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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
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
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
Biotechnology
Chinese small-molecule drug discovery and development company Tyligand Bioscience has signed collaboration agreements with privately-held US company Context Therapeutics for the development, manufacturing, registration and future commercialization of onapristone extended release (ER). 13 March 2020
Pharmaceutical
Swiss cancer giant Roche has been given EU approval for a combo of Venclyxto (venetoclax) plus Gazyvaro (obinutuzumab) as a first-line option for chronic lymphocytic leukemia (CLL). 12 March 2020
Biotechnology
Phio Pharmaceuticals Corp, a US biotech developing immuno-oncology (I-O) drugs based on its self-delivering RNAi (INTASYL) therapeutic platform, is to collaborate with MediGene AG to advance compounds in adoptive cell therapy to enhance immune cell function. 12 March 2020
Biotechnology
Disappointing high-level results from the Phase III GY004 trial, led by NRG Oncology and sponsored by the US National Cancer Institute (NCI), that examined primarily the efficacy and safety of the potential new medicine Recentin (cediranib) added to Lynparza (olaparib) versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer have been released . 12 March 2020
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. 11 March 2020
Biotechnology
Stock in Stockholm-based Cantargia has been lifted by news the firm has bought an important patent portfolio from Cellerant Therapeutics. 10 March 2020
Biosimilars
UK-domiciled Mylan and India’s Biocon aid today that the US Food and Drug Administration has accepted the Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway. 9 March 2020
Biotechnology
A court has dismissed a class action and related litigation that was filed against USA-based OncoSec Medical Incorporated by an investor that had launched a takeover attempt. 9 March 2020
Biotechnology
Located at the heart of the Cambridge biotech cluster in Massachusetts, Kymera Therapeutics is exploring the notion that targeted protein degradation could provide a way to treat previously untreatable conditions. 9 March 2020
Biotechnology
US pharma major Bristol-Myers Squibb has announced disappointing top-line results from ELOQUENT-1, a Phase III, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. 9 March 2020
Biotechnology
China and USA-based Harbour BioMed (HBM) and Mount Sinai Health System have entered into a multi-year, multifaceted collaboration to develop novel, fully human antibodies for the treatment and prevention of various diseases including oncology and immunology. 9 March 2020
Biotechnology
Data and analytics firm GlobalData suggest that, out of all the drugs that are currently in the pre-registration phase and are expected to launch in 2020, 10 have the potential to reach blockbuster status over the next six years. 9 March 2020
Pharmaceutical
The financial results for the latest quarter and 2019 as a whole made for satisfying reading for shareholders of Germany’s Merck KGaA. 5 March 2020
Pharmaceutical
Shares of Spanish drugmaker PharmaMar rose nearly 15% on Tuesday, after the company revealed it has a potential treatment for coronavirus. 5 March 2020
Pharmaceutical
Ono Pharmaceutical has submitted to broaden the Japanese label for Braftovi (encorafenib) plus Mektovi (binimetinib), in combination with the chemotherapy cetuximab. 5 March 2020
Biotechnology
East Coast, USA-based Karyopharm Therapeutics has announced positive topline results from the Phase III BOSTON study of Xpovio (selinexor). 3 March 2020
Biotechnology
Some eight weeks earlier than expected, the US Food and Drug Administration has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have 3 March 2020
Pharmaceutical
Leading Russian doctors along with representatives of local medical communities have called on Russia’s Prime Minister Mikhail Mishustin to ensure the supplies of original drugs to the domestic market, particularly those used for the treatment of some serious diseases, reports The Pharma Letter’s local correspondent. 3 March 2020
Biotechnology
Privately-held UK-based T cell receptor (TCR) biotech firm Immunocore today announced the completion of its Series B private financing round, generating more than $130 million. 2 March 2020
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