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Biotechnology
In an R&D review presentation, Sage Therapeutics has announced it will pivot towards developing options for treatment-resistant depression. 25 July 2019
Pharmaceutical
Belgium’s largest pharma company UCB today released financial results for the first six months of 2019, noting that revenues grew 2% (+4% at constant exchange rates) to 2.3 billion euros ($2.56 billion), with net sales rising 3% (+5% CER) to 2.2 billion euros. 25 July 2019
Pharmaceutical
The US District Court for the District of Columbia (District Court) granted Braeburn Pharmaceutical’s (Nasdaq: BBRX) motion for summary judgment, vacating the US Food and Drug Administration’s December 2018 exclusivity determination which blocked Brixadi (buprenorphine) extended release injection from final approval through November 30, 2020. 24 July 2019
Biotechnology
A set of quarterly financial results that exceeded expectations and led to improved full-year guidance prompted shares in Biogen increasing by 5% in Tuesday morning’s trading. 23 July 2019
Biotechnology
Acadia Pharmaceuticals saw its shares fall 16% to $21.62 in after-hours trading on Monday, after it released disappointing top-line results from its Phase III ENHANCE study. 23 July 2019
Pharmaceutical
Vanda Pharmaceuticals has hit turbulence in its efforts to broaden the label of its sleep-wake disorder drug Hetlioz (tasimelteon). 22 July 2019
Generics
The US Food and Drug Administration today announced that, on July 19, it approved multiple applications for first generics of Lyrica (pregabalin), thus opening the flood gates for competition to Pfizer’s blockbuster treatment. 22 July 2019
Biotechnology
Israeli biotech firm Intec Pharma (Nasdaq: NTEC) saw its market capitalization plummet after it announced top-line data from the company's pivotal Phase III trial (the ACCORDANCE trial). 22 July 2019
Pharmaceutical
Biohaven Pharmaceutical revealed that it has received a Complete Response Letter (CRL) from the Food and Drug Administration for the 505(b)2 application seeking approval for Nurtec (riluzole) for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease. 22 July 2019
Pharmaceutical
Japan’s Sumitomo Dainippon Pharma has announced positive top-line results from a Phase III Japanese study of the antipsychotic Lonasen (blonanserin), in adolescents. 22 July 2019
Pharmaceutical
The US Department of Justice (DoJ) has hailed the progress made in the year since the formation of Operation Synthetic Opioid Surge (SOS). 17 July 2019
Biotechnology
Privately-held US biotech Skyhawk Therapeutics has announced a multi-target exclusive option and license agreement with the Roche company Genentech to develop and commercialize small molecules that modulate RNA splicing. 17 July 2019
Biotechnology
US biopharma Anavex Life Sciences has presented new clinical data identifying gut microbiota biomarkers associated with improved response in Alzheimer’s disease patients treated with its selective sigma-1 receptor agonist. 17 July 2019
Pharmaceutical
The share price of Johnson & Johnson was down by more than 1% at lunchtime on Tuesday after the US healthcare giant announced its financial results for the second quarter. 16 July 2019
Pharmaceutical
Spanish drugmaker Grifols has presented additional results from its AMBAR – Alzheimer management by albumin replacement – clinical trial. 16 July 2019
Pharmaceutical
Significant deal-making news last week included UK biotech Mirati Therapeutics linking up with Swiss giant Novartis to test a combination of their respective compounds, MRTX849 and TNO155, in solid tumors. Also, Redx Pharma saw its shares rocket after it signed a deal to sell its pan-RAF inhibitor program to Jazz Pharmaceuticals last Wednesday. Clinical trials news included discontinuation of Novartis and Amgen’s CNP520 program in Alzheimer’s disease prevention, adding to the litany of failures in this therapy sector. On the M&A front, US biotech Altimmune announced it was acquiring Spitfire Pharma in an up to $93 million deal and bringing with it a liver disease candidate. 14 July 2019
Biotechnology
In yet another setback in the quest for Alzheimer’s therapies it was decided to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer's Prevention Initiative Generation Program. 12 July 2019
Pharmaceutical
A special initiative of the Hospital for Special Surgery (HSS), designed to provide practical measures for combating the ongoing opioid epidemic in the USA, has reported a number of successes. 11 July 2019
Pharmaceutical
Leading dementia figures from universities, pharmaceutical companies and charities have identified six gaps in dementia research that present new opportunities to speed up the search for the first life-changing treatment for the condition. 11 July 2019
Pharmaceutical
UK-headquartered consumer products giant Reckitt Benckiser today announced it has reached agreements with the US Department of Justice (DoJ) and the Federal Trade Commission to resolve the long-running investigation into the sales and marketing of Suboxone (buprenorphine and naloxone) Film by its former prescription pharmaceuticals business Indivior, a business that was wholly demerged in 2014. 11 July 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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