Underlying M&A activity appeared to pick up in the second quarter after a slow start to the year, when tumbling equity markets put the frighteners on dealmakers. 17 July 2016
Shares of US clinical-stage biotech Sage Therapeutics surged 51% pre-market, on positive top-line results from its Phase II clinical trial of its lead candidate SAGE-547 for the treatment of severe postpartum depression (PPD). 12 July 2016
At its July meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. 11 July 2016
RedHill Biopharma together with IntelGenx today announced the signing of an exclusive license agreement with Grupo Juste for the commercialization of Rizaport in Spain, and a right of first refusal for additional territories. 6 July 2016
US-based specialty pharma company Insys Therapeutics has received US Food and Drug Administration (approval for its cannabis-derived drug Syndros. 6 July 2016
Investment research firm Edison has raised its valuation on German specialty pharma company Paion but decreased the earnings per share (EPS) assessment after the out-licensing of certain rights to Italian drugmaker Cosmo Pharmaceuticals. 6 July 2016
The European Commission (EC) has granted marketing authorization for Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (RMS). 6 July 2016
Bial said today that its Ongentys (opicapone) for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission. 5 July 2016
Daiichi Sankyo and Belgian drugmaker UCB today announced the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Vimpat (lacosamide). 4 July 2016
The US not-for-profit organization the Institute for Clinical and Economic Review (ICER) has posted a draft scoping document which will inform a report on drug therapies for treatment of relapsing-remitting multiple sclerosis (RRMS). 4 July 2016
Swedish drug developer Orexo has granted Mundipharma’s network of independent associated companies´ exclusive global (ex-US) rights to Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII), for treatment of opioid dependence. 1 July 2016
US drugmaker OPKO Health has entered a definitive agreement under which OPKO will acquire Transition Therapeutics, a Canada-based clinical stage biotechnology company. 30 June 2016
Stronger warnings are needed on drugs that can cause patients to lose control of their behavior, leading to pathological gambling, hypersexuality, and compulsive shopping or eating, Public Citizen said in a petition to the US Food and Drug Administration. 29 June 2016
Ireland-headquartered Shire saw its shares rise 3.3% to 4,384 pence today after it released new clinical trial results for its investigational attention-deficit hyperactivity disorder (ADHD) candidate SHP465. 29 June 2016
The marketing application submitted by Swiss pharma giant Roche or Ocrevus (ocrelizumab) to treat two forms of multiple sclerosis has been accepted for review by both the European and US regulators. 28 June 2016
The UK’s GW Pharmaceuticals has announced positive results of the first randomized, double-blind, placebo-controlled Phase III trial of Epidiolex (cannabidiol or CBD) for Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. 28 June 2016
Italian CNS-focused drug developer Newron Pharmaceuticals’ key value driver is safinamide (branded Xadago), a once daily oral add-on therapy for all stages of Parkinson's disease with a unique dual mechanism of action. 23 June 2016
The US Food and Drug Administration has announced the approval of a supplemental New Drug Application (sNDA) modifying the risk evaluation mitigation strategy (REMS) for Sabril (vigabatrin) from Danish CNS drug specialist Lundbeck. 23 June 2016
Mundipharma International today announced that Penthrox (low dose methoxyflurane) has been granted marketing authorization in France for the emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain. 21 June 2016
Mitsubishi Tanabe Pharma today revealed that a New Drug Application has been submitted to the US Food and Drug Administration for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease. 20 June 2016
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