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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
Biotechnology
The UK National Institute for Health and Care Excellence (NICE) has recommended Ajovy (fremanezumab) for preventing chronic migraine. 12 March 2020
Pharmaceutical
The UK's Competition and Markets Authority (CMA) has failed to overturn a decision from the Competition Appeal Tribunal (CAT), which set aside certain penalties imposed on Pfizer and UK-based Flynn Pharma. 10 March 2020
Pharmaceutical
South Korea-based SK Biopharmaceuticals’ subsidiary SK life science today announced that the US Drug Enforcement Administration (DEA) has designated its epilepsy treatment Xcopri (cenobamate tablets) as a Schedule V medicine. 10 March 2020
Biotechnology
Alessia Deglincerti, Frank Borowsky and Rachel Laing from consulting firm Bionest Partners, explore in an Expert View how the development of spinal muscular atrophy (SMA) therapies could provide a blueprint for genetic diseases. 9 March 2020
Pharmaceutical
Osaka, Japan-headquartered Shionogi has moved a step closer to taking full ownership of rare disease specialist and co-developer Tetra Therapeutics. 6 March 2020
Pharmaceutical
Swedish drugmaker Orexo has submitted an application to the US Food and Drug Administration (FDA) for vorvida to enable commercialization in the USA. 6 March 2020
Pharmaceutical
The financial results for the latest quarter and 2019 as a whole made for satisfying reading for shareholders of Germany’s Merck KGaA. 5 March 2020
Biotechnology
US healthcare giant Johnson & Johnson’s subsidiary Janssen has filed a marketing authorization application (MAA) with the European Medicines Agency seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (MS). 4 March 2020
Pharmaceutical
The Indian government has restricted exports of 26 active pharmaceutical ingredients (APIs) and finished pharmaceutical products, raising concerns about access to medicines as the novel coronavirus begins to spread more rapidly outside of China. 4 March 2020
Pharmaceutical
The US Food and Drug Administration has reviewed and accepted the filing of a New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder. 4 March 2020
Biotechnology
The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC) for patients with chronic pain due to moderate-to-severe osteoarthritis (OA), who have experienced inadequate relief with other analgesics. 2 March 2020
Pharmaceutical
US regulatory approvals featured significantly in last week’s news, with Esperion Therapeutics receiving Food and Drug Administration clearance for its cholesterol lowering drug Nexletol, marking the company’s first approval. Baudax Bio received FDA approval for its non-opioid pain drug Anjeso and the agency granted approval for Lundbeck’s Vyepti, the first intravenous treatment for migraine. In M&A news, Takeda exercized its option to acquire PvP Biologics, while deals included Sangamo’s collaboration with Biogen for its zinc finger protein technology and Alzheimer’s and Parkinson’s disease. 1 March 2020
Biotechnology
Biohaven Pharmaceutical Holding late Thursday gained regulatory approval for its migraine treatment drug to join the already competitive market sector, with the news sending its shares up 5.3% to $40.82 in after-hours trading, after falling 8.5% in the regular session. 28 February 2020
Biotechnology
After the bell on Thursday US biotech major Biogen and genomic medicines company Sangamo Therapeutics announced that they have executed a global licensing collaboration agreement, that could be worth over $2.5 billion, with the news sending the latter’s shares almost 40% higher to $9.31 in after-hours trading. 28 February 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine. 26 February 2020
Biotechnology
Danish CNS specialist Lundbeck late on Friday revealed that Vyepti (eptinezumab-jjmr) has been approved by the US Food and Drug Administration for the preventive treatment of migraine in adults and will be available in April 2020. 22 February 2020
Pharmaceutical
Israeli drugmaker Teva Pharmaceutical Industries was down by nearly 3% in pre-trading in New York on Thursday morning. 20 February 2020
Biotechnology
Belgian drugmaker UCB was trading more than 3% higher by lunchtime on Thursday after presenting its financial results for 2019. 20 February 2020
Pharmaceutical
At a European Parliament lunch debate hosted by Christophe Hansen MEP (Luxembourg) today, the non-profit non-governmental organization (NGO) Alzheimer Europe launched a new report presenting the findings of its collaborative analysis of recent prevalence studies and setting out updated prevalence rates for dementia in Europe. 18 February 2020
Biotechnology
Independent drugmaker Servier and fellow France-based biotech Oncodesign (Euronext: ALONC) late Monday announced reaching an important milestone in their strategic partnership on potential drug candidates for Parkinson’s disease, news of which sent Oncodesign’s shares leaping 17% to 11.70 euros in early trading this morning. 18 February 2020
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