experience of perampanel, presented on May 9 at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland. Perampanel was approved for use in the Europe Union in July 2012 and is now prescribed in several European countries, including Germany, Austria and Switzerland.
Total real per capita spending on medicines in the USA fell 3.5% in 2012
9 May 2013
Total spending on US medicines fell 3.5 percent on a real per capita basis in 2012 and the use of health care services overall declined for the second consecutive year, according to a new study released today by the IMS Institute for Healthcare Informatics.
- Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines
- Elan makes "transformational" acquisitions and a divestment
- HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst
- CIS countries prepare for the introduction of drug reimbursement schemes
- Greek research-based drugmaker group AIFD challenges generics assumptions in Draft Patent Law
