The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Gene therapy research in Japan has gained significant momentum due to the SAKIGAKE designation system and government-led initiatives like the “Project for Regenerative/Cellular Medicine and Gene Therapies” to accelerate research and development (R&D) to create new technologies for gene/cell therapy. 18 September 2024
The HERTHENA-Lung02 Phase III trial of patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment, has met its primary endpoint. 17 September 2024
US biotech Capricor Therapeutics has entered into a binding term sheet with Japanese drugmaker Nippon Shinyaku for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel. 17 September 2024
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
Privately-owned Alvotech and DKSH have announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets. 22 September 2020
South Korean contract development and manufacturing organization Samsung Biologics has signed a long-term supply agreement, valued at around $330.8 million, with UK pharma major AstraZeneca. 22 September 2020
Chinese biotech company Hutchison China MediTech, commonly-known as Chi-Med, today announced that its New Drug Application (NDA) for surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors (NET) has been accepted for review by the China National Medical Products Administration (NMPA). 17 September 2020
Aiming to capitalize on a fast-growing Asian market, Japanese drug major Eisai has established a new, wholly-owned, pharmaceutical sales subsidiary in Ho Chi Minh City, Vietnam, which will be named Eisai Vietnam Co. 17 September 2020
The CPhI predicts dramatic growth of new monoclonal antibody (Mab) production in China, capacity shortages for cell and gene therapies in the USA, and the widespread global adoption of single-use technologies, in its latest annual report, launched ahead of the first CPhI Festival of Pharma (October 5-16, 2020). 16 September 2020
Japan’s largest drugmaker Takeda Pharmaceutical says it has expanded its US cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. 16 September 2020
US drugmaker AbbVie and I-Mab signed a broad, global agreement for the development and commercialization of lemzoparlimab, an innovative anti-CD47 monoclonal antibody internally discovered and developed by the Chinese biopharma for the treatment of multiple cancers. 4 September 2020
China’s Fosun Pharma’s biotech arm Henlius, best known for its biosimilars capability, is setting its sights on novel drug development, said Henlius chief executive Scott Liu at a recent press meeting in Shanghai. 4 September 2020
There is a long-term opportunity in the making in India. As formulators evaluate options to source from outside China, India can become a preferred supplier for certain products, according to a report. 3 September 2020
When Russia chose to approve the Moscow-developed Sputnik V vaccine for COVID-19 this month, more than a few eyebrows were raised in the western world, in particular due to the absence of Phase III data. 28 August 2020
Japanese drugmaker Chugai Pharmaceuticals (TYO: 4519) today launched its in-house developed drug Enspryng (satralizumab) subcutaneous injection 120 mg syringe for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD) [including neuromyelitis optica: NMO] 26 August 2020
China made the marketing authorization holder (MAH) scheme official in the country in December last year after running it as a three-year pilot program. The move was largely welcomed by China’s pharma industry, especially start-ups which have the research capacity but lack the funds to build a manufacturing facility. 25 August 2020
China-based biotech firms Bio-Thera Solutions and BeiGene have executed a license, distribution, and supply agreement for China for Bio-Thera’s BAT1706, an investigational biosimilar to Roche’s (ROG: SIX) Avastin (bevacizumab). 25 August 2020
Japan’s Ono Pharmaceutical has received a supplemental approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, in Japan for additional indication of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma, for a partial change in approved items of the manufacturing and marketing approval. 21 August 2020
UK pharma major AstraZeneca has secured approval in Japan for Imfinzi (durvalumab) as a treatment for extensive-stage small cell lung cancer (ES-SCLC). 21 August 2020
Tokyo’s Chugai Pharmaceutical has secured a label update for Kadcyla (trastuzumab) from the Japanese Ministry of Health, Labour and Welfare. 21 August 2020
Shanghai Henlius Biotech says that its trastuzumab biosimilar HLX02, developed and manufactured by Henlius independently, has been approved by China’s National Medical Products Administration (NMPA), referencing Roche’s blockbuster cancer drug Herceptin. 17 August 2020
Diurnal Group has announced that Alkindi (hydrocortisone granules in capsules for opening) has been approved by the Australian Therapeutic Goods Administration (TGA) as a replacement therapy of adrenal insufficiency (AI), with no age restriction. 10 August 2020