Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
NewCo, a relatively new business model that involves a joint venture (JV) between a biotech and a group of investors to bring the biotech’s promising assets to the global market, is gaining popularity among Chinese biotechs, who traditionally rely on out-licensing deals to capitalize assets, s 11 September 2024
Detailed results were released from the TROPION-Lung01 Phase III trial, which showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxe. 10 September 2024
Chinese companies Innovent Biologics and GenFleet have recently secured approval from China’s National Medical Products Administration (NMPA) for Dupert (fulzerasib). 9 September 2024
Summit Therapeutics on Sunday announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab compared to Merck & Co’s) mega blockbuster drug Keytruda (pembrolizumab). 9 September 2024
Organon KK, a Japan subsidiary of Organon & Co, announced that the primary endpoint was achieved in a domestic Phase III clinical trial evaluating the efficacy and safety of OG-8276A 6 September 2024
Targeted alpha therapy (TAT), or radioligand therapy, is a recent hot area that attracted big pharmas like Bristol Myers Squibb and Novartis. 5 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Privately-held Chinese biotech EpimAb Biotherapeutics and Vignette Bio have entered into a license agreement for EpimAb’s BCMA-targeting T-cell engager (TCE) EMB-06. 5 September 2024
Rigel Pharmaceutical’s shares dipped 4.4% to $12 .85 by late morning, despite announcing what could be a lucrative deal for the company. 3 September 2024
Chinese gene therapy specialist YolTech Therapeutics has entered into an exclusive licensing agreement with Salubris Pharmaceuticals (SHE: 002294). 3 September 2024
Japan’s Nxera Pharma today announced that it will receive a $35 million payment from Neurocrine Biosciences, triggered by the successful completion of the Phase II trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia. 2 September 2024
Chinese biopharma Hutchmed on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib. 2 September 2024
Jacobio Pharma announced that it has granted the China rights to KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals. 2 September 2024
Japanese drugmaker Chugai Pharmaceutical says it will transfer the business of the secondary hyperparathyroidism drug Oxarol for Injection (maxacalcitol) to LTL Pharma in Japan. 29 August 2024
Chinese biotech DualityBio has shown that it means business in a filing to the Hong Kong stock exchange that reveals its plans for an initial public offering (IPO). 28 August 2024
Japanese pharma major Astellas Pharma today revealed that the European Commission has granted Marketing Authorization for Padcev (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with Keytruda (pembrolizumab). 28 August 2024
Chugai Pharmaceutical has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an additional indication for Alecensa (alectinib). 28 August 2024
Immuno-oncology firm I-Mab saw its shares slip 4.5% to $1.91 pre-market today, as it announced that, as part of its strategy to become a USA-based biotech, it is divesting its Chinese subsidiaries. 8 February 2024
China-based Hutchmed has reported data from FRUTIGA, its Phase III trial of fruquintinib alongside paclitaxel for the treatment of second-line advanced gastric cancer in China, at the American Society of Clinical Oncology (ASCO) Plenary Series Session. 8 February 2024
Shares of French ophthalmology biotech Nicox shot up 16.8% to 0.48 euros this morning, after it announced a deal with privately-held Japanese firm Kowa Company. 8 February 2024
Hong Kong-listed biotech BeiGene has received Health Canada authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL). 8 February 2024
California, USA-based biotech BridgeBio Pharma today announced a partnership wherein its affiliate, QED Therapeutics, grants Japan’s Kyowa Kirin an exclusive license for infigratinib. 7 February 2024
Japan’s largest drugmaker Takeda Pharma has appointed Dr Phuong Khanh (PK) Morrow as head of the Oncology Therapeutic Area Unit, effective as of January 29. 3 February 2024
Positive high-level results from the Japan Phase III trial of acoramidis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed consistency to those in the global BridgeBio Pharma ATTRibute-CM Phase III trial, including survival, cardiac-related hospitalizations and other measures of improved functions and quality of life, at 30 months. 2 February 2024
Chinese biopharma Hutchmed today announced that Hong Kong-based Inmagene Biopharmaceuticals has exercised options to license two drug candidates discovered by Hutchmed. 2 February 2024
Clinical-stage US pharma company Protagonist Therapeutics' shares rose 6% to $26.5O in early trading, on news of a licensing deal for its blood disorder candidate rusfertide. 1 February 2024
Japan has recently approved Dutch immunology specialist argenx’ (Euronext: ARGX) Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) subcutaneous (SC) injection for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). 31 January 2024
A division of Indian generics drugmaker Glenmark Pharmaceuticals has agreed terms for a licensing deal with Chinese firms Alphamab Biopharmaceuticals and 3D Medicines. 30 January 2024
Following on from its recent approval of Hyqvia (immune globulin) in Europe, Japanese pharma major Takeda has picked up a US approval for another CIDP product. 30 January 2024
Takeda has secured European approval for Hyqvia (immune globulin) as maintenance therapy for people with chronic inflammatory demyelinating polyneuropathy (CIDP). 29 January 2024
The US supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review for patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options. 29 January 2024
The US subsidiary of South Korea’s Celltrion is the latest to file for US approval of a biosimilar version of Swiss pharma giant Roche’s Actemra (tocilizumab). 29 January 2024
US pharma major AbbVie is strengthening its manufacturing capabilities by breaking ground last week on a new $223 million (S$301 million) expansion of its Singapore manufacturing facility. 29 January 2024
Korean immuno-oncology company CanariaBio has taken a stock market battering following the failure of its Phase III trial of oregovomab, an antibody targeting CA125, for ovarian cancer patients. 25 January 2024