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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
Drugs that combat aging may be available within five years, following landmark work led by an Australian researcher. The work, published in the March 8 issue of Science, finally proves that a single anti-aging enzyme in the body can be targeted, with the potential to prevent age-related diseases and extend lifespans. 9 March 2013
Pharmaceutical
USA-based Sorrento Therapeutics, Inc. (SRNE: OB) has signed an exclusive option to acquire IGDRASOL, a private company focused on the development of oncologic agents for the treatment of metastatic breast cancer (MBC), non-small cell lung cancer (NSCLC) and other cancers. 8 March 2013
Biotechnology
UK pharma giant GlaxoSmithKline plc (LSE: GSK) says it has submitted a Marketing Authorization Application for albiglutide, with the proprietary name Eperzan, to the European Medicines Agency. Albiglutide is an investigational once-weekly treatment for adult patients with type 2 diabetes which is not yet approved anywhere in the world. A filing with the US Food and Drug Administration was made earlier this year (The Pharma Letter January 15). 7 March 2013
Generics
Privately-held US specialty pharmaceutical company Sagent Pharmaceuticals has announced the approval and launch of zoledronic acid injection 4mg, the generic form of Swiss drug major Novartis' (NOVN: VX) injectable bisphosphonate Zometa, used for the treatment of tumor-induced hypercalcemia, in a latex-free plastic vial. 7 March 2013
Biotechnology
Privately-held USA-based cancer drug developer Presage Biosciences has entered into a strategic collaboration with US biotech major Celgene (Nasdaq: CELG) under which Presage and Celgene will take advantage of Presage's proprietary technology platform to identify novel drug combinations for solid tumor indications. 6 March 2013
Biotechnology
The European Medicines Agency has approved Swiss drug major Roche's (ROG: SIX) Perjeta (pertuzumab) for patients with previously untreated HER2-positive metastatic breast cancer (mBC). The drug was approved in the USA last summer (The Pharma Letter June 11, 2012). 6 March 2013
Generics
After much delay, the verdict into German pharmaceutical major Bayer's (BAYN: DE) appeal against the grant of a compulsory licence has now been issued by India's Intellectual Property Appellate Board (IPAB) in Chennai, upholding the March 2012 granting of the first compulsory license for the firm's kidney and liver cancer drug Nexavar (sorafenib tosylate). 5 March 2013
Biotechnology
The global epigenetic therapies market is expected to reach a total value of around $2.518 billion by the end of 2013, with the industry forecast to increase at a compound annual growth rate (CAGR) of over 10% through to 2017, according to a new report added to the offering of companiesandmarkets.com. 4 March 2013
Biotechnology
In an early benefit assessment under Germany's Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether the fixed combination of the drugs saxagliptin and metformin, marketed by US drugmaker Bristol-Myers Squibb (NYSE: BMY) and Anglo-Swedish pharma firm AstraZeneca (LSE: ANZ) as Komboglyze and Onglyza, offers an added benefit versus the current standard treatment for diabetes. The agency also examined Cell Therapeutics' (Nasdaq: CTIC) non-Hodgkin lymphomas treatment Pixuvri (pixantrone). 4 March 2013
Pharmaceutical
German family-owned drug major Boehringer Ingelheim has started a Phase III trial of its polo-like kinase (Plk) inhibitor volasertib alongside chemotherapy in patients with acute myeloid leukemia (AML). 1 March 2013
Biotechnology
Spanish drugmaker Grupo Zeltia (ZEL: MC) is approaching a material catalyst this year in the form of the read-out from its Phase II study of lurbinectedin (PM01183) in platinum resistant ovarian cancer, say analysts at Edison Investment Research. If positive, this could form the basis of a licensing deal that could transform Zeltia's fortunes, they believe. 28 February 2013
Pharmaceutical
Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka (TYO: 4768) says that it submitted an application for approval of the manufacture and marketing of the novel oral nucleoside antitumor agent TAS-102 (combination of trifluorothymidine [FTD] and tipiracil hydrochloride [TPI]) to the Japanese Ministry of Health, Labor and Welfare. Taiho Pharmaceutical is seeking approval of TAS-102 for the treatment of unresectable, advanced, recurrent colorectal cancer. 27 February 2013
Biotechnology
German biopharmaceutical company Antisense Pharma has announced its revised corporate and development strategy, which include revision of its development program for its cancer drug candidate trabedersen, receiving full support from its main investors. 26 February 2013
Pharmaceutical
The US Food and Drug Administration yesterday expanded the approved use of German drug major Bayer's (BAYN: DE) Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. 26 February 2013
Generics
Belgium drug developer Ablynx (Euronext Brussels: ABLX]) has entered into a research collaboration with closely-held UK-based Spirogen to evaluate the potential of a novel anti-cancer drug conjugate combining Spirogen's proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBD), and associated linker technology, with Nanobodies generated using Ablynx' proprietary technology platform. 25 February 2013
Biotechnology
The US Food and Drug Administration on Friday approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, developed by Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX). 25 February 2013
Biotechnology
German drug major Merck KGaA (MRK: DE) revealed this morning that the Phase III CENTRIC trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). Merck's shares dipped 2.15% to 102.55 euros in early trading. 25 February 2013
Biotechnology
US biotech firm Exelixis (Nasdaq: EXEL) has entered into a three-year with Swedish Orphan Biovitrum (STO: SOBI) to support the distribution and commercialization of Cometriq (cabozantinib) for metastatic medullary thyroid cancer (MTC) in the European Union and potentially other countries. 22 February 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued new draft guidance not recommending US pharma major Eli Lilly's Alimta (pemetrexed) for the maintenance treatment of non-small-cell lung cancer (NSCLC) following induction therapy with pemetrexed and cisplatin 22 February 2013
Pharmaceutical
Canada's Valeant Pharmaceuticals International (TSX: VRX) says that it has acquired US rights for Targretin (bexarotene) capsules and Targretin gel 1% from Japanese drug major Eisai (TYO: 4523) for $65 million upfront, plus potential contingent payments based on certain milestones. 21 February 2013
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