Oncology
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Pharmaceutical
Shares of Clovis Oncology gained 5.85% to $55.52 on the news that its PARP inhibitor Rubraca (rucaparib) had won US approval for an additional indication under priority review. 7 April 2018
Biosimilars
Following warnings from the US Food and Drug Administration last year, and again in February, related to its manufacturing practices, South Korean drugmaker Celltrion has now been handed a Complete Response Letter from the agency related to two of its proposed biosimilars. 6 April 2018
Biotechnology
Daiichi Sankyo has agreed a deal that allows it exclusive access to the cancer target database of DarwinHealth, a privately-held US oncology specialist. 5 April 2018
Biotechnology
Nordic Nanovector saw its share plunge 9.66% to 4.21 euros as markets opened this mornings, after the Norway-based biotech firm revealed that its chief executive, Luigi Costa, will step down from the post by mutual agreement with the board of directors. 5 April 2018
Pharmaceutical
Dacomitinib took a step towards becoming a new treatment option in locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) on Wednesday. 5 April 2018
Biotechnology
More pharma money is heading into the field of immuno-oncology (I-O), this time from privately-owned pharma company Boehringer Ingelheim. 5 April 2018
Pharmaceutical
Eli Lilly has announced top-line results from its Phase III REACH-2 study of Cyramza (ramucirumab) as a second-line treatment for liver cancer patients. 4 April 2018
Biotechnology
Puma Biotechnology has sold the Latin American rights to Nerlynx (neratinib) to Pint Pharma International, a company which focuses on oncology and other treatments in the region. 4 April 2018
Pharmaceutical
Helsinn has entered into a licensing agreement with Indian drugmaker Glenmark Pharmaceuticals to introduce Akynzeo, an oral fixed combination of netupitant and palonosetron. 4 April 2018
Biotechnology
The European Commission has approved an expanded indication for Xgeva (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone. 3 April 2018
Pharmaceutical
The European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. 3 April 2018
Biotechnology
The US Food and Drug Administration on Friday granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). 30 March 2018
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted SAKIGAKE ’fast-track’ designation for Merck KGaA’s tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. 27 March 2018
Biotechnology
Daiichi Sankyo today announced that DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), has received SAKIGAKE designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labor and Welfare (MHLW). 27 March 2018
Biotechnology
An interim analysis shows that Roche’s Phase III IMpower150 study has met its co-primary endpoint of overall survival (OS). 27 March 2018
Biotechnology
With the rolling submission of the New Drug Application (NDA) now complete, there will be more than a few fingers crossed at both US biotech Loxo Oncology and German pharma major Bayer. 26 March 2018
Pharmaceutical
Positive long-term results on Iclusig (ponatinib) in chronic myeloid leukemia (CML) have prompted a prominent biotech analyst to suggest that Japanese pharma major Takeda might yet seek approval in the first-line setting. 25 March 2018
Pharmaceutical
The big news stories last week featured clinical research, with some positive results and a disappointment. First up, Regeneron presented strong new data on Eylea that could open up a wider ophthalmic market for it and partner Bayer. Late-stage data on Heron Therapeutics' pain drug HTX-011 suggests it has a faster regulatory path. On the negative side, AbbVie’s lung cancer drug Rova-T (rovalpituzumab tesirine) failed to achieve objectives, while Novo Nordisk added to the promise of semaglutide in the treatment of obesity. 25 March 2018
Pharmaceutical
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting. 24 March 2018
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
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
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