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Pharmaceutical
French biopharma company Hybrigenics has received a takeover offer through a partial asset transfer from a French public company listed on Euronext, which does not wish to be named at this stage of discussions under confidentiality agreement. 21 January 2019
Pharmaceutical
In October last year, the Hungarian government’s health department decided about the inclusion of new innovative medicines, and their indications, into social security subsidy. 21 January 2019
Pharmaceutical
The US Food and Drug Administration has published a revised draft guidance - Rare Diseases: Common Issues in Drug Development. 18 January 2019
Pharmaceutical
Shares of Indian pharma major Sun Pharmaceutical Industries lost as much as 12.12% to 375.4 rupees, its lowest since February 2013, after a media report of a complaint by a whistleblower to the Securities and Exchange Board of India (SEBI) raised fresh concerns over corporate governance at the company, according to local media reports. 18 January 2019
Pharmaceutical
Kicking off today (January 17) was the high-level meeting in Brussels, PREPARE and COMBACTE, which will commence the development of the business plan for ECRAID, the European Clinical Research Alliance on Infectious Diseases. 17 January 2019
Pharmaceutical
A startup specializing in the fight against multi-drug resistant bacteria is among 10 that on Wednesday joined the accelerator program at German company Merck KGaA. 16 January 2019
Pharmaceutical
Elasmogen and ImmunoForge, a firm focusing on sarcopenia and cancer, have agreed a license agreement whereby Elasmogen’s proprietary NDure half-life extension technology will be used for two non-disclosed targets. 16 January 2019
Pharmaceutical
The European Medicines Agency (EMA) has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation. 16 January 2019
Pharmaceutical
The European Medicines Agency (EMA) has approved flutiform (pMDI 50/5 µg) for twice-daily use in the treatment of children with asthma aged five years and over. 14 January 2019
Pharmaceutical
Calliditas Therapeutics has appointed Frank Bringstrup as VP of regulatory affairs, leading regulatory efforts related to the firm’s Phase III NEFIGARD study of people with IgA nephropathy (IgAN). 14 January 2019
Pharmaceutical
Privately-held New York-based Blue Water Vaccines has entered into an option agreement with the University of Oxford in the UK providing the company with the option to exclusively license a novel and potentially revolutionary universal influenza vaccine. 11 January 2019
Pharmaceutical
Japan’s Astellas has made a number of senior leadership changes in its medical and development (M&D) division, including the appointment of Juan Maya as VP of medical science for the medical specialties therapeutic area. 11 January 2019
Pharmaceutical
Precision oncology firm Black Diamond Therapeutics has raised $85 million in a series B financing round led by New Enterprise Associates and RA Capital Management. The company now has raised $105 million. 11 January 2019
Pharmaceutical
Shares in Japanese drug major Daiichi Sankyo edged up 1.02% to 3,564 yen today, after it announced the receipt of marketing approval in Japan for Minnebro (esaxerenone) tablets for the treatment of hypertension. 8 January 2019
Pharmaceutical
China-based Ascentage Pharma has entered into a five-year collaboration with the Anderson Cancer Center at the University of Texas to advance the development of five potential new cancer therapies. 8 January 2019
Pharmaceutical
Ireland-headquartered drugmaker Allergan has pulled out of its commercialization deal with Debiopharm for Trelstar (triptorelin pamoate), a drug used in the USA to treat prostate cancer. 7 January 2019
Pharmaceutical
Switzerland-based Sophia Genetics has raised $77 million in an investment round led by Generation Investment Management, bringing the total raised by the firm to $140 million. 7 January 2019
Pharmaceutical
The UK license for prescribing Levosert (levonorgestrel intrauterine system) has been extended to five years in its indications for contraception and the treatment of heavy menstrual bleeding. 3 January 2019
Pharmaceutical
Netherlands-headquartered independent drugmaker Norgine has agreed a deal with Korea Pharma under which the Seoul-based manufacturer will commercialize Plenvu (1 liter PEG and ascorbate bowel preparation) in the Asian country. 3 January 2019
Pharmaceutical
More than three dozen drugmakers in the USA began 2019 by raising the cost of hundreds of medicines, according to an analysis from Rx Savings Solutions. 2 January 2019
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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