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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
Biotechnology
US drug developer Lexicon Pharmaceutical (Nasdaq: LXRX) yesterday updated its drug development pipeline, highlighting progress with its LX4211, telotristat etiprate and other drug candidates. 21 February 2013
Biotechnology
German drug discovery firm 4SC AG (VSC: DE) says that its wholly-owned research subsidiary 4SC Discovery GmbH has entered into an extensive research partnership in the field of cancer medicines with fellow Germany-based biopharmaceutical company BioNTech AG. 21 February 2013
Pharmaceutical
Results from the StiL NHL-1 study published in the Lancet today (February 20) show that a first-line treatment regimen of bendamustine (marketed under the trade name Levact by privately-held Swiss drugmaker Mundipharma) plus rituximab (B-R) doubles progression-free survival (PFS) compared with the most often used treatment CHOP plus rituximab (CHOP-R), in newly diagnosed patients with indolent non-Hodgkin lymphoma (iNHL) and mantle cell lymphoma (MCL). 20 February 2013
Pharmaceutical
A new drug combination shows promise in reducing the risk for patients with advanced oral precancerous lesions to develop squamous cell carcinoma of the head and neck. The results of the study, which included preclinical and clinical analyses, were published in Clinical Cancer Research, a journal of the American Association for Cancer Research. 20 February 2013
Pharmaceutical
An expanding patient population will largely contribute to the growth of the market for treating breast cancer in Mexico, according to a new report from health care advisory firm Decision Resources. The number of incident cases of breast cancer will increase by nearly 40% between 2011 and 2021, mainly due to increases in population size and aging. 20 February 2013
Biotechnology
French biotech firm BioAlliance Pharma (Euronext Paris - BIO) has announced the extension of its Phase II clinical trial with Validive (clonidine Lauriad) in the USA in radio/chemotherapy-induced oral mucositis prevention in patients with head and neck cancer. 19 February 2013
Pharmaceutical
AbbVie (NYSE: ABBV), the new spin-out from Abbott Laboratories, has announced the first long-term, patient-reported health outcomes data from analyses of the Phase III IMAgINE-1 trial, reporting positive findings in pediatric patients with Crohn's disease treated with the company's blockbuster rheumatoid arthritis drug Humira (adalimumab), which generated sales of $9.26 billion in I 2012. 17 February 2013
Biotechnology
US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) yesterday announced that total revenues were $415 million in the fourth quarter of 2012 (beating consensus analysts' forecasts of $392.4 million) and $1.4 billion for the full year 2012, compared to $123 million in the fourth quarter and $446 million for the full year 2011. Total revenues included Eylea (aflibercept) US net product sales of $276 million in the fourth quarter and $838 million for the full year 2012. 15 February 2013
Pharmaceutical
The market for breast cancer therapies in the BRIC countries (Brazil, Russia, India and China) will grow 8% annually over the next five years, from $1.7 billion in 2012 to $2.5 billion in 2017, according to a new report from health care advisory firm Decision Resources. The market's growth can be attributed to the launch of several premium priced agents, a gradual increase in the use of targeted therapies and a rise in the incident population. 14 February 2013
Biotechnology
Shares of US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) leapt 16% to $2.45, when it announced results from its 70 patient open-label, randomized Phase II clinical trial of its lead investigation compound bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer, showing a 28% tumor response rate, compared with a 13% rate in patients treated with gemcitabine alone. 14 February 2013
Biotechnology
US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, says that the US Food and Drug Administration has granted Breakthrough Therapy Designations for the investigational oral agent ibrutinib as a monotherapy for two B-cell malignancies: in patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior therapy, and in patients with Waldenstrom's macroglobulinemia (WM). 14 February 2013
Pharmaceutical
German pharma major Bayer (BAYN: DE) has received notification from the US Food and Drug Administration granting priority review of the New Drug Application filed in December 2012 for the investigational oncology compound radium-223 dichloride (radium-223), formerly referred to as Alpharadin. 14 February 2013
Biotechnology
US biotech AVEO Oncology (Nasdaq: AVEO) and Japanese drug major Astellas Pharma (TYO: 4503) have announced disappointing overall survival (OS) for tivozanib, an investigational agent, from the Phase III TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study in patients with advanced renal cell carcinoma (RCC). 14 February 2013
Pharmaceutical
Swedish Orphan Biovitrum (STO: SOBI) says that it has entered into a distribution agreement with privately-held PharmaSwiss to market four products approved for the treatment of indications within the oncology, cardiovascular and anti-infective therapy areas. Financial terms of the deal were not disclosed. 13 February 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today (February 13) issued new draft guidance not recommending the use on the National Health Service of Swiss drug major Novartis' (NOVN: VX) Jakavi (ruxolitinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adults with primary myelofibrosis, or myelofibrosis secondary to polycythemia vera or essential thrombocythemiai. 13 February 2013
Generics
The Indian patent office has again ruled in favor of domestic drugmaker Cipla (BSE: 500087), reinstating its earlier decision to revoke pharma behemoth Pfizer's (NYSE:PFE) patent for kidney cancer agent Sutent (sunitinib) in India, Cipla counsel and managing partner of the law firm Singh & Singh, Prathiba Singh, told the local newspaper Business Standard. 12 February 2013
Biotechnology
Celgene Corp's (Nasdaq: CELG) European subsidiary revealed that Revlimid (lenalidomide) has been granted full approval, which includes an Import Drug License (IDL) by the China State Food and Drug Administration (SFDA) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. 12 February 2013
Biotechnology
USA-based Albany Molecular Research (Nasdaq: AMRI) has signed an exclusive license agreement with Chai Therapeutics, an affiliate of privately-held Bessor Pharma, for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer. 12 February 2013
Biotechnology
In the first-targeted therapy clinical trial for low-grade serous ovarian cancer, eight of 52 (15%) patients had a complete or objective partial response (tumor shrinkage) and 34 (65%) had no disease progression during the two-year course of the study. Results of the Phase II clinical trial, in which the drug selumetinib was evaluated by the National Cancer Institute's Gynecological Oncology Group, appear in the February edition of The Lancet Oncology. 11 February 2013
Biotechnology
The US Food and Drug Administration on Friday approved biotech firm Celgene's (Nasdaq: CELG) Pomalyst (pomalidomide) to treat patients with multiple myeloma, a form of blood cancer, whose disease progressed after being treated with other cancer drugs. The news pushed Celgene's stock up 2.4% to $100.13 by close of trading on Friday, and a further $0.17 to $100.30 in after-hours business. 11 February 2013
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