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Biotechnology
Selvita, a leading Poland-based biotechnology firm, and the country’s Institute of Hematology and Transfusion Medicine have published results of a research projects concerning therapeutic potential of SEL24 in Hodgkin Lymphoma. 15 July 2017
Biotechnology
US biotech major Amgen has announced positive results from the final analysis of the Phase III ASPIRE trial, confirming results of the previous ENDEAVOR study. 14 July 2017
Biosimilars
At its meeting yesterday, the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously for recommending approval of biosimilars of two top-selling drugs from Swiss pharma giant Roche. 14 July 2017
Biosimilars
Monday might have been a bad day for the biosimilar development partnership of Indian drugmaker Biocon and Netherlands-headquartered Mylan as a manufacturing setback held up its plans for the European market. 12 July 2017
Biotechnology
The human epidermal growth factor receptor type 2 (HER2)-positive breast cancer market across the eight major countries of the US, France, Germany, Italy, Spain, the UK, Japan, and China, is set to rise from $6.4 billion in 2015 to $9.89 billion in 2025, representing a compound annual growth rate (CAGR) of 4.4%. 12 July 2017
Pharmaceutical
Bristol-Myers Squibb has announced that the US Food and Drug Administration will review the company’s application to broaden the label for Sprycel. 12 July 2017
Pharmaceutical
Japanese pharma major Daiichi Sankyo has signed an agreement with Germany’s Max Planck Innovation and the Lead Discovery Center providing Daiichi Sankyo with the option to receive the exclusive rights to a new lead compound for the treatment of cancer to be discovered and developed at the Lead Discovery Center. 11 July 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and granted it a Priority Review designation. 11 July 2017
Biotechnology
Reflecting the nature of current oncology research, three companies are putting their dollars and euros into a new study involving three big-name cancer drugs combining immune checkpoint inhibitors and tyrosine kinase inhibitors. 11 July 2017
Pharmaceutical
In a reversal of a negative draft guidance in February, the medicines cost-effectiveness watchdog for England and Wales has today issued final guidance recommending cabozantinib for some kidney cancer patients. 10 July 2017
Pharmaceutical
The Hong Kong Alliance of Patients' Organizations and representatives from numerous cancer concern groups have met with physicians and politicians to discuss ways of improving cancer care in the territory. 10 July 2017
Pharmaceutical
Events in the pharma sector hitting the headlines last week included a hitch for Merck & Co’s Keytruda, mixed results for Cara Therapeutics’ pain drug candidate CR848, Celgene’s deal with China’s BeiGene and an overview on the sluggish first-half 2017 M&A activity. 9 July 2017
Pharmaceutical
The UK Supreme Court has decided in the litigation relating to alternative salt forms of Alimta (pemetrexed disodium) that Actavis' products directly infringe US pharma major Eli Lilly's vitamin regimen patents in the UK, France, Italy and Spain. 7 July 2017
Biotechnology
Daniel O’Connor has resigned as chief executive of US biotech Advaxis. 7 July 2017
Generics
Indian generic drugmaker Hetero Labs has announced plans to build a plant for the production of drugs against cancer and AIDS in Russia. 7 July 2017
Biotechnology
Merck & Co looked set to open 1% down on Thursday at around $63.50 after some rare bad news relating to Keytruda (pembrolizumab). 6 July 2017
Biotechnology
US biotech major Celgene has entered into a strategic collaboration to develop and commercialize Chinese firm BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the USA, Europe, Japan and rest of world outside Asia. 6 July 2017
Biotechnology
Positive new clinical trial results on the use of Ceplene (histamine dihydrochloride) for relapse prevention in patients with acute myeloid leukemia (AML) have been published in the Leukemia, a leading hematology journal. 6 July 2017
Biotechnology
Colorado-based Array BioPharma has submitted two applications to the US Food and Drug Administration, for binimetinib and encorafenib as treatments for BRAF-mutant advanced, unresectable or metastatic melanoma. 5 July 2017
Biotechnology
A paper from researchers at the Spanish National Cancer Research Center, published in Nature, has provided new insight into the role of midkine in promoting cancer growth. 5 July 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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