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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The Russian government plans to speed up the development and production of domestic drugs against rare diseases amid the ever tightening pressure caused by sanctions on the country due to its military conflict with Ukraine. 6 October 2022
In the USA, Eli Lilly and Teva Pharmaceutical will meet in court after a federal judge slapped down an attempt to invalidate three of the latter’s patents. 6 October 2022
The PERLA Phase II trial of cancer drug Jemperli (dostarlimab) met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) criteria as determined by blinded independent central review, says UK pharma major GSK, which is a late comer to the PD-/PD-Li inhibitors sector. 6 October 2022
Glenmark Pharmaceuticals’ shares rose 1.2% to 408.75 rupees today, after the Indian drugmaker announced that it became the first company in India to launch thiazolidinedione lobeglitazone for the treatment of type 2 diabetes in adults. 6 October 2022
Market authorization was granted to 92 new medicines in the European Union (EU) last year.Market authorization was granted to 92 new medicines in the European Union (EU) last year. 5 October 2022
Victor Grifols Roura, who has devoted 50 years to building Spanish plasma-derived drugmaker Grifols (MCE: GRF) in senior roles including chief executive for 30 years, retires as non-executive chairperson. He is designated as chairperson of honor in recognition of his numerous contributions. 5 October 2022
Allecra Therapeutics, a France-based biopharmaceutical company dedicated to the development of novel antibiotics, today revealed that the prestigious Journal of the American Medical Association (JAMA) has published the final results from its Phase III ALLIUM trial investigating the combination of cefepime/enmetazobactam in patients with complicated urinary tract infections (cUTIs). 5 October 2022
The ability of patent holders to preserve their market exclusivity, a lack of consumer understanding and other factors have held up the widespread adoption of biosimilars in the USA compared to other markets. 5 October 2022
The US Government has expressed a vote of confidence in Vir Biotechnology, awarding the company a multi-year contract to advance the development of a full portfolio of innovative medicines. 5 October 2022
US pharma giant Pfizer has presented promising results on its PARP inhibitor Talzenna (talazoparib) alongside Xtandi (enzalutamide) in metastatic castration-resistant prostate cancer (mCRPC). 5 October 2022
Cash rich Pfizer has completed its $11.6 billion acquisition of Biohaven Pharmaceutical, including its money-making calcitonin gene-related peptide (CGRP) programs. 5 October 2022
Japanese biotech Kyowa Kirin today announced it has launched its corporate venture capital (CVC) fund and invested in its first biotech start-up. 5 October 2022
Shares of Japanese drugmaker Astellas Pharma rose 2.2% to 1,965 yen yesterday, after it announced a research deal with Germany’s Pantherna Therapeutics, which aims to generate mRNA-based regenerative medicine programs using direct reprogramming (transdifferentiation). 5 October 2022
Japan’s largest drugmaker Takeda says that it will discontinue manufacturing its injectable parathyroid hormone Natpar/Natpara globally at the end of 2024 due to unresolved supply issues that are specific to the product. 5 October 2022
Privately-held US biotech company ImaginAb has had what it has describes as ‘a transformational year’ in an update on its achievements over the year. 4 October 2022
French pharma major Sanofi has entered into a collaboration and licensing agreement with little known US biotech miRecule, an innovator of next-generation RNA therapeutics. 4 October 2022