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.
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
French pharma major Sanofi has opened negotiations to sell a 50% controlling stake in its consumer health business Opella to US private equity firm Clayton Dubilier & Rice (CD&R). 21 October 2024
Angelini Pharma, part of Italy’s Angelini Industries, has entered into an exclusive option agreement with South Korea-based Cureverse for the global development and commercialization of a clinical-stage brain health asset. 21 October 2024
It’s been an important week for clinical research, with two important documents published which should go a long way in helping to support clinical research as the UK leaves the European Union, writes Dr Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry (ABPI). 9 August 2018
Synergy Pharmaceuticals traded up 7.06 % to $1.76 yesterday, when the company announced a licensing deal for its best selling gastrointestinal drug in China. 8 August 2018
In an Expert View piece, Mark Davison, head of operations in the European Union for software company RFXCEL, outlines everything marketing authorization holders need to know and what you need to do for a seamless serialization process – before regulators remove your right to trade. 8 August 2018
Glenmark Pharmaceuticals today announced that the US Food and Drug Administration has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltris. 8 August 2018
Droves of investors shed Bellerophon Therapeutics stock on Tuesday, after monitors suggested stopping the Phase III INOvation-1 study early due to a lack of results. 8 August 2018
Yesterday, delivering on proposals in President Trump’s American Patients First blueprint, the USA’s Health and Human Services (HHS) Department announced that Medicare Advantage plans will be able to use tools employed by private-sector insurers to negotiate lower prescription drug prices for patients. 8 August 2018
Shares in the world’s leading diabetes drug producer were down by 4% on Wednesday lunchtime after the company revealed its latest financial results and details on its US prices for next year. 8 August 2018
Danish CNS specialist Lundbeck saw its shares fall as much as 10% early this morning, after reporting what appear to be strong financial results for first-half 2018, that beat analysts’ expectations but which nevertheless failed to impress investors. 8 August 2018
I-MAK, a pressure group composed of lawyers, health professionals and academics, has published a report excoriating pharma giants for allegedly exploiting patent laws in order to drive up prices. 7 August 2018
The China National Drug Administration (CNDA) has granted approval of Ibrance (palbociclib), the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. 7 August 2018
Following on from a series of measures aimed at challenging the ongoing opioid addiction epidemic in the USA, the US Food and Drug Administration announced new action on Monday, with a set of revised scientific recommendations. 7 August 2018
The University of Texas MD Anderson Cancer Center and Ireland-incorporated Jazz Pharmaceuticals late Monday announced a five-year collaboration agreement with a goal of evaluating therapies for multiple hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes. 7 August 2018
Indian drug major Sun Pharmaceutical Industries has launched Kapspargo Sprinkle (metoprolol succinate) extended-release capsules in the USA. 7 August 2018
Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application (NDA) for the abuse-deterrent opioid drug Remoxy ER (oxycodone) extended-release capsules CII. 6 August 2018
Daiichi Sankyo published a report on Monday, identifying Lixiana (edoxaban) as an appropriate alternative to current standard of care Fragmin (dalteparin), in patients with venous thromboembolism (VTE) but raising a red flag for those with gastrointestinal cancer. 6 August 2018
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has released an update on clinical trials regulations following the UK’s exit from the European Union, so-called “Brexit”. 6 August 2018
The Institute for Clinical and Economic Review has issued a final report for AbbVie’s Orilissa (elagolix), raising serious questions over the affordability of the product. 6 August 2018
Alzheon, a privately-held American biopharmaceutical company, has announced its hiring of former IVAX president Neil Flanzraich as vice chairman of the board. 6 August 2018
Menarini Ricerche, a part of Italian family-controlled drugmaker Menarini Group, announced today that the sponsorship of the ongoing Phase I/II study that is investigating MEN1703/SEL24 for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) in the USA has been transferred from Poland’s Selvita to Menarini Ricerche on June 30, 2018. 6 August 2018
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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.