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Pharmaceutical
Massachusetts, USA-based psychoactive medicine specialist Sensorium Therapeutics has appointed Jeffrey Brown as chief scientific officer. 19 January 2023
Biotechnology
Neurodegenerative diseases specialist APRINOIA Therapeutics has announced a merger with Ross Acquisition Corp II, a special purpose acquisition company (SPAC) founded by former US Secretary of Commerce Wilbur Ross. 18 January 2023
Pharmaceutical
Sygnature Discovery, which claims to be the UK’s largest independent drug discovery expert and research partner, revealed that it has acquired Scotland-based SB Drug Discovery, a provider of ion channel and receptor drug discovery research delivering cell line generation and compound screening solutions in neuroscience and other therapeutic indications. 18 January 2023
Biotechnology
Following the controversial approval and dismal launch of their first Alzheimer’s drug, Aduhelm (aducanumab), expectations for Eisai and Biogen’s follow on treatment are mixed, given that their anti-amyloid beta (Aβ) monoclonal antibody (MAb), Leqembi (lecanemab) gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment of Alzheimer’s disease (AD) in patients with early AD. 17 January 2023
Biotechnology
Shares of Japanese drugmaker Eisai were lifted by more than 3% to 8,327 yen this morning, after it revealed it has filed for domestic approval of its Alzheimer’s drug Leqembi (lecanemab), which was granted accelerated approval in the USA earlier this month. 16 January 2023
Pharmaceutical
British biotech Pheno Therapeutics has announced a licensing deal with Belgium’s largest drugmaker UCB, focusing on the science of remyelination. 11 January 2023
Biotechnology
Shares of Voyager Therapeutics were up almost 30% at $9.00 pre-market this morning, as it announced a second lucrative strategic collaboration with Neurocrine Biosciences. 9 January 2023
Pharmaceutical
Stalicla, a Swiss company specializing in the identification of specific phenotypes of autism spectrum disorder (ASD), has entered into an exclusive in-licensing agreement with pharma giant Novartis to develop mavoglurant (AFQ056) as a treatment for substance-use disorder and neurodevelopmental disorders (NDDs). 9 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. 9 January 2023
Biotechnology
Among featured research news last week, US pharma giant Pfizer impressed when it released positive Phase III data on its hemophilia B gene therapy fidanacogene elaparvovec. Italian drugmaker Newron Pharmaceuticals last Monday released what it called “compelling” trial results for its antipsychotic candidate evenamide. Also, Deciphera Pharmaceuticals last Tuesday touted the benefits of its gastrointestinal stromal tumor (GIST) drug Qinlock. Kicking off the 2023 M&A season, US mRNA specialist Moderna last Wednesday announced its first ever full acquisition, that of Japanese firm OriCiro Genomics for $85 million. Fate Therapeutics has terminated its deal with Johnson & Johnson subsidiary Janssen to develop CAR-T cell therapies for cancer targets. 8 January 2023
Biotechnology
Having controversially approved the first new Alzheimer’s disease drug Aduhelm (aducanumab) in decades in 2021, dead on schedule, the US Food and Drug Administration on Friday announced its decision on a follow-on product. 7 January 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche and Belgium’s UCB, and granted them accelerated review. 6 January 2023
Biotechnology
An eye-catching start to life has put Belharra Therapeutics firmly on the biotech map. 5 January 2023
Pharmaceutical
UK-based ADVANZ PHARMA has acquired exclusive rights to register and commercialize AT-007, a Phase III development compound for the treatment of several rare neurological diseases, including galactosemia and SORD deficiency, in the European Economic Area, the UK, and Switzerland. 4 January 2023
Biotechnology
Faith in the transparency of the US regulatory process has been shaken, following an accusatory report from influential congressional committees into the approval of Aduhelm (aducanumab). 30 December 2022
Generics
A growing number of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) coming into India have become 25% to 35% more expensive as reports of Covid infections spiral out of control in China, squeezing margins and increasing drug prices. The Indian government's production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates (DIs) and APIs is soon set to come to the aid of many domestic players, reports The Pharma Letter’s India correspondent. 29 December 2022
Biotechnology
Paris, France-based neurodegenerative disease specialist Pharnext has attracted a strategic investment from fellow French firm Néovacs. 29 December 2022
Biotechnology
Research news last week featured strong Phase III results for Madrigal Pharmaceuticals’ investigational drug resmetirom in the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis, sending the firm’s share rocketing as much as 270%. Also of note, AbbVie announced that its Vraylar has gained a fourth approval from the US Food and Drug Administration, this one for major depressive disorder. On the deal-making front, Canada’s Zymeworks leapt on the news that Ireland’s Jazz Pharmaceuticals had opted into a previously announced collaboration that could be worth nearly $2 billion for the development of zanidatamab. And Germany’s Merck KGaA last Thursday revealed a new collaboration with Mersana Therapeutics using its STING platform to develop antibody-drug conjugates (ADCs). 26 December 2022
Biotechnology
A draft report on amyloid beta-targeting antibodies in Alzheimer’s disease, prepared by the Boston, Massachusetts-based pricing watchdog the Institute for Clinical and Economic Review (ICER), recommends a price range below the current or anticipated cost. 23 December 2022
Biosimilars
Canada’s largest public drug plan has announced a transition to cost-saving biosimilar medicines. 21 December 2022
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
Pharmaceutical
Intra-Cellular Therapies has announced positive results from Study 304 evaluating the efficacy and safety of Caplyta (lumateperone) 42mg for the prevention of relapse in adult patients with schizophrenia. 6 November 2024
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