Oncology
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Biosimilars
Following in the footsteps of Celltrion, Samsung Bioepis, Amgen and others, Prestige BioPharma is making headway with its Herceptin (trastuzumab) biosimilar. 29 May 2019
Biotechnology
The US Food and Drug Administration has approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. 29 May 2019
Biotechnology
The US Food and Drug Administration has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older 28 May 2019
Pharmaceutical
Among noteworthy research news last week was new data for The Medicines Company’s cholesterol lowerer inclisiran showing the drug has dosing advantage. Also, Ocular Therapeutix posted disappointing results for its OTX-TP in glaucoma, but hopes to still get it approved. And Merck & Co’s blockbuster cancer drug Keytruda failed as a tripe-negative breast cancer treatment. Merck was also in the news with its proposed acquisition of biotech firm Peloton Therapeutics, which has a kidney cancer focus. Additionally, German biotech firm Evotec said it is forking out $90 million to buy US firm Just Biotherapeutics. 26 May 2019
Pharmaceutical
French drugmaker Ipsen is to present new data on three of its drugs at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting – namely Cabometyx (cabozantinib), Onivyde (irinotecan) and Somatuline/Somatuline Depot (lanreotide autogel). 24 May 2019
Biotechnology
As industry majors prepare to make a splash at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO), 2003-founded nanomedicine specialist Nanobiotix hopes it can punch above its weight. 24 May 2019
Biotechnology
Biotherapeutics revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for its TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy. 24 May 2019
Pharmaceutical
British drugmaker GlaxoSmithKline has reintroduced its bonus program for sales staff, to “better recognise and reward individual effort.” 24 May 2019
Biotechnology
The Province of Ontario has become Canada’s first to reimburse Venclexta (venetoclax) monotherapy under its Drugs and Devices Division's (DDD) Exceptional Access Program. 23 May 2019
Biotechnology
Akrevia Therapeutics, a privately-held biopharma that was launched in September 2018 by Atlas and F-Prime, has now named its first chief executive. 23 May 2019
Biotechnology
US biotech Nektar Therapeutics today announced the formation of Inheris Biopharma, a wholly-owned subsidiary of Nektar and a central nervous system (CNS)-focused company, as well as an oncology collaboration with fellow USA-based Trovagene. 23 May 2019
Biotechnology
German clinical-stage biopharma company Affimed has announced a plan to focus its research and development investments on advancing on-going and previously announced clinical trials for its innate cell engager candidates, AFM13 and AFM24. 23 May 2019
Biotechnology
Oncology heavyweight Robin Taylor has made the switch from VP level at big pharma to chief commercial officer at an emerging, multi-product biotech company. 23 May 2019
Generics
The UK Competition and Markets Authority (CMA) has provisionally found that four pharmaceutical companies broke the law by agreeing not to compete in the supply of an anti-nausea drug in the UK, driving up the price paid by the National Health Service (NHS) by some 700%. 23 May 2019
Biotechnology
It’s ASCO time again. The annual meeting of the American Society of Clinical Oncology (ASCO) is now almost upon us, with the event due to start in Chicago on Friday, May 31. 22 May 2019
Biotechnology
Amgen today offered to acquire all the shares of its research partner, Copenhagen, Denmark-headquartered Nuevolution, for a consideration of 32.50 Swedish kronor in cash per share. 22 May 2019
Biotechnology
Shares in Array Biopharma closed 23% up on Tuesday and have now almost doubled in the year-to-date. 22 May 2019
Biotechnology
US pharma giant Merck & Co announced yesterday that it will acquire privately held Peloton Therapeutics in a deal which could exceed $2.2 billion, and which would bring the company a late-stage kidney cancer candidate. 22 May 2019
Biotechnology
Merck & Co’s Keytruda (pembrolizumab) is the world’s top-selling immuno-oncology drug with approvals across 12 different cancer types, but even it cannot help in the metastatic triple-negative breast cancer (TNBC) setting. 21 May 2019
Biotechnology
German biotech Evotec has bought Seattle, USA-based Just Biotherapeutics for up to $90 million, including performance-based payments over the next three years. The initial consideration upon closing is $ 60 million. 21 May 2019
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
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
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