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Biotechnology
Privately-held US biotech Ambrx has announced a second collaboration with NovoCodex Biopharmaceuticals Ltd, a majority-owned company of Chinese group Zhejiang Medicine. 24 October 2019
Biotechnology
Californian infectious disease specialist Qpex Biopharma has entered into a multi-product collaboration with Shanghai’s Brii Biosciences. 23 October 2019
Biotechnology
Japanese drugmaker Shionogi has filed a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) in its native country for the postexposure prophylaxis of influenza virus infection. 16 October 2019
Pharmaceutical
Japan's Daiichi Sankyo has bought an antiemetic and two anti-hypertensive products from fellow Tokyo-based firm Astellas Pharma. 15 October 2019
Biotechnology
Independent pharma company Specialised Therapeutics Asia (STA) has gained rights to market Yondelis (trabectedin) to patients in Australia, New Zealand and throughout south east Asia. 14 October 2019
Pharmaceutical
China is currently the second largest pharmaceutical market in the world and is aiming to be a major innovator as well, as part of its ‘Made in China 2025’ program. 14 October 2019
Pharmaceutical
Tokyo’s Daiichi Sankyo has launched its oral FLT3 inhibitor Vanflyta (quizartinib) in Japan. 10 October 2019
Biotechnology
US biotech major Gilead Sciences yesterday announced that the New Drug Application (NDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA), has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). 8 October 2019
Biotechnology
The Japanese Intellectual Property High Court has ruled in favor of the Roche majority-owned subsidiary Chugai in relation to allegations that its hemophilia A drug Hemlibra (emicizumab-kxwh) breached another company’s patent. 3 October 2019
Generics
The US Food and Drug Administration has published a letter warning a Chinese company about the potential impact of its refusal to undergo an inspection of its drug product testing facility. 2 October 2019
Biotechnology
Keytruda (pembrolizumab) has been approved in China for first-line treatment of certain patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. 2 October 2019
Generics
In a second collaboration between the companies, Eisai and fellow Japanese firm Nichi-Iko Pharmaceutical have entered into a comprehensive agreement for generic pharmaceuticals in China. 30 September 2019
Biotechnology
German pharma and sciences firm Merck KGaA says that Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. 27 September 2019
Generics
China is changing the way it buys generic products, seeking to pressure drumakers and drive down prices. 25 September 2019
Pharmaceutical
The Chinese business of Japanese drugmaker Mitsubishi Tanabe Pharma has filed for approval to market Tenelia (teneligliptin) for type 2 diabetes. 24 September 2019
Biotechnology
China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency 23 September 2019
Generics
China's revised drug law is set to provide a major fillip to the Indian pharma industry. As cancer patients in China gear up to import drugs not registered with the Chinese regulators, the move is expected to be a shot in the arm for Indian oncology drug majors, reports The Pharma Letter’s local correspondent. 21 September 2019
Biotechnology
Japanese drugmaker JCR Pharmaceuticals has withdrawn its application with the Ministry of Health, Labor and Welfare of Japan (MHLW) for additional marketing approval of Temcell HS Inj, allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB) (development code: JR-031EB). 20 September 2019
Pharmaceutical
Japanese drugmaker Astellas Pharma and its partner FibroGen have announced that Evrenzo (roxadustat) has been approved in Japan to treat anemia associated with chronic kidney disease (CKD) in dialysis patients. 20 September 2019
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Trintellix (vortioxetine) for the treatment of depression and depressed state, according to the drug’s developers, Danish CNS specialist Lundbeck and its partner Japan’s Takeda Pharmaceuticals
. 20 September 2019
Biotechnology
South Korea’s Alteogen has signed an exclusive licensing agreement with Japanese pharmaceutical company Daiichi Sankyo for its human hyaluronidase, ALT-B4. 9 November 2024
Pharmaceutical
Pfizer has announced plans to invest $1 billion in China by 2030, targeting accelerated innovation, diagnostics improvements, and support for the local biotechnology sector. 8 November 2024
Biotechnology
Japanese ophthalmology company Santen Pharmaceutical has crossed the East China Sea in its latest collaboration, announced on Thursday. 8 November 2024
Pharmaceutical
UK pharma major AstraZeneca, which has invested heavily in China, hosted a sell-side analyst call on Wednesday (November 6) to discuss the recent media reports about ongoing investigations in China. 7 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Biotechnology
Japan’s Nxera Pharma – formerly known as Sosei – and Antiverse, a UK techbio company designing antibodies for challenging targets, have today announced a multi-target partnership and licensing agreement to design antibodies for G-protein coupled receptors (GPCRs). 5 November 2024
Pharmaceutical
Denmark’s privately-held dermatology specialist LEO Pharma and Japan’s Kyowa Kirin have revealed that they will terminate the distribution and co-promotion agreement for the psoriasis vulgaris treatment Dovobet Ointment, Gel, and Foam (calcipotriol hydrate / betamethasone dipropionate) in Japan on December 31, 2024. 1 November 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Pharmaceutical
Japanese pharma major Takeda today announced earnings results for the first half of fiscal year 2024 (six months ended September 30, 2024), with continued momentum in its Growth & Launch Products driving growth. 31 October 2024
Biosimilars
The US unit of South Korea-based biosimilar drug developer Celltrion
has announced a late-breaking post hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of Zymfentra (infliximab-dyyb), during the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 30 October 2024
Biotechnology
Takeda has release positive interim results from a Phase III-enabling proof-of-concept study for mezagitamab (TAK-079), a potential best-in-class anti-CD83 monoclonal antibody, in patients with primary immunoglobulin A nephropathy (IgAN). 29 October 2024
Biotechnology
South Korea’s GemVax & KAEL has reported positive top-line results from a Phase IIa trial of GV1001, for progressive supranuclear palsy (PSP). 29 October 2024
Pharmaceutical
Corxel Pharmaceuticals and LENZ Therapeutics have reported encouraging topline results from a Phase III trial in China testing LENZ’s aceclidine-based eye drop, LNZ100. 29 October 2024
Pharmaceutical
Japanese drugmaker Shionogi saw its shares rise 2.3% to 2,173 yen today after it released positive research findings. 29 October 2024
Biotechnology
Yongyin-based biopharma company GC Biopharma has announced a partnership with Novelty Nobility for the joint development of a new treatment for geographic atrophy (GA). 28 October 2024
Pharmaceutical
Japanese drugmaker Astellas Pharma revealed it has decided to withdraw its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP). 28 October 2024
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical has announced its financial results for the third quarter of fiscal year 2024. 28 October 2024
Biotechnology
Biostar Pharmaceuticals has announced its upcoming initial public offering (IPO) on the Hong Kong Stock Exchange, aiming to raise funds to advance its growing oncology pipeline and support its global expansion efforts. 25 October 2024
Pharmaceutical
US privately-held drug developer NImmune Biopharma has acquired development and commercialization rights for omilancor in Asia from Sino-American biotech LianBio. 25 October 2024
Biotechnology
Legend Biotech has removed Genscript Biotech as its majority shareholder, in a move coinciding with rising US concerns over Chinese ties within the biotech sector. 24 October 2024
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