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Biotechnology
US clinical-stage biotech Sage Therapeutics has entered into a strategic collaboration for the clinical development and commercialization of SAGE-217 for the treatment of major depressive disorder (MDD) and other indications in Japan, Taiwan and South Korea. 14 June 2018
Pharmaceutical
The China Food and Drug Administration (CFDA) has approved Ganovo (danoprevir; ASC08), for the treatment of viral hepatitis C. 14 June 2018
Generics
Indian pharma majors selling copycat drugs in the USA are facing the heat given the steep competition and pricing pressure, and President Donald Trump's new policy on lowering drug prices, reports The Pharma Letter’s India correspondent. 12 June 2018
Biotechnology
Frontier Biotechnologies is responsible for reaching market with the first new HIV medicine discovered and developed in China. 7 June 2018
Biotechnology
Privately-held Chinese biopharma CStone Pharmaceuticals has paid $40 million upfront for a license to develop and commercialize three drugs from US biotech Blueprint Medicines Corporation in China, either as monotherapies or combination therapies. 5 June 2018
Biotechnology
The China State Drug Administration (CSDA) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 30 May 2018
Pharmaceutical
As the high price of orphan drugs continues to be a major issue, the Indian government is looking to exempt orphan drugs from price control. The government has decided to take legal and other measures to control the price of drugs for rare diseases in order to ensure their affordability and health system sustainability, reports The Pharma Letter’s India correspondent. 30 May 2018
Pharmaceutical
Japanese drugmaker Astellas has announced a restructuring of operations in its home country, involving a reduction of the workforce by around 600. 23 May 2018
Pharmaceutical
Multinationals (MNCs) were thrilled by China’s recent policies on opening up the domestic pharmaceutical market to the world, notes The Pharma Letter’s local correspondent, Wang Fangqing, in her latest report from the ChinaBio partnering forum held recently in Suzhou. 21 May 2018
Biotechnology
GC Pharma, a South Korean biopharma formerly known as Green Cross Corporation, has set up a USA-based company dedicated to the development of new vaccines. 21 May 2018
Pharmaceutical
For the 14th consecutive year, the USTR has put China on a ‘priority watch list' on its annual analysis of countries’ adherence to standards governing intellectual property rights. 17 May 2018
Biotechnology
For foreign biotechs, how to get the attention from wealthy Chinese investors? At the ChinaBio partnering forum held in Suzhou on Apr 26, Chinese investors offered some tips, report The Pharma Letter’s local correspondent, Wang Fangqing. 11 May 2018
Pharmaceutical
The Drugs Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) have come under fire for approving the human papillomavirus (HPV) vaccine for cervical cancer patients, despite a report by India's Parliament opposing its use. The government, meantime, continues to dither over introducing the HPV vaccine in its Universal Immunization Program, reports The Pharma Letter’s India correspondent. 10 May 2018
Pharmaceutical
US healthcare giant Johnson & Johnson has opened its new Asia Pacific (APC) headquarters amid much fanfare in Singapore. 10 May 2018
Pharmaceutical
Aquinox Pharmaceuticals has entered into an exclusive license agreement for Japan and certain other countries in the Asia-Pacific region for Astellas Pharma to develop and commercialize rosiptor (AQX-1125). 10 May 2018
Biotechnology
An attempted coup is proving costly at Sinovac Biotech, a Chinese vaccines developer. 1 May 2018
Pharmaceutical
Central nervous system (CNS) specialist Lundbeck has announced a decision from the Japanese Ministry of Health, Labor and Welfare granting the Danish firm a further two years of market exclusivity on its antidepressant Lexapro (escitalopram oxalate). 27 April 2018
Pharmaceutical
Japanese drug major Astellas Pharma today announced that, on March 23, it submitted a New Drug Application (NDA) for marketing approval of gilteritinib in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML). 24 April 2018
Biosimilars
USA-based Pfenex has granted the China NT Pharma Group non-exclusive development and exclusive commercialization rights to PF708, a teriparatide therapeutic equivalent candidate to Forteo, 21 April 2018
Pharmaceutical
A report from market analyst GlobalData finds that the Chinese pharmaceutical market is expected to grow at an annual rate of 30% up to 2022, pushing the size of the market up to $573 billion. 16 April 2018
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
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