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30 December 2024 Antibody-drug conjugates (ADCs) combine monoclonal antibody (MAb) specificity with cytotoxic drug potency via a linker, delivering targeted cancer therapy. ADCs concentrate treatment at tumor sites, enhancing efficacy while minimizing harm to healthy tissues.
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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
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. 10 June 2024
Pharmaceutical
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
Pharmaceutical
The Chinese National Medical Products Administration (NMPA) held a meeting recently to carry out the 2023 annual review of the vaccine regulatory quality management system (QMS). 10 June 2024
Pharmaceutical
Dr Michaela Eikermann has now taken up the position of deputy director of Germany’s watchdog the Institute for Quality and Efficiency in Health Care (IQWiG). 10 June 2024
Pharmaceutical
Japanese drugmaker Shionogi has entered into an option agreement with French firm Cilcare to acquire the exclusive license for the development, manufacturing, and commercialization of CIL001 and/or CIL003, a hearing loss treatment drug candidates worldwide. 8 June 2024
Pharmaceutical
Swiss pharma giant Roche on Friday announced new five-year data confirming the sustained efficacy and safety profile of Evrysdi (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study. 8 June 2024
Pharmaceutical
Global biopharma firm Structure Therapeutics has announced the pricing of an expanded public offering, aiming to raise $476 million. 7 June 2024
Pharmaceutical
Abu Dhabi’s Department of Health has signed a Memorandum of Understanding (MoU) with AstraZeneca (LSE: AZN) to establish a world-class Rare Diseases Centre of Excellence (CoE) in the emirate. 7 June 2024
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim has reinforced previously announced data showing that adults treated with survodutide achieved statistically-significant improvement in metabolic dysfunction-associated steatohepatitis (MASH). 7 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) late Thursday announced the approved of Geron Corporation’s Rytelo (imetelstat), an oligonucleotide telomerase inhibitor. 7 June 2024
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Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
Pharmaceutical
Hutchmed has announced agreements to divest its 45% equity stake in Shanghai Hutchison Pharmaceuticals Limited (SHPL) for $608 million in cash. The buyers are GP Health Service Capital and Shanghai Pharmaceuticals. 2 January 2025
Pharmaceutical
Kazia Therapeutics, an oncology-focused Australian drug developer, has been advised by the US Food and Drug Administration (FDA) that accelerated approval for its brain cancer drug, paxalisib, is unlikely. 2 January 2025
Pharmaceutical
The type 1 diabetes (T1D) market across the seven major markets (7MM: USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow at a compound annual growth rate (CAGR) of 13.3% from $2.2 billion in 2023 to $9.9 billion in 2033. 2 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib. 2 January 2025
Pharmaceutical
The new $2,000 cap on out-of-pocket costs for prescription drugs went into effect as of January 1, 2025, the US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced. 2 January 2025
Pharmaceutical
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
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