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.
Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. 13 July 2018
Be they about boosting generics, advancing gene therapies or other aspects of the drug development and manufacturing industry that it is trying to improve, announcements have been coming thick and fast from the US Food and Drug Administration (FDA). 13 July 2018
Japan’s largest drugmaker Takeda Pharmaceutical and Netherlands-based Norgine have agreed to terminate the license and development agreement for the development, manufacture and sale in Japan of Oblean (cetilistat), a drug for the treatment of obesity, as of October 13, 2018. 13 July 2018
After many years of litigation from cancer patients, a court in Missouri, USA, has ordered healthcare giant Johnson & Johnson to pay an eye-watering $4.7 billion in damages to 22 women who allege harm caused by products containing talc. 13 July 2018
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) at its meeting on Thursday voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older. 13 July 2018
Andrew Rut, chief executive of MyMeds&Me, writes an Expert View piece on Japanese openings for tech-based pharmacovigilance firms in the wake of regulatory changes. 12 July 2018
When it comes to reducing the cost of prescription medicines, where President Trump has increasingly failed, a new price transparency law in California appears to be succeeding. 12 July 2018
Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programs. 12 July 2018
A new draft guidance document, published by the UK’s National Institute for Health and Care Excellence (NICE), warns physicians to take antimicrobial resistance (AMR) into account when prescribing antibiotics for COPD. 12 July 2018
Switzerland’s Roche and Chicago, USA-based AbbVie have submitted to extend the US label for Venclexta (venetoclax) as a first-line acute myeloid leukaemia (AML) therapy. 12 July 2018
With antimicrobial resistance (AMR) on the rise and health authorities and foundations around the world crying out for new antibiotics, Novartis has become the latest big pharma company to exit the space. 12 July 2018
Germany’s Merck KGaA has signed an agreement with Xian Janssen Pharmaceuticals to launch Invokana (canagliflozin), an innovative drug for adults with type 2 diabetes, in China. 12 July 2018
DUSA Pharmaceuticals has filed trade secret misappropriation and tortious interference claims in an ongoing patent infringement lawsuit against Germany-based skin cancer specialist Biofrontera and subsidiaries in the US District Court for the District of Massachusetts. 12 July 2018
At the annual meeting of 340B Health, a trade body representing hospitals participating in the 340B scheme, Health Secretary Alex Azar promised greater oversight in an effort to reign in costs. 11 July 2018
Takeda announced on Wednesday that Ninlaro (ixazomib) achieved its primary endpoint in the Phase III TOURMALINE-MM3 trial oriented toward multiple myeloma treatment. 11 July 2018
Having come under direct castigation from the US president, pharma giant Pfizer said yesterday that it will pull back on planned drug prices increases. 11 July 2018
With safety reviews underway in Europe and warnings for the Canadian regulator, the Food and Drug Administration is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. 11 July 2018
The European Medicines Agency (EMA) has warned that a failure to prepare for Britain leaving the European Union could lead to major supply chain disruption for around 100 medicines. 11 July 2018
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
Berlin, Germany-based Ariceum Therapeutics has presented data at the European Association of Nuclear Medicine 2024 conference on its first-in-class radiopharmaceutical drug, 225Ac-satoreotide. 22 October 2024
Philadelphia, USA-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn (iloprost), the only FDA-approved treatment for severe frostbite in the USA. 22 October 2024
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Novo Nordisk today announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomized trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). 21 October 2024
Sweden-based OncoZenge has announced the intention to partner with UK-based specialty pharma Pharmanovia to secure exclusive rights to commercialize BupiZenge in Europe, the Middle East, and Northern Africa (EMENA). 21 October 2024
Gilead Sciences and Merck & Co have announced new results from a Phase II clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor. 21 October 2024
Trade group the Association of the British Pharmaceutical Industry (ABPI) has had its say on UK government plans to overhaul the National Health Service (NHS). 21 October 2024
Vertex Pharmaceuticals on Sunday presented its pivotal Phase III data on suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor for the treatment of moderate-to-severe acute pain. 21 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.