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In November last year, Ireland-incorporated biotech Alkermes submitted a New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder, and today announced that the US Food and Drug Administration has accepted the NDA for review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2020 28 January 2020
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued draft guidance not to recommend Spravato (esketamine) nasal spray. 28 January 2020
Biotechnology
Japanese drugmaker Otsuka Pharmaceutical has announced positive preliminary results from two, Phase II/III trials for fremanezumab as a prophylactic migraine drug. 28 January 2020
Biotechnology
In the search for non-opioid options to treat pain, Australian biotech Mesoblast has turned to a stem cell approach, which is currently in late-stage development for chronic low back pain. 25 January 2020
Pharmaceutical
Berlin-based ATAI Life Sciences has invested in two separate joint ventures (JV) with Florida-based opioid use disorder (OUD) specialist DemeRx. 24 January 2020
Pharmaceutical
Eisai clocked up Japanese approvals for two of its drugs on Thursday. 23 January 2020
Biotechnology
UK clinical-stage biotech PureTech Health says it has sold 2.1 million shares of its affiliate Karuna Therapeutics for a cash consideration of around $200 million to Goldman Sachs & Co. 23 January 2020
Pharmaceutical
Ireland-incorporated Jazz Pharmaceuticals today revealed it has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. 22 January 2020
Pharmaceutical
US healthcare giant Johnson & Johnson opened nearly 2% lower in Wednesday’s trading after presenting its financial results for the fourth quarter of 2019, and the year as a whole. 22 January 2020
Pharmaceutical
In a second new drug approval on Monday, the European Commission cleared Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). 21 January 2020
Pharmaceutical
A judge in Philadelphia, USA, has handed healthcare giant Johnson & Johnson a slight reprieve, reducing an earlier judgement of $8 billion in damages to $6.8 billion. 20 January 2020
Pharmaceutical
Licensing featured in the news last week, with Germany’s MorphoSys announcing a deal with USA-based Incyte to commercialize its B-cell malignancies candidate tafasitamab, and Biogen taking over an early-stage drug from Pfizer - PF-05251749 - which has potential for treating sleep disorders associated with Alzheimer’s and Parkinson’s disease. Also, UK-based Adaptimmune entered into a lucrative collaboration with Japan’s Astellas Pharma on cancer research. Elsewhere, Swiss giant Novartis’ novel arrangement with the UK’s National Health Service for access to its cardiovascular drug inclisiran attracted a fair amount of attention. On the M&A front, German biotech BioNTech said last Thursday it was buying USA-based Neon Therapeutics to boost its T-cell pipeline. 19 January 2020
Pharmaceutical
The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) have issued another negative vote on a opioid alternative pain drug within a matter of days. 17 January 2020
Biotechnology
Tuesday’s meeting of the Food and Drug Administration's (FDA's) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) to discuss the New Drug Application (NDA) for oxycodegol (formerly NKTR-181) did not recommend approval of oxycodegol, by a vote of 27 to 0. 15 January 2020
Pharmaceutical
Adding to the so far unsuccessful pursuit of trying to find an effective treatment for the devasting condition, Eagle Pharmaceuticals late Monday announced that Eagle and the University of Pennsylvania (Penn) have agreed on terms of a new exclusive worldwide license agreement for the development of dantrolene sodium for the potential treatment of people living with Alzheimer’s disease, including an agreement to fund additional research and provisions regarding commercialization of products developed under the license. 14 January 2020
Biotechnology
After US biotech major Biogen scrapped development of its experimental Alzheimer’s drug aducanumab in March last year, but resuming development in October, the company has now announced an agreement to acquire an early-stage central nervous system (CNS) candidate from Pfizer. 13 January 2020
Biotechnology
A group of three new treatments for acute migraine have been assessed by the Institute for Clinical and Economic Review (ICER) to deem what a fair US price for these yet-to-be-launched medicines might look like. 13 January 2020
Pharmaceutical
The US Department of Justice (DoJ) revealed on Friday that it has obtained more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2019. 11 January 2020
Pharmaceutical
California’s Neurocrine Biosciences and Swiss firm Idorsia (SIX: IDIA) have amended a 2019 deal related to the investigational epilepsy drug ACT-709478. 10 January 2020
Pharmaceutical
China's National Medical Products Administration (NMPA) has recently approved Shanghai Green Valley Pharmaceuticals’ brown algae-extracted drug – oligomannate (GV-971) – for mild to moderate Alzheimer's disease. 9 January 2020
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Pharmaceutical
New York-based Mind Medicine, a company developing MM120, a form of LSD (lysergide d-tartrate), for mental health conditions, has announced the appointment of Gregg Pratt, as chief regulatory and quality assurance officer. 19 November 2024
Biotechnology
Last week saw US pharma major AbbVie release disappointing Phase II trial results on its emraclidine in schizophrenia, which benefited Bristol Myers Squibb. Also on the research front, Germany’s Merck KGaA and Abbisko’s pimicotinib showed positive results in tenosynovial giant cell tumor (TGCT). M&A news saw German BioNTech punting $800 million upfront to acquire China based oncology focused Biotheus. Also of note, US drugmaker Halozyme Therapeutics made an unsolicited takeover bid for Evotec, valuing the German firm, at around 2 billion euros. 17 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Biotechnology
Swiss clinical-stage biopharma AC Immune saw its shares gain 8% to $3.38 in US trading this morning, after it released positive interim safety and immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Pharmaceutical
Digital therapeutics company GAIA has announced the signing of a licensing agreement for attexis with fellow German firm MEDICE Arzneimittel Pütter. 14 November 2024
Biotechnology
Cambridge, USA-based Vesalius Therapeutics has entered into a multi-target strategic alliance with the UK’s GSK to discover and develop novel treatments for Parkinson's disease, and another undisclosed neurodegenerative indication. 13 November 2024
Biotechnology
Neurogene has announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase I/II open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. 13 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Pharmaceutical
The Parkinson’s disease (PD) therapeutic landscape is heavily genericized, leaving substantial unmet needs in neuroprotective and disease-modifying therapies (DMTs), says data and analytics company GlobalData in an overview of ongoing PD research.. 11 November 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 10 November 2024
Pharmaceutical
Jazz Pharmaceuticals has reported third-quarter revenue of $1 billion, a 9% increase over the prior year, fueled by strong performance in its key sleep and epilepsy portfolios. 7 November 2024
Biotechnology
US clinical-stage drug developer Acumen Pharmaceuticals has appointed Amy Schacterle as chief regulatory officer and head of quality, reporting to Jim Doherty, president and chief development officer at Acumen. 7 November 2024
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