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Pharmaceutical
Shares in Jazz Pharmaceuticals have risen 5% after the firm won US approval for Xywav (calcium, magnesium, potassium, and sodium oxybates), a treatment for catalepsy. 22 July 2020
Biotechnology
Shares in US biotech Biogen were up by 1.5% following 90 minutes of trading on Wednesday after the company presented its second quarter financial results. 22 July 2020
Biotechnology
Houston, USA-based CNS Pharmaceuticals has lined up both American and European manufacturers for berubicin, its lead drug candidate for the treatment of glioma brain tumors. 21 July 2020
Biotechnology
Privately-held US start-up Jnana Therapeutics has entered a strategic, multi-target collaboration and license agreement with Roche (ROG: SIX) for the discovery of small molecule drugs directed at the solute carrier (SLC) family of metabolite transporters. 21 July 2020
Biotechnology
Connecticut company BioXcel Therapeutics closed 14% higher after Monday’s trading. 21 July 2020
Pharmaceutical
The first new product for amyotrophic lateral sclerosis (ALS) in decades has won approval in Indonesia, several years after it was first given marketing authorization, in Japan. 17 July 2020
Pharmaceutical
Last week brought good regulatory news for Acacia Pharma, with the US Food and Drug Administration approving the firm’s Byfavo as a procedural sedation product, and Biogen and Eisai filing for FDA approval for aducanumab as a treatment for Alzheimer’s disease. On the research front, Swiss biotech Idorsia presented positive new Phase III results for its insomnia candidate daridorexant, and Germany’s Bayer released much-anticipated Phase III results for its diabetic kidney disease drug finerenone. Meantime, USA-based Novavax rocketed after revealing its COVID-19 vaccine has been selected for a massive funding award via the US government’s Operation Warp Speed program. 12 July 2020
Pharmaceutical
The US Food and Drug Administration approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox (onabotulinumtoxinA) for the treatment of spasticity in pediatric patients two years of age and older, including those with lower limb spasticity caused by cerebral palsy, says Allergan. 10 July 2020
Biotechnology
Shares in Biogen were 5.5% higher at midday on Wednesday. 8 July 2020
Pharmaceutical
Sunovion Pharmaceuticals, a US subsidiary of Japan’s Sumitomo Dainippon Pharma, has released top-line results from study SEP380-201 that did not hit main goal, but are still seen to be encouraging. 8 July 2020
Biotechnology
Cambridge, USA-based Dragonfly Therapeutics today announced a new research collaboration with Bristol-Myers Squibb to discover and develop Dragonfly's novel immunotherapies for multiple sclerosis and neuro-inflammation targets. 6 July 2020
Biotechnology
Belgian biotech BCI Pharma has appointed Didier Malherbe as chairman of the board of directors. 6 July 2020
Pharmaceutical
Shares of Eisai edged up 1.1% to 8,615 yen by close of trading today, after the Japanese pharma revealed it has launched two products on the domestic market. 6 July 2020
Biotechnology
Swiss biotech Idorsia today announced positive top-line results of the second pivotal Phase III study investigating 10mg and 25mg doses of its dual orexin receptor antagonist, daridorexant, in 924 adult and elderly patients (39.3% ≥ 65 years) with insomnia. 6 July 2020
Pharmaceutical
The US Food and Drug Administration has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, marking the second approval for UK-based Acacia Pharma. 3 July 2020
Pharmaceutical
In the context of widespread lockdowns linked to the coronavirus pandemic, Swedish digital therapy specialist Orexo DTx sees an increasingly significant treatment opportunity for two newly-launched products. 2 July 2020
Pharmaceutical
Ireland-incorporated Avadel Pharmaceuticals has sold its hospital sterile injectable drug portfolio to Exela Sterile Medicines for a total of $42.0 million. 2 July 2020
Pharmaceutical
Shaun Thaxter, the chief executive of Indivior, has pleaded guilty to causing the introduction into interstate commerce of the opioid drug Suboxone Film (buprenorphine) which was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. 1 July 2020
Biotechnology
Japan’s Ono Pharmaceutical has received a manufacturing and marketing approval of Ongentys (opicapone) Tablets 25mg, a catechol-O-methyltransferase (COMT) inhibitor (COMTi), in its home country. 29 June 2020
Biotechnology
The new drug application for Enspryng (satralizumab) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica). 29 June 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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