Oncology
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Biotechnology
Ono Pharmaceutical has received manufacturing and marketing approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of recurrent or refractory primary central nervous system lymphoma, in Japan. 25 March 2020
Biotechnology
Netherlands-based Norgine says it has acquired Azanta, a Denmark-based specialty biopharmaceutical company operating within women’s healthcare, addiction medicine and oncology. Azanta becomes a wholly-owned subsidiary of Norgine. 25 March 2020
Pharmaceutical
Japanese drugmaker Daiichi Sankyo saw its shares shoot up by 9% in Wednesday’s trading. 25 March 2020
Pharmaceutical
US oncology biotech CytomX Therapeutics and Japan’s Astellas Pharma have entered into a strategic collaboration agreement focused on the discovery, research, development and commercialization of novel T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens for the treatment of cancer. 25 March 2020
Pharmaceutical
Germany’s Merck KGaA has won Japanese approval for Tepmetko (tepotinib), for the treatment of certain people with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC). 25 March 2020
Biotechnology
Boston, USA-based biotech Pieris Pharmaceuticals has announced that its immuno-oncology collaboration with independent French drugmaker Servier is now to be focused on the two most advanced programs. 24 March 2020
Biotechnology
US biopharma AbbVie today announced that the Phase III VIALE-A trial of (venetoclax) in combination with azacitidine versus azacitidine in combination with placebo met its dual primary endpoints. 23 March 2020
Biotechnology
Clinical-stage biotech Tarveda Therapeutics and China-owned SciClone Pharmaceuticals have entered into a licensing agreement for PEN-866, the initial clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform. 20 March 2020
Biotechnology
China’s National Medical Products Administration (NMPA) has granted marketing authorization for Ameile (almonertinib, previously also known as HS-10296) once daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after other EGFR tyrosine kinase inhibitor (TKI) therapy. 19 March 2020
Biotechnology
US precision medicines company IDEAYA Biosciences saw its shares leap 15.5% to $3.50 by mid-day, after it revealed a clinical trial collaboration with pharma giant Pfizer. 18 March 2020
Biotechnology
UK gene and cell therapy company Oxford Biomedica has signed a new licence and clinical supply agreement (LSA) with Juno Therapeutics, a part of Bristol-Myers Squibb. 18 March 2020
Biotechnology
Privately-held Singapore-based company Tessa Therapeutics’ CD30-directed autologous CAR-T therapy has received US Food and Drug Administration (FDA) regenerative medicine advanced therapy (RMAT) designation. 17 March 2020
Biosimilars
Israel’s Teva Pharmaceutical Industries and partner South Korea’s Celltrion Healthcare today announced that Herzuma (trastuzumab-pkrb) for Injection, a biosimilar to Roche’s blockbuster Herceptin, is now available in the USA .
. 16 March 2020
Biotechnology
Germany’s Merck and Pfizer today announced a disappointing update from the Phase III JAVELIN head and neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). 16 March 2020
Biotechnology
Stockholm-based biotech Medivir has agreed a licensing deal for one of its pre-clinical research programs, with US biotech Tango Therapeutics. 16 March 2020
Pharmaceutical
Apart from the novel coronavirus COVID-19 totally dominating the news all last week, there were other things of note. On the research front, last Monday, Bristol-Myers Squibb released disappointing Phase III results for the combination of Empliciti, Revlimid and dexamethasone in untreated multiple myeloma. In another flop in ovarian cancer, AstraZeneca and Merck & Co released new data on cediranib and Lynparza that failed its Phase III endpoint. Kala Pharmaceuticals last week presented positive Phase III results for its dry eye disease drug candidate KPI-121, or Eysuvis. Elsewhere, India’s Zydus Cadila gained domestic approval for its Lipaglyn as a treatment for non-alcoholic steatohepatitis (NASH). 14 March 2020
Pharmaceutical
As a result of discussions at its March 9-12 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that patients receiving fluorouracil given by injection or infusion (drip) and the related medicines capecitabine and tegafur, which are converted to fluorouracil in the body, should be tested for the lack of an enzyme called dihydropyrimidine dehydrogenase (DPD) before starting treatment. 14 March 2020
Biotechnology
A bolstering of hopes that Spanish drugmaker PharmaMar (MSE: PHM) might have an answer for the COVID-19 coronavirus sent the company’s share price spiralling upwards on Friday. 13 March 2020
Pharmaceutical
UK biotech firm Redx Pharma has a new majority shareholder, investment group Redmile, after the US-based company bought up nearly 40% of the company, bringing its total shareholding to over 45%. 13 March 2020
Biotechnology
US biotech major Gilead Sciences’ recent $4.9 billion buyout of Forty Seven put a spotlight on the latter’s star asset magrolimab, an anti-CD47 monoclonal antibody (MAb), as well as the target CD47, a protein on cancer cells sending out “don’t eat me” signal to avoid phagocytosis by microphages. 13 March 2020
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
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
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