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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
New Zealand's pharmaceutical management agency PHARMAC has approved the proposal to fund AstraZeneca's (LSE: AZN) Iressa (gefitinib) and to amend the Special Authority criteria applying to Roche's (ROG: SIX) Tarceva (erlotinib). This was the subject of a consultation letter dated May 31, 2012. 5 July 2012
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of Anglo-Swedish drug major AstraZeneca's Caprelsa (vandetanib) under the Act on the Reform of the Market for Medicinal Products (AMNOG), concluding that there is no proof of added benefit, because no data on patient-relevant outcomes for those patients for whom the drug is approved were presented by the drug manufacturer in its dossier. In view of these deficiencies, the IQWiG says it considered itself compelled to declare the contents of the dossier as "incomplete." 5 July 2012
Pharmaceutical
The European Medicines Agency has been formally notified by US health care giant Johnson & Johnson's (NYSE: JNJ) European subsidiary Janssen-Cilag International of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorized drug Velcade (bortezomib). 5 July 2012
Pharmaceutical
The global Neuroendocrine carcinoma therapeutics market was worth $127 million in 2011 and now the market is forecast to increase at compound annual growth rate (CAGR) of 17.9% to reach $475 million by 2019, according to a new report from GlobalData, titled Neuroendocrine Carcinoma Therapeutics - Pipeline Assessment and Market. 4 July 2012
Pharmaceutical
Japanese drugmakers Otsuka Pharmaceutical (TYO: 4578) and Kyowa Hakko Kirin (TYO: 4151) have entered into an agreement to pursue a strategic alliance in the fields of diabetes and oncology. 3 July 2012
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) and Toyama Chemical have received approval from Japan's Ministry of Health, Labor and Welfare to market iguratimod (development code: T-614) for the treatment of rheumatoid arthritis. 3 July 2012
Generics
Taiwan based active pharmaceutical ingredients maker ScinoPharm (TWSE: 1789) says it plans to invest NT$1.1 billion (around $37.6 million) in the construction of a high potency cytotoxic injectable plant suitable for production of oncological injectable products at the company's premises on the Tainan Science Park. 3 July 2012
Biotechnology
Bayer HealthCare, a US unit of Germany's Bayer (BAYN: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX) said yesterday that the US Food and Drug Administration has granted priority review designation for the New Drug Application filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies. 29 June 2012
Pharmaceutical
Japanese drug major Astellas Pharma (TYO: 4503) yesterday filed a marketing authorization application to the European Medicines Agency for enzalutamide (USAN, MDV3100) for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy. 28 June 2012
Pharmaceutical
Physicians in the USA said they would use Zytiga (abiraterone acetate), from health care giant Johnson & Johnson's (NYSE: JNJ) Janssen subsidiary, in more than half of their castrate-resistant prostate cancer (CRPC) patients who are asymptomatic or minimally symptomatic in the pre-chemotherapy setting, according to a survey conducted by Kantar Health, a health care-focused consultancy. 27 June 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today published new technology appraisals, updating on its previous decisions announced earlier this year. 26 June 2012
Pharmaceutical
US drug behemoth Pfizer (NYSE: PFE) is finalizing confidions for the transfer of a license for the production of Factor VIII, which is used to treat hemophilia to Biocad, one of Russia's leading biotechnology companies, said Dmitry Morozov, recently appointed chairman of Biocad. 26 June 2012
Pharmaceutical
Cancer cell signaling has long been an attractive target for oncology drug development. Increased activation of cell survival signaling cascades promotes tumor cell growth and makes cancer cells difficult to kill, notes a new report from intelligence provider GlobalData. Inhibiting proteins that are involved in these survival pathways is one strategy to selectively destroy cancerous cells. 24 June 2012
Biotechnology
Celgene International, the European subsidiary of USA-based Celgene Corp (Nasdaq: CELG), has provided a regulatory update for Revlimid (lenalidomide) and pomalidomide as treatments for multiple myeloma, saying that it has decided to withdraw the new indication submission to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). 22 June 2012
Pharmaceutical
Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of views on approval recommendations relating to products from Onyx, Sanofi, Pfizer and Merck & Co products. 21 June 2012
Biotechnology
USA-based biotech company Cell Therapeutics (Nasdaq and MTA: CTIC) said yesterday that it is re-aligning its resources and re-prioritizing its product development pipeline to focus on the launch of Pixuvri (pixantrone) in the European Union and accelerate the advancement of pacritinib, the company's recently-acquired, highly-selective JAK 2 inhibitor, into Phase III clinical trials. 21 June 2012
Pharmaceutical
US oncologists surveyed by advisory firm Decision Resources say they prescribe drugs behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) for the treatment of non-small-cell lung cancer (NSCLC) just 10 months after the drug's launch, illustrating the power of a targeted agent with a strongly predictive biomarker to achieve usage, despite a small eligible patient population. 21 June 2012
Generics
French drug major Sanofi (Euronext: SAN) and the Joslin Diabetes Center, a teaching and research affiliate of Harvard Medical School, USA, have entered a new collaboration to promote the development of new drugs for the treatment of diabetes and related disorders. 20 June 2012
Pharmaceutical
US drug discovery firm Infinity Pharmaceuticals (Nasdaq: INFI) saw its shares plummet 20% to $11 in pre-marketing trading yesterday morning when it announced disappointing interim data from its Phase II, double-blind, randomized, placebo-controlled study of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma. 19 June 2012
Pharmaceutical
Swedish drugmaker Meda AB (OMX: MEDA A) says that is Edluar, an oral sublingual formulation of zolpidem, has received registration approval in Europe via the decentralized procedure with Sweden acting as reference member state. Edluar is used for treating sleep disorders. National registration processes will now follow in each country., the company stated, noting that the first launches are expected early next year. 19 June 2012
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