Oncology
Refine Search
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
Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority owned by Swiss major Roche (ROG: SIX), has filed a New Drug Application to the Ministry of Health, Labor and Welfare (MHLW), for antibody-drug conjugate trastuzumab emtansine (T-DM1) for the treatment of HER2-positive metastatic or recurrent breast cancer. Roche has already filed for approval of T-DM1 in both the USA and Europe (The Pharma Letter October 16, 2012). 30 January 2013
Pharmaceutical
Privately-held Swiss pharmaceutical group Helsinn has granted Latin American specialty company Stendhal exclusive commercialization rights for Mexico, Venezuela, Colombia, Peru, Ecuador and most of Central American countries, to its novel ghrelin receptor agonist, anamorelin, a new first-in-class, once daily drug being developed for the treatment of cachexia-anorexia in non-small cell lung cancer (NSCLC), a serious multifactorial disorder which involves muscle wasting, metabolic impairment and loss of appetite and commonly affects people with advanced cancer. 29 January 2013
Pharmaceutical
Merck Serono, the pharma division of Germany's Merck KGaA (MRK: DE), has initiated the global Phase III MAESTRO study, assessing the efficacy and safety of the investigational hypoxia-targeted drug TH-302 in combination with gemcitabine (Eli Lilly's Gemzar) in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma. 29 January 2013
Pharmaceutical
DelMar Pharmaceuticals (OTCQB: BRRY) has announced the successful acquisition, through a share exchange agreement, of all of the outstanding shares of Del Mar Pharmaceuticals (BC) Ltd, a clinical and commercial stage drug development company with a focus on the treatment of cancer. DelMar also completed the first closing in a private placement consisting of around 6.7 million units of its securities to qualified accredited investors, for total gross proceeds of around $5.4 million. 28 January 2013
Pharmaceutical
In what was a busy news day for the US Food and Drug Administration, the agency on Friday approved three new related products from Japan's largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride) and Oseni (alogliptin and pioglitazone) tablets. 28 January 2013
Biotechnology
Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) on Friday released positive top-line results of two Phase III trials of KRN125 (pegfilgrastim; marketed by Amgen as Neulasta) which is developed to decrease the risk of febrile neutropenia in chemotherapy-received patients. 28 January 2013
Biotechnology
The US Food and Drug Administration has approved a new use for Swiss drug major Roche's (ROG: SIX) US subsidiary Genentech's Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). 25 January 2013
Pharmaceutical
JSC Pharmstandard (PHST: MM), one of Russia's largest pharmaceutical producers, has signed an agreement with Janssen Pharmaceutica, a subsidiary of US health care giant Johnson & Johnson (JNJ) on the licensing, production and promotion of bedaquiline, a drug for the treatment of multidrug-resistant TB, in Russia, according to Naira Adamian, general director of Janssen Russia and the CIS. 24 January 2013
Pharmaceutical
US cancer drug developer Celsion Corp (Nasdaq: CLSN) and Chinese drugmaker Zhejiang Hisun Pharmaceutical (SSE: 600267) have entered into a technology development agreement for ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the greater China territory. 24 January 2013
Biotechnology
US biotech firm Celgene Corp (Nasdaq: CELG) says that its Phase III clinical trial of Abraxane (nab-paclitaxel) in combination with gemcitabine (Eli Lilly's Gemzar). in treatment-naive patients with metastatic pancreatic cancer demonstrated a statistically-significant improvement in overall survival compared to patients receiving gemcitabine alone [(median of 8.5 versus 6.7 months) (HR 0.72, P=0.000015)]. 23 January 2013
Biotechnology
USA-based Progenics Pharmaceuticals (Nasdaq: PGNX) revealed yesterday that it has acquired Molecular Insight Pharmaceuticals, a clinical-stage private biotechnology company with a small molecule chemistry pipeline aimed at enhancing cancer treatment. 23 January 2013
Pharmaceutical
Negative NICE final guidance for Pierre Fabre's Javlor in bladder cancer; fast-track FAD for Eliquis
In final guidance published (January 23, 2013), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has not recommended National Health Service use of French independent drugmaker Pierre Fabre's Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract which has progressed following prior treatment with platinum-containing chemotherapy. This confirms a previous negative draft final guidance on the drug (The Pharma Letter March 11, 2011). 23 January 2013
Biotechnology
Following its monthly meetings last week, the European Medicines Agency the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorization for US drugs behemoth Pfizer's (NYSE: PFE) Bosulif (bosutinib) 100mg and 500mg film-coated tablets intended for the treatment of chronic myelogenous leukemia (CML). 21 January 2013
Biotechnology
Bayer's Nexavar continues to dominate advanced liver cancer therapy, as other late-stage trials fail
Sufferers of hepatocellular carcinoma (HCC), the most common form of liver cancer, have a poor diagnosis rate, due to the disease's symptoms tending to only emerge in the advanced stages of the disease, according to a new report by health care experts GBI Research. Disease awareness is also low due to a lack of public and professional understanding, with no mandatory screening guidelines even existing for HCC diagnosis. 17 January 2013
Biotechnology
The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says the US Food and Drug Administration has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations. 17 January 2013
Pharmaceutical
The US subsidiary of German independent drug major Boehringer Ingelheim revealed yesterday that the New Drug Application for its investigational oncology compound afatinib, proposed trade name Tomtovok, has been accepted for filing and granted Priority Review by the US Food and Drug Administration. 16 January 2013
Pharmaceutical
UK-based Horizon Discovery, a provider of research tools to support the development of personalized medicines, has signed a research service collaboration agreement with German family-owned drug major Boehringer Ingelheim. Financial terms of the deal were not disclosed. 15 January 2013
Generics
The Indian government's move to issue compulsory licences to three more patented cancer drugs has left a few of the pharma multinational in a lurch, reports the local Business Standard newspaper. 15 January 2013
Pharmaceutical
US drug developer ArQule (Nasdaq: ARQL) saw its shares plunge 23% to $2.25 in premarket trading on Friday, as the company, along with partner Japanese pharma major Daiichi Sankyo (TSE 4568) announced disappointing top-line results of a randomized Phase II signal generation trial of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC). 14 January 2013
Biotechnology
USA-based Morphotek, a wholly-owned subsidiary of Japanese drug major Eisai (TYO: 4523) which acquired the firm for $325 million in 2007, presented disappointing top-line results from a Phase III study of its investigational agent farletuzumab (MORAb-003) in combination with carboplatin and a taxane in patients with platinum-sensitive epithelial ovarian cancer in first relapse. 14 January 2013
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze