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.
Three corporate behemoths have hatched a plan to step in to the American healthcare market, with the aim of “improving employee satisfaction and reducing costs.” 31 January 2018
French pharma major Sanofi has asked the European Medicines Agency to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi). 31 January 2018
The UK’s National Health Service (NHS) and other European healthcare providers should start administering quadrivalent vaccines to better protect against the influenza virus. 31 January 2018
In the second of two Expert View columns to whet the appetite for the eyeforpharma Barcelona event in March, Sanofi’s Chief Data Officer (CDO), Milind Kamkolkar, expounds the possibilities of digital and the role of the CDO in this burgeoning landscape. 31 January 2018
Remarks by US president Donald Trump at the swearing in ceremony of new HSS Secretary Alex Azar confirm his administration’s determination to drastically lower the price of prescription medications in the USA. 30 January 2018
While some including Johnson & Johnson (NYSE: JNJ) and Biogen (Nasdaq: BIIB) took hefty tax charges in the final part of 2017, New York’s Pfizer (NYSE: PFE) was one of those to benefit from US tax reforms, the firm’s annual results statement shows. 30 January 2018
The UK’s first stab at creating a Cancer Drugs Fund (CDF), to give patients access to oncology treatments not available on the National Health Service (NHS), became unsustainable after the Department of Health overspent the fund’s £480 million ($678 million) budget for two years between 2013 and 2015 by £167 million. 30 January 2018
US specialty drug firm Aradigm saw its shares plummet at much as 39% to $1.36 in morning trading on Monday, after it said it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Linhaliq. 30 January 2018
The pRED research base of Switzerland’s Roche has scored an R&D win in the form of US FDA Breakthrough status for balovaptan for autism spectrum disorder (ASD). 30 January 2018
Sunovion Pharmaceuticals has revealed positive top-line data from its Phase III trial of Parkinson’s disease (PD) candidate APL-130277. 30 January 2018
Looking back on the past year, last week the president of the Greek pharmaceutical industry association, SFEE, Pascal Apostolides, said that 2017 was a lost year, with missed opportunities and without substantial reforms. 30 January 2018
As a result of the UK leaving the European Union effective March 29, 2019, the relocation of the European Medicines Agency from London to Amsterdam in the Netherlands is likely to cause some logistic problems, the EMA executive director Guido Rasi explained at a meeting in The Hague with Dutch health authorities. 29 January 2018
The US Food and Drug Administration has approved Firvanq (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. 29 January 2018
Shanghai Pharma is set to expand to San Diego with a new R&D hub, and is also seeking to gain technology and market access “through the short-cut route of acquisitions,” chairman Zhou Jun told the South China Morning Post recently. 29 January 2018
China’s Food and Drug Administration recently issued many new polices to push healthcare reform and drug innovation in the country. One of them is to acknowledge foreign trial data and hire more staff to speed up Investigational New Drug (IND) and New Drug Applications (NDA) approval, writes The Pharma Letter’s China correspondent Wang Fangqing. 29 January 2018
Medicines Australia welcomes the government’s announcement of an outcome from the Post-market Review of the Life Saving Drugs Programme (LSDP review). 29 January 2018
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
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
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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.