Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
US pharma major Eli Lilly has announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer's disease. 13 September 2024
US neurological diseases specialist Ovid Therapeutics has announced the promotion of Meg Alexander to president and chief operating officer (COO). 12 September 2024
The global migraine market in mature economies is projected to grow from $9.2 billion in 2023 to $16.4 billion by 2033, according to a report from GlobalData. 10 September 2024
Cartesian Therapeutics today announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). 9 September 2024
California’s Lykos Therapeutics is still trying to regroup after being rocked by the US Food and Drug Administration’s (FDA) rejection of midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD). 6 September 2024
The cost of prescribed dependency-forming medicines has decreased by £410 million ($539.6 million) since 2015/16, according to newly released data from the UK’s National Health Service (NHS). 6 September 2024
Shares in US biopharma Axsome Therapeutics, a biopharmaceutical company developing and delivering novel therapies for the management of CNS disorders, closed 7% higher on Wednesday. 5 September 2024
Mid-Atlantic BioTherapeutics (MABT) has announced a collaboration with Accelero Biostructures to identify novel inhibitors of USP30, a protein linked to neurological disorders and other conditions. 5 September 2024
Praxis Precision Medicines shared positive top-line results for its Phase II, proof of concept study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathy (DEE) patients. 4 September 2024
Clinical-stage biotech firm Prothena said today that it will receive the $30 million upfront payment from Swiss drug major Roche a result of the license agreement having become effective upon the expiration of the Hart-Scott-Rodino waiting period. 23 January 2014
US pharma behemoth Pfizer has released top-line results from a Phase III study of ALO-02 (oxycodone HCl and naltrexone HCl extended-release capsules) showing that the investigational agent met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo. 23 January 2014
Lundbeck (LUN: CO) and Takeda Pharmaceutical (TYO: 4502) jointly announced today that Brintellix (vortioxetine) for the treatment of major depressive disorder in adults is available in pharmacies across the USA. 22 January 2014
In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi’s biotech subsidiary Genzyme’s oral multiple sclerosis drug Aubagio (teriflunomide). 22 January 2014
Israel-based Teva Pharmaceutical Industries seems set to bag ownership of US drugmaker NuPathe), which was already in a deal to be acquired by Endo Health Solutions, with the company accepting Teva's higher bid first announced earlier this month (The Pharma Letter January 9). 21 January 2014
Switzerland-based Santhera Pharmaceuticals (SIX: SANN) announced today that the French National Agency for Medicines and Health Products Safety (ANSM) has granted a temporary authorization for use (ATU) for Raxone (idebenone) in the treatment of Leber's Hereditary Optic Neuropathy (LHON). 21 January 2014
Swiss drug major Roche (ROG: SIX) has revealed disappointing results from two Phase III studies of its investigational medicine bitopertin (RG1678) in adults with persistent, predominant negative symptoms of schizophrenia. 21 January 2014
Privately-held drugmaker Mundipharma International has acquired exclusive global rights to a family of patents for heroin substitution, including a morphine/naloxone combination from Switzerland-based Phoenux. 20 January 2014
An unprecedented $122 million increase for Alzheimer's research, education, outreach and caregiver support stemming from the efforts of Alzheimer's Association advocates was passed swiftly by the US Congress on January 16. 17 January 2014
The US Food and Drug Administration is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325mg of acetaminophen per tablet, capsule, or other dosage unit. 16 January 2014
Ireland-headquartered drugmaker Jazz Pharmaceuticals has inked an agreement with the USA’s Aerial BioPharma to acquire rights to ADX-N05, a novel compound in clinical development by Aerial for the treatment of excessive daytime sleepiness in patients with narcolepsy. 14 January 2014
Based on positive Phase II data, US drug major Eli Lilly has acquired all development rights for a calcitonin gene-related peptide (CGRP) antibody currently being studied as a potential treatment for the prevention of frequent, recurrent migraine headaches. 13 January 2014
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of proposals to amend access to sugammadex and atomoxetine and to fund baclofen injection in the community. 13 January 2014
Swedish research based company NovaSAID (a Karolinska Development portfolio firm) and Cadila Pharmaceuticals, one of India’s largest privately-held pharmaceuticals companies, have entered into a strategic partnership to develop new treatments for inflammation and pain in conditions such as rheumatoid arthritis. 10 January 2014
Dutch pharma company InteRNA Technologies has entered into a collaboration with the Neuroallianz Consortium, an academic industry partnership with Belgian drugmaker UCB and the Rheinische Friedrich-Wilhelms-University of Bonn in Germany. 10 January 2014
California, USA-based Adamas Pharmaceuticals revealed yesterday (January 9) that it has received $40 million in milestone payments under its collaboration with Forest Laboratories for MDX-8704 10 January 2014
In yet another negative opinion from the German Institute for Quality and Efficiency in Health Care (IQWiG) this week, the agency has issued a negative view of French drug major Sanofi’s multiple sclerosis drug Aubagio (teriflunomide). 8 January 2014
Shares of Neurocrine Biosciences were up almost 80% yesterday after it announced that NBI-98854, a small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia symptoms. 8 January 2014
The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil Hydrochloride 5mg and 10mg tablets, a generic version of Japanese drug major Eisai’s Aricept, from Health Canada. 8 January 2014
US specialty drugmaker Impax Laboratories has entered into an agreement with fellow USA-based DURECT granting Impax the exclusive worldwide rights to develop and commercialize Eladur, DURECT’s investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN). 7 January 2014