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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 pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
New data show that Japanese pharma major Eisai’s Lenvima (lenvatinib) improves progression-free survival for people with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC) regardless of metastatic site, with the exception of the brain. 20 October 2015
Pharmaceutical
The Food and Drug Administration has granted Breakthrough Therapy designation for US pharma giant Pfizer’s once failed inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia (ALL). 20 October 2015
Biotechnology
Danish biotech company Nuevolution has entered into a collaboration with Janssen Biotech, one of the Janssen Pharmaceutical companies of Johnson & Johnson. 19 October 2015
Pharmaceutical
Athenex, until recently known as Kinex Pharmaceuticals, announced on Friday the completion and execution of a definitive agreement with the Banan District in Chongqing, China, to construct two separate pharmaceutical manufacturing plants on Banan sites. 19 October 2015
Biotechnology
French biotech firm Oncodesign has announced the creation of a sales and marketing subsidiary based in Cambridge, Oncodesign Biotechnology, near Boston, USA, and the establishment of a joint venture, Synergie MTL, with Mispro Biotech Service, to develop a research facility in Montreal, Canada. 19 October 2015
Biotechnology
Bristol-Myers Squibb has entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Five Prime Therapeutics’ colony stimulating factor 1 receptor (CSF1R) antibody program. 15 October 2015
Biotechnology
Peregrine Pharmaceuticals says it has expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, later-stage trial. 15 October 2015
Biotechnology
Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson, today announced collaborations with two Canadian biotechnology companies, Toronto-based Novera Therapeutics and Montreal-based enGene. 14 October 2015
Biotechnology
Contract development and manufacturing company ProBioGen and antibody therapeutics company Zymeworks have signed an agreement where ProBioGen will complete cell line development of a Zymeworks candidate. 14 October 2015
Biotechnology
UK organization the Cell Therapy Catapult has signed an agreement with Asterias Biotherapeutics, engaging the Cell Therapy Catapult in advancing development of an Asterias product. 13 October 2015
Pharmaceutical
Aeterna Zentaris on Tuesday said Data and Safety Monitoring Board (DSMB) has recommended the late stage trial for zoptarelin doxorubicin to treat advanced, recurrent or metastatic endometrial cancer, continue as planned. 13 October 2015
Biotechnology
Boehringer Ingelheim and Swiss-Italian biotech firm Philogen plan to collaborate on investigating novel treatment approaches for acute myeloid leukemia (AML). 13 October 2015
Pharmaceutical
The Scottish Medicines Consortium (SMC) has made decisions on three products. 12 October 2015
Biotechnology
Can-Fite BioPharma says that its oncology drug candidate, CF102, has been granted Orphan Drug designation by the European Medicines Agency for the indication of hepatocellular carcinoma. 12 October 2015
Biotechnology
Eli Lilly and China’s Innovent Biologics have expanded their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company. 12 October 2015
Pharmaceutical
Anglo-Swedish drug major AstraZeneca has halted studies looking at the combination of two experimental drugs, AZD9291 and MEDI4736 (durvalumab) in advanced non-small cell lung cancer. 12 October 2015
Pharmaceutical
New Phase III data has shown Halaven (eribulin) from Eisai can offer a significant overall survival benefit in rare soft tissue sarcomas compared to dacarbazine. 12 October 2015
Biotechnology
The US Food and Drug Administration on Friday granted approved for pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. 10 October 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has issued final draft guidance recommending Keytruda (pembrolizumab) from Merck to treat advanced skin cancer not treated with ipilimumab. 9 October 2015
Pharmaceutical
Japanese pharma major Eisai says it has received marketing approval of its novel in-house developed anticancer agent Lenvima (lenvatinib mesylate) from the regulatory authority in South Korea (Ministry of Food and Drug Safety). 9 October 2015
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