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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
There was a batch of bad news emanating from the US drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today (April 27) for UK pharma major GlaxoSmithKline (LSE: GSK) regarding its lupus drug Benlysta (belimumab) and its breast cancer agent Tyverb (lapatinib, as well as for Switzerland's Roche (ROG. SIX) on its Herceptin (trastuzumab). 27 April 2012
Biotechnology
Privately-held Epizyme and Celgene International Sarl, a subsidiary of USA-based Celgene Corp (Nasdaq: CELG) have formed a strategic partnership to discover, develop and commercialize personalized therapeutics for patients with genetically-defined cancers by inhibiting histone methyltransferases (HMTs), an important epigenetic target class. 27 April 2012
Generics
In Poland, the recent procurement problems of cancer drugs is far from solved, writes Sebastian Gensior on the europe-health-care.eu web site. While most of the hospitals received urgently needed drugs this week, health care experts argue that there will be problems throughout the year. The problems emerged when Swiss pharma major Novartis (NOVN: VX) generics drug unit Sandoz's Austrian production facilities faced problems in early April. 26 April 2012
Pharmaceutical
The European Commission has approved Swiss drug major Novartis' (NOVN: VX) Signifor (pasireotide) for the treatment of adult patients with Cushing's disease, a rare hormonal disorder, for whom surgery is not an option or for whom surgery has failed. 25 April 2012
Pharmaceutical
In final guidance issued this morning, UK drugs watchdog the National Institute for Health and Clinical Excellence ( NICE) has recommended National Health Service use of Tasigna (nilotinib) and Glivec (imatinib), both made by Swiss drug major Novartis (NOVN: VX), for the first line treatment of chronic myeloid leukemia (CML), confirming draft guidance issued last month (The Pharma Letter March 22). 25 April 2012
Pharmaceutical
The German Federal Joint Committee (G-BA), the supreme decision-making body of the self-governing medical system in Germany, says that it considers the use of Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin) to have additional benefit versus comparative treatments, defined by the G-BA for women who have already had extensive prior treatment of metastatic or locally advanced breast cancer. The decision comes despite a negative initial assessment by the G-BS's advisory body, the IQWiG (The Pharma Letter February 17). 23 April 2012
Pharmaceutical
USA-based Agenus (Nasdaq: AGEN) says that a Phase II multicenter trial of its autologous heat shock protein-peptide vaccine (HSPPC-96; vitespen) for recurrent glioblastoma multiforme (GBM) patients showed improved survival compared to a contemporary cohort controlled for age, KPS and extent of resection. 22 April 2012
Biotechnology
US biotech firm Cell Therapeutics (Nasdaq and MTA: CTIC) and Singapore-based S*BIO Pte have entered into an asset purchase agreement under which CTI would acquire world-wide rights to S*BIO's pacritinib, a highly selective JAK2 inhibitor. 20 April 2012
Pharmaceutical
UK drug watchdog the National Institute for Health and Clinical Excellence (NICE), said this morning that it has opened a consultation on new, draft guidance which does not recommend Avastin (bevacizumab), from Swiss drug major Roche (ROG: SIX), for the first-line treatment of metastatic breast cancer, when used in combination with the chemotherapy drug, capecitabine. 18 April 2012
Biotechnology
Following National Health Insurance price listing yesterday, Japanese drug major Daiichi Sankyo (TYO: 4568) has launched Ranmark (denosumab), which was approved earlier this year for treatment for bone complications stemming from multiple myeloma and bone metastases from solid tumors. 17 April 2012
Biotechnology
US biotechnology firm ImmunoGen (Nasdaq: IMGN) says that the Investigational New Drug (IND) application for its IMGN853 product candidate is now active. IMGN853 is a potential new therapeutic for ovarian cancer, NSCLC, and other epithelial malignancies which over-express FOLR1. The company expects Phase I evaluation of IMGN853 to begin in mid-2012. 17 April 2012
Biotechnology
US drug giant Merck & Co (NYSE: MRK) has entered into an agreement to develop and commercialize Endocyte's (Nasdaq: ECYT) novel investigational therapeutic candidate vintafolide (EC145). The news pushed Endocyte's shares a massive 99% higher to $7.57 in pre-market trading yesterday. 17 April 2012
Biotechnology
USA-based Affymax (Nasdaq: AFFY) and the US subsidiary of Japanese drug major Takeda Pharmaceuticals (TYO: 4502) revealed on Friday that the Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code, or Q-code, for Omontys (peginesatide) Injection. The move follows Food and Drug Administration approval of the drug last month for the treatment of anemia due to CKD in adult patients on dialysis. (The Pharma Letter March 28). 16 April 2012
Pharmaceutical
Norwegian cancer therapeutics developer Algeta ASA (OSE: ALGETA) says that it has exercised its option to co-promote Alpharadin (radium-223 chloride), for the treatment of cancer patients with bone metastases in the USA. The drug is the subject of a licensing deal with German drug major Bayer (BAY: DE), originally worth a potential $800 million to Algeta (The Pharma Letter September 3, 2009). 13 April 2012
Biotechnology
Switzerland-based Lonza (SIX: LONN) and Agennix AG (FSE: AGX) of Germany have announced an agreement for the production of the first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI), talactoferrin, currently in Phase III testing for the treatment of non-small cell lung cancer (NSCLC) by Agennix. 12 April 2012
Pharmaceutical
Women with aggressive metastatic breast cancer in the UK capital London now have access to a drug which could give them five-10 extra months of life but up until this month has been unavailable on the National Health Service, says Swiss drug major Roche (ROG: SIX). 12 April 2012
Generics
ViroPharma I (Nasdaq: VPHM) saw its shares plunge 19% to $23.25 yesterday after it announced that the US Food and Drug Administration had denied the citizen petition the company filed on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of Abbreviated New Drug Applications referencing its antibiotic Vancocin (vancomycin hydrochloride, USP) Capsules. 11 April 2012
Biotechnology
UK pharma giant GlaxoSmithKline group (LSE: GSK) and Tokyo, Japan-based biotech-venture company Chiome Bioscience (TYO:4583) have entered into a pilot study and option agreement under which the two companies will generate monoclonal antibodies (MAbs) using Chiome's proprietary ADLib system for GSK's research and evaluation use with an option for development. Financial terms of the accord were not disclosed. 10 April 2012
Biotechnology
US biotech firm Spectrum Pharmaceuticals (Nasdaq: SPPI) saw its shares plunge as much as 14%, before closing down 7.9% at $11.25 last Thursday, after announcing disappointing results for its bladder-cancer drug candidate apaziquone, as well as revealing that it had made a takeover bid for fellow USA-based rival Allos Therapeutics (Nasdaq: ALTH). Shares of Allos rose 27% to $1.81 on the news. 10 April 2012
Pharmaceutical
Encouraging Phase II trial with selumetinib, a small-molecule MEK inhibitor developed by USA-based Array BioPharma (Nasdaq: ARRY), in women with recurrent low-grade serous ovarian or peritoneal cancer, were presented this week by the Gynecologic Oncology Group at the American Association for Cancer Research Annual Meeting 2012. 5 April 2012
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