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Pharmaceutical
Shares of Japanese mid-size drugmaker Kyowa Hakko Kirin rose 3.55% to 1,138 yen by afternoon trading in Japan, after the company revealed that it has entered into a license agreement with the USA’s privately held Syndax Pharmaceuticals for the exclusive rights to develop and commercialize entinostat in Japan and South Korea. 8 January 2015
Pharmaceutical
England’s Cancer Drugs Fund is overspent and 42 drugs are being reassessed as price caps are brought in for the first time. NHS England said the current system was unsustainable and that there were new drugs "that will do more for patients." 8 January 2015
Pharmaceutical
Aveo Oncology has appointed Michael Bailey as president, chief executive and director. 7 January 2015
Pharmaceutical
Late-stage biopharma company Soligenix has said that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the US Food and Drug Administration. 7 January 2015
Biotechnology
Swedish Orphan Biovitrum today announced that its agreement with Exelixis has been restructured and extended to December 31, 2019. 7 January 2015
Biotechnology
Belgian biotech firmCardio3 BioSciences has acquired OnCyte, the oncology division of privately-held US biotechnology company Celdara Medical, and its portfolio of immuno-oncology product candidates. 6 January 2015
Biotechnology
Oncology biotech company CytomX has appointed Michael Kavanaugh as chief scientific officer and head of research and early development. 5 January 2015
Biotechnology
Kite Pharma has announced a strategic research collaboration and license agreement with US biotech giant Amgen to develop and commercialize the next generation of novel chimeric antigen receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy (eACT) platform and Amgen's extensive array of cancer targets. 5 January 2015
Pharmaceutical
Nanotechnology is poised to become the ‘next big thing’ in global health care. While big pharma companies clamor to partner with small biotech firms developing nanotech solutions, French nanomedicine company Nanobiotix is already at the forefront of nanotechnology. Its NanoXray platform, which enhances radiotherapy for the local treatment of cancer, is already making waves in oncology. Chief executive Laurent Levy, who is also the co-founder and president of the Executive Board and vice chair for the European Technology Platform on Nanomedicine, spoke to The Pharma Letter about the company’s aims and the scope of nanomedicine. 5 January 2015
Pharmaceutical
Canada-based OncoGenex Pharmaceuticals saw its shares rise 0.9% to $2.19 on Tuesday, despite announcing that Israeli drugmaker Teva Pharmaceutical Industries is returning rights to custirsen. 31 December 2014
Pharmaceutical
US specialty pharma firm Ariad Pharmaceuticals has granted Italian drugmaker Angelini exclusive rights to commercialize Iclusig (ponatinib), for the leukemia indications approved by the European Medicine Agency, in Central and Eastern Europe. 31 December 2014
Biotechnology
Israel’s Tikcro Technologies has entered into a research and license accord with Yeda Research and Development Company, the technology transfer arm of the Weizmann Institute of Science in Israel. 31 December 2014
Pharmaceutical
UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has today published its Final Appraisal Determination (FAD) which recommends that Abraxane (nab-paclitaxel), from US biotech company Celgene Corp, given with gemcitabine, should not be funded by the National Health Service for previously untreated metastatic pancreatic cancer, because it concluded that its benefits compared to current treatments do not justify its cost. 30 December 2014
Biosimilars
Ahmedabad, India-based Torrent Pharmaceuticals last week entered into an exclusive licensing agreement with privately-held Indian drugmaker Reliance Life Sciences for marketing three biosimilars in India. 29 December 2014
Biotechnology
US specialty pharma firm Ariad Pharmaceuticals has entered into an agreement for Japan’s Otsuka Pharmaceuticals to commercialize its Iclusig (ponatinib) in Japan and nine other Asian countries and to fund future clinical trials in those countries. 24 December 2014
Biotechnology
Shares of US biotech firm MacroGenics rocketed 11.7% to a 10-month high of $38.58 yesterday, on the news of a global collaboration and license agreement for MGD011 with Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson. 23 December 2014
Pharmaceutical
The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic (advanced) melanoma who no longer respond to other drugs. 23 December 2014
Pharmaceutical
Eli Lilly has received marketing authorization from the European Commission for its drug Cyramza. 22 December 2014
Biotechnology
Swiss pharma major Roche saw its shares plunge 6.4% to 270.40 Swiss francs on Friday following release of disappointing Phase III trial results with its new cancer treatment Kadcyla (ado-trastuzumab emtansine). 22 December 2014
Pharmaceutical
The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s Lynparza (olaparib). 20 December 2014
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Pharmaceutical
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
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