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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
Through 2021, growth in the market for colorectal cancer (CRC) treatments will decline in the face of generic competition for a key cytotoxic agent, oxaliplatin (Sanofi's Eloxatin/Eloxatine, Yakult Honsha's Elplat), as well as the entry of biosimilar competitors for key targeted biological agents, according to a new report from Decision Resource. 4 November 2012
Pharmaceutical
At its 3rd International Research & Development press conference, family-owned German drug major Boehringer Ingelheim unveiled a pipeline of unique asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and lung cancer compounds that builds on the company's vast respiratory experience over many decades. 1 November 2012
Pharmaceutical
The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) this morning (November 2) issued new final draft guidance recommending two new treatments for advanced malignant melanoma: US drug major Bristol-Myers Squibb (NYSE: BMY) Yervoy (ipilimumab) and Switzerland-based Roche's (ROG: SIX) Zelboraf (vemurafenib). 1 November 2012
Pharmaceutical
The total number of diagnosed incident cases of prostate cancer in Russia will increase at five percent annually from 2011 to 2016, driven mostly by an aging population and the rising number of disease diagnoses, according to Prostate Cancer in Russia, a new report form health care advisory firm Decision Resources, which notes that the expanding patient population will largely contribute to the growth of the Russia's prostate cancer drug market, which is forecasted to grow 6% annually over the next 10 years. 1 November 2012
Biotechnology
Millennium, a wholly owned subsidiary of Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that the European Commission has granted conditional marketing authorization for Adcetris (brentuximab vedotin) for two indications. 1 November 2012
Pharmaceutical
German drug major Bayer (BAYN: DE) and US partner Onyx Pharmaceuticals (Nasdaq: ONXX) said yesterday that the US Food and Drug Administration granted priority review for their New Drug Application filed at the end of August 2012 for Stivarga (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors. The submission was based upon data from the pivotal, global Phase III GRID study. 30 October 2012
Biotechnology
The world's largest biotech firm Amgen (Nasdaq: AMGN) and venture capital group Kleiner Perkins Caufield & Byers (KPCB) have established Atara Biotherapeutics, a new drug development company with a focus on innovative therapies for patients with chronic diseases in therapeutic areas including nephrology and oncology. 29 October 2012
Biotechnology
In a second major deal within just over a year for the UK-based antibody-based drug developer, BioTherapeutics (OBT) has entered into a major innovative and strategic alliance with family-owned Italian drugmaker Menarini to develop a portfolio of antibody-based drugs in the field of cancer. 29 October 2012
Pharmaceutical
The US Food and Drug Administration on Friday approved Israel-headquartered Teva Pharmaceutical Industries' (NYSE: TEVA) Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. 29 October 2012
Biotechnology
While branded versions of monoclonal antibodies for cancer are expected to maintain sales of $6.7 million across the USA, the EU5 countries (France, Germany, Italy, Spain and the UK) and Japan, biosimilar versions of MAbs are forecast to garner sales of $4.9 billion in 2021, says BioTrends Research, a unit of Decision Resources. 28 October 2012
Pharmaceutical
The European Commission yesterday gave conditional marketing authorization for global drugs behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) in the European Union for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). 25 October 2012
Biotechnology
Fujifilm Kyowa Kirin Biologics has that it will endeavor to develop a biosimilar version of bevacizumab, an anti-VEGF humanized monoclonal antibody which has impressive therapeutic effects for cancers such as colorectal cancer and non-small cell lung cancer, and is the active ingredient of Roche's blockbuster Avastin. 25 October 2012
Biotechnology
Seattle Genetics and Abbott expand ADC collaboration 24 October 2012
Biotechnology
New guidance published today (October 24) by the UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) commits the National Health Service to funding US biotech firm Amgen's (Nasdaq; AMGN) Xgeva (denosumab) for cancer patients whose disease has spread from most solid tumour sites (eg, breast, lung, liver) to their bones, known as bone metastasis. 24 October 2012
Biotechnology
US biotech firm Celgene's (Nasdaq: CELG) European subsidiary yesterday revealed that its phase III, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma met the primary endpoint of improvement in progression-free survival (PFS) as reviewed by a data safety monitoring board (DSMB). 23 October 2012
Pharmaceutical
Chugai Pharmaceutical (TYO: 44519), which is majority-owned by Swiss drug major Roche (ROG: SIX), has succeeded for the first time in the world in establishing stable cell lines with the nature of colon cancer stem cells that are thought to be involved in the recurrence/metastasis of cancer. 22 October 2012
Generics
Jordanian drugmaker Hikma Pharmaceuticals (LSE: HIK) has signed a license and supply agreement for the registration and marketing of Lutrate 1 month (leuprolide acetate 3.75mg), Spain-based GP Pharm's leading anti-cancer compound, for the Middle East and North Africa (MENA) region. The drug is a hormonal androgen deprivation therapy to prevent tumor growth in patients with advanced prostate cancer. 22 October 2012
Pharmaceutical
US drug major Eli Lilly (NYSE: LLY) says that patients may receive Alimta (pemetrexed for injection) as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic non-squamous non-small cell lung cancer (NS NSCLC). The US Food and Drug Administration approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients, the company noted. 19 October 2012
Pharmaceutical
US drugs behemoth Pfizer (NYSE: PFE) revealed yesterday that a Phase III study of Inlyta axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus sorafenib (Bayer/Onyx's Nexavar), in treatment-naive patients with advanced renal cell carcinoma (RCC). 18 October 2012
Pharmaceutical
France-based AB Science SA (NYSE Euronext - FR0010557264 - AB) has confirmed the filing of a Marketing Authorization Application for masitinib in the treatment of pancreatic cancer with the European Medicines Agency. 17 October 2012
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