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Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
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
Generics
While the ongoing trade war between the USA and China will have huge ramifications on the biopharmaceutical industry for both countries, it appears that China is in a much better position from a negotiation standpoint, according to analysts. 12 April 2018
Generics
The global pharmaceutical industry will be one casualty of US President Trump’s nascent trade war with China, should his proposed 25% tariff on an extensive list of products be put in place. 6 April 2018
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted SAKIGAKE ’fast-track’ designation for Merck KGaA’s tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. 27 March 2018
Biotechnology
Daiichi Sankyo today announced that DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), has received SAKIGAKE designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labor and Welfare (MHLW). 27 March 2018
Pharmaceutical
Shares in Japanese drugmaker Chugai Pharmaceutical are up almost 5% on news that the China Food and Drug Administration (CFDA) is to consider the firm’s regulatory application for eldecalcitol, an osteoporosis treatment marketed in Japan as Edirol. 22 March 2018
Biotechnology
Taipei, Taiwan-based United Biopharma (UBP) partnered with GE Healthcare Life Sciences to build a biologics facility in Yangzhou, Jiangsu province, mainland China, reports The Pharma Letter’s correspondent Wang Fangqing. 13 March 2018
Pharmaceutical
Takeda’s latest move to boost its fast-growing global vaccines business is to set up a Center of Excellence (CoE) in Singapore. 9 March 2018
Biotechnology
Japan’s Eisai and US pharma giant Merck & Co have agreed on a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor discovered by Eisai. 8 March 2018
Pharmaceutical
The president of Japanese drugmaker Takeda’s consumer healthcare business, Masashi Sugimoto, is to step down after a year in the role. 8 March 2018
Pharmaceutical
Geopolitical stability, gradually rising living standards and the introduction of universal healthcare systems is fuelling investor interest across South East Asia – particularly for Indonesia, which is home to the largest and fastest growing market. 1 March 2018
Generics
Continuing its tirade against some developed and developing countries, the US drugmakers lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the office of the US Trade Representative (USTR) to take immediate action to address serious market access and intellectual property (IP) barriers in 19 overseas markets, including India, reports The Pharma Letter’s India correspondent. 28 February 2018
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved single-dose influenza drug Xofluza (baloxavir marboxil) for the treatment of influenza types A and B. 26 February 2018
Biotechnology
Honk Kong-based Golden Meditech, a diversified medtech and healthcare services firm, has acquired licenses to permit genetic testing and cell and tissue storage services in Shanghai. 26 February 2018
Pharmaceutical
A McKinsey report commissioned by national trade group the Indian Pharmaceutical Alliance (IPA) indicates that pharmaceuticals manufacturers in India are receiving a lower proportion of letters from the US Food and Drug Administration. 22 February 2018
Pharmaceutical
Over half a billion pounds’ ($700 million) worth of healthcare agreements were signed between UK and Chinese groups in the course of the Prime Minister’s recent visit to China, it has been revealed. 20 February 2018
Biosimilars
YL Biologics (YLB) has announced that a Phase III clinical trial of its investigational Enbrel (etanercept) biosimilar YLB113 has met its primary endpoint. 9 February 2018
Biotechnology
International aid group Médecins Sans Frontières (MSF) has launched legal action in South Korea to try to force a review of Pfizer’s pneumococcal conjugate vaccine (PCV) patent. 5 February 2018
Biotechnology
Privately-held Beijing-based biotech CANbridge Life Sciences has bought the exclusive rights to seek approval for and to commercialize Nerlynx in China, Taiwan, Hong Kong and Macao from Puma Biotechnology. 2 February 2018
Generics
A report from sustainability nonprofit Changing Markets has criticized what it characterizes as uncontrolled pollution from pharmaceuticals manufacturers in India. 31 January 2018
Generics
Even as India's national drug pricing regulator NPPA fixed the retail prices of five formulations including those used for the treatment of hypertension, asthma and heart failure, the Central Drugs Standard Control Organization (CDSCO), India's drug regulator, is gearing up to re-inspect manufacturing plants of several pharma majors across the country to ensure that they are complying with stringent quality measures to weed out supplies of substandard drugs in the market, reports The Pharma Letter’s India correspondent. 25 January 2018
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