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
Zydus Cadila, a part of Cadila Healthcare, has agreed a licensing deal with California's XOMA Corporation (Nasdaq: XOMA) for a new combination therapy in immuno-oncology. 9 March 2020
Canadian drugmaker Bausch Health has picked up Taiwanese approval for the eye drug Vyzulta (latanoprostene bunod), shortly after the firm scored a green light in Mexico. 9 March 2020
The European subsidiary of Japanese drugmaker Shionogi today said it has launched its Mulpleo (lusutrombopag) in the UK for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing invasive procedures. 9 March 2020
Zydus Cadila, a part of Cadila Healthcare, has scored approval in India for a non-alcoholic steatohepatitis (NASH) treatment, saroglitazar, the first ever marketing authorization in this indication. 5 March 2020
Ono Pharmaceutical has submitted to broaden the Japanese label for Braftovi (encorafenib) plus Mektovi (binimetinib), in combination with the chemotherapy cetuximab. 5 March 2020
The Indian government has restricted exports of 26 active pharmaceutical ingredients (APIs) and finished pharmaceutical products, raising concerns about access to medicines as the novel coronavirus begins to spread more rapidly outside of China. 4 March 2020
German pharma and sciences firm Merck KGaA says that its Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in combination with platinum-based therapy with fluorouracil. 2 March 2020
Pharma major Eisai is to acquire exclusive development and marketing rights for dotinurad in China from fellow Japanese company Fuji Yakuhin. 25 February 2020
The US Food and Drug Administration has granted priority review for the supplemental New Drug Application (sNDA) to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 25 February 2020
On the day that the company presented its annual financial results, Almirall has announced a license agreement for Seysara (sarecycline) in China. 24 February 2020
In early December 2019, the first cases of a new coronavirus emerged, a virus that has since come to grip the world’s media and worry regulators in every country. 24 February 2020
India's Biocon, Asia's premier biotechnology company, revealed that the US Food and Drug Administration had conducted a pre-approval inspection of its subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for insulin glargine between February 10 and 21. 24 February 2020
Bristol-Myers Squibb has announced the approval of Opdivo (nivolumab) for unresectable advanced or recurrent esophageal cancer in Japan. 21 February 2020
In a bonanza day for the Japanese drugmaker, Chugai Pharmaceutical today announced that expanded indications have been approved by the domestic regulator for three of its already-marketed medicines. 21 February 2020
Self-reliance is turning out to be key in India as the ongoing novel coronavirus (COVID-19) issue stretches supply chains, reports The Pharma Letter’s local correspondent. 20 February 2020
Swiss drugmaker Vifor Pharma today said it has entered into strategic partnership with Germany-headquartered Fresenius Kabi to create a new joint company based in the People’s Republic of China expanding its access to the second largest pharmaceutical market in the world. 20 February 2020
Indian drugmaker Zydus Cadila’s licensing agreement with China Medical System (CMS) last month for the development and commercialization of desidustat will provide a momentous boost to the overall commercialization strategy for the anemia drug. 19 February 2020
In the battle against the novel coronavirus (COVID-19), Chinese Ministry of Science and Technology (MOST) has launched "Dealing With the Outbreak of COVID-19 Using Science and Technology," a program including four batches of 20 emergency projects until now. 19 February 2020
CANbridge Pharmaceuticals has raised $98 million in a series D financing round. General Atlantic and WuXi AppTec led the round, and both have the option to invest up to $10 million extra, if certain conditions are met. 18 February 2020
The Chinese Communist Party has said that biotech companies located at the heart of the coronavirus outbreak can now return to work, reports GlobalData. 14 February 2020