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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, draft guidance issued today (March 25) by the UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) does not recommend Swiss drug major Roche's (ROG: SIX) Avastin (bevacizumab) for National Health Service use as an ovarian cancer treatment. 25 March 2013
Pharmaceutical
A new gentler chemotherapy drug in the form of nanoparticles has been designed by Northwestern Medicine scientists to be less toxic to a young woman's fertility but extra tough on cancer. This is the first cancer drug tested while in development for its effect on fertility using a novel in vitro test. 24 March 2013
Biotechnology
In a second licensing accord this month, US biotech firm Celgene Corp (Nasdaq: CELG) has signed a strategic alliance with privately-held biotech firm bluebird bio to discover, develop and commercialize novel disease-altering gene therapies in oncology. 22 March 2013
Pharmaceutical
Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502) and its oncology subsidiary Millennium have submitted a new drug application to Japan's Ministry of Health, Labor and Welfare (MHLW) for brentuximab vedotin for the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) and relapsed or refractory CD30 positive anaplastic large cell lymphoma (ALCL). 22 March 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN), ahead of its Investor Day briefing in New York later today, announced two major alliances to bolster its research productivity. The firm's new chief executive, Pascal Soriot, who just a few days ago revealed plans for a major overhaul of its research sites including 1,600 job cuts (The Pharma Letter March 19), said: "Our vision is clear - to be a global biopharmaceutical company with a focused portfolio in core therapy areas, underpinned by distinctive science and a growing late-stage pipeline, with sound financials offering attractive returns for investors." 21 March 2013
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech company, has presented positive top-line results from the Phase III trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec (TVEC) for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). 21 March 2013
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) today (March 21) issued an Appraisal Consultation Document (ACD) recommending that Swiss drug major Novartis' (NOVN: VX) advanced breast cancer treatment Afinitor (everolimus) should not be available to patients on the National Health Service. 21 March 2013
Pharmaceutical
In the EU5 countries (France, Germany, Italy, Spain and the UK), interviewed payers and surveyed oncologists recognize that molecularly driven management is a valuable innovation in cancer care, according to the findings of health care advisory firm Decision Resources. However, payer insight and oncologist survey findings show that targeted populations must be highly defined, companion diagnostics optimized, and the cost of diagnostic testing subsidized in order to maximize a new brand's market access potential. 20 March 2013
Biotechnology
US biopharma company Affymax (Nasdaq: AFFY) says that it will reduce its workforce as part of a plan to focus the company's resources on the ongoing investigation of reported hypersensitivity reactions in patients receiving the anemia drug Omontys (peginesatide) Injection following the nationwide voluntary recall of product from the market. Affymax' shares plunged nearly 57% to $1.27 in extended trade on Monday. 19 March 2013
Biotechnology
Biocad, one of Russia's leading biotechnology companies, plans to launch production of several of its drugs for the treatment of serious diseases in Brazil, in cooperation of local producers. The agreement was reached during a recent visit of Russia's Prime Minister to Brazil. 19 March 2013
Biotechnology
US biotech firm Seattle Genetics (Nasdaq: SGEN) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). 19 March 2013
Pharmaceutical
The gonadotropin releasing hormone (GnRH) antagonist degarelix (brand name Firmagon, from Swiss drugmaker Ferring Pharmaceuticals) may be associated with lower risk of a cardiovascular (CV) events or death compared to commonly prescribed luteinizing hormone-releasing hormone (LHRH) agonists, according to data presented at the European Association of Urology (EAU) 2013 annual meeting in Milan, Italy. 18 March 2013
Generics
Indian generic drugmaker BDR Pharmaceuticals has applied to India's patent office for a compulsory licence to sell a generic version of Bristol-Myers Squibb (NYSE: BMY) leukemia drug Sprycel (dasatinib) under a global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, a BDR executive said on Monday, reports Reuters. 18 March 2013
Pharmaceutical
As part of a European Union-supported IMI-PREDECT consortium (http://www.predect.eu), a Dutch study showed that anti-androgenic properties of the drug abiraterone may provide an additional mechanism of action in blocking tumor growth of castration resistant prostate cancer (CRPC). 17 March 2013
Pharmaceutical
Results from the PrefHer (Patient Preference for Subcutaneous (SC) versus Intravenous (IV) Herceptin) trial show that 92% of early HER2-positive breast cancer patients favored quicker SC administration of Swiss drug major Roche's (ROG: SIX) Herceptin (trastuzumab) compared to the standard IV infusion. The data were presented at the St Gallen Breast Cancer Conference in Switzerland. 15 March 2013
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) says that its investigational compound LDK378 has received Breakthrough Therapy designation from the US Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during treatment with, or were intolerant to, crizotinib. 15 March 2013
Pharmaceutical
Ligand Pharmaceuticals (Nasdaq: LGND) has signed a global license and supply agreements with fellow US drugmaker Spectrum Pharmaceuticals (Nasdaq: SPPI) for the development and commercialization of Ligand's Captisol-enabled, propylene glycol-free (PG-free) melphalan. 14 March 2013
Pharmaceutical
The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) and USA-based privately held firm Ambit Biosciences announced that they will end their collaboration for the joint development and commercialization of FMS-like tyrosine kinase-3 (FLT3) inhibitors, including quizartinib, effective September 3, 2013. 12 March 2013
Pharmaceutical
Canada's AEterna Zentaris (TSX: AEZ) saw its stock plunge as much as 29% (closing down 22.3% at C$2.09), after the company said yesterday (March 11) that an independent Data Safety Monitoring Board (DSMB) has recommended discontinuing the ongoing Phase III study comparing the efficacy and safety of its oral cancer drug candidate perifosine to placebo when combined with bortezomib (Takeda's Velcade) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. 12 March 2013
Pharmaceutical
A new study has found that women who take aspirin have a reduced risk of developing melanoma - and that the longer they take it, the lower the risk. The findings suggest that aspirin's anti-inflammatory effects may help protect against this type of skin cancer. The study is published early on-line in CANCER, a peer-reviewed journal of the American Cancer Society. 11 March 2013
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