Ear disease and disorder specialist Otonomy and French drugmaker Ipsen have entered into a licensing agreement which will enable Otonomy to use Ipsen’s gacyclidine data in the development and registration of OTO-311. 6 November 2014
In what was clearly a difficult period for Danish CNS specialist Lundbeck due to patient expiries, the company reported a downturn in both sales and earnings for the third-quarter and first nine months of 2014. 5 November 2014
Israeli generics giant Teva Pharmaceutical Industries and Sweden’s Active Biotech are expanding their laquinimod clinical development program with the initiation of the ARPEGGIO trial, which will evaluate the potential of laquinimod to treat primary progressive multiple sclerosis (PPMS). 5 November 2014
Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are less than half as likely to obtain marketing approval as other drugs, according to a newly-completed study by the Tufts Center for the Study of Drug Development. 5 November 2014
Emerging Swedish addiction specialist company Orexo has achieved success by capturing a 4% share by volume of the US opioid dependence market a year after its launch of lead product Zubsolv (buprenorphine and naloxone). 5 November 2014
Japanese drug major Astellas Pharma has entered into a collaboration with US drug developer Proteostasis Therapeutics to develop new drugs for an unspecified genetic disease and, potentially, other unnamed disease types. 5 November 2014
A new study has suggested that drugs currently being used to treat diabetes also have the potential to be effective in Alzheimer’s disease. 4 November 2014
Danish CNS specialist Lundbeck and the US subsidiary of Japan’s Otsuka Pharmaceutical have released positive results from the QUALIFY study; the first trial of its kind comparing two atypical long-acting injectable anti-psychotic therapies in a close-to-real life setting. 4 November 2014
Fycompa (perampanel), manufactured by Japanese drug major Eisai, has been approved for reimbursement in Australia for the treatment of partial-onset seizures, the most common form of epilepsy. 3 November 2014
In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its discussions with biotech firm Sarepta Therapeutics on its investigational Duchenne muscular dystrophy (DMD) drug. 31 October 2014
US discovery and development company Receptos saw its shares rocket 47% to a new high, after it announced that TOUCHSTONE, the Phase II trial of RPC1063 in ulcerative colitis (UC), met its primary endpoint . 29 October 2014
US CNS focused drugmaker Zogenix says it has acquired Brabant Pharma, a privately-held UK-based pharmaceutical company for $20 million in cash and $15 million in stock plus potential future milestone and royalty payments. 28 October 2014
US drugmaker Alexza Pharmaceuticals and privately-held Spanish firm Grupo Ferrer Internacional have amended their agreement for the schizophrenia or bipolar disorder drug Adasuve (Staccato loxapine). 28 October 2014
Shares of Durect Corp plunged 42.9% to $0.79 after it revealed that pharma giant Pfizer has decided to discontinue its agreement to develop and commercialize Remoxy (oxycodone) extended-release capsules CII. 27 October 2014
Danish CNS drug specialist Lundbeck says that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application seeking approval of Carbella (carbamazepine) injection. 25 October 2014
Through analysis of US longitudinal patient-level claims data, Bristol-Myers Squibb and Otsuka’s Abilify (aripiprazole) was the antipsychotic that captured the highest first-line patient share among newly-diagnosed bipolar disorder patients. 24 October 2014
US biotech firm Biogen Idec saw its share price plunge 7% to $303.51, after its posted third-quarter 2014 financial results, despite revealing that net income of $856.9 million (a year-on-year-leap of 76%), or $3.62 per share, beat consensus analysts’ forecasts of $3.43 per share. 23 October 2014
Japanese drug major Astellas Pharma and US biotech firm CoMentis have said they will end their worldwide exclusive collaboration agreement for research, development and commercialization of beta-secretase inhibitors for Alzheimer’s disease. 20 October 2014
The US government has initiated a major effort to prevent and effectively treat Alzheimer's disease by 2025. However, a workgroup of nearly 40 Alzheimer's researchers and scientists says the research milestones in the US government's National Plan to Address Alzheimer's Disease must be broadened in scope, increased in scale, and adequately funded in order to successfully achieve this goal. 20 October 2014
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