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Pharmaceutical
Spain’s leading drugmaker Almirall has successfully concluded the pricing of its 250 million-euro ($2984 million) in aggregate principal amount of senior unsecured bonds due 2021 conditionally convertible into or exchangeable for new and/or existing ordinary shares of the company. 7 December 2018
Pharmaceutical
Vaccine specialist Valneva and HOOKIPA Pharma have agreed on a three-year collaboration and manufacturing deal. 7 December 2018
Pharmaceutical
UK-based hospital products firm Acacia Pharma says that the US Food and Drug Administration has accepted its resubmission of the New Drug Application (NDA) for Barhemsys (amisulpride injection) as a complete response, addressing the deficiencies identified in the October 5 complete response letter. 7 December 2018
Pharmaceutical
Sandoz Inc, a US division of Swiss pharma giant Novartis, plans to launch Symjepi (epinephrine) 0.3mg Injection in the USA in early first-quarter 2019 for the emergency treatment of allergic reactions (Type 1), including anaphylaxis. 6 December 2018
Pharmaceutical
Despite moves by a small minority of shareholders to derail the deal, a vast majority of shareholders today voted in favor of Japanese drug major Takeda Pharmaceutical’s £46 billion ($58.6 billion) acquisition of Ireland-headquartered rare diseases specialist Shire. 5 December 2018
Pharmaceutical
Radiopharmaceuticals specialist Fujifilm Toyama Chemical has sold development and commercialization rights to its novel small molecule compound, FF-10158, to Advanced Accelerator Applications (AAA), a Novartis company. 4 December 2018
Pharmaceutical
Japan’s Takeda Pharmaceutical has agreed terms for a loan of up to $3.7 billion from Japan Bank, to help finance the acquisition of Shire and reduce current bridging loan commitments. 3 December 2018
Pharmaceutical
Swiss pharma firm Helsinn Group and Mundipharma China Pharmaceutical, the market leader of pain management have received approval from the Chinese National Medical Products Administration (NMPA) for their anti-emetic agent Aloxi (palonosetron). 3 December 2018
Pharmaceutical
Privately-held US skin care company Crown Laboratories has acquired North American distribution rights to five over-the-counter consumer brands from UK pharma major GlaxoSmithKline. 1 December 2018
Pharmaceutical
Torii Pharmaceutical and Japan Tobacco have agreed to terminate the license agreements by which JT grants Torii the exclusive rights to market the six anti-HIV drugs on behalf of US firm Gilead Sciences in Japan and at yesterday’s Torii board of directors meeting the resolution on the termination of the license agreements was adopted. 30 November 2018
Pharmaceutical
Novartis will move its UK headquarters to become part of an emerging life sciences cluster in London. 28 November 2018
Pharmaceutical
Ono Pharmaceutical has filed for Japanese approval of ONO-7643, anamorelin hydrochloride, a candidate for improvement of body weight loss and anorexia in patients with cancer cachexia. 28 November 2018
Pharmaceutical
The multi-billion dollar merger of pharmacy CVS Health and insurer Aetna has been approved by New York state, the last regulatory hurdle for the deal to be finalized. 27 November 2018
Pharmaceutical
CTI BioPharma yesterday announced that the company has received a second round of questions related to the Day 180 List of Outstanding Issues, for the marketing authorization application (MAA) for pacritinib, from the European Medicines Agency. 27 November 2018
Pharmaceutical
ViiV Healthcare, the HIV-focused drugmaker that is majority-owned by UK pharma major GlaxoSmithKline, has won approval in Japan for Juluca (dolutegravir/rilpivirine) for the maintenance treatment of human immunodeficiency virus type 1 (HIV-1) infection. 26 November 2018
Pharmaceutical
Vifor Pharma has sought to shine a light on iron deficiency, a condition that it claims is present in one third of the world’s population. 26 November 2018
Pharmaceutical
Chi-Med, a Chinese biopharma company that is majority owned by the conglomerate CK Hutchison Holdings, has launched Elunate (fruquintinib) in China, in collaboration with its launch partner Eli Lilly. 26 November 2018
Pharmaceutical
Daiichi Sankyo has been granted Priority Review status by the US regulator for the investigational acute myeloid leukemia (AML) therapy quizartinib. 22 November 2018
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of treatments for peanut allergy. 21 November 2018
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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