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
Pharmaceutical
US health care major Johnson & Johnson (NYSE: JNJ) yesterday reviewed its growth strategies for its Pharmaceuticals business at a meeting with the investment community today. The company, which is in the process of launching six key pharmaceuticals products since 2009, said it plans to file for approval of 11 new drugs - and over 30 indication extensions - by 2015 as it moves to expand its pharmaceutical business. 27 May 2011
Pharmaceutical
Cancer Research UK and Cancer Research Technology - the charity's development and commercialization arm - have partnered with Centella Therapeutics, a subsidiary of Varian Medical Systems (NYSE: VAR), to develop, manufacture and trial a promising new drug candidate, CEN-209 in cancer patients with solid tumors. 26 May 2011
Biotechnology
New Jersey, USA-based biotech firm Enzon Pharmaceuticals (Nasdaq: ENZN) says that, in light of evolving standards of care for the treatment of metastatic colorectal cancer (mCRC), the company will discontinue its PEG-SN38 (EZN-2208) clinical program in this disease, following conclusion of its Phase II study. 25 May 2011
Pharmaceutical
The UK's drug rationing watchdog the National Institute for Health and Clinical Excellence (NICE) today issued a positive Final Appraisal Determination (FAD), recommending extended use of Swiss drug major Roche's (ROG: SIX) already blockbuster antibody MabThera (rituximab, also marketed as Rituxan) as a first-line maintenance treatment for patients with follicular lymphoma (FL). 24 May 2011
Biotechnology
Anglo-Swedish drug major AstraZeneca (LSE: AZN) today announced a co-promotion agreement in Japan with locally based Daiichi Sankyo (TSO: 4568) for denosumab, a drug for the treatment of bone disorders stemming from bone metastasis. The drug was originated by US biotech giant Amgen (Nasdaq: AMGN); it is already approved in the USA and recently gained backing for clearance in Europe under the trade name Xgeva (The Pharma Letter March 23). Financial terms of this deal are not disclosed. 24 May 2011
Pharmaceutical
USA-based Genta (OTCBB: GNTA) received a blow yesterday, when it announced that overall survival for patients treated with Genasense (oblimersen sodium) Injection plus chemotherapy in AGENDA, the company's Phase III trial of the drug in patients with advanced melanoma, was not significantly superior compared with subjects treated with chemotherapy alone. 24 May 2011
Pharmaceutical
The US Food and Drug Administration on Friday approved US health care giant Johnson & Johnson's (NYSE: JNJ) Edurant (rilpivirine) tablets for use in combination with other antiretroviral agents (ARVs) in the treatment of human immunodeficiency virus type 1 (HIV-1) in adults who have never taken HIV therapy (treatment-naive). 23 May 2011
Biotechnology
Friday proved to be a good day for some of the world's leading drugmakers, as the European Medicines Agency's advisory unit, the Committee for Medicinal Products for Human Use (CHMP), came out with a batch of positive recommendations regarding European Union approval. 23 May 2011
article
Canada's Ontario Institute for Cancer Research (OICR) has announced investments in three new Ontario companies aimed at bringing promising anticancer technologies to market. 23 May 2011
Pharmaceutical
A number of leading pharmaceutical companies ' include Pfizer, Bayer, Roche and AstraZeneca - have pre-released data regarding investigation cancer drugs that are due to be presented at the forthcoming 47th Annual American Society of Clinical Oncology (ASCO) meeting in Chicago, which takes place June 3-7, 2011. 20 May 2011
Pharmaceutical
In the USA, 10% of cancer patients failed to fill their initial prescriptions for oral anti-cancer drugs, according to a new study published jointly in the Journal of Oncology Practice (JOP) and American Journal of Managed Care (AJMC). The study was based on an analysis conducted by Avalere Health using pharmacy transaction data over a two-year period from 2007 to 2009. 20 May 2011
Pharmaceutical
Expensive new cancer drugs treating increasing numbers of patients could drive cancer drug spending by as much as 15% a year through 2013. At this accelerated rate, oncology drugs will likely rise to the second or third largest trend-driving category by 2015, following only diabetes and central nervous system (CNS) treatments, according to the newly-released 2011 Medco Drug Trend Report which tracks utilization and spending. 19 May 2011
Biotechnology
Amgen (Nasdaq: AMGN), the world's largest biotech company, has announced primary results of a pivotal Phase III trial (Study 147) demonstrating that Xgeva (denosumab) significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone. Full results of the '147 study were presented for the first time today in a late-breaking plenary session at the American Urological Association (AUA) 2011 Annual Meeting in Washington DC. 19 May 2011
Pharmaceutical
Japanese drug major Eisai (TYO: 4532), says that its Halaven(eribulin) has been approved for use in Switzerland by Swissmedic, the Swiss Agency for Therapeutic Products, as a monotherapy treatment of patients with locally advanced and metastatic breast carcinoma with progression after prior therapy with an anthracycline, a taxane and capecitabine. 19 May 2011
Pharmaceutical
In just over a month following the US Food and Drug Administration's approval last fall of Swiss drug major Roche's (SIX: ROG) Herceptin (trastuzumab;) for HER2-positive metastatic gastric cancer (The Pharma Letter October 22, 2010), more than 80% of US physicians report using the drug, according to new research by GfK HealthCare. However, the research study also shows that physicians are not truly satisfied with current treatment options for gastric cancer, including Herceptin. 19 May 2011
Pharmaceutical
Researchers at the CHUM Research Centre (CRCHUM) and the Peter MacCallum Cancer Centre in Australia have identified a new avenue for treating breast cancer. 19 May 2011
Pharmaceutical
US drug behemoth Pfizer (NYSE: PFE) says that its New Drug Application for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, has been accepted for filing and granted Priority Review status by the US Food and Drug Administration and has been filed with the Japanese Ministry of Health, Labor and Welfare (MHLW). The proposed indication is for the treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC). 18 May 2011
Pharmaceutical
Adding low doses of the targeted agent sorafenib (German drug major Bayer and Onyx' kidney and liver cancer drug Nexavar) to the chemotherapy and radiation now often used to treat head and neck cancer might significantly improve patient care and quality of life, according to a new study by researchers at the Ohio State University Comprehensive Cancer Center-Arthur G James Cancer Hospital and Richard J Solove Research Institute (OSUCCC ' James). 17 May 2011
Generics
Hyderabad, India-based generic drugmaker Dr Reddy's Laboratories (NYSE: RDY) has launched its Peg-grafeel, the firm's brand of pegfilgrastim, which has been marketed in that country since 2007 by the local subsidiary of Swiss drug major Roche (SIX: ROG) as Neulastim. 16 May 2011
Pharmaceutical
USA-based Allos Therapeutics (Nasdaq: ALTH) and privately-held Mundipharma International have entered into a strategic collaboration to co-develop Folotyn (pralatrexate injection). Under the agreement, Allos retains full commercialization rights for the drug in the USA and Canada, with Mundipharma having exclusive rights to commercialize Folotyn in all other countries. 13 May 2011
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