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
Adding the drug cetuximab, the active ingredient of Erbitux from German drug major Merck KGaA (MRK: DE), to a regimen of drugs used for the treatment of patients following surgery for stage III colon cancer did not result in improved disease-free survival, according to a study in the April 4 issue of JAMA. 4 April 2012
Pharmaceutical
The colorectal cancer drug market in China will grow from a value of $261 million in 2011 to $404 million in 2016, according to a new report from advisory firm Decision Resources, titled Colorectal Cancer in China, which notes that the increased use of targeted therapies will be a key factor driving growth in this market. 4 April 2012
Pharmaceutical
German drug major Bayer (BAY: DE) yesterday announced positive results from its Phase III trial GRID (GIST - Regorafenib In Progressive Disease) evaluating its investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with imatinib and sunitinib. 4 April 2012
Pharmaceutical
The European subsidiary of Japanese drug major Eisai (TYO: 4523) and PharmaSwiss, a division of Canada-based Valeant Pharmaceuticals International (TSX: VRX) have entered into an agreement to promote and distribute its metastatic breast cancer drug Halaven (eribulin) in Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, Hungary and Slovenia. Financial terms of the deal were not disclosed. 4 April 2012
Pharmaceutical
A pair of targeted therapies shrank tumors in some patients with treatment-resistant Ewing's sarcoma or desmoplastic small-round-cell tumors, according to research led by investigators from The University of Texas MD Anderson Cancer Center, USA, reported at the American Association of Cancer Research (AACR) annual meeting. 3 April 2012
Pharmaceutical
In a third rejection, the UK drug watchdog the National Institute for Health and clinical Excellence (NICE) has issued new guidance not recommending Halaven (eribulin), from Japanese drug major Eisai (TYO: 4523), for the treatment of locally advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease (The Pharma Letter November 17, 2011). 3 April 2012
Pharmaceutical
Canadian drug developer AEterna Zentaris (TSX: AEZ) and US licensee Keryx Pharmaceutical (Nasdaq: KERX) both saw their shares plummet after revealing that their colorectal cancer drug candidate had failed in a late-stage clinical trial. 3 April 2012
Biotechnology
Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III study of trastuzumab emtansine (T-DM1), show that patients with advanced metastatic breast cancer treated with T-DM1 lived significantly longer without their disease getting worse compared to patients treated with Tykerb (lapatinib) from GlaxoSmithKline (LSE: GSK). 3 April 2012
Pharmaceutical
Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY: DE), of the clinical and cost effectiveness of its Xarelto (rivaroxaban), UK drug watchdog the National Institute of Health and Clinical Excellence (NICE) this morning published final draft guidance recommending the drug as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation. 30 March 2012
Pharmaceutical
Depending on the tumor type, around one-quarter to one-third of surveyed Brazilian and Mexican oncologists' patients who are eligible for treatment with angiogenesis inhibitors do not receive such therapy, primarily because of reimbursement and/or budget-related factors, according to a new report from advisory firm Decision Resources. 28 March 2012
Biotechnology
UK pharma giant GlaxoSmithKline (LSE: GSK) has agreed a settlement with Genentech, a unit of Roche (ROG: SIX), and City of Hope (a California not-for-profit organization) concerning two US patents that relate to recombinant antibody production for ofatumumab, which is being commercialized in the USA and Europe by GSK under the trade name Arzerra for the treatment of chronic lymphocytic leukemia. 28 March 2012
Biotechnology
USA-based private equity firm Celtic Therapeutics Management has announced a significant commitment to antibody-drug-conjugate (ADC) products, with the launch of a new Switzerland-based company, ADC Therapeutics Sarl. 26 March 2012
Pharmaceutical
Data from the Phase III HannaH trial presented last Friday at the European Breast Cancer Conference, Vienna, Austria, could mean that women living with HER2-positive early stage breast cancer may soon be able to receive Herceptin (trastuzumab) in approximately five minutes via a subcutaneous (SC) injection instead of the current 30 minute intravenous (IV) infusion. 25 March 2012
Pharmaceutical
In final draft guidance issued this morning, UK drugs watchdog the National Institute for Health and Clinical Excellence ( NICE) has recommended National Health Service use of Tasigna (nilotinib) and Glivec (imatinib), both made by Swiss drug major Novartis (NOVN: VX), for the first line treatment of chronic myeloid leukemia (CML). 22 March 2012
Biotechnology
Belgian drug developer Ablynx (Euronext Brussels: ABLX) yesterday announced a two-year extension of the initial five-year research funding by independent German drug major Boehringer Ingelheim of their global strategic alliance to discover, develop and commercialize up to 10 different Nanobody therapeutics. 21 March 2012
Pharmaceutical
The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) yesterday voted by 13 to one against approving Taltorvic (ridaforolimus), from US drug giant Merck & Co (NYSE: MRK) and partner Ariad Pharmaceuticals (Nasdaq: ARIA), as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy. 21 March 2012
Pharmaceutical
Providing welcome news for UK pharma giant GlaxoSmithKline (LSE: GSK), the Oncologic Drugs Advisory Committee (ODAC) to the US Food and Drug Administration voted 11 to two that evidence from clinical studies support a favorable benefit-risk assessment for use of Votrient (pazopanib) in treating patients with advanced soft tissue sarcoma who have received prior chemotherapy, noting that those with gastrointestinal stromal tumors (GIST) and adipocytic sarcomas were not included in the Phase III trial. 21 March 2012
Pharmaceutical
The European Medicines Agency has recommended that the manufacturing processes for the anticancer medicines Caelyx (doxorubicin hydrochloride) from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV and Ceplene (histamine dihydrochloride) made by EpiCept (Nasdaq: EPCT) be transferred from the Ben Venue Laboratories in Ohio, United States, to alternative facilities. 18 March 2012
Pharmaceutical
Ireland-headquartered Shire (LSE: SHP) said yesterday that it has signed an agreement to acquire privately-held US firm FerroKin BioSciences for an upfront payment of $100 million, payable in cash at closing, plus potential post-closing milestone payments of up to $225 million, depending upon the achievement of certain clinical development, regulatory and net sales targets. 16 March 2012
Pharmaceutical
The European Medicines Agency says it has been formally notified by the Irish subsidiary of US drugmaker Alkermes (Nasdaq: ALKS) of its decision to withdraw its application for a centralized marketing authorization for the medicine Megestrol Alkermes (megestrol), 125mg/ml oral suspension. Megestrol Alkermes was intended to be used for the treatment of anorexia, cachexia or an unexplained significant weight loss in adult AIDS and oncology patients. 13 March 2012
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