Ireland-headquartered generics major Actavis says it has entered into an agreement with Cephalon to settle all outstanding patent litigation related to Actavis' generic version of Nuvigil. 1 June 2014
Israel-based Teva Pharmaceutical Industries received positive news on Friday, when the US District Court for the Northern District of West Virginia denied a motion filed by US generic drugmaker Mylan. 31 May 2014
Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon revealed that the New Drug Application for safinamide was submitted today to the US Food and Drug Administration. 30 May 2014
French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme said today that the US Food and Drug Administration has accepted for review the company's resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. 30 May 2014
Japanese drug majors Dainippon Sumitomo Pharma and Daiichi Sankyo have entered into a license agreement for the commercialization of lurasidone, an atypical antipsychotic agent discovered by DSP, in Brazil and Venezuela. In addition, DSP has granted Daiichi Sankyo the option right for the commercialization for lurasidone in Argentina and Colombia. 28 May 2014
The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Genzyme’s Lemtrada (alemtuzumab) be reimbursed on the National Health Service for treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. 28 May 2014
In yet another setback for Australia-based QRxPharma, the US Food and Drug Administration has issued a second complete response letter (CRL) regarding the MoxDuo (morphine and oxycodone) New Drug Application for the treatment of moderate to severe acute pain. 27 May 2014
Japanese drug major Eisai Co says that its R&D subsidiary KAN Research Institute held a dedication ceremony on Monday for its new research facility in Kobe, Hyogo prefecture, and has now officially commenced full-scale operation of its research and development activities at this facility. 27 May 2014
US biotech firm Biogen Idec said on Friday that it had received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval of its Plegridy (peginterferon beta-1a), a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis (RRMS). 25 May 2014
Teva Pharmaceutical Industries, the world’s largest generic drugs firm, and Swedish partner Active Biotech announced Friday that the Committee for Medicinal Products for Human Use (CHMP) confirmed its January 23, 2014 opinion (The Pharma Letter January 24) to recommend against approval for the treatment of relapsing-remitting multiple sclerosis in the European Union (EU) at this time. 25 May 2014
New research forecasts that the therapeutics market for major depressive disorder (MDD) will face a dynamic phase up until the end of 2023, thanks to the potential launch of new treatments following the patent expirations of top-selling products. 23 May 2014
Privately-held US firm Neurotez has executed an exclusive license agreement covering its Leptin derivatives, for the treatment of Alzheimer’s disease and other cognitive disorders, with GCA Therapeutics. 23 May 2014
Privately held US generic drugmaker Prasco Laboratories has entered into a distribution and supply agreement with Recordati Rare Diseases, a unit of Italian pharma firm Recordati, for the rights to distribute the authorized generic version of NeoProfen (ibuprofen lysine) Injection. 22 May 2014
Adamas Pharmaceuticals says it has received a $25 million milestone payment from Forest Laboratories related to the development of MDX-8704. Adamas gained 8.6% to $20.50 on the news. 21 May 2014
Japanese pharma company Eisai has launched its Fycompa (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), in France. 21 May 2014
The US unit of UK consumer goods conglomerate Reckitt Benckiser has entered into a definitive agreement with USA-based AntiOp to co-develop a naloxone nasal spray to aid in the reversal of opioid overdose with the option to acquire all rights to the product upon receipt of regulatory and marketing approval. 19 May 2014
The US Food and Drug Administration says it has required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. The drug is sold by Sunovion Pharmaceuticals, a US subsidiary of Japanese drug major Dainippon Sumitomo Pharma. 16 May 2014
Reckitt Benckiser’s US pharma subsidiary and XenoPort have entered into a license agreement pursuant to which Reckitt Benckiser Pharmaceuticals will be granted exclusive worldwide rights for the development and commercialization of XenoPort's clinical-stage oral product candidate arbaclofen placarbil for all indications. 15 May 2014
A US district court has dismissed a case by Israeli drugmaker Teva Pharmaceutical Industries intended to block the US Food and Drug Administration from approving generic versions of Teva's blockbuster multiple sclerosis drug Copaxone (glatiramer acetate), including from US generics maker Mylan. 15 May 2014
UK pharma giant GlaxoSmithKline will divest all of its rights to migraine drug Treximet (sumatriptan/naproxen sodium), US rights to which it had acquired from USA-based Pozen in 2003, to Pernix Therapeutics. 15 May 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