Novartis files Migraine drug, erenumab, with the EMA

novartis-logoNovartis has filed its migraine drug erenumab with the EMA, putting it in a vital position amongst pharma companies competing to develop a new class of drugs to treat the debilitating condition.

The Swiss drug company has stated that erenumab is the first monoclonal antibody inhibiting calcitonin gene-related peptide (CGRP) to be filed with the European regulator. Continue reading

NICE recommends use of Lartruvo for soft tissue sarcoma in England and Wales

NICE LogoPatients with soft tissue sarcoma in England and Wales look set to gain routine NHS access to Eli Lilly’s Lartruvo after NICE backed funding for the drug in draft guidelines.

Lartruvo in combination with doxorubicin has been recommended by the cost regulators as an option for advanced soft tissue sarcoma in adults who have not had any previous systemic chemotherapy for advanced soft tissue sarcoma and cannot have curative treatment with surgery or their disease does not respond to radiotherapy. Continue reading

NICE recommends Allergan’s Ozurdex and AbbVie’s Humira for Uveitis to prevent vision loss.

NICE LogoNational Institute for Health and Care Excellence in England and Wales are backing routine use of Allergan’s Ozurdex and AbbVie’s Humira as treatment for non-infectious posterior uveitis, which is a form of preventable vision loss.

The cost regulators published their Final Appraisal Determination recommending the drugs as cost and clinically-effective treatment options for those with sight-threatening posterior non-infectious posterior uveitis. Continue reading

Eleven therapies put forward to the EMA for EU approval

EMAEleven new medicines have been put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, including new options for a rare eye disease, schizophrenia and cartilage defects.

Oxervate won backing as a treatment for moderate or severe neurotrophic keratitis, a rare eye disease that can lead to loss of sight. Continue reading

FDA priority review given to Bayer’s investigational blood cancer drug

Bayer announces that its investigational blood cancer treatment, copanlisib, has been awarded priority review designation from the FDA, thereby meaning the regulator pledges to review the product within a six-month timeframe.

The blood cancer drug is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. It is indicated in the treatment of follicular lymphoma. A regular subtype of indolent non-Hodgkin’s lymphoma, in cases where the disease has seen resurgence after use of two previous therapies. In Phase 2 trials, the drug proved its promising efficacy, causing cancer to recede in around 60% of patients. Continue reading

First Immunotherapy for High Risk Neuroblastoma approved for use in the EU

EU regulators have issued approval for the first immunotherapy for high-risk neuroblastoma, which will offer a new treatment option to thousands of children affected by the rare and devastating form of cancer.

EUSA Pharma’s dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen (GD2) on neuroblastoma cells, now indicated to treat the condition in children aged 12 months and above. Continue reading

National Institute for Health and Care Excellence approves Lilly’s Psoriasis Drug

eli lilly logoPatients with plaque psoriasis will be able to gain routine access to Eli Lilly’s Taltz on the NHS within the next three months if they meet certain eligibility criteria.

NICE, has published final guidelines backing use of the drug but only if the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, and has not responded to standard systemic therapies or patients can’t take them. Continue reading

Double fast-track status awarded to Enzyvant’s rare disease drug by FDA

Swiss biopharma start-up Enzyvant has gained double fast track status from the FDA for its new rare disease candidate RVT-802.

The investigational tissue-based therapy is for the treatment of complete DiGeorge Syndrome (cDGS), which represents a tiny subset of patients with the rare condition, DiGeorge Syndrome which is caused by a single gene defect. Continue reading

FDA reverses decision on home genetic testing kit developed by Google backed company

The USA’s FDA has officially approved a home genetic test kit developed by 23andMe, after several years of instructing the company to stop providing the service.

The regulator has given the authorisation to a 23andMe kit that tests for gene sequences linked to 10 diseases or conditions that include Alzheimer’s and Parkinson’s disease. A move which is expected to open the door for more direct-to-consumer genetic test approvals. Continue reading