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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
Biotechnology
Australian biotech company Regeneus has expanded its portfolio to include licensing of global rights to an autologous human cancer vaccine. 22 July 2014
Biotechnology
US biotech firm Cell Therapeutics has received approval from the Israeli Ministry of Health (MOH) for Pixuvri (pixantrone). 21 July 2014
Pharmaceutical
The organization that reviews oncology medicines in Canada may unnecessarily delay approvals while cancer patients suffer, according to the findings of a new study released by the Fraser Institute, an independent, non-partisan Canadian public policy think-tank. 21 July 2014
Pharmaceutical
Cancer Research UK scientists have discovered how two genes – called MEK and MET – cause bowel cancer cells to become resistant to treatments used against the disease, according to research in the journal Cell Reports. 21 July 2014
Biotechnology
Spanish drugmaker Zeltia, through its biotech subsidiary PharmaMar, and Japan’s Chugai Pharmaceutical have entered into a license agreement where Chugai Pharma Marketing would promote PharmaMar’s Aplidin (plitidepsin) for the treatment of multiple myeloma (MM) in eight European countries (France, Germany, the UK, Belgium, the Netherlands, Luxemburg, Ireland and Austria). 17 July 2014
Pharmaceutical
GlaxoSmithKline says that the Independent Data Monitoring Committee (IDMC) has recommended a Phase III study of its MEK inhibitor, trametinib, in combination with its BRAF inhibitor, dabrafenib, compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unreselectable or metastatic cutaneous melanoma be stopped early. 17 July 2014
article
Japanese drugmaker Chugai, which is majority-owned by Swiss drug major Roche, has gained marketing rights to palonosetron in the UK and NEPA in the UK and Ireland from privately-held Swiss cancer specialists Helsinn Group. 17 July 2014
Generics
Having failed (so far) in its mega billion dollar ($116 billion) attempt to buy Anglo-Swedish drug major AstraZeneca, US pharma giant Pfizer is going for a much more modest target, announcing a takeover bid for InnoPharma, a privately held pharmaceutical development company. 17 July 2014
Biotechnology
UK-based biotech firm Immunocore and US drug major Eli Lilly today announced they have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies, worth more than $25 million. 16 July 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has today published the results of a literature search for evidence-based clinical practice guidelines on the treatment of people with breast cancer. 16 July 2014
Pharmaceutical
The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists CellAct Pharma orphan drug designation to the company’s CAP7.1, an adapted version of the well-established anticancer agent etoposide, for the treatment of biliary tract cancers. 16 July 2014
Biotechnology
Germany’s privately-held immatics biotechnologies GmbH has received 22 million euros ($29 million) to complete a Series D financing round, adding to 12 million euros it received in October as part of a total 34 million-euro funding round. 16 July 2014
Biotechnology
In an interview with The Pharma Letter, Nicholas Saccomano, chief science officer of Array BioPharma, discusses its lead product filanesib, its partnerships with big pharma and why there are many more kinase targets to be discovered. 15 July 2014
Pharmaceutical
Breakthrough therapy designation is likely to positively influence perceptions of the drug for both oncologists and payers, according to research carried out by analysis and data provider Decision Resources Group. 15 July 2014
Pharmaceutical
US specialty pharma firm Ariad Pharmaceuticals says that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has requested limited additional information regarding leukemia drug Iclusig (ponatinib) as part of its ongoing review under the Article 20 referral procedure. 15 July 2014
Biotechnology
USA-based Hemispherx Biopharma has entered a strategic alliance to develop multiple projects with Bioclones, a leading South African biotechnology company. 14 July 2014
Pharmaceutical
Swiss drug major Roche announced that the Phase III study of investigational medicine cobimetinib, with Zalboraf (vemurafenib), met its primary endpoint. 14 July 2014
Pharmaceutical
Japanese drug major Astellas Pharmaceuticals outlined its research framework at its R&D meeting held in Tokyo on July 10, including a comprehensive overview of the company’s late-stage clinical programs and corporate strategy. 11 July 2014
Pharmaceutical
US-based oncology specialist Jounce Therapeutics has announced the appointment of Richard Murray to chief executive officer. Dr Murray has more than 20 years of experience in building research and development capabilities in small startups and large pharmaceutical companies. He replaces the interim chief executive, Cary Pfeffer. 11 July 2014
Pharmaceutical
New US research released yesterday quantifies the extent to which centralized value assessments by the UK’s health care cost watchdog National Institute for Health and Care Excellence (NICE) lead to coverage denials and patient access restrictions to new drugs and biologics. 11 July 2014
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