https://www.epmmagazine.com/new-drug-development-approvals-regulatory-news/index.rss The latest pharmaceutical manufacturing news and developments on new drug development and regulations throughout pharmaceutical industries and the pharma manufacturing supply chain en-gb © Rapid Life Sciences Ltd, a Rapid News Group Company. All Rights Reserved. Thu, 16 Sep 2021 14:15:43 -0000 The first patient has been dosed with psilocybin in a world-first clinical trial exploring how the hallucinogenic medicine can treat Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA). https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/first-patient-dosed-with-psilocybin-in-headache-study/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/first-patient-dosed-with-psilocybin-in-headache-study/ Thu, 16 Sep 2021 14:15:43 -0000 Headache.png Biopharmaceutical company MGC Pharmaceuticals has had its cannabinoid treatment for drug-resistant epilepsy approved for import in the UK by the Medicine and Healthcare products Regulatory Agency (MHRA). https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/mhra-approves-cannabinoid-treatment-for-epilespy/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/mhra-approves-cannabinoid-treatment-for-epilespy/ Mon, 13 Sep 2021 11:00:00 -0000 Medical cannabis The National Institute for Health and Care Excellence (NICE) has launched its most wide-ranging review into the way it develops recommendations across its health technology evaluation programmes. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nice-launches-wide-ranging-consultation-to-update-health-tech-evaluation/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nice-launches-wide-ranging-consultation-to-update-health-tech-evaluation/ Thu, 19 Aug 2021 10:50:00 -0000 evaluation.png Pharmaceutical company Shorla Pharma is teaming up with commercial services supplier EVERSANA to support the launch and commercialisation of its oncology portfolio. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/shorla-pharma-partners-with-eversana-to-support-launch-of-ca/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/shorla-pharma-partners-with-eversana-to-support-launch-of-ca/ Wed, 18 Aug 2021 13:15:00 -0000 Cancer research.png The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new indication for GW Pharmaceutical’s cannabidiol for the treatment of tuberous sclerosis complex (TSC). https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/mhra-approves-new-indication-for-gw-s-cannabidiol/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/mhra-approves-new-indication-for-gw-s-cannabidiol/ Fri, 13 Aug 2021 13:45:00 -0000 cannabidiol.png Medical device company Terumo has teamed with immunotherapy developer PhotonPharma on a collaboration to develop a vaccine for solid tumours. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/photonpharma-terumo-to-collaborate-on-cancer-vaccine/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/photonpharma-terumo-to-collaborate-on-cancer-vaccine/ Fri, 13 Aug 2021 12:50:00 -0000 Oncology Pharmaceutical company AstraZeneca’s treatment for chronic kidney disease has been granted approval in the EU. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/astrazeneca-treatment-for-kidney-disease-granted-approval-in-eu/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/astrazeneca-treatment-for-kidney-disease-granted-approval-in-eu/ Mon, 09 Aug 2021 10:00:59 -0000 kidneys.png The National Institute for Health and Care Excellence (NICE) has used a new pilot to approve a drug for severe plaque psoriasis, in a bid to speed up the approval process for certain medicines. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nice-approv/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nice-approv/ Wed, 04 Aug 2021 13:45:00 -0000 fast-track.png The National Institute for Health and Care Excellence (NICE) has granted conditional marketing authorisation for a treatment targeting a rare form of bile duct cancer. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nice-approves-treatment-for-rare-form-of/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nice-approves-treatment-for-rare-form-of/ Fri, 23 Jul 2021 10:37:30 -0000 cancer cell.png Paula Urruticoechea Ioanna Stefani Cécile Matthews Charles River Associates (CRA) assesses the changes to the Autorisation Temporaire d’Utilisation (ATU) programme and what it means for patients with diseases where there is an unmet need in therapies. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/reforms-in-the-french-atu-system-increased-payer-recognition/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/reforms-in-the-french-atu-system-increased-payer-recognition/ Tue, 13 Jul 2021 08:45:00 -0000 France health.png A biotech spin-out from Cancer Research UK has been given FDA approval to trial its T-cell therapy in humans. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/cancer-research-uk-spinout-to-trial-t-cell-therapy/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/cancer-research-uk-spinout-to-trial-t-cell-therapy/ Tue, 22 Jun 2021 10:40:00 -0000 blood cancer research.png The German Parliament has approved legislation that could help accelerate patient access to cell and gene therapies by addressing a bureaucratic barrier that delayed their availability in hospitals. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/germany-approves-legislation-to-improve-gene-therapy-availab/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/germany-approves-legislation-to-improve-gene-therapy-availab/ Tue, 15 Jun 2021 13:30:00 -0000 Gene therapy.jpg Caraway Therapeutics will work together with Abbvie to develop therapies for Parksinson’s disease and other neurodegenerative disorders, the companies have announced. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/caraway-therapeutics-and-abbvie-collaborate-to-develop-thera/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/caraway-therapeutics-and-abbvie-collaborate-to-develop-thera/ Thu, 10 Jun 2021 12:59:14 -0000 Neurology.png Reece Armstrong The FDA has approved Biogen’s Alzheimer’s drug Aduhelm making it the first new treatment for the disease to come to market since 2003. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/fda-approves-controversial-alzheimer-s-drug-from-biogen/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/fda-approves-controversial-alzheimer-s-drug-from-biogen/ Thu, 10 Jun 2021 09:52:02 -0000 Alzheimers.png The UK’s only bile duct cancer charity, AMMF, and experts from the University of Nottingham are collaborating on research investigating possible treatments for this primary liver cancer. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/university-of-nottingham-and-ammf-target-new-treatments-for-/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/university-of-nottingham-and-ammf-target-new-treatments-for-/ Tue, 01 Jun 2021 08:35:00 -0000 Cancer research.png A malaria vaccine undergoing testing has become the first to have reached efficacy levels of 75%, a target set out by the World Health Organisation (WHO). https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/malaria-vaccine-first-to-reach-who-efficacy-level-in-clinica/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/malaria-vaccine-first-to-reach-who-efficacy-level-in-clinica/ Tue, 27 Apr 2021 10:37:03 -0000 Malaria The FDA has accepted a filing for oncology company Shorla Pharma’s T-cell leukaemia treatment, SH-111. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/shorla-pharma-s-leukaemia-treatmet/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/shorla-pharma-s-leukaemia-treatmet/ Fri, 23 Apr 2021 10:25:00 -0000 Shorla Pharma One of the world’s first artificial intelligence (AI)-designed molecules for immuno-oncology is to enter human clinical trials in an effort to treat patients with advanced solid tumours. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/ai-designed-molecule-to-enter-clinical-trials/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/ai-designed-molecule-to-enter-clinical-trials/ Fri, 09 Apr 2021 09:07:53 -0000 AI The Jenner Institute has been awarded $2 million to develop a vaccine to prevent gonorrhoea, in a bid to combat the bacterial infection’s resistance to most antibiotics. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/jenner-institue-developing-gonorrhoea-vaccine/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/jenner-institue-developing-gonorrhoea-vaccine/ Thu, 01 Apr 2021 13:34:31 -0000 Antibiotic resistance Five teams of scientists have been awarded up to £1 million each to find new way of preventing and treating cancers found in children and young people. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/five-cancer-projects-targeting-disease-in-children-given-gre/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/five-cancer-projects-targeting-disease-in-children-given-gre/ Fri, 26 Mar 2021 11:15:00 -0000 Oncology Mental health company Novamind has been selected to work alongside pharmaceutical company Merck & Co on a clinical trial focused on treatment-resistant depression (TRD). https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/novamind-partners-with-merck-on-depression-trial/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/novamind-partners-with-merck-on-depression-trial/ Mon, 22 Mar 2021 11:05:00 -0000 Depression Speciality chemicals provider Evonik has entered into a supply agreement with the biotechnology company Cassava Sciences. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/evonik-to-supply/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/evonik-to-supply/ Tue, 09 Mar 2021 14:29:07 -0000 Alzheimer's NHS England has been granted access to the world’s most expensive drug to treat infants with a rare and often fatal disease. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nhs-england-granted-access-to-novartis-gene-therapy/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/nhs-england-granted-access-to-novartis-gene-therapy/ Mon, 08 Mar 2021 12:16:47 -0000 Spinal x-ray A new treatment for the rare childhood illness Duchenne Muscular Dystrophy (DMD) could be possible due to the work scientists have done to “rescue” muscle cells that have genetically mutated. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/new-drug-molecules-could-lead-to-treatment-for-rare-disease/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/new-drug-molecules-could-lead-to-treatment-for-rare-disease/ Tue, 23 Feb 2021 12:37:45 -0000 Research A combination of chemotherapy and immunotherapy could be key to treating lymphoma that has spread to the brain or spine, according to a new study published Lancet Haematology. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/largest-ever-clinical-trial-points/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/largest-ever-clinical-trial-points/ Tue, 26 Jan 2021 23:35:00 -0000 Blood Test A new drug target for the treatment of schizophrenia is being investigated in a partnership between the University of Oxford, the Earlham institute, and global pharmaceutical companies Biogen and Boehringer Ingelheim https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/research-collaboration-targets-new-treatment-for-schizophren/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/research-collaboration-targets-new-treatment-for-schizophren/ Mon, 25 Jan 2021 11:45:00 -0000 MRI The MS Society has described the National Institute for Health and Care Excellence’s (NICE) decision not to recommend a new treatment for people with multiple sclerosis as “frustrating”. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/ms-sociey/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/ms-sociey/ Fri, 22 Jan 2021 11:36:25 -0000 MS The chairman of a major pharmaceutical company is urging businesses to act now if they are to be ready for new trading rules between the UK and EU in 2021. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/morningside-pharmaceuticals-urges-industry-to-act-on-new-bre/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/morningside-pharmaceuticals-urges-industry-to-act-on-new-bre/ Fri, 18 Dec 2020 12:20:00 -0000 brexit The world’s first clinical trial to treat depression using a type of psychedelic chemical will begin its first phase next year. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/worlds-first-clinical-trial-for-depression/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/worlds-first-clinical-trial-for-depression/ Mon, 14 Dec 2020 11:30:00 -0000 Mental Health Roche has announced a partnership with Moderna to use the Elecsys Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/moderna-to-use-roche-s-covid-19-diagnostic-test-in-vaccine-t/ https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/moderna-to-use-roche-s-covid-19-diagnostic-test-in-vaccine-t/ Mon, 14 Dec 2020 10:05:00 -0000 Clinical Trials