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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
Biotechnology
Swiss drug major Roche (ROG: SIX) US subsidiary Genentech has announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly extended the lives (improved overall survival) of people with HER2-positive metastatic breast cancer (mBC) compared to the combination of lapatinib and Xeloda (capecitabine). 29 August 2012
Pharmaceutical
Sweden-based Meda (OMX: MEDA A) yesterday announced that the European Commission has granted marketing authorization for Zyclara (imiquimod 3.75% cream), a patented product for the treatment of actinic keratosis. The approval is valid in all European Union countries. 29 August 2012
Biotechnology
As more pharmaceutical companies prepare to bring new oncology drugs to market, their sales representatives face a rising hurdle - oncologists in the USA are reducing the number of times they will see them. 28 August 2012
Pharmaceutical
US drug major Eli Lilly (NYSE: LLY) revealed last Friday that the primary endpoints, both cognitive and functional, were not met in either of the two Phase III, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease. Nevertheless, Lilly's shares rose 3.4% on Friday to $43.86, as the company indicated that the drug showed some potential to help in mild cases of the disease. 28 August 2012
Pharmaceutical
The European Medicines Agency last Friday agreed a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis, which is produced by US drugmaker Pacira Pharmaceuticals and marketed in Europe by Sigma Tau and Mundipharma. 27 August 2012
Pharmaceutical
In the USA and Europe there is strong physician desire for new therapies for the treatment of early stage melanoma, according to a new report from BioTrends Research, a Decision Resources unit, titled The TreatmentTrends Melanoma (US) and TreatmentTrends Melanoma (EU). This confirms there is higher use of adjuvant therapy which is often used to treat early stage melanoma in the US market compared to the major European markets (France, Germany, Italy, Spain and the UK). 23 August 2012
Generics
India's Intellectual Property Appellate Board (IPAB) in Chennai has postponed hearing the appeal by German pharmaceutical major Bayer over the granting of a compulsory licence for its cancer drug Nexavar (sorafenib tosylate) to Indian generic company Natco Pharma (524816: BY) until Monday September 3, Bayer confirmed to The Pharma Letter, without explaining the reason for the delay from the scheduled start of August 21. 22 August 2012
Biotechnology
The latest and final guidance from the UK's drug watchdog the National Institute for Health and Clinical Excellence (NICE) does not recommend Swiss drug major Roche's (ROG: SIX) Avastin (bevacizumab) treatment (when used in combination with the chemotherapy drug, capecitabine) for the first-line treatment of metastatic breast cancer in people for whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. 21 August 2012
Pharmaceutical
An inexpensive US Food and Drug Administration approved antifungal drug, thiabendazole, slows tumor growth and shows promise as a chemotherapy for cancer. Scientists in the College of Natural Sciences at The University of Texas at Austin made this discovery by exploiting the evolutionary relatedness of yeast, frogs, mice and humans. The generic drug taken orally that has been in clinical use for 40 years as an antifungal. It is not currently used for cancer therapy. 21 August 2012
Biotechnology
California, USA-based Pharmacyclics (Nasdaq: PCYC) announced yesterday that the SPARK (MCL2001) clinical trial of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient, triggering a second $50 million milestone payment from Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ) under a collaboration signed last year worth a potential of nearly $1 billion (The Pharma Letter December 9, 2011). 21 August 2012
Biotechnology
Japanese drug major Dainippon Sumitomo Pharma (TYO: 4506) says it plans to establish a new organization specializing in the oncology area to be called the DSP Cancer Institute and also announced organizational changes. 21 August 2012
Biotechnology
Through 2021, the uptake of three new market entrants, Roche (ROG: SIX)/Genentech's Perjeta (pertuzumab) and trastuzumab-DM1 (T-DM1), and Novartis' (NOVN: VX) Afinitor (everolimus) will drive growth in the breast cancer market, according to health care advisory firm Decision Resources. 20 August 2012
Biotechnology
US development stage company TG Therapeutics (GTX:OTC B) has entered into an exclusive global agreement with privately-held Swiss firm Rhizen Pharmaceuticals to collaborate on the development and commercialization of Rhizen's lead product candidate, a novel PI3K delta inhibitor, TGR-1202 (previously referred to as RP5264). 17 August 2012
Pharmaceutical
USA-based Medivation (Nasdaq: MDVN) and Japanese drug major Astellas (TSE: 4503) has announced the publication in the New England Journal of Medicine of the results from the Phase III AFFIRM trial, an international, randomized, double-blind, placebo-controlled clinical study, showing that enzalutamide (formerly MDV3100) achieved statistically significant benefit in overall survival compared to placebo in metastatic castration-resistant prostate cancer patients. 17 August 2012
Biotechnology
US biotech firm Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals (OTCQB: ABPI), saw its shares plunge nearly 27% to $0.30 on Tuesday, after it revealed negative news from a meeting with the US Food and Drug Administration to determine the most expeditious US registration pathway for BiovaxID, its personalized cancer vaccine for the consolidation treatment of follicular non-Hodgkin's lymphoma (NHL). 16 August 2012
Biotechnology
Last year's acquisition of Roche's RNAi (RNA interference) business (The Pharma Letter October 25, 2011) makes USA-based nano-medicine developer Arrowhead Research Corp (Nasdaq: ARWR) one of the leaders in RNAi and delivery solutions for RNAi, note analysts at Edison Investment Research. 16 August 2012
Pharmaceutical
Cancer Research Technology (CRT), the commercial arm of Cancer Research UK, is entering into two licences with Cancer Therapeutics CRC (CTx), an Australian cancer drug and development company, to commercialize CTx's preclinical focal adhesion kinase (FAK) inhibitor programs. 15 August 2012
Biotechnology
Treatment with denosumab resulted in a greater reduction in skeletal-related events in patients with breast cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a phase III study published in Clinical Cancer Research, a journal of the American Association for Cancer Research. 15 August 2012
Pharmaceutical
The Scottish Medicines Consortium (SMC) announced yesterday that it has accepted Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Zytiga (abiraterone acetate) for restricted use within NHS Scotland, as a treatment option for patients in Scotland with metastatic castration resistant prostate cancer (mCRPC) who have received only one prior chemotherapy regimen. 13 August 2012
Pharmaceutical
A large new observational study finds more evidence of an association between daily aspirin use and modestly lower cancer mortality, but suggests any reduction may be smaller than that observed in a recent analysis. The study, appearing early on-line in the Journal of the National Cancer Institute (JNCI), provides additional support for a potential benefit of daily aspirin use for cancer mortality, but the authors say important questions remain about the size of the potential benefit. 13 August 2012
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