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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
US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International said Friday that the European Commission has approved an extension to the license of the oral, once-daily prostate cancer drug Zytiga (abiraterone acetate). 14 January 2013
Pharmaceutical
Norwegian drug developer Algeta (OSE: ALGETA) this morning announced that the US Nuclear Regulatory Commission (NRC) has issued a positive licensing decision on the medical use of radium-223 dichloride (radium-223). The NRC licensing decision follows the recommendation from the Advisory Committee on the Medical Use of Isotopes (ACMUI) report, dated November 20, 2012. 14 January 2013
Pharmaceutical
After uncovering a mechanism that promotes chronic intestinal inflammation and the development of colorectal cancer, scientists from Virginia Commonwealth University Massey Cancer Center, USA, have found that fingolimod, a drug currently approved for the treatment of multiple sclerosis, could potentially eliminate or reduce the progression of colitis-associated cancer (CAC). The drug is marketed by Swiss drug major Novartis (NOVN: VX) under the trade name Gilenya. 10 January 2013
Pharmaceutical
GVK Biosciences, a Hyderabad, India-based contract research and development organization, and privately-held US biopharma company Onconova Therapeutics have entered into a novel joint partnership to develop new drugs for cancer. Financieal terms were not disclosed. 9 January 2013
Biotechnology
The small-molecule targeted cancer therapy revenues will reach a value of $32.7 billion worldwide in 2016, compared with $21.7 billion in 2011, according to Small-Molecule Targeted Cancer Therapies: World Market 2013-2023, published by business information provider Visiongain. The work analyses the USA, Japan, Germany, France, the UK, Spain, Italy (EU5), India and China. 9 January 2013
Biotechnology
BIND Biosciences, a US clinical stage investor backed company, and Amgen (Nasdaq: AMNG), the world's largest biotech firm, have announced an agreement for the worldwide development and commercialization of a kinase inhibitor nanomedicine. 9 January 2013
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined the added benefit of US drug behemoth Pfizer's (NYSE: PFE) kidney cancer drug Inlyta (axitinib) under the Act on the Reform of the Market for Medicinal Products (AMNOG), finding. "a hint of a considerable added benefit) over the drug sorafenib (Bayer's Nexavar), because the risk of certain side effects is lower with axitinib. In contrast, an added benefit in comparison with everolimus is not proven, because of the lack of suitable data. 9 January 2013
Biotechnology
Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) and USA-based therapeutic antibody developer Adimab have entered into a collaboration whereby Adimab will use its proprietary discovery and optimization platform to identify fully human antibodies against two targets selected by Kyowa Hakko Kirin. 8 January 2013
Biotechnology
French biotech firm BioAlliance Pharma (Euronext Paris - BIO) has announces the launch of Oravig (miconazole buccal tablets, known as Loramyc in Europe) in the USA by its commercial partner, privately-held Vestiq Pharmaceuticals. 8 January 2013
Biotechnology
Swiss pharmaceutical ingredients and specialty chemicals firm Lonza (SIX: LONN) plans to invest 14 million Swiss francs ($15.1 million) to expand antibody drug conjugate (ADC) manufacturing capacity in Visp, Switzerland. Oncology therapeutics including ADCs represent one of the fastest growing segments of the pharma and biotech industry and the deployment of ADC targeted therapies has intensified in recent years, the company noted. 8 January 2013
Biotechnology
Netherlands and Belgium-based preclinical stage biotech firm arGEN-X, specialized in the discovery and development of highly differentiated human monoclonal antibody products, is broadening its therapeutic antibody collaboration with Ireland-headquartered Shire (LSE: SHP). 8 January 2013
Pharmaceutical
A new target to improve treatment of pancreatic ductal adenocarcinoma cancer, which accounts for more than 95% of pancreatic cancer cases, has been identified by researchers at the Mayo Clinic in Florida, USA. This fast-growing, often lethal cancer is resistant to conventional chemotherapy. The findings were published in the January 3 on-line issue of PLOS ONE. 6 January 2013
Pharmaceutical
Taiwan's PharmaEngine (TWO: 4162) says it has executed of a collaboration and research agreement with China's Guangzhou BeBetter Medicine Technology Co (BeBetter). The two companies will collaborate to design, synthesize and develop new chemical entities against predefined targets in oncology. 3 January 2013
Biotechnology
With the rollout of at least eight new therapeutic monoclonal antibody products and expanded indications for existing products expected, the monoclonal antibodies market has been forecast to increase at a compound annual growth rate (CAGR) 10.6% through to 2015, according to a new report added to the offering of companiesandmarkets.com. 3 January 2013
Pharmaceutical
German drug major Bayer (BAYN: DE) and US partner Onyx Pharmaceuticals (Nasdaq: ONXX) this morning revealed that a Phase III trial of Nexavar (sorafenib) in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement in progression-free survival. 3 January 2013
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary Actavis has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade (bortezomib), which is a proteasome inhibitor, for intravenous or subcutaneous administration, approved for the treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy. 31 December 2012
Pharmaceutical
French drug major Sanofi (Euronext: SAN) has entered into a binding agreement to acquire the animal health division of the Indian company Dosch Pharmaceuticals Private Limited, creating a market entry for its Animal Health division Merial in that country's strategically important and growing animal health sector. 21 December 2012
Biotechnology
US biotechnology company ImmunoGen (Nasdaq), which develops anticancer therapeutics using its Targeted Antibody Payload (TAP) technology and antibody expertise, has licensed the exclusive right to use its maytansinoid TAP technology to global independent biotech Amgen (Nasdaq AMGN) to develop anticancer therapeutics to a third target, which is undisclosed. Amgen licensed rights for two other targets in 2009 and has two compounds in clinical testing under those licenses. 20 December 2012
Pharmaceutical
Merck Serono, a division of Germany's Merck KGaA (MRK: DE), Darmstadt, says that the Phase III START trial of its investigational vaccine product L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS). 20 December 2012
Biotechnology
Use of Nexavar (sorafenib, from Bayer [BAYN: DE] and Onyx Pharmaceuticals) has nearly doubled in first-line advanced hepatocellular carcinoma (HCC) patients in China in 2012 from 2011, according to new findings from CancerMPact Treatment Architecture China, conducted by health care consultants Kantar Health and Draco Healthcare, a leading China-focused consultancy. 19 December 2012
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