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Biotechnology
Deal-making news last week included Italian family-owned Chiesi Farmaceutici announcing a licensing agreement with USA-based Gossamer Bio for the latter’s pulmonary hypertension candidate seralutinib worth up to $486 million. Among other news of note, the US Food and Drug Administration (FDA) plans to hold and advisory committee meeting on June 10 to review US Pharma major Eli Lilly’s Alzheimer’s disease candidate donanemab. Flagship Pioneering announced the launch of another start-up, Prologue Medicines, with $50 million financing to develop protein therapies. Gilead Science’s Kite unit and partner Arcellx updated on their development of investigational multiple myeloma drug anitocabtagene autoleucel. 12 May 2024
Pharmaceutical
Israel’s Teva Pharmaceutical Industries and France-based Medincell have announced results from the efficacy portion of the Phase III SOLARIS trial of olanzapine once-monthly long-acting injectable in schizophrenia compared to placebo. 9 May 2024
Generics
Israeli drugmaker Teva Pharmaceutical Industries missed estimates relating to earnings and exceeded expected revenue levels in presenting its first-quarter financial results. 9 May 2024
Biotechnology
Today, the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to delpacibart etedesiran (AOC 1001). 8 May 2024
Pharmaceutical
The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for midomafetamine (MDMA) capsules. 8 May 2024
Biotechnology
The US Food and Drug Administration (FDA) has now said it will convene an in person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on June 10, 2024, to discuss the Alzheimer's drug donanemab. 8 May 2024
Pharmaceutical
Final results from a three-year open-label extension study of Fintepla (fenfluramine) have been released by Belgium’s UCB. 8 May 2024
Series A
Philadelphia, USA-based Latus Bio, a biotech developing novel gene therapy candidates for disorders of the central nervous system (CNS), has announced its launch and an initial close of $54 million in Series A financing. 7 May 2024
Biotechnology
M&A news featured again last week, first with Japan’s Ono Pharmaceutical announcing a $2.4 billion takeover of US oncology focused Deciphera Pharmaceuticals, and then Swiss pharma giant Novartis revealing that is acquiring US biotech start-up Mariana Oncology for up to $1.75 billion to expand its radioligand therapy portfolio. Also of note, Italy’s Newron Pharmaceuticals released positive new Phase II/III data for its schizophrenia candidate evenamide. And, US pharma giant Pfizer presented strong first-quarter 2024 financial results, despite significant loss of revenue from covid-related products. 5 May 2024
Psychedelics
Philadelphia, USA-based Reunion Neuroscience, a company developing psychedelics for the treatment of mental health conditions, has announced the closing of a $103 million Series A financing. 3 May 2024
Pharmaceutical
Shares in USA-based NRx Pharmaceuticals have fallen by around a fifth, after the firm announced disappointing results from a trial of NRX-101. 1 May 2024
Pharmaceutical
Neurocrine Biosciences has secured US Food and Drug Administration approval for Ingrezza Sprinkle (valbenazine). 1 May 2024
Pharmaceutical
Shares of US developer of rare neurological drugs Harmony Biosciences (Nasdaq: HRMY) rose more than 10% to $32.30 today, after it announced the acquisition of Epygenix Therapeutics. 30 April 2024
Pharmaceutical
Italy-based biopharma Newron Pharmaceuticals was trading 14% higher at lunchtime on Tuesday. 30 April 2024
Pharmaceutical
USA-based neurodegenerative disorders specialist Annovis Bio saw its shares plunge 60% to $7.28 by close of trading, despite what it said were positive results for its Alzheimer’s disease (AD) candidate. 30 April 2024
Biotechnology
Switzerland’s clinical-stage biotech Addex Therapeutics saw its shares plunge 50% to 0.058 francs this morning, after it reported disappointing trial results for its epilepsy candidate. 29 April 2024
Biotechnology
Biogen presented its first-quarter 2024 financial results on Wednesday. 24 April 2024
Pharmaceutical
A Takeda Pharmaceutical-partnered program has delivered strong mid-stage data, sending shares in Neurocrine Biosciences up 5%. 24 April 2024
Pharmaceutical
A single-line order from the US Supreme Court has scotched hopes on the part of Vanda Pharmaceuticals of resurrecting patents for Hetlioz (tasimelteon). 23 April 2024
Biotechnology
Long-term partners BioArctic and Eisai have announced a new research agreement regarding BAN2802, a potential treatment combining the former company’s proprietary BrainTransporter technology with an undisclosed Alzheimer drug candidate. 23 April 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
Pharmaceutical
US neuroscience-focused biopharma Neurocrine Biosciences presented new data from more than 300 patients diagnosed with tardive dyskinesia and treated with Ingrezza (valbenazine) capsules at the 2024 Psych Congress in Boston. 5 November 2024
Pharmaceutical
Privately-held German drugmaker Boehringer Ingelheim and researchers from the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard, are collaborating on a project to tackle the urgent and unmet needs of people living with mental health conditions. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
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