Oncology
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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 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
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
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
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
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
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
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
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Biotechnology
USA-based drug developer ArQule (Nasdaq: ARQL) saw its shares plunge 62% to $1.90 after, along with its partner Japan's Daiichi Sankyo (TYO: 4568), announced they were halting a Phase III study in non-small cell lung cancer (NSCLC) of its tivantinib after independent monitors concluded the drug would not meet its endpoint of prolonging overall patient survival. 3 October 2012
Biotechnology
In further news coming out at the European Society of Medical Oncology (ESMO) Congress taking place in Vienna, Austria (see also The Pharma Letter October 1), USA-based ImmunoGen (Nasdaq: IMGN) announced overall survival data for its trastuzumab emtansine (T-DM1) Phase III EMILIA trial, showing that the product reduced the risk of death by 32% compared to the standard-of-care treatment arm of the trial. 2 October 2012
Pharmaceutical
Scotland-based ProStrakan, a subsidiary of Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151), has acquired exclusive US commercialization rights to Fareston (toremifene citrate) for the treatment of metastatic breast cancer in postmenopausal women, from US biotech firm GTx Inc (Nasdaq: GTXI), for a lump sum payment of $21.7 million. 2 October 2012
Biotechnology
USA-based AVEO Oncology (Nasdaq: AVEO) and Japanese drug major Astellas Pharma (TSE:4503) have submitted a New Drug Application to the US Food and Drug Administration seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors. 2 October 2012
Biotechnology
New studies that reveal for the first time the real economic and human costs of caring for cancer patients in Europe have presented during the European Society for Medical Oncology (ESMO) 2012 Congress now taking place in Vienna, Austria. These showed that cancers cost the European Union 124 billion euros ($159.5 billion) each year, according to the first ever estimate of the economic burden of malignancies in the region. Lung cancer is responsible for the highest overall burden, the new study shows. 1 October 2012
Pharmaceutical
The European Commission on Friday approved the marketing authorization for Janssen-Cilag's (a unit of US health care giant Johnson & Johnson [NYSE: JNJ]) Dacogen (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy. Dacogen also has been granted Orphan Drug designation for the treatment of AML. 1 October 2012
Pharmaceutical
The European Society for Medical Oncology (ESMO) Congress kicked off in Vienna, Austria, last Friday with a flood of new and updated clinical research presented on a variety of cancer drugs currently in development and some already marketed. The following are highlights of presentations by GlaxoSmithKline, Pfizer and Janssen. 1 October 2012
Pharmaceutical
Bayer said Stivarga will be ready for distribution as soon as today (September 28 and set a wholesale price for the drug of $9,350 for a 28-day cycle of treatment, according to Reuters. The company is currently awaiting a colon cancer approval decision for the drug in the European Union, as well as seeking US approval of regorafenib as a treatment for gastrointestinal stromal tumors. 28 September 2012
Biotechnology
Switzerland-based Roche (SIX: ROG), the world's largest cancer drug company, has licensed exclusive worldwide development and commercialization rights to privately-held US firm Galaxy Biotech's antibodies targeting fibroblast growth factor 2 (FGF2) for the treatment of cancer for an upfront payment of $8 million. 26 September 2012
Pharmaceutical
Denmark's Topotarget (Nasdaq OMX: TOPO) said that the primary endpoint has been met for the pivotal trial with its potential blockbuster cancer drug candidate belinostat for patients with peripheral T-cell lymphoma (PTCL), causing the company's shares to rocket 135% to 2.42 Danish kroner. 26 September 2012
Biotechnology
Earlier this month, the investment committee of Maxwell Biotech Venture Fund (MBVF), founded with the participation of the Russian government's RVC, approved the binding terms and the amount of an investment in a newly-established private Russian biotech company, Osteros Biomedica, formed for the development and commercialization of drugs for the treatment of cancer-induced bone disease. 26 September 2012
Biotechnology
The European Society for Medical Oncology (ESMO) will kick off its 2012 annual meeting on Friday, September 28 in Vienna, Austria. ESMO reports that this year's meeting will be bigger and better than ever as abstract submissions increased by 30% compared to the previous year. 25 September 2012
Biotechnology
Shares of US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) went into free-fall in pre-market trading yesterday, dropping 85.7% to $0.82, when the company revealed a problem with one clinical trial of its lead drug candidate bavituximab. 25 September 2012
Biotechnology
US drug developer Astex Pharmaceuticals (Nasdaq: ASTX) saw its shares fall 8.1% to $3.05 by close last Friday, after the company revealed that clinical development of amuvatinib (MP-470) has been discontinued. 25 September 2012
Pharmaceutical
Privately-held Swiss company Helsinn Group says it has signed a license agreement with CJ CheilJedang of South Korea for Helsinn's new product for potential use in the prevention of chemotherapy-induced nausea and vomiting (CINV). 25 September 2012
Pharmaceutical
Japanese drug major Astellas Pharma (TYO: 4503) has entered into a collaboration with the High Energy Accelerator Research Organization (KEK), also based in Japan, to discover new drugs for the treatment of neglected tropical diseases (NTDs) through the use of synchrotron X-ray crystallography. No commercial terms of the accord were released. 25 September 2012
Biotechnology
Treatment with denosumab, a drug from Amgen (Nasdaq: AMGN), the world's largest biotech firm which markets the compound as Xgeva and Prolia, targeted against a protein that helps promote bone destruction, decreased the number of tumor giant cells in patients with giant-cell tumor of the bone, and increased new bone formation, according to the results of a Phase II study published in Clinical Cancer Research, a journal of the American Association for Cancer Research. 25 September 2012
Pharmaceutical
German family-owned drug major Boehringer Ingelheim said yesterday that it has submitted a Marketing Authorization Application to the European Medicines Agency for approval of its first oncology compound, afatinib, the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). 21 September 2012
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss drug major Roche (ROG: SIX), says that it has filed an application with the Japanese Ministry of Health, Labor and Welfare (MHLW) for the approval of an additional indication of recurrent glioblastoma for the anti-cancer agent/ anti-VEGF humanized monoclonal antibody Avastin (bevacizumab) IV Infusion 100mg/4mL and 400mg/16mL. 21 September 2012
Biotechnology
US biotech firm Celgene (Nasdaq: CELG) says that the US Food and Drug Administration's Oncologic Drugs Advisory Committee will hold a review of the company's New Drug Application for pomalidomide at its meeting on November 8, 2012. 21 September 2012
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