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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
Last month, Peregrine Pharmaceuticals (Nasdaq: PPHM) announced the discovery of "major data discrepancies" between reported results and patient treatment code assignments for its randomized, double-blind, Phase IIb clinical trial investigating bavituximab as second-line treatment in stage IIIb and IV non-small cell lung cancer (NSCLC) patients (The Pharma Letter September 25). Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is believed to trigger vascular disruption, and enhance antitumor and antiviral immune responses. 17 October 2012
Biotechnology
Recently-formed drug discovery company PharmAria has entered into an agreement with US biotech firm Celgene (Nasdaq: CELG) to advance the discovery of new high quality small-molecule therapeutics targeting cancer and fibrotic diseases, which includes an option to acquire PharmAria at a later stage. 16 October 2012
Pharmaceutical
US pharma major Eli Lilly (NYSE: LLY) revealed yesterday that the REGARD trial, a Phase III study of ramucirumab (IMC-1121B) in patients with metastatic gastric cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. This trial is the first Phase III data read-out for ramucirumab, the company noted. Lilly's shares jumped 4.1% to $52.53 as investors welcomed the findings. 16 October 2012
Biotechnology
The US Food and Drug Administration on Friday approved biotech firm Celgene's (Nasdaq: CELG) Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. 15 October 2012
Pharmaceutical
In a little more than a year after its launch, a sizeable proportion of surveyed US oncologists indicate they are prescribing Johnson & Johnson/Janssen Biotech/Janssen-Cilag's Zytiga (abiraterone), according to its approved indication, according to a new report from Decision Resources. 14 October 2012
Biotechnology
UK gene-based biopharma company Oxford BioMedica (LSE: OXB) says that it plans to close the Phase II study in the USA to assess the activity of TroVax (MVA-5T4) in patients with progressive hormone refractory prostate cancer (HRPC). TroVax continues to have an active Phase II development program in other indications led by academic collaborators in the UK. 12 October 2012
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss drug major Roche (ROG: SIX) says that it filed an application with the Japanese Ministry of Health, Labor and Welfare (MHLW) for the approval of an additional indication of ovarian cancer (including primary peritoneal cancer and fallopian tube cancer) for the anti-cancer agent/ anti-VEGF humanized monoclonal antibody, Avastin (bevacizumab (recombinant) for Infusion]). 11 October 2012
Pharmaceutical
German family-owned drug major Boehringer Ingelheim last month announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for the approval of afatinib, its first anti-cancer drug candidate (The Pharma Letter September 21). 11 October 2012
Biotechnology
Efficient resource to therapy of complex disorders with lesser side effects has accelerated growth of monoclonal antibodies based therapeutics against conventional chemical drugs, according to a new report from Frost & Sullivan. 10 October 2012
Pharmaceutical
French drug major Sanofi (Euronext: SAN) says that positive detailed results from the pivotal Phase III VELOUR study evaluating Zaltrap (aflibercept) Injection for Intravenous Infusion for the treatment of patients with previously treated metastatic colorectal cancer have been published in the October edition of the Journal of Clinical Oncology (JCO). 10 October 2012
Pharmaceutical
French drug major Sanofi (Euronext: SAN) has entered in to a two-year agreement with Massachusetts General Hospital (MGH) aimed at furthering translational medicine research to develop new treatments for various types of hematological malignancies and solid tumors. 9 October 2012
Pharmaceutical
Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) says that it has filed an application based on evidence in the public domain to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval for additional dosage and administration for intramuscular administration and dosage of Leunase (L-asparaginase) Injection 5000 KU and Leunase Injection 10000 KU. 8 October 2012
Pharmaceutical
The HIV protease inhibitor nelfinavir, marketed by Swiss drug major Roche as Viracept, can be used to treat HER2-positive breast cancer in the same capacity and dosage regimen that it is used to treat HIV, according to a study published October 5 in the Journal of the National Cancer Institute. 8 October 2012
Generics
In yet another setback for research-based pharmaceutical companies, last week the Indian patent office revoked US drugs behemoth Pfizer's(NNYSE: PFE) patent for an anti-cancer drug in that country, the Indian Business Standard reported. 8 October 2012
Biotechnology
The earlier than expected US Food and Drug Administration approval of German drug major Bayer's (BAYN: DE) Stivarga (regorafenib) last month (The Pharma Letter September 28), provides a new treatment for patients with metastatic colorectal cancer (mCRC) who have exhausted all other options, note analysts at industry expert GlobalData. 7 October 2012
Biotechnology
VentiRx Pharmaceuticals, a privately held US biopharmaceutical company dedicated to the development of novel Toll-like receptor 8 (TLR8) agonists and antagonists, has entered a collaboration with biotech firm Celgene (Nasdaq CELG) for the development of VTX-2337, a highly potent and selective TLR8 agonist for the treatment of cancer. 5 October 2012
Biotechnology
USA-based Theravance (Nasdaq: THRX) and Italy headquartered Alfa Wassermann have entered into an exclusive development and commercialization agreement in certain countries for velusetrag, the US firm's investigational 5-HT4 agonist in development for gastrointestinal motility disorders. 5 October 2012
Biotechnology
Celgene International Sarl, a subsidiary of the USA's Celgene Corp (Nasdaq: CELG) has announced results of its Phase III, randomized, international study (CA033) of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in chemotherapy-naive patients with metastatic melanoma. In the study, the primary endpoint was met with patients receiving Abraxane demonstrating a statistically-significant improvement in progression-free survival compared to patients receiving dacarbazine (DTIC) chemotherapy. 4 October 2012
Pharmaceutical
Privately-held US biotech startup Epizyme says it has received a$4 million in milestone payments from UK pharma giant GlaxoSmithKline (LSE: GSK) based on the achievement of preclinical milestones. Last year, Epizyme and GSK formed a worldwide strategic alliance to discover, develop, and market novel small molecule therapeutics targeting histone methyltransferases (HMTs), an important class of epigenetic enzymes, for the treatm 3 October 2012
Biotechnology
The multiple myeloma drug market will experience significant growth, increasing from $4.4 billion in 2011 to $7.2 billion in 2021 (a 5.2% annual growth) in the USA, France, Germany, Italy, Spain, the UK and Japan, according to a new report from health care advisory firm Decision Resources. 3 October 2012
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