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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
Biotechnology
Philadelphia-based Penn Medicine is not only one of the world’s leading research bodies, it is also a symbol of the global relevance of one of the USA’s proudest academic institutions to healthcare and scientific progress. 25 January 2019
Biotechnology
The European Commission has approved the use of its Rubraca (rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. 25 January 2019
Pharmaceutical
New Jersey, USA-based Rafael Holdings has bought a majority stake in Rafael Pharmaceuticals, building on prior investments in the metabolic oncology-therapeutics firm. 24 January 2019
Biotechnology
While full results from the confirmatory study are awaited, the European Medicines Agency late yesterday recommended that no new patients should start treatment with Lartruvo (olaratumab). 24 January 2019
Biotechnology
Israeli cell therapy company Cellect Biotechnology has been given confidence in its ability to progress its goals rapidly by the US Food and Drug Administration’s (FDA) hiring of 50 new clinical reviewers who specialize in this area. 23 January 2019
Pharmaceutical
In a unanimous opinion, the US Supreme Court solidified that inventors lose patent protection for inventions that they had sold or offered to sell more than a year before submitting the patent application - even if those sales were confidential and did not publicize the invention’s details. 23 January 2019
Pharmaceutical
Nearly £60 million ($77 million) has been given to researchers from across North America, Europe and Israel by the world’s leading cancer research charity. 23 January 2019
Pharmaceutical
Shares in Johnson & Johnson slumped by 2% in Tuesday morning’s trading after the US healthcare conglomerate announced its 2018 financial results and outlook for 2019. 22 January 2019
Biotechnology
The European Commission (EC) has approved an expanded indication for Blincyto (blinatumomab) monotherapy. 22 January 2019
Pharmaceutical
The UK’s reimbursement agency has reversed a conditional decision not to recommend funding for the breast cancer therapy Verzenio (abemaciclib) through the country’s national healthcare provider. 21 January 2019
Pharmaceutical
Patients in England who have a mutation of the most serious and life-threatening type of skin cancer will now have a new treatment option. 21 January 2019
Biotechnology
US pharma major Eli Lilly has released disappointing results with its cancer treatment Lartruvo (olaratumab) and said it was suspending promotion of the drug. 21 January 2019
Pharmaceutical
Government affairs were the focus of pharma on both sides of the Atlantic last week. Drug prices remained top news in the USA, with the Democrats launching a sweeping investigation, while in the UK Prime Minister Theresa May suffered a historic and crushing defeat of her proposed Brexit deal, with significant implications for the pharmaceutical industry and patients. On the research front, Array and Pierre Fabre presented encouraging Phase III data on the triple combination colorectal cancer therapy -Braftovi, Mektovi and Erbitux. Regulatory news included a Food and Drug Administration advisory panel recommending approval of Amgen and UCB’s osteoporosis drug candidate Evenity, and another panel failing to reach agreement on the benefits of Lexicon Therapeutics and Sanofi’s diabetes candidate Zynquista. 20 January 2019
Biosimilars
The US Food and Drug Administration on Friday approved South Korean firm Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 over-expressing gastric cancer. 19 January 2019
Pharmaceutical
French drugmaker Servier and Taiho, a subsidiary of Japanese company Otsuka, have added to the case for approval of Lonsurf (trifluridine/tipiracil) in a new indication. 18 January 2019
Pharmaceutical
USA-based Obsidian Therapeutics has announced a strategic collaboration with Celgene for the discovery and development of novel, regulated cell therapies that utilize Obsidian’s Destabilizing Domain (DD) technology. 18 January 2019
Biotechnology
In a filing with the Securities and Exchange Commission revealed yesterday, USA biotech Immunomedics said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration for the Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan. 18 January 2019
Pharmaceutical
Nevada, USA-based Spectrum Pharmaceuticals says it has agreed terms to sell seven FDA-approved hematology/oncology products to Acrotech Biopharma, of New Jersey, USA. 18 January 2019
Biotechnology
Just a couple of months after it won European approval, Venclyxto (venetoclax) has been recommended for routine use alongside rituximab on the National Health Service (NHS) in England for previously-treated chronic lymphocytic leukemia (CLL). 18 January 2019
Pharmaceutical
Janssen, the pharmaceuticals arm of US healthcare giant Johnson & Johnson (NYSE: JNJ), has won European approval for Erleada (apalutamide) for non-metastatic castration-resistant prostate cancer (nmCRPC). 17 January 2019
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