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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
Japanese drug major Astellas Pharma (TYO: 4503) has entered into a collaboration with venture capital backed US biotech firm Ambrx for the discovery and development of novel antibody drug conjugates (ADCs). 5 April 2013
Biotechnology
USA based Cyclacel Pharmaceuticals (Nasdaq: CYCC) says that it has entered into a definitive agreement with biotech major Celgene (Nasdaq: CELG) to sell to Celgene four Cyclacel-owned patents related to the use of romidepsin injection. In connection with the agreement Celgene has made a one-time payment of $5.5 million to Cyclacel. 5 April 2013
Biotechnology
US clinical stage, investor backed biopharma company BIND Therapeutics has entered into a global collaboration with global drug behemoth Pfizer (NYSE: PFE). to develop and commercialize its therapeutics known as Accurins utilizing select small-molecule targeted therapies. The collaboration aims to employ BIND's Medicinal Nanoengineering platform to impart tissue and cellular targeting capabilities to molecularly targeted drugs. 4 April 2013
Biotechnology
Denmark-based biotech firm Genmab A/S (OMX: GEN) says that the US Food and Drug Administration has granted fast track designation for daratumumab (HuMax-CD38), which is being developed with Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech. 3 April 2013
Biotechnology
Shares of Norwegian cancer drug developer Clavis Pharma (OSE: CLAVIS) plunged 83.8% to 1.10 Norwegian kroner this morning (April 2), as markets reopened to the news that results of the Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML) showed that there was no significant difference in overall survival (OS) between the two arms where patients were randomized to receive either elacytarabine or investigator's choice of treatment. 2 April 2013
Generics
In a landmark decision issued on Monday (April 1) by the Indian Supreme Court has denied Swiss drug major Novartis' (NOVN: VX) patent on the blockbuster cancer drug Glivec (imatinib mesylate). Shares in Novartis' Indian unit ended 1.8 % lower after falling as much as 6.8% after the verdict, noted a Reuters report. European markets were closed for the Easter holiday. 2 April 2013
Pharmaceutical
Taking a regular low dose of aspirin could prevent head and neck cancers by almost a quarter, according to new research. The results of the study, published in the British Journal of Cancer (2013) 108, 1178-1181, concluded that people were almost a quarter (22%) more likely to avoid developing head and neck cancers if they took aspirin on a weekly and monthly basis. Throat cancers had the most benefit from regular aspirin use. 29 March 2013
Pharmaceutical
Shares of US drugmaker AP Pharma (OTCBB: APPA.OB) plunged 34.8% to $0.378 in early trading on March 28, on the news that the Food and Drug Administration has declined approval for its investigational drug to treat chemotherapy-induced nausea and vomiting (CINV). 28 March 2013
Biotechnology
The European Commission has granted conditional marketing authorization for US drugs behemoth Pfizer's (NYSE: PFE) Bosulif (bosutinib) in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. 28 March 2013
Biotechnology
The failure of Ziopharm's palifosfamide in metastatic soft tissue sarcoma (STS; The Pharma Letter March 26) is viewed as incrementally positive for US biopharma firm CytRx' (Nasdaq: CYTR) aldoxorubicin by analysts at Edison Investment Research. 28 March 2013
Pharmaceutical
In a second disappointment from the agency this week, US drugs behemoth Pfizer (NYSE: PFE) Ltd expressed concern that guidance from the UK's drug watchdog National Institute for Health and Clinical Excellence (NICE) does not recommend its Inlyta (axitinib), a new treatment for patients with advanced renal cell carcinoma (commonly known as kidney cancer) who are no longer receiving clinical benefit from treatment with sunitinib or a cytokine.
This final draft guidance comes just a day after the firm also received a negative preliminary guidance for its lung cancer drug Xalkori (crizotinib; The Pharma Letter March 27). 28 March 2013
Biotechnology
Ganetespib, a drug under development by USA-based Synta Pharmaceuticals (Nasdaq: SNTA) that indirectly impairs the function of several cancer-driving proteins, including anaplastic lymphoma kinase (ALK), may be an effective new treatment for patients with ALK--positive non-small cell lung cancer (NSCLC). 27 March 2013
Biotechnology
US and European oncologists surveyed by health care advisory firm Decision Resources agree that a therapy's effect on overall survival and disease progression are the attributes that most influences their decisions regarding prescribing in advanced renal cell carcinoma (kidney cancer). Clinical data and the opinions of interviewed thought leaders indicate that Aveo Oncology (Nasdaq: AVEO)/Astellas Pharma (TYO: 4503)/Kyowa Hakko Kirin's (TYO: 4152) Tivopath (tivozanib) has advantages over currently used therapies on disease progression. 27 March 2013
Pharmaceutical
Dijon, France-based Oncodesign, a company specializing in drug discovery and providing pharmacological evaluation services in the field of oncology, has signed a second research collaboration agreement with French drug major Sanofi (Euronext: SAN). Financial details of the accord have not been disclosed. 27 March 2013
Pharmaceutical
Much to the disappointment of the company, this morning (March 27), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) said it does not recommend global drugs behemoth Pfizer's (NYSE:PFE) Xalkori (crizotinib) for use on the National Health Service. 27 March 2013
Pharmaceutical
US drug developer Ziopharm Oncology (Nasdaq: ZIOP) saws its shares plunge $3.21 to $1.92 after it said its Phase III trial of palifosfamide (ZIO-201) - its lead product candidate - for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS). 26 March 2013
Biotechnology
After around two months on the market, 37% of US rheumatologists have prescribed Pfizer's (NYSE: PFE) Xeljanz (tofacitinib) in an average of three of their rheumatoid arthritis (RA) patients, according to a new report from BioTrends Research, part of health care advisory firm Decision Resources. 26 March 2013
Pharmaceutical
Japanese drug major Eisai (TYO; 4523, through its EMEA (Europe, Middle East and Africa) unit, has announced it is expanding its operations by establishing a new sales and marketing operation in Russia, a market that has seen a great deal attention from multinational pharmaceutical companies in recent times. 26 March 2013
Pharmaceutical
UK-based Clinigen Group (LSE: CLIN) says it has acquired (AIM: CLIN) the oncology support therapy Cardioxane (dexrazoxane) from Swiss drug giant Novartis (NOVN: VX) for $33 million in cash, payable in two tranches. 26 March 2013
Biotechnology
Drug regulator Health Canada has approved German drug major Bayer's Stivarga (regorafenib tablets), indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. 26 March 2013
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