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In what could prove to be something of a landmark development, Shanghai-based Green Valley Pharmaceuticals says that China's National Medical Products Administration (NMPA) has granted conditional approval for oligomannate (GV-971) as new drug for the treatment of mild-to-moderate Alzheimer's disease (AD) and improving cognitive function." 4 November 2019
Pharmaceutical
For the last five years or so, the narrative around the Swiss pharma giant Roche has been about a company that is likely to be hit harder than any other by the arrival of biosimilars, as they will ferociously erode sales from key products. 4 November 2019
Pharmaceutical
Japanese drugmaker Takeda closed 2% up on Friday, having presented its latest financial results. 1 November 2019
Biotechnology
The US Food and Drug Administration approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. 30 October 2019
Biotechnology
The European Medicines Agency has validated the Marketing Authorization Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it accelerated assessment. 30 October 2019
Pharmaceutical
Last week’s research news included a boost on Monday for Seattle Genetics, with positive top-line results for its breast cancer candidate tucatinib, and Biogen surprised when it revealed a new analysis of what seemed to be abandoned Alzheimer’s disease drug aducanumab would now be filed with the US Food and Drug Administration. On the deal-making front, Bavarian Nordic acquired the travel vaccine brands from GlaxoSmithKline for up to 955 million euros. There was also good news last Monday for Vertex Pharma, with the FDA approval for its cystic fibrosis drug Trikafta coming five months earlier than a decision was expected. 27 October 2019
Pharmaceutical
The case for approval of Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome has been given a boost by the addition of new data. 25 October 2019
Biotechnology
PTC Therapeutics has released new results from its investigational gene therapy, PTC-AADC, in patients living with aromatic L-amino acid decarboxylase (AADC) deficiency. 25 October 2019
Biotechnology
Just five weeks after announcing the acquisition, Danish CNS specialist Lundbeck has completed its takeover of US drug developer Alder BioPharmaceuticals. 25 October 2019
Pharmaceutical
The US medicines regulator has provided an update on its work to address the country’s ongoing opioid epidemic, leveraging new powers granted in 2018 under the SUPPORT Act. 25 October 2019
Pharmaceutical
US healthcare giant, Johnson & Johnson and its USA-based Janssen Pharmaceutical Companies confirm an agreement in principle to settle opioid litigation as publicly announced and outlined by a committee of State Attorneys General on October 21, 2019, the company revealed in a filing with the Federal Trade Commission. 24 October 2019
Biotechnology
US biotech major Biogen’s decision to resurrect the development of its previously-failed Alzheimer’s disease (AD) candidate aducanumab and move on with a regulatory filing came as a big revelation to industry watchers. 24 October 2019
Biotechnology
News that the company is to file for US approval of the previously dumped Alzheimer’s drug aducanumab is dominating industry news on Tuesday, but Biogen will also have contented long-term investors with its third quarter 2019 financial results. 22 October 2019
Pharmaceutical
Israeli drugmaker Teva Pharmaceutical Industries has announced progress in its attempts to settle cases that allege the company had a role in the US opioid crisis. 22 October 2019
Biotechnology
US biotech major Biogen saw its shares rocket more than 41% to $315.74 in pre-market trading, after, along with partner Eisai, today announced that, following consulting with the US Food and Drug Administration, Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer’s disease (AD), which has previously seen disappointing clinical results. 22 October 2019
Pharmaceutical
US pharma major Eli Lilly is to close its neuroscience research center in Surrey, UK. 16 October 2019
Biotechnology
Shares of Reata Pharmaceuticals rocketed yesterday, after it said it will seek FDA approval for drug candidate omaveloxolone (omav) for the treatment of Friedreich’s ataxia (FA) following Monday’s announcement of positive data from its registrational clinical trial. 15 October 2019
Pharmaceutical
Last week’s deal-making news included Akcea Therapeutics and majority owner Ionis Pharmaceuticals joining forces with US pharma giant Pfizer on cardiovascular and metabolic diseases research. Also, bluebird bio entered into a gene editing deal with Denmark’s Novo Nordisk to tackle hemophilia A. Regulatory news included Swiss giant Novartis announcing that its much-anticipated anti-VEGF treatment Beovu (brolucizumab) for wet age-related macular degeneration had received approval from the Food and Drug Administration. On the M&A front, investors applauded on Thursday when US biotech Ra Pharma agreed to a $2.1 billion takeover offer from Belgium’s UCB. 13 October 2019
Pharmaceutical
The US Food and Drug Administration on Friday approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. 12 October 2019
Pharmaceutical
Privately-held US pain specialist Neumentum has entered into a global licensing agreement with Janssen Pharmaceutica and McNeil Consumer Pharmaceuticals, both part of US healthcare giant Johnson & Johnson, for the rights to an oral analgesic, JNJ-10450232, plus a portfolio of backup compounds. 10 October 2019
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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