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
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
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
All news
Biosimilars
Increasing access to capital has resulted in a surge of Indian biopharmaceutical companies focusing on research and development. A think-tank has advised the government that it is imperative to streamline regulatory approval procedures for the biotechnology industry and eliminate redundant steps so as to expedite the approval process, reports The Pharma Letter’s India correspondent. 28 September 2022
Pharmaceutical
Japanese drugmaker Shionogi closed 1% higher after Tokyo trading on Wednesday after reporting progress with its COVID-19 antiviral. 28 September 2022
Biotechnology
Elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM) by US pharma giant Pfizer, has been granted an ‘Innovation Passport’ from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 28 September 2022
Biotechnology
AstraZeneca has written to US healthcare professionals to notify them of the company’s volunatary withdrawal of an indication for Lynparza (olaparib). 28 September 2022
Pharmaceutical
Drugmakers in Europe are arguing for a new economic model for reimbursement of antibiotics, paving the way for a breakthrough in the fight against antimicrobial resistance. 28 September 2022
Biotechnology
Shares in Avidity Biosciences were down as much as 26% on the news that the US Food and Drug Administration (FDA) has placed a partial clinical hold on new participant enrollment in the Phase I/II MARINA clinical trial of AOC 1001 - an antibody-oligonucleotide conjugate (AOC) - in adults with myotonic dystrophy type 1 (DM1). 28 September 2022
Pharmaceutical
The Russian Parliament (State Duma) has said it will consider establishing the priority of using domestic reference materials in the pharmaceutical industry. 28 September 2022
Biotechnology
Japanese drugmaker Eisai’s shares gained more than 17% to 6,784 yen today, after it released top-line results from the Clarity AD Phase III clinical trial for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential treatment of early Alzheimer’s disease. 28 September 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW )has granted approval of the manufacturing and marketing application for Berinert SC Injection 2000 submitted by CSL Behring KK, a subsidiary of Australia’s CSL Limited. 28 September 2022
Biotechnology
A new UK-based antibody-drug conjugate (ADC) company, Pheon Therapeutics, has launched with $68 million in series A backing. 28 September 2022
Biotechnology
Californian genetic medicine company Scribe Therapeutics has scored a major strategic collaboration with French giant Sanofi. 27 September 2022
Biotechnology
Privately-held Arsenal Biosciences, a programmable cell therapy company engineering advanced CAR T therapies for solid tumors, has announced a multi-year collaboration with the Roche subsidiary Genentech. 27 September 2022
Biotechnology
North Carolina, USA-based 9 Meters Biopharma saw its shares rise nearly 22% to $0.25, after it announced positive final results from the Phase II study of vurolenatide and the outcome from its End-of-Phase II meeting with the US Food and Drug Administration (FDA). 27 September 2022
Biotechnology
Merck & Co has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW). 27 September 2022
Biotechnology
Cambridge, USA-base immuno-oncology company DEM BioPharma has appointment of Nenad Grmusa as chief executive and Christophe Quéva, as chief scientific officer. 27 September 2022
Biotechnology
KiOmed Pharma, a Belgian biotech developing medical devices based on a highly pure natural chitosan-derivative, has announced a deal with China’s Hansoh Pharmaceutical Group. 27 September 2022
Pharmaceutical
The US business of Japanese ophthalmology firm Santen Pharmaceutical has secured approval for Omlonti (omidenepag isopropyl). 27 September 2022
Biotechnology
In a busy day for the Japanese regulator, the Japanese Ministry of Health, Labor and Welfare (MHLW) has cleared three new medicines from European drugmakers for marketing in the country. 27 September 2022
Biotechnology
The EU may have turned its back, but Valneva hasn't given up on its coronavirus vaccine just yet. 27 September 2022
Pharmaceutical
China-based Contract Research Development and Manufacturing Organization (CRDMO) WuXi STA has opened its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. 27 September 2022
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