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
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
Pfizer and BioNTech have received a third major order in a month for their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval. 31 July 2020
Israel-based Teva Pharmaceutical Industries announced that its partner, Otsuka Pharmaceutical, has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for Ajovy (fremanezumab) injection for the preventive treatment of migraine. 30 July 2020
Japanese drugmaker Daiichi Sankyo has teamed up with Paris-based cancer research institute Gustave Roussy in a multi-year, multi-study research collaboration. 22 July 2020
The first new product for amyotrophic lateral sclerosis (ALS) in decades has won approval in Indonesia, several years after it was first given marketing authorization, in Japan. 17 July 2020
Nerlynx, (neratinib), a new breast cancer drug shown to significantly reduce the risk of cancer recurrence, is now approved for use in Malaysia. 17 July 2020
Guangzhou, China-based LintonPharm is launching a Phase III trial program for catumaxomab in peritoneal carcinomatosis, a form of advanced gastric cancer. 16 July 2020
German pharma and life sciences major Merck KGaA today announced the opening its M Lab Collaboration Center in Shanghai, China, the company’s largest of nine centers worldwide. 10 July 2020
Japanese drugmaker Shionogi says that the full results from the positive Phase III BLOCKSTONE study investigating its in-house developed Xofluza (baloxavir marboxil) as a post-exposure prophylaxis treatment to prevent influenza in household members, has been published in The New England Journal of Medicine on July 8, 2020. 9 July 2020
Evive Biotech, a Shanghai-based biologics firm formerly known as Generon Biomed, has announced positive Phase III results for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients. 8 July 2020
CSL Behring has announced that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options, for Idelvion (coagulation Factor IX [recombinant], albumin fusion protein; albutrepenonacog alfa). 3 July 2020
Following in the footsteps of AstraZeneca and others, Boehringer Ingelheim has become the latest big pharma company to make a major investment in accessing external innovation in China. 2 July 2020
A TLR-4 antagonist has been selected as the first investigational immune modulation therapy to be included in the “moderate” arm of an adaptive trial testing therapies against COVID-19. 1 July 2020
Chinese inventory costs for Indian drug companies have soared by 10% compared to the pre-COVID-19 days. Indian companies are dependent on China for all the key ingredients made using the fermentation process, where China has achieved global dominance and capacities 1 July 2020
A second patient in the ASPIRO clinical trial investigating AT132 (the investigational gene therapy product candidate) for X-linked myotubular myopathy (XLMTM) has tragically passed away, Audentes Therapeutics has revealed. 30 June 2020
Consignments originating from China are being subjected to heavy scrutiny at Indian ports. The hold up of Chinese imports is disrupting COVID-19 medical supplies, with the Pharmaceutical Export Promotion Council (Pharmexcil), the apex pharma export body, writing to the Department of Pharmaceuticals seeking urgent government intervention. 30 June 2020
The Chinese HIV market has long been dominated by multinationals, but recent years saw local Chinese companies join the battlefield attracted by the huge potential - about 1.25 million infected people, according to the World Health Organization (WHO) and China’s Center for Disease Control and Prevention (CDC). 30 June 2020
Japan’s Ono Pharmaceutical has received a manufacturing and marketing approval of Ongentys (opicapone) Tablets 25mg, a catechol-O-methyltransferase (COMT) inhibitor (COMTi), in its home country. 29 June 2020
The new drug application for Enspryng (satralizumab) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica). 29 June 2020