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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
The entry of seven new agents into the non-small cell lung cancer (NSCLC) drug market - and in particular the entry of two immunotherapies - in addition to increased use of drugs behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) will drive the NSCLC drug market to increase from $4.6 billion in 2011 to over $6 billion in 2021, according to the findings of a new study by health care advisory firm Decision Resources. 5 December 2012
Biotechnology
California, USA-based Geron Corp (Nasdaq: GERN), which scrapped its stem cell business a year ago to focuses on cancer treatments, tumbled 28% to $1.07 yesterday morning, after it said that it has discontinued development of GRN1005, its peptide-drug conjugate designed to treat cancers in the brain. 5 December 2012
Biotechnology
Shares of US biotech firm Galena Biopharma (Nasdaq: GALE) leapt 13.7% to $2.32 in pre-market trading yesterday, when the company revealed it has signed an agreement with a subsidiary of Israel's Teva Pharmaceutical Industries (NYSE: TEVA) for the commercialization of its breast cancer vaccine candidate NeuVax (nelipepimut-S or E75) in Israel. 5 December 2012
Biotechnology
French drugmaker Ipsen (Euronext: IPN) and Switzerland-headquartered Galderma have expanded their collaboration for the promotion and distribution of Dysport (abobotulinumtoxinA for Injection) in new territories. 4 December 2012
Pharmaceutical
Pharma Mar, a subsidiary of Spain's Grupo Zeltia (ZEL: MC), says it has been advised by its licensee Janssen Product, part of the Johnson & Johnson (NYSE: JNJ) group, that regulatory authorities in 10 countries have granted 14 new authorizations to sell the cancer drug Yondelis (trabectedin, developed by Zeltia's PharmaMar unit): 10 for treating relapsed platinum-sensitive ovarian cancer (ROC), in combination with Caelyx (pegylated liposomal doxorubicin), and four as monotherapy for treating soft tissue sarcoma (STS). 4 December 2012
Pharmaceutical
Breakthrough drugs have made it possible for people to live with HIV longer than ever before, but more work must be done to actually cure the disease. One of the challenges researchers face involves fully eradicating the virus when it is latent in the body. A new report appearing in the December 2012 issue of the Journal of Leukocyte Biology suggests that a cancer drug, called JQ1, may be useful in purging latent HIV infection by activating the virus in the presence of potent therapy - essentially a dead end for the virus. 2 December 2012
Biotechnology
There were two items of good news yesterday for US drug developer Exelixis' (Nasdaq: EXEL), the first being that the US Food and Drug Administration approved Cometriq (cabozantinib) to treat medullary thyroid cancer (MTC) that has spread to other parts of the body (metastasized), which will be the first product for the company to comer to market. 30 November 2012
Biotechnology
US drug development firm Curis (Nasdaq: CRIS) that it has licensed from Genentech, a subsidiary of Swiss pharma major Roche (ROG: SIX), exclusive, worldwide rights for the development and commercialization of GDC-0917, a small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins. 30 November 2012
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) says it has formally notified the European Medicines Agency of its decision to withdraw the Marketing Authorization Application (MAA) for ridaforolimus, which was filed last year for the treatment of patients with metastatic sarcomas (The Pharma Letter August 2, 2011). 30 November 2012
Pharmaceutical
A new study by an international team of investigators led by Dana-Farber Cancer Institute scientists is the first to demonstrate that chemotherapy and a new, targeted therapy- selumetinib - work better in combination than chemotherapy alone in treating patients with the most common genetic subtype of lung cancer. 29 November 2012
Pharmaceutical
The global chemotherapy-induced nausea and vomiting (CINV) market was worth $1.3 billion in 2011 and is expected to reach $2.1 billion in 2018, expanding at a compound annual growth rate (CAGR) of 7.1% from 2013 to 2018, according to a new market report published by Transparency Market Research. 29 November 2012
Biotechnology
Among a batch of European Union regulatory news in the last day or two, US biotech firm Gilead Sciences (Nasdaq: GILD) announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread (tenofovir disoproxil fumarate). 29 November 2012
Pharmaceutical
US clinical-stage biopharma company focused on oncology and central nervous system (CNS) therapeutics Rexahn Pharmaceuticals (NYSE Amex: RNN) that Israel's Teva Pharmaceutical Industries (NYSE: TEVA) provide an additional funding to the firm. 28 November 2012
Biotechnology
Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss drug major Roche (ROG: SIX) has entered into an agreement with Nippon Shinyaku (TYO: 4516) to co-develop and co-market GA101 (obinutuzumab), a potential challenger for Roche's blockbuster drug Rituxan/MabThera (rituximab). 28 November 2012
Pharmaceutical
Through 2021, small-molecule angiogenesis inhibitors will dominate the renal cell carcinoma (RCC) drug market. In 2011, this drug class held a 68% market share - this share will peak in 2017 at nearly 85%, according to a new report from health care advisory firm Decision Resources. 27 November 2012
Biotechnology
In the USA, the Multiple Myeloma Research Foundation (MMRF) and the Department of Veterans Affairs (VA) have entered into an unprecedented public/private partnership to accelerate the development of personalized medicine for multiple myeloma (MM). 27 November 2012
Biotechnology
US biotech firm Seattle Genetics (Nasdaq: SGEN) says its Adcetris (brentuximab vedotin) has been granted orphan drug designation by the US Food and Drug Administration for the treatment of mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma (CTCL). 27 November 2012
Pharmaceutical
Italian drugmaker Recordati (RC: MI) says it has entered into an agreement with French development-stage biopharma company Erytech Pharma, granting Recordati's subsidiary Orphan Europe exclusive rights for the commercialization and distribution of Graspa for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) in Europe. 25 November 2012
Biotechnology
A new targeted drug - German drug major Bayer's (BAYN: DE) regorafenib (trade name Stivarga) - demonstrated its ability to control metastatic gastrointestinal stromal tumor, an uncommon and life-threatening form of sarcoma, after the disease had become resistant to all existing therapies, report investigators at Dana-Farber Cancer Institute who led the worldwide clinical trial. 22 November 2012
Biotechnology
Norway-based Algeta (OSE: ALGETA) and Belgian firm Ablynx (Euronext Brussels: ABLX) have entered a research collaboration to evaluate a novel targeted thorium conjugate (TTC) based on combining Algeta's proprietary thorium-227 alpha-pharmaceutical payload with Nanobodies generated using Ablynx' proprietary technology platform. 22 November 2012
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