24 October 2024 Shares of Californian clinical-stage biotech Alto Neuroscience plummeted 70% to $4.36 yesterday, as is announced disappointing trial results for depression candidate.
Under pressure from the US Food and Drug Administration, Ireland-incorporated Endo International has agreed to voluntarily withdraw its opioid pain drug Opana ER (oxymorphone hydrochloride extended release) from the US market. 7 July 2017
Following a review of health data from 77 countries, the World Health Organization has issued a warning about the rise of antibiotic-resistant strains of gonorrhea. 7 July 2017
A conference on the role of the Russian professional medical community in healthcare development, which was dedicated to the 10th anniversary of the Association of Clinical Pharmacologists of St Petersburg, took place earlier this week. 7 July 2017
Eli Lilly announced in March that it would invest $850 million in US operations this year, and a new collaboration suggests a desire to fund research not just in the USA, but in the company’s home state. 6 July 2017
UK drugmaker GlaxoSmithKline will be hoping for a stabilization in its share price on Thursday afternoon after a significant slide was started by a broker downgrading its stock recommendation. 6 July 2017
American diabetes startup Diasome Pharmaceuticals has received up to $30 million in funding from a group of four investors, led by British life science venture capitalists Medicxi. 6 July 2017
The European Commission has sent three separate Statements of Objections to Germany’s Merck KGaA and its subsidiary Sigma-Aldrich, General Electric and Canon alleging they breached EU merger rules. 6 July 2017
National Health Service trusts in England reported a £791 million ($1 billion) deficit last year, despite receiving an additional £1.8 billion from government through a reform program. 5 July 2017
Members of the European Parliament (MEPs) today urged the Commission to address the increase in HIV/AIDS, tuberculosis and viral hepatitis cases in the EU and to develop long-term programs. 5 July 2017
Italian drugmaker Recordati has announced the US launch of a 350mg single-vial dosage strength of Panhematin (hemin for injection) for the amelioration of recurrent attacks of acute intermittent porphyria (AIP). 5 July 2017
The National Institute for Health and Care Excellence (NICE) today published final draft guidance recommending asfotase alpha for people with pediatric-onset hypophosphatasia – a very rare inherited condition affecting between one and seven babies each year in England. 5 July 2017
The growing number of clinical trials and increasing complexity across the clinical lifecycle are putting pressure on life sciences organizations to improve study quality and execution, writes Rik Van Mol, vice president of R&D strategy, Europe, Veeva Systems, in an Expert View piece. 4 July 2017
Dr Nicola Davies looks at how real world evidence carries ever greater importance in an industry where often regulatory approval alone is no longer enough. 4 July 2017
After a year of uncertainty, a letter written by two senior government ministers has finally sought to clear up what the UK’s relationship with the European Medicines Agency (EMA) might look like after Brexit. 4 July 2017
The European Commission has published a new action plan which reviews the global problem of antimicrobial resistance and sets out guidance for EU bodies to combat the issue. 4 July 2017
An approach that aims to facilitate development of rare pediatric diseases in general, and as a starting point Gaucher disease in particular, has been outlined by regulatory bodies in the European Union and the USA. 4 July 2017
The restoration of key occupations for the medical technology, biotechnology, research and pharmaceutical sector to the skilled migration visa list has been welcomed by six representative organizations in Australia. 4 July 2017
The purchase of major pharma contract research organization Parexel was the largest deal of the month as it was taken private by Pamplona Capital Management. 3 July 2017
Obstacles standing in the way of successful launches of Russian products to international pharma markets have been highlighted by trade group the Association of Russian Pharmaceutical Manufactures (ARPM) following industry meetings. 3 July 2017
Marking its second major regulatory approval, Eli Lilly and Incyte Corp today revealed that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Olumiant (baricitinib) tablets for the treatment of rheumatoid arthritis. 3 July 2017
Germany’s Bayer has entered into an exclusive licensing agreement with privately-held Dewpoint Therapeutics for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. 25 October 2024
Finnish pharma group Orion has announced it is discontinuing development of ODM-111, a pain management drug candidate, following a toxicology study suggesting it may not be suitable for long-term use. 25 October 2024
US pharma major GSK yesterday announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. 25 October 2024
The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends Capvaxive (pneumococcal 21-valent conjugate vaccine) for pneumococcal vaccination in adults 50 years of age and older. 25 October 2024
US privately-held drug developer NImmune Biopharma has acquired development and commercialization rights for omilancor in Asia from Sino-American biotech LianBio. 25 October 2024
Sanofi reported 15.7% sales growth for the third quarter of the year, reaching 13.4 billion euros ($14.2 billion), with adjusted earnings per share (EPS) rising by 12.2% to 2.86 euros, surpassing many forecasts. 25 October 2024
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Alpha-9 Oncology, a Canadian radiopharmaceutical company, has raised $175 million in an oversubscribed series C financing round led by Lightspeed Venture Partners and Ascenta Capital. 24 October 2024
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including Prevnar 20 (20-valent pneumococcal conjugate vaccine) for all adults aged 50 and older. 24 October 2024
Sino-America clinical-stage biotech Eccogene announced that it will receive a $60 million payment from AstraZeneca, which is being triggered by successfully achieving milestones related to the development of ECC5004/AZD5004 including the first patient dosed in the Phase IIb program. 24 October 2024
Swiss pharma giant Roche this morning reported that, in the first nine months of 2024 group sales increased by 6% at CER (2% in francs) to 45.0 billion francs ($52.0 billion). 23 October 2024
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. 23 October 2024
Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
UK pharma major AstraZeneca’s Alexion Rare Disease unit has received a positive recommendation for Voydeya (danicopan), from the UK’s National Institute for Health and Care Excellence (NICE). 22 October 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Melbourne, Australia-based Telix Pharmaceuticals has announced the launch of Rhine Pharma, a subsidiary aimed at increasing global access to radiopharmaceuticals for cancer treatment and imaging. 22 October 2024
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Company Spotlight
Dewpoint is a biotech company pioneering the application of biomolecular condensate biology – the science studying the organization of biomolecules within membrane-less compartments – towards the development of a new generation of therapeutics to address diseases of high unmet need.