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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
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
Despite there being around 27 drugs on the market indicated for the treatment of breast cancer, there is currently an unmet need to treat patients, according to new research from Frost & Sullivan. 17 May 2012
Pharmaceutical
There was disappointment for global pharma behemoth Pfizer (NYSE: PFE) when it said that the Phase III INTORSECT (B1771003) study, evaluating Torisel (temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after therapy with Sutent (sunitinib malate, also a Pfizer drug), did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib (Bayer's Nexavar). 17 May 2012
Biotechnology
US biotech firm Enzon Pharmaceuticals (Nasdaq: ENZN) and Chinese drugmaker Zhejiang Hisun Pharmaceuticals (SSE: 600267) have entered into a long-term strategic research, development and licensing collaboration. 17 May 2012
Biotechnology
Ahead of the annual American Society of Clinical Oncology (ASCO) meeting which takes place in Chicago June 1-5, Amgen (Nasdaq: AMGN), the world's largest independent biotech company reported results from an exploratory biomarker analysis on a previously reported Phase II study showing that rilotumumab + chemotherapy improved median overall survival in metastatic gastric or gastroesophageal cancer patients (OS from 5.7 months to 11.1 months; HR=1.84, 95% CI; 0.78 - 4.34), whose tumors exhibited high MET protein expression. 17 May 2012
Pharmaceutical
UK drugs watch dog the National Institute for Health and Clinical Excellence (NICE) has reversed an earlier negative decision (The Pharma Letter February 2), issuing new draft guidance recommending the National Health Service use of Zytiga (abiraterone), from Johnson & Johnson's (NYSE: JNJ) Janssen unit, in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed after one docetaxel-containing therapy. 16 May 2012
Pharmaceutical
USA-based Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals (OTCQB: ABPI), says that it plans to file for marketing approval in the European Union for BiovaxID, its personalized cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma, an incurable cancer of the immune system. 16 May 2012
Pharmaceutical
Swiss independent drug developer Debiopharm) and Switzerland-based Vifor Pharma - part of Galenica (SIX: GALN) - have signed an exclusive agreement covering the distribution and commercialization in Switzerland of the one-, three- and six-month formulations of Pamorelin LA and Salvacyl a three-month formulation of the gonadotropin releasing hormone agonist analog triptorelin. 15 May 2012
Biotechnology
Multiple myeloma is a form of cancer where the plasma cells in the bone marrow grow out of control, causing damage to bones as well as predisposing patients to anemia, infection and kidney failure. A medical procedure called autologous hematopoietic stem cell transplantation, commonly known as a stem cell transplant, is frequently an important treatment option for many patients. 14 May 2012
Biotechnology
US biotech firm Cell Therapeutics (Nasdaq and MTA: CTIC) last week received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). Pixuvri is the first approved treatment in the European Union in this patient setting. 14 May 2012
Biotechnology
The popularity of combination therapies in the treatment of cancer is set to increase, which will help offset revenue losses in the cytotoxic therapies market due to blockbuster patent expiries, according to a new report by pharmaceutical experts GBI Research. 13 May 2012
Pharmaceutical
Confirming previous negative guidance (The Pharma Letter January 12), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), has today (11 May) published final guidance in which it recommends against the routine National Health Service use of French pharma major Sanofi's (Euronext: SAN) Jevtana (cabazitaxel) in combination with prednisone or prednisolone as a second line treatment for prostate cancer. 11 May 2012
Biotechnology
The US Food and Drug Administration this week issued a notification of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received drugmaker Celgene (Nasdaq: CELG) Revlimid (lenalidomide). 11 May 2012
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) in the past few days issued a mixed batch of opinions for backing the use three drugs under Germany's new legislation, the Act on the Reform of the Market for Medicinal Products (AMNOG). 9 May 2012
Generics
German drug major Bayer (BAYN: DE) has launched an appeal against the Indian Patent Office, which a couple of months ago issued what was the first compulsory license in India to a generic drug manufacturer, Natco Pharmaceuticals (524816: BY), for its kidney and liver cancer drug Nexavar (sorafenib tosylate) under section 84 (1) (b) of the country's Patents Act (The Pharma Letter march 13). 8 May 2012
Generics
Indian drugmaker Cipla (BSE: 500087) has slashed the prices of certain life-saving cancer drugs used in the treatment of brain, lung and kidney cancer by up to 76%, according to domestic media reports. 4 May 2012
Pharmaceutical
its application for a Phase I/II clinical trial with Amep in the metastatic melanoma, and the signing of a partnership agreement for the development of its biotherapy with the Department of Oncology of the Herlev Hospital of Copenhagen, Denmark. 2 May 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) and Danish company Genmab A/S (OMX: GEN) have submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Arzerra (ofatumumab) for the treatment of chronic lymphocytic leukemia (CLL). 2 May 2012
Pharmaceutical
USA-based MannKind Corp (Nasdaq: MNKD) has granted an exclusive worldwide license to privately-held Tolero Pharmaceuticals for rights to develop and commercialize compounds from MannKind's novel BTK (Bruton's tyrosine kinase) program, which are currently being developed for the treatment of hematological malignancies and inflammatory diseases. 1 May 2012
Biotechnology
USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued a Complete Response Letter relating to its supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases. 30 April 2012
Pharmaceutical
The US Food and Drug Administration last week gave its approval for new indications for currently marketed drugs - Votrient (pazopanib from the UK-based GlaxoSmithKline (LSE: GSK) and Afinitor (everolimus), from Switzerland's Novartis (NOVN: VX). 29 April 2012
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