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Biotechnology
In an expert view, Maggie Chang, vice president, regulatory affairs, at China-based Hangzhou Tigermed Consulting, takes a look at what is now happening in China’s amended new drug approval system. 28 September 2018
Pharmaceutical
The world’s largest healthcare plan has been launched by Indian Prime Minister Narendra Modi, providing free or subsidized coverage for the poorest 40% of India’s population. 27 September 2018
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). 26 September 2018
Pharmaceutical
China’s State Council, the executive body that oversees government operations, has listed a series of improvements that are needed for the selection and adoption of essential drugs. 21 September 2018
Biotechnology
A few short months after Merck & Co won its first Chinese approval for flagship immuno-oncology product Keytruda (pembrolizumab), the firm has reportedly agreed a price reduction plan that will enable patients to gain access for around half the US list price. 20 September 2018
Pharmaceutical
Swiss pharma giant Roche is to build a $126 million innovation center in Shanghai, according to sources in China. 20 September 2018
Pharmaceutical
China’s public health watchdog, the National Health Commission (NHC), has released three sets of guidelines covering the burgeoning market for internet-based medical services. 17 September 2018
Biotechnology
Osaka-based firms Shionogi and Rohto Pharmaceutical have agreed to work together on the Japanese development and possible future commercialization of ADR-001, a candidate for the treatment of liver cirrhosis. 14 September 2018
Generics
As the US Food and Drug Administration approves a record number of Abbreviated New Drug Applications (ANDAs) in FY2018, Indian drug makers continue to reel under the regulator's scanner, with many rushing to correct mistakes in manufacturing standards, reports The Pharma Letter’s India correspondent. 12 September 2018
Pharmaceutical
Japanese drug major Daiichi Sankyosaw its share move up 4.3% to 4,563 yen after it revealed its quizartinib, an investigational FLT3 inhibitor, has been granted Orphan Drug designation by the Japan Ministry of Health, Labor and Welfare (MHLW) for the treatment of FLT3-mutated acute myeloid leukemia (AML). 11 September 2018
Generics
India’s Sun Pharmaceutical Industries has received six adverse observations after a US Food and Drug Administration inspection found one of its plants to be lacking in certain processes. 10 September 2018
Pharmaceutical
There was a double first for Japanese pharma major Eisai, with the first approval of its cancer drug Lenvima (lenvatinib) in China as well as being the first new therapy for first-line treatment of unresectable hepatocellular carcinoma (HCC) in China. 5 September 2018
Biotechnology
With the approval of Elunate (fruquintinib), China not only has a promising new option for colorectal cancer (CRC), a disease diagnosed in around 380,000 new Chinese people each year. 5 September 2018
Biotechnology
Family-owned drugmaker Boehringer Ingelheim has agreed a broad collaboration with Beijing-based Tsinghua University to research and develop immunological therapies for infectious diseases. 5 September 2018
Pharmaceutical
US President Donald Trump’s recently initiated trade war with China has divided opinion between those who see it as a potentially industry-damaging misstep, and those who view the Chinese state as an aggressive opponent increasingly willing to rig the global trading system in its favor. 4 September 2018
Pharmaceutical
Sanofi Genzyme, the specialty care global business unit of French multinational pharma company Sanofi, has recently launched its multiple sclerosis (MS) drug Aubagio (teriflunomide, 14mg) in India. 28 August 2018
Pharmaceutical
The China cancer drugs market is projected to reach $30 billion by the year 2024 due to the increasing prevalence of various types of cancer, changing lifestyle and dietary habits, growing aging population, rising demand of targeted drug therapy and the patent expiration of key cancer drugs, according to a new report from ResearchAndMarkets. 24 August 2018
Biotechnology
A leading Chinese investment group has taken a stake in Oxford BioDynamics (AIM: OBD), a UK biotech focused on the discovery and development of epigenetic biomarkers for use within the pharmaceutical and biotechnology industry. 22 August 2018
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Tagrisso (osimertinib) for the first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. 21 August 2018
Pharmaceutical
The China Food and Drug Administration (CFDA) has asked the country’s second-biggest rabies vaccine maker Changchun Changsheng Biotechnology to terminate the production of its Vero-cell rabies vaccines in July 2018 for violating the country’s drug production quality protocols. 21 August 2018
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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