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Pharmaceutical
German life sciences company Merck KGaA on Sunday became the latest pharma major to back the big data revolution that some believe will transform healthcare. 11 September 2017
Biosimilars
Japan’s Chugai Pharmaceutical saw its shares gain 2.15% to 4,515 yen, after it revealed legislation to protect one of its top-selling drugs from biosimilar competition. 11 September 2017
Pharmaceutical
From December 1, 2017, approved suppliers will be required to enter a Compounder ID when submitting claims for eligible Australia’s Prescription Benefits Scheme (PBS) efficient funding of chemotherapy claims (EFC) items through PBS Online. Claims submitted without a compounder ID will not be paid, the country’s health regulator has announced. 11 September 2017
Pharmaceutical
Eli Lilly has presented results at the European Society of Medical Oncology congress in Madrid, which look set to bolster the Indianapolis-based firm’s hopes of competing in the CDK4 and CDK6 inhibitor space with its candidate abemaciclib. 11 September 2017
Biotechnology
French drugmaker Ipsen and San Francisco’s Exelixis have presented new data from the CABOSUN trial at the European Society of Medical Oncology (ESMO) congress in Madrid, showing improved progression-free survival over the current standard of care in kidney cancer. 10 September 2017
Biotechnology
While it’s not unheard of to find a biotech firm in the American Mountain States, it is unusual. In the case of Clovis Oncology, the explanation for its location in Colorado is clear, as co-founder and chief executive Pat Mahaffy explains: “I started the firm, and I live here.” 10 September 2017
Pharmaceutical
In the news last week was Sarepta Therapeutics with its Duchenne drug golodirsen, and AstraZeneca hit the limelight with news of disappointing results in its Mystic lung cancer trial of the PD-1/L1-plus-CTLA4 combination of Imfinzi (durvalumab) and tremelimumab. The news that Novartis chief executive Joseph Jimenez is to step down from the post grabbed a lot of comment. There was also disappointing news for Cellectis with its novel target for CAR-T cells, CD123 and positive results for Insmed’s Arikayce, but not for Alnylam’s hemophilia drug candidate fitusiran. 10 September 2017
Pharmaceutical
The UK’s AstraZeneca has presented full results from the Phase III FLAURA trial at the top tier presidential symposium of the European Society of Medical Oncology congress in Madrid. 9 September 2017
Pharmaceutical
Clovis Oncology will present comprehensive data from its Phase III ARIEL3 study of its leading product Rubraca in ovarian cancer. The presentation will take place at the European Society for Medical Oncology congress, currently underway in Madrid. 8 September 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. 8 September 2017
Biotechnology
Risks identified with using Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for multiple myeloma patients have emerged as bad news not just for the rights holder to that drug, Merck & Co. 7 September 2017
Biotechnology
Adaptimmune Therapeutics’ shares were up 11.57% at $7.52 mid-morning today on the news that GlaxoSmithKline has exercised its option to exclusively research, develop and commercialize its NY-ESO SPEAR T-cell therapy 7 September 2017
Biotechnology
Cancer drug developer Verastem might have found a jewel on the scrapheap, if newly-presented Phase III results are anything to go by. 7 September 2017
Biotechnology
The US Food and Drug Administration has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma. 7 September 2017
Biotechnology
UK medicines cost effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued final technology appraisal guidance recommending the use of Abraxane (nab paclitaxel) in combination with gemcitabine, in eligible patients, for the first-line treatment of a type of metastatic pancreatic cancer, known as metastatic pancreatic ductal adenocarcinoma (mPDAC). 7 September 2017
Biosimilars
Russia’s leading biotech firm Biocad has completed the clinical research program of the first Russian dianbepoetin alpha-drug - BCD-066 - for the treatment of anemia in patients with chronic renal failure and with oncological diseases. 6 September 2017
Biotechnology
The death of the very first patient treated has forced Cellectis to stop running its two Phase I trials of a gene edited ‘off-the-shelf’ immunotherapy, sending the France-based company’s share price plummeting by more than 20% on Tuesday. 6 September 2017
Pharmaceutical
Roche today announced results from the global Phase III ALUR study showing that Alecensa (alectinib) significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). 6 September 2017
Biotechnology
The European Commission (EC) has given the green light to another use of Merck & Co’s (NYSE: MRK) multi-indication immuno-oncology drug Keytruda (pembrolizumab), this time for the treatment of certain patients with locally-advanced or metastatic urothelial carcinoma, a type of bladder cancer. 5 September 2017
Pharmaceutical
Missing data to prove that a combination involving Ninlaro (ixazomib) prolongs overall survival in relapsed or refractory (R/R) multiple myeloma (MM) compared with the current treatment has added further delay to National Health Service (NHS) funding for patients in England and Wales. 5 September 2017
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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