Latest Pharma and Biotech News
Pharmaceutical
27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
French specialty vaccine company Valneva today announced the appointment of Dipal Patel as chief commercial officer (CCO) and management board member. 17 November 2022
Biotechnology
Australia’s Therapeutic Goods Administration (TGA) has granted a provisional determination to US pharma giant Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran and famtozinameran (Comirnaty bivalent Omicron BA.4/BA.5 COVID-19 vaccine). 17 November 2022
Pharmaceutical
The unexpected news of a positive Food and Drug Administration advisory committee vote yesterday sent US cardiorenal-focussed drugmaker Ardelyx’ shares surging 84.4% to $2.25 in pre-market trading this morning. 17 November 2022
Biotechnology
Research from industry analyst GlobalData has identified challenges in the development of new CAR-T cell therapies for chronic lymphocytic leukemia (CLL). 17 November 2022
Biotechnology
Japanese drug major Astellas Pharma today announced positive top-line results from the Phase III SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). 17 November 2022
Biotechnology
Germany’s Merck KGaA has announced an investment of more than 290 million euros ($302 million) in its biosafety testing capacity at Rockville, Maryland, USA. 16 November 2022
Pharmaceutical
Due to the high-risk nature of drugs being developed for neurology diseases, most product launches in the recent history of Parkinson’s disease have been the result of strategic partnerships for marketing and sales, with few exceptions. 16 November 2022
Biotechnology
Marking a second M&A deal this year, USA-based gene therapy company Kriya Therapeutics today announced the acquisition of a privately held biotechnology company Redpin Therapeutics, which is developing regulatable gene therapies for intractable diseases of the nervous system. 16 November 2022
Biotechnology
Bonum Therapeutics, a biopharma using allosteric regulation to create conditionally active and less toxic medicines, has announced a $93 million Series A financing. 16 November 2022
Biosimilars
Access to therapies used to treat major chronic diseases remains particularly limited in Central and Eastern Europe (CEE). Off patent medicines are often the first opportunity for patients to access the essential medicines they need, says Medicines for Europe, the trade body representing bakers of biosimilar and generic drugs. 16 November 2022
Biotechnology
In a draft recommendation, the UK’s reimbursement agency has found in favor of three COVID-19 treatments, while sidelining several others. 16 November 2022
Pharmaceutical
Cambridge, UK-based Napp Pharmaceuticals today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing authorization application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. 16 November 2022
Biotechnology
Positive top-line results from a trial in atopic dermatitis (AD) lifted shares in Californian biotech Arcutis Biotherapeutics around 4% on Tuesday. 16 November 2022
Biotechnology
Swiss biotech Idorsia has entered into an exclusive licensing agreement with China’s Simcere Pharmaceutical for the commercialization of its dual orexin receptor antagonist daridorexant, a treatment for adult patients with insomnia, in China. 16 November 2022
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain non-prescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to non-prescription status. 16 November 2022
Biotechnology
A think tank report has been published ahead of the UK government’s autumn statement, calling for a reform of R&D tax credits. 15 November 2022
Biotechnology
Boston, USA-based biotech start-up Jnana Therapeutics, which is leveraging its next-gen chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced two important milestones for the company. 15 November 2022
Biotechnology
Moderna has announced that both of its bivalent Omicron-targeting booster candidates trigger a superior antibody response compared to a booster of mRNA-1273, the firm's prototype vaccine, against Omicron, in Phase II/III trials. 15 November 2022
Biotechnology
Japanese drugmaker Daiichi Sankyo edged up 1.7% to 4,486 yen today, as it announced that a trial evaluating the efficacy and safety of booster vaccination with DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19), the primary endpoint was achieved. 15 November 2022
Pharmaceutical
Clinical-stage biopharma company Satsuma Pharmaceuticals on Monday revealed that its experimental lead treatment for acute migraine headaches failed to meet the main goals of a late-stage trial, sending its shares plunging 83% to $0.68. 15 November 2022
All news
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
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