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Following litigation over pregabalin’s second-use medical patent for neuropathic pain NHS England were required by the court to instruct GPs to prescribe the branded form (Lyrica) for Pain, notes a new study led by Oxford University researchers and published by BioRxiv. 26 February 2018
Biotechnology
UCB recorded revenue of 4.53 billion euros ($5.6 billion) in 2017, up 9% on the figure from 2016, the company announced in presenting its annual results. 26 February 2018
Pharmaceutical
At a public meeting in Washington DC, FDA Commissioner Scott Gottlieb outlined some of the ways the US medicines regulator is working to combat the opioid addiction epidemic, RAPS reports. 23 February 2018
Pharmaceutical
GW Pharmaceuticals has announced that a Phase IIa proof of concept study of a pipeline compound GWP42006 in adult patients with focal seizures did not meet its primary endpoint, causing the firm’s shares to drop 6%. 23 February 2018
Pharmaceutical
A systematic review and network meta-analysis of 522 randomized controlled trials of 21 drugs used to treat major depressive disorder (MDD) in adults has been published in The Lancet, revealing that their use has brought benefits compared to placebo. 22 February 2018
Pharmaceutical
A new real-world analysis published today in the Journal of Clinical Psychiatry illuminates the significant economic burden of treatment-resistant depression (TRD) on healthcare costs, resource utilization, work productivity and employment, underscoring the critical need to treat the illness with a greater urgency. 21 February 2018
Biotechnology
East Coast-based Wave Life Sciences has landed a near quarter billion dollar deal with Japan’s Takeda Pharmaceutical to bring forward nucleic acid therapies for central nervous system disorders. 21 February 2018
Biotechnology
Developing an effective new treatment for Alzheimer’s disease has become the Mount Everest of pharma, with ambitious companies setting off into clinical trials with the best of intentions but unable to reach the summit of late-stage success. 20 February 2018
Pharmaceutical
In the regulatory news sector last week, Vertex Pharmaceuticals came up with another drug approval, this time for Symdeko in cystic fibrosis. Two collaboration agreements attracted attention, most notably the record-breaking $3.6 billion deal between Nektar Therapeutics and Bristol-Myers Squibb focussed on its immuno-oncology candidate NKTR-214, but also Bioverativ’s accord with Oxford BioMedica on its LentiVector platform technology. There were two new questions in the Alzheimer’s disease space, those regarding Biogen with aducanumab and Merck & Co with verubecestat. 18 February 2018
Biotechnology
A day after Merck & Co pulled the plug on its Phase III verubecestat program, alarm bells started ringing over news that Biogen is adjusting its aducanumab trial, adding over 500 more patients. 16 February 2018
Pharmaceutical
French drugmaker Ipsen followed up its outstanding 2017 financial results – that included a 21% rise in group sales – with the promise that more good times are to come. 15 February 2018
Biotechnology
The US Food and Drug Administration has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson's disease, after receiving meeting minutes from the January 2018 meeting with the FDA. 15 February 2018
Biotechnology
US pharma giant Merck & Co has halted a Phase III trial of verubecestat (MK-8931) in people with prodromal Alzheimer’s disease (AD) based on a recommendation by the external Data Monitoring Committee (eDMC). 14 February 2018
Pharmaceutical
Chris Miller, scientific lead at 3D Communications, provides his perspective on the regulatory challenges facing pharmaceutical companies that are developing opioid products designed to deter abuse in an Expert View piece. 14 February 2018
Biotechnology
A new report from US-based Biotechnology Innovation Organization (BIO) advocates greater levels of investment in analgesics and addiction therapeutics. 13 February 2018
Generics
The tough times keep coming for Teva Pharmaceutical Industries. 13 February 2018
Biotechnology
Axovant Sciences today announced that its chief executive Officer David Hung has resigned to pursue other opportunities and has also resigned from the company’s board of directors. 12 February 2018
Pharmaceutical
Privately-held US drugmaker Purdue Pharma is to cease its activities to push sales of its opioid drugs to doctors. 12 February 2018
Biotechnology
The latest to join the ranks of failure in the search for a meaningful treatment for Alzheimer’s disease is Boehringer Ingelheim, which today announced that its Phase II Alzheimer’s disease trials with investigational compound BI 409306 had not met their efficacy endpoints. 9 February 2018
Biotechnology
Biogen said yesterday it would halt development of Tysabri (natalizumab) as a potential treatment for ischemic stroke, on the back of weak Phase II data. 8 February 2018
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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