Patient Access Scheme: guidance for companies considering a proposal in England
Source: Department of Health (DH) Area: News Guidance for companies considering a Patient Access Scheme (PAS) proposal in England has been published.  Please see the link below for further information. (Source: NeLM - News)
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Regulatory application filed in Japan for simeprevir for the treatment of genotype 1 hepatitis C
Source: BioSpace Area: News According to a BioSpace report, a regulatory application has been submitted to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV.   Simeprevir is an oral once-daily NS3/4A protease inhibitor in late Phase III clinical development. The application is supported by data from four Japanese phase III clinical s...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Review: Muscular dystrophies
Source: Lancet Area: News This Seminar on muscular dystrophies discusses their clinical manifestations, molecular pathogenesis, diagnostic strategy, and therapeutic developments. (Source: NeLM - News)
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices 'Behind the Headlines' assessment of press reports that a "new antiviral may help in flu fight"
Source: NHS Choices Area: News The 'Behind the Headlines' service from NHS Choices has featured a quality assessment of press reports that a 'flu drug shows promise in overcoming resistance' (BBC news and other; 22nd Feb 2013).   The reports are based on early stage laboratory and animal research, which examined the effectiveness of a possible new antiviral treatment for flu. It was found in the laboratory to be similarly or more effective than zanamivir at stopping the influenza virus from spreading between cells, including strains with demonstrated resistance to oseltamivir and zanamivir. The chemical was also...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Voluntary US recall of peginesatide injection due to postmarketing reports of serious hypersensitivity reactions
Source: FDA Area: News The US FDA is informing the public about a voluntary recall of all lots of peginesatide (Omontys®) injection. This action is being taken due to new postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, that have occurred within 30 minutes after administration.   Peginesatide injection is licensed in the US for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis. It is not currently licensed in the EU but a Marketing Authorisation Application is currently under review by the European Medicines Agency (see link below).   ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Vaccine Update: February 2013
Source: Department of Health (DH) Area: News The February 2013 issue of the Vaccine Update bulletin is now available. The current issue discusses the following issues:   . Pertussis vaccine uptake in pregnant women . increasing numbers of flu cases . the commissioning of immunisation services after 1 April 2013 . European Immunization Week and World TB Day . vaccine deliveries for the Easter and May Bank holidays . updates on the availability of a variety of vaccines   Please see the link below for details. (Source: NeLM - News)
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

CHMP recommends approval of Privigen® (human normal immunoglobulin) for chronic inflammatory demyelinating polyneuropathy
Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a variation to the terms of the marketing authorisation for Privigen® (human normal immunoglobulin). The CHMP recommends the adoption of a new indication: the treatment of adults, and children and adolescents (0-18 years) with chronic inflammatory demyelinating polyneuropathy (CIDP).  Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.   Detailed recommendations for the use of this product will be described in ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

CHMP recommends approval of sodium phenylbutyrate (Pheburane®) for urea cycle disorders
Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the granting of a marketing authorisation for sodium phenylbutyrate (Pheburane®) as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.  It is indicated in all patients with neonatal-onset presentation, and in patients with late-onset disease who have a history of hyperammonaemic encephalopathy.   Sodium phenylbutyrate ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

HMP recommends approval of extension to Cervarix® human papillomavirus vaccine therapeutic indication
Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of an extension to the therapeutic indication for the Cervarix® human papillomavirus vaccine.   The full proposed indication would be as follows (with the changes in bold):   "Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic human papillomavirus (HPV) types."   Detailed recommendations fo...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

CHMP recommends refusal of Qsiva® (phentermine/ topiramate) marketing authorisation following re-examination
Source: European Medicines Agency Area: News Following a re-examination of a previous opinion, the Committee for Medicinal Products for Human Use (CHMP) has confirmed its recommendation to refuse the marketing authorisation for Qsiva® (phentermine and topiramate), intended for the treatment of obesity.   The CHMP noted concerns about the long-term cardiovascular effects of Qsiva® (particularly those of the phentermine component, which is known to increase heart rate). There were additionally concerns about the long-term psychiatric and cognitive effects related to the topiramate component. Topiramate is also ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

CHMP recommends approval of Imatinib Actavis
Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the granting of a marketing authorisation for Imatinib Actavis for the treatment of:   . Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.   . Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.   ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

EMA recommends approval of 6-in-1 paediatric vaccine
Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new paediatric vaccine intended for the primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib). The new vaccine will be commercialised under the brand name Hexyon® in Western European countries and Hexacima® in Eastern European countries.   Please see the links below for fu...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: US FDA approves ado-trastuzumab emtansine or T-DM1 (KadcylaT) for HER2-positive metastatic breast cancer
Source: BioSpace Area: News The US FDA has approved the antibody-drug conjugate ado-trastuzumab emtansine or T-DM1 (KadcylaT) for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with trastuzumab (Herceptin®) and a taxane.   KadcylaT, which is composed of the cytotoxic agent DM1 conjugated to trastuzumab, is the first antibody-drug conjugate to be approved by the FDA for the treatment of metastatic breast cancer. The approval was based on the results of the EMILIA Phase III study (n=991), which compared KadcylaT alone to lapatinib in combination with capecit...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Phase III safety study of once-daily fluticasone furoate plus vilanterol in the treatment of asthma
Source: Thorax Area: News The results of a Phase III study evaluating the safety of an investigational combination of fluticasone furoate and vilanterol in the treatment of asthma have been published early online in Thorax.   The authors note that long-acting ?2 agonists (LABA) are recommended in combination with inhaled corticosteroids (ICS) for patients with asthma who remain symptomatic on low-medium dose ICS alone. The ICS fluticasone furoate (FF), together with the LABA vilanterol (VI), are in development as a novel, once-daily ICS/LABA combination inhaler for asthma and chronic obstructive pulmonary disease...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Colestilan (BindRen®) approved in the EU for treatment of hyperphosphataemia in adults with CKD
Source: European Medicines Agency Area: News Colestilan (BindRen®) has been approved in the EU for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. Further details of this product, including the European Public Assessment Report, are available via link below.   (Source: NeLM - News)
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news