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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
Pharmaceutical
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) this morning (June 13) issued final draft guidance not recommending US drug major Eli Lilly's Alimta (pemetrexed) for the maintenance treatment of non-small-cell lung cancer (NSCLC) following induction therapy with pemetrexed and cisplatin. 13 June 2013
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) says that the therapeutic effects of lenvatinib, a VEGF receptor tyrosine kinase inhibitor and multi-kinase inhibitor discovered in-house, on melanoma have been confirmed in one of a series of joint development programs being conducted as part of the company's strategic collaboration with Quintiles (NYSE: Q). The finding has provided the basis for the first proof of concept (POC) to be achieved under the partnership. 12 June 2013
Pharmaceutical
UK-based Abcam (AIM: ABC), a producer and distributor of protein research tools, has entered into a license agreement with global pharma behemoth Pfizer (NYSE: PFE). Under the terms of the agreement, Abcam's Biochemicals division will supply a range of authentic Pfizer compounds for use as preclinical research tools by researchers worldwide, alongside the Abcam Biochemicals range of over 2000 bioactive small molecules. 12 June 2013
Biotechnology
US biopharmaceutical company Immunomedics (Nasdaq: IMMU) reports that adding two doses of epratuzumab labeled with the radioisotope, yttrium-90 (90Y), to a combination of rituximab and CHOP chemotherapy (R-CHOP), the standard of care for patients with diffuse large B-cell lymphoma (DLBCL), appeared to improve elderly patients' responses to treatment. 11 June 2013
Biotechnology
US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from the US Food and Drug Administration saying that the FDA will not approve in its present form the New Drug Application for the company's investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC). 11 June 2013
Biotechnology
The effect of an emerging therapy on key efficacy endpoints, including time to disease progression and overall survival, has the most influence over surveyed US and European oncologists' prescribing decisions for platinum-resistant advanced ovarian cancer, according to a new report from health care advisory firm Decision Resources. 11 June 2013
Pharmaceutical
USA-based Isis Pharmaceuticals (Nasdaq: ISIS) revealed that privately-held Canadian firm Xenon Pharmaceuticals has exercised its option to an exclusive worldwide license to XEN701, an antisense drug discovered in a collaboration between Isis and Xenon. 10 June 2013
Biotechnology
US biotech firm CytomX Therapeutics, which is developing a new generation of targeted antibody therapeutics, has entered into a global strategic collaboration with global pharma behemoth Pfizer (NYSE: PFE) to develop and commercialize multiple Probody-Drug Conjugates (PDCs) that could provide the smaller company with as much as $635 million in upfront and milestone payments. 7 June 2013
Biotechnology
The US Food and Drug Administration has approved US biotech firm Celgene's (Nasdaq: CELG) supplemental New Drug Application for Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. 6 June 2013
Pharmaceutical
Symptom control and quality of life is one of the factors the most influences surveyed US and European oncologists' treatment decisions for second- and subsequent-line metastatic castrate-resistant prostate cancer (mCRPC), and that improved symptom control and quality of life is one of the greatest unmet needs in this indication. 6 June 2013
Pharmaceutical
Astellas signs enzalutamide distribution deal in Latin America; Oxford Pharmascience links with Ache
The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) has entered into a distribution agreement with Tecnofarma International to distribute enzalutamide (trade name Xtandi in the USA) in Latin America, excluding Brazil, upon regulatory approvals in the various countries. Financial terms of the agreement were not disclosed. 5 June 2013
Biotechnology
US biotech firm Onyx Pharmaceuticals (Nasdaq: ONXX) and the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center have formed the Oncology Innovation Alliance (OIA), a public-private partnership focusing on the discovery and development of novel therapies and their potential role in treating various types of hematologic cancers and solid tumors. 5 June 2013
Biotechnology
Following a recent negative opinion on its lead product candidate from a Food and Drug Administration advisory panel in the treatment of renal cell carcinoma (The Pharma Letter May 3), US biotech firm AVEO Oncology (Nasdaq: AVEO) has announced a strategic restructuring that will refocus the company's efforts and resources on the ongoing clinical development of tivozanib in colorectal and breast cancer, as well as advancing key pipeline and preclinical assets. 5 June 2013
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) says that its study of Tykerb/Tyverb (lapatinib) in combination with chemotherapy in patients with HER2-positive advanced gastric cancer did not meet the primary endpoint of improved overall survival (OS) compared to chemotherapy alone. 4 June 2013
Pharmaceutical
Continuing our coverage of the ongoing American Society of Clinical Oncology (ASCO) meeting in Chicago, herewith are the latest presentations on important research in the field of cancer therapies, including some early-stage data. 4 June 2013
Biotechnology
Leading provider of injectable drugs and infusion technologies Hospira (NYSE: HSP) says that results from a post-marketing study of the company's European biosimilar epoetin, Retacrit, met the primary endpoint, as defined by hemoglobin treatment response, in the management of chemotherapy-induced anemia in adult patients with solid tumors, lymphomas and myelomas, regardless of chemotherapy cycle. 4 June 2013
Pharmaceutical
USA-based Isis Pharmaceuticals (Nasdaq: ISIS) says that Anglo-Swedish drug major AstraZeneca (LSE: AZN) has added a second development candidate, ISIS-ARRx, to its collaboration, meaning that Isis has earned a $10 million milestone payment associated with this decision. 4 June 2013
Pharmaceutical
A new study released by The Moran Company finds that, between 2005 and 2011, the relative number of chemotherapy administration procedures performed in US hospital outpatient settings for Medicare Fee-for-Service (FFS) beneficiaries increased by more than 150% (13.5% in 2005 to 33.0% in 2011) compared to administration in physician community cancer clinics. 4 June 2013
Pharmaceutical
Among further highlights from the ongoing American Society of Clinical Oncology (ASCO) meeting in Chicago, Japanese drug major Eisai (TYO: 4523) presented new data from Phase III 301 study showing that Halaven (eribulin) improved Global Health Status and overall quality of life more than capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. 3 June 2013
Biotechnology
US clinical-stage biopharma firm Soligenix (OTCQB: SNGX) says that its SGX942 development program for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients has received "Fast Track" designation from the US Food and Drug Administration. 3 June 2013
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