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30 December 2024 For many in the life sciences, the year gone by has been marked by volatility across a range of metrics, as political and economic disruptions threaten to upend the standard operating model.
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The market for artificial intelligence (AI) in cancer care is projected to grow from $2.2 billion in 2024 to $6.3 billion by 2029, reflecting a growth rate of 23.1%, according to a recent study by BCC Research. 31 December 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), from US pharma giant Merck & Co. 31 December 2024
Pharmaceutical
US CNS specialist Axsome Therapeutics yesterday announced the completion of its Phase III clinical program evaluating AXS-05 (dextromethorphan-bupropion). 31 December 2024
Pharmaceutical
It has been a year since the launch of Zepbound (tirzepatide) for obesity, and US pharma major Eli Lilly’s competition with Denmark’s Novo Nordisk continues. 31 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) is reopening the comment period for the Federal Register notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry. 31 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning urging the public to avoid purchasing weight-loss medicines without a prescription. 30 December 2024
Pharmaceutical
For many in the life sciences, the year gone by has been marked by volatility across a range of metrics, as political and economic disruptions threaten to upend the standard operating model. 30 December 2024
Pharmaceutical
China’s National Medical Products Administration (NMPA) has recently approved Zorifer (zorifertinib), an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) specifically for the treatment of non-small cell lung cancer (NSCLC) with CNS metastases. 30 December 2024
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 2024
Pharmaceutical
Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024
Pharmaceutical
USA-based clinical-stage biopharma Traws Pharma saw its shares leap more than 150% to $12.57 as it announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Pharmaceutical
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
Pharmaceutical
Spanish plasma-based medicines maker Grifols has announced disappointing top-line data from its Phase III PRECIOSA clinical trial evaluating the potential of long-term albumin treatment with Grifols Albutein on patients with decompensated cirrhosis and ascites, sending its share down 2.4% to 9.27 euros on Friday. 23 December 2024
Pharmaceutical
Denmark has introduced a three-year agreement to regulate price ceilings for hospital medicines, aimed at providing stability for the public healthcare system and pharmaceutical companies. 23 December 2024
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Pharmaceutical
As the UK heads for a general election next month, the Association of the British Pharmaceutical Industry (ABPI) today assessed the Labour Party manifesto, having yesterday appraised the UK Conservative pledges. 13 June 2024
Pharmaceutical
Alzheon, a clinical-stage biopharma company, has secured $100 million in a series E funding round led by Alerce Medical Technology Partners. 13 June 2024
Pharmaceutical
Johnson & Johnson says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England 13 June 2024
Pharmaceutical
AstraZeneca’s Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration to improve glycemic control in children with type-2 diabetes (T2D). 13 June 2024
Series C
Aardvark Therapeutics might not have scored the biggest venture haul in May, but its $85 million Series C round will further strengthen rumors that the California-based company is gearing up for an IPO this summer, which could come as soon as late July. 13 June 2024
Pharmaceutical
The US Centers for Medicare & Medicaid Services’ (CMS) Office of the Actuary has released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2023-2032. 13 June 2024
Pharmaceutical
Flagship Pioneering and its founded company ProFound Therapeutics today announced a collaboration to conduct foundational research to identify potential next-generation first-in-class therapies for the treatment of obesity. 12 June 2024
Pharmaceutical
The Health Emergency Preparedness and Response Authority (HERA), part of the European Commission (EC), has selected Australian drugmaker CSL Ltd’s subsidiary CSL Seqirus to provide 665,000 pre-pandemic vaccine doses for 15 European Union and European Economic Area (EEA) member states as well as to the "Union Civil Protection Mechanism" (rescEU). 12 June 2024
Pharmaceutical
Helsinn Group and Chugai Pharma Europe have announced the renewal of their distribution and license agreement for Akynzeo (netupitant-palonosetron) in the UK and Ireland. 12 June 2024
Pharmaceutical
US Senator Bernie Sanders, chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), has announced that members will vote next week on whether to subpoena Doug Langa, senior vice president, head of North America operations and president of Novo Nordisk. 12 June 2024
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has had its say on the upcoming UK election for a second time this week. 12 June 2024
Pharmaceutical
Russia is sharply cutting centralized state purchases of anti-HIV drugs due to the problems with funding and the reduction of supplies to Russia by global drugmakers, reports The Pharma Letter’s local correspondent. 12 June 2024
Pharmaceutical
In a post on LinkedIn, Bayer senior vice president and biotech head Jens Vogel has announced his intention to step down. 12 June 2024
Pharmaceutical
Syntis Bio, a new clinical-stage biopharmaceutical company, has officially launched. 11 June 2024
Pharmaceutical
Genfit, a biopharmaceutical company focused on rare liver diseases, has announced that it has received an Accelerated Approval for Iqirvo (elafibranor). 11 June 2024
Pharmaceutical
The US Food and Drug Administration issued a Federal Register Notice announcing the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP). 11 June 2024
Pharmaceutical
Biotechnology star-tup Alumis is set to go public, filing with the US Securities and Exchange Commission for an initial public offering (IPO). 11 June 2024
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has issued a challenge to the UK’s political parties ahead of next month’s election. 10 June 2024
Pharmaceutical
Calico Life Sciences, a biotech company specializing in aging and age-related diseases, has had its candidate fosigotifator accepted into the US Food and Drug Administration’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. 10 June 2024
Pharmaceutical
British pharma major AstraZeneca's bid to broaden the label for Tagrisso (osimertinib) will be considered under the Priority Review scheme. 10 June 2024
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