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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
The number of diagnosed incident cases of non-small-cell lung cancer (NSCLC) in urban China will increase 5% annually between 2011 and 2016, says a new report from advisory firm Decision Resources. 29 July 2012
Biotechnology
Shares of US biotech firm Onyx Pharmaceuticals (Nasdaq: ONXX) leapt 11.7% to $76.38 on Friday, after the US Food and Drug Administration approved the firm's investigational drug Kyprolis (carfilzomib) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. 23 July 2012
Biotechnology
Reversing an earlier negative opinion (The Pharma Letter April 22), the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion that recommends marketing authorization of Netherlands-based uniQure's Glybera (alipogene tiparvovec) as a treatment for lipoprotein lipase deficiency (LPLD). 23 July 2012
Pharmaceutical
There was good news for Swiss drug major Novartis (NOVN: VX) on Friday, when the US Food and Drug Administration approved the firm's already marketed Afinitor (everolimus) for an additional indication, for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. 23 July 2012
Pharmaceutical
A Phase III trial evaluating the efficacy and safety of the addition of Roche's Tarceva (erlotinib) tablets to German drug major Bayer's (BAYN: DE) Nexavar (sorafenib) - which is being commercialized with Onyx Pharmaceuticals (Nasdaq: ONXX) and Japan's Astellas Pharma - for patients with hepatocellular carcinoma (HCC; liver cancer) did not further improve overall survival versus the standard therapy with Nexavar alone. 23 July 2012
Pharmaceutical
US drug major Bristol-Myers Squibb (NYSE: BMY) yesterday reported results of the Phase III BRISK-FL clinical trial of the investigational agent brivanib compared with Bayer and Onyx Pharmaceuticals' Nexavar (sorafenib) as first-line treatment in patients with advanced hepatocellular carcinoma (HCC; liver cancer), showing that the study did not meet its primary overall survival objective based upon a non-inferiority statistical design. 20 July 2012
Biotechnology
Spanish health care group Grifols (GRLS: MC), the world's third largest plasma product manufacturer, has acquired 40% of the equity of Catalan biotechnology firm VCN Biosciences, dedicated to the R&D of new therapeutic approaches for tumors for which there is no effective treatment. Financial terms of the transaction were not disclosed. 16 July 2012
Biotechnology
US RNAi therapeutics specialties Alnylam Pharmaceuticals (Nasdaq: ALNY) and Ascletis Pharmaceuticals, a privately held US-China joint venture pharmaceutical company, have formed a strategic collaboration for the development of ALN-VSP, a first-in-class, systemically delivered RNAi therapeutic for the treatment of liver cancers including hepatocellular carcinoma (HCC), a significant area of unmet need in China. 15 July 2012
Generics
UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New Drug Application to the US Food and Drug Administration for Tykerb (lapatinib) in combination with trastuzumab (Roche's Herceptin) for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy. 13 July 2012
Pharmaceutical
In what is claimed "a world first" by the Department of Health and Ageing, Australian schoolboys will be able to get treatment with Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, and 18] vaccine, recombinant, from Merck & Co), which will protect them against developing a range of cancers and bolster the effectiveness of this vaccine in women. 12 July 2012
Biotechnology
Cancer patients in the USA get faster access to more oncology drugs to treat their disease than patients in Europe, according to a newly-completed study by the Tufts Center for the Study of Drug Development. 11 July 2012
Biotechnology
Cancer treatments are becoming increasingly personalized, as regulators are approving therapeutics offering significant benefits to small target populations, according to a new report by health care experts GBI Research, which states that, although therapeutic options that target a small population are expensive, their uptake is expected to be rapid in the target population. 11 July 2012
Biotechnology
Privately-held US biotech firm PDS Biotechnology says it has entered into an exclusive worldwide licensing agreement with Germany's Merck KGaA (MRK: DE) for use of its novel Versamune nanotechnology platform in two of Merck's investigational antigen-specific cancer immunotherapies currently in preclinical development. 10 July 2012
Pharmaceutical
Australia-based Alchemia (ASX: ACL) says it is progressing well with preparations to demerge its oncology assets, with a proposal anticipated to be put to shareholder vote in late September/early October 2012. 9 July 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) says that it has completed the previously indicated sale of the assets of its subsidiary, Aptium Oncology. The company first revealed that it planned to divest these assets, as well as its dental and medical devices unit Astra Tech last year. 9 July 2012
Pharmaceutical
Family-controlled German drug major Boehringer Ingelheim has established a translational research collaboration with the presidents and fellows of USA-based Harvard College. The goal of the collaboration is for the scientists of Boehringer Ingelheim to work together with the scientific community of Harvard to advance the company's knowledge in areas of high unmet medical need. 9 July 2012
Pharmaceutical
UK-based Horizon Discovery, a provider of research tools to support the development of personalized medicines, has signed a collaboration agreement with German drug major Bayer (BAYN: DE)) to develop preclinical cell line models that will support Bayer's oncology R&D programs, using Horizon's precision genome editing technology, GENESIS. 9 July 2012
Pharmaceutical
US drug majors Eli Lilly (NYSE: LLY) and Bristol-Myers Squibb (NYSE: BMY) on Friday received full approval from the Food and Drug Administration for their Erbitux (cetuximab) for a new indication, making it the first biologic treatment regimen cleared in nearly a decade for newly-diagnosed metastatic colorectal cancer (mCRC). 9 July 2012
Biotechnology
US biotech firm Spectrum Pharmaceuticals (Nasdaq: SPPI) said late Friday that it has again extended tender offer to purchase all of the outstanding shares of common stock of Allos Therapeutics (Nasdaq: ALTH; The Pharma Letter April 10) for $1.82 per share in cash (around $206 million in total), plus one contingent value right, which entitles Allos stockholders to an additional payment of $0.11 per share in cash if certain European regulatory approval and commercialization milestones for lymphoma drug Folotyn (pralatrexate injection), a folate analog metabolic inhibitor, are achieved. 9 July 2012
Pharmaceutical
Final draft guidance published today (July 6) by the UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) does not recommend Swiss drug major Roche's (RGO: SIX) Avastin (bevacizumab), when used in combination with capecitabine (Xeloda, also from Roche), as a treatment for a particular set of people with metastatic breast cancer. This confirms an earlier negative draft guidance (The Pharma Letter April 18). 6 July 2012
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