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
Recursion (Nasdaq: RXRX) has seen its shares fall by more than 15% following the announcement of Phase II trial results for REC-994, an investigational treatment for symptomatic cerebral cavernous malformation (CCM). 4 September 2024
UK-based Amphista Therapeutics—which calls itself a leader in next generation targeted protein degradation (TPD) approaches—has named Antony Mattessich its new chief executive (CEO) and member of the board of directors. 3 September 2024
Japan’s Nxera Pharma today announced that it will receive a $35 million payment from Neurocrine Biosciences, triggered by the successful completion of the Phase II trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia. 2 September 2024
US pharma giant Merck & Co has opted to pull the plug on two mid-stage trials of Alzheimer’s disease candidate MK-1942, due to safety worries. 26 October 2023
USA-based BioXcel Therapeutics on Wednesday revealed that an independent third-party review of the data from a site in its TRANQUILITY II Phase III trial showed "positive findings." 26 October 2023
Barcelona, Spain-based plasma-derived medicine specialist Grifols saw its shares close down more than 5% at 9.88 euros, despite announcing positive results for a potential Alzheimer’s vaccine candidate. 25 October 2023
After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutics has opted to withdraw its submission. 19 October 2023
October marks the annual Rett Syndrome Awareness Month, a time to examine the support and research being afforded to advance pharmacological treatments for this rare condition. 18 October 2023
In what the company said was a big day for Monte Rosa Therapeutics, a clinical-stage biotech company developing novel molecular glue degrader (MGD)-based medicines, the company announced two major milestones. 17 October 2023
Israeli drugmaker Teva Pharmaceutical Industries has announced that data from the UNITE study presented at the World Congress of Neurology in Montreal, Canada, show that Ajovy (fremanezumab) reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder. 17 October 2023
USA-based CNS disease specialist Supernus Pharmaceuticals has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD). 13 October 2023
In the USA, the National Institutes of Health has outlined significant new investments to support research into amyotrophic lateral sclerosis (ALS). 10 October 2023
Welcome to The Pharma Letter Podcast for a promotional episode, sponsored by Janssen, where we will deep dive into barriers and challenges in treating major depressive disorder (MDD), and finish with a few reasons for optimism. 10 October 2023
US pharma major AbbVie has exercised its exclusive right and completed the acquisition of Mitokinin, a discovery-stage biotechnology company developing a potentially first-in-class disease-modifying treatment for Parkinson's disease (PD). 6 October 2023
On Wednesday, the US Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. 5 October 2023
California-based Vistagen Therapeutics, a company aiming to transform the treatment landscape for anxiety, depression, and other central nervous system (CNS) disorders, has raised $100 million through an underwritten offering of its common stock. 4 October 2023
Karuna Therapeutics has taken a significant step with its submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for KarXT (xanomeline-trospium), its ground-breaking product aiming to revolutionize the treatment of schizophrenia. 28 September 2023
Shares in New York-based stem cell specialist BrainStorm Cell Therapeutics have fallen around half ahead of the opening bell, after the firm provided a negative regulatory update. 28 September 2023
Having been collaborating for a decade, US RNA-targeted drug developer Ionis Pharmaceuticals and Swiss pharm giant Roche have signed a new agreement. 28 September 2023
California, USA-based biotech AcuraStem has entered into a license agreement with Japan’s largest pharma company Takeda to develop and commercialize AcuraStem's PIKFYVE targeted therapeutics including AS-202, an innovative antisense oligonucleotide (ASO) for the treatment of amyotrophic lateral sclerosis (ALS). 26 September 2023
Ahead of an advisory panel meeting of the US Food and Drug Administration’s scientists, the agency’s briefing notes paint a pessimistic picture for the amyotrophic lateral sclerosis (ALS) candidate NurOwn (autologous MSC-NTF cells). 26 September 2023