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
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
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
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
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
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
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
The attention-deficit/hyperactivity disorder (ADHD) market across the seven major markets (7MM) is forecast to decline at a negative compound annual growth rate (CAGR) of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032. 4 June 2024
Israel-based artificial intelligence (AI) focused biotech Biolojic Design has entered into a multi-target drug discovery collaboration with Germany’s Merck KGaA. 4 June 2024
French pharma major Sanofi released positive new data from the IMROZ Phase III study at the American Society of Clinical Oncology (ASCO) annual meeting. 4 June 2024
Privately-held company GAIA has had more than a front-row seat to observe the arrival of digital therapeutics and applications of AI in pharma over the past quarter century. 4 June 2024
While cancer-focused pharma and biotech are busy presenting their latest research achievements at the ongoing American Society of Clinical Oncology (ASCO) meeting, Germany’s Merck KGaA also held its own Oncology R&D Update Call. 3 June 2024
Japanese pharma giant Takeda and Pfizer have announced positive results from the Phase III HD21 trial at the annual meeting of the American Society of Clinical Oncology (ASCO). 3 June 2024
Faced with plenty of competition from other drugmakers at the 2024 American Society of Clinical Oncology (ASCO) meeting, Novartis has sought to show the strength of its cancer medicines with its latest data. 3 June 2024
US clinical-stage biotech start-up QurAlis has signed an agreement with Eli Lilly granting the pharma major global rights to develop and commercialize QRL-204. 3 June 2024
Asahi Kasei Medical's US subsidiary Bionova Scientific, a full-service biologics CDMO, has decided to launch a new business line providing services leveraging plasmid DNA, and establish a dedicated facility for this purpose in Texas, USA, with a $100 million investment. 3 June 2024
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals today announced results from the company’s MOTION pivotal Phase III study of vimseltinib in patients with Tenosynovial Giant Cell Tumor TGCT) in an oral presentation at ASCO. 3 June 2024
Privately-held neurology company Tris Pharma has received approval from the US Food and Drug Administration for Onyda XR (clonidine hydrochloride). 3 June 2024
Positive results have been presented from the LAURA Phase III trial on AstraZeneca’s Tagrisso (osimertinib) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. 3 June 2024
CSL Seqirus is set to complete the fill and finish process for pre-pandemic vaccine to support the US government’s outbreak and preparedness response. 3 June 2024
At the 2024 annual meeting of the American Society of Clinical Oncology (ASCO), Bristol Myers Squibb has announced promising results from the Phase III KRYSTAL-12 study. 3 June 2024
US biotechs Gilead Sciences and Arcus Biosciences on Saturday announced longer-term efficacy and safety results from Arm A1 of the Phase II EDGE-Gastric study. 3 June 2024
With a steady flow of oncology results emerging from the ongoing ASCO meeting, a company such as Pierre Fabre, which does not have major data to present, might not usually claim the spotlight. 3 June 2024
Researchers from UK-based biotech Immunocore Holdings shared new data at the American Society of Clinical Oncology (ASCO) meeting on Kimmtrak (tebentafusp-tebn), the first-ever treatment approved for metastatic uveal melanoma (mUM), showing there is treatment benefit for patients with stable disease and any confirmed tumor reduction. 3 June 2024