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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
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
The National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending Perjeta (pertuzumab), from Swiss pharma giant Roche, to treat HER2-positive breast cancer because it is uncertain how the responses to treatment seen in the clinical trials translate into long term benefits for patients. 20 May 2016
Pharmaceutical
China's health authority on Friday announced cuts of over 50% in the prices of three patent drugs, reports the state news agency Xinhua. 19 May 2016
Biotechnology
Swiss pharma giant Novartis has been advised to stop its Phase III trial of LEE011 (ribociclib) for advanced breast cancer as it met the primary endpoint. 19 May 2016
Biotechnology
The US Food and Drug Administration has granted accelerated approval to Tecentriq (atezolizumab injection) from Genentech, for the treatment of a specific type of bladder cancer. 19 May 2016
Biosimilars
Polish biotechnology company Mabion believes it is a leading contender to win the race for the global rituximab market. 19 May 2016
Pharmaceutical
Patients with metastatic colorectal cancer are more likely to survive if their tumor originates on the left-side of the colon versus the right, a study has revealed. 19 May 2016
Biotechnology
Cancer diagnostics and personalized medicines specialist ValiRx has started manufacturing its lung cancer drug VAL401 ahead of a Phase II trial. 19 May 2016
Pharmaceutical
Stem cell transplant should remain the preferred treatment for patients with multiple myeloma aged 65 and under, according to a new study. 18 May 2016
Biotechnology
Merck & Co’s Keytruda improves long-term survival rates in newly diagnosed and previously treated patients with advanced melanoma and might even offer a complete cure, according to the results of an early-stage study. 18 May 2016
Pharmaceutical
Anglo-Swedish company AstraZeneca has announced that its cancer drug Lynparza (olaparib) in combination with paclitaxel chemotherapy has failed to increase overall survival (OS) in patients with advanced gastric cancer. 18 May 2016
Generics
ANI Pharmaceutical has signed an exclusive distribution and supply agreement with South Africa’s Aspen Pharmacare for hydroxyprogesterone caproate Injection. 18 May 2016
Biotechnology
The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for to treat relapsed chronic lymphocytic leukemia (CLL) patients. 18 May 2016
Pharmaceutical
Olmutinib (BI 1482694/HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). 18 May 2016
Pharmaceutical
The US Food and Drug Adminstration has approved Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for patients with a rare blood cancer, marking the first approval of a PD-1 inhibitor in a hematological malignancy. 18 May 2016
Pharmaceutical
Germany’s Merck KGaA and Pfizer’s Phase III JAVELIN Renal 101 trial, which will assess the combination of the checkpoint inhibitor avelumab and Pfizer’s anti-angiogenesis tyrosine kinase inhibitor (TKI) Inlyta (axitinib) in the first-line renal cell carcinoma (RCC) setting, is the most likely immunotherapy combination to be first to market in the treatment space, says an analyst. 18 May 2016
Pharmaceutical
Novartis late yesterday announced major changes to focus its Pharmaceuticals Division by creating two business units reporting to the chief executive: Novartis Pharmaceuticals and Novartis Oncology. 18 May 2016
Pharmaceutical
US-based Aduro Biotech lost almost a third of its share price on Monday after missing the primary endpoint in its trial of CRS-207, a treatment that was being evaluated alone, and alongside GVAX Pancreas, for pancreatic cancer. 17 May 2016
Biotechnology
US drugmaker AbbVie has announced that its oral B-cell lymphoma-2 (BCL-2) inhibitor venetoclax has shown high overall response rates in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) with 17p deletion. 16 May 2016
article
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new and updated data investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in more than 15 types of cancer will be presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016. 16 May 2016
Pharmaceutical
New research from the Canadian Cancer Trials Group (CCTG) has discovered that a new subset of patients with metastatic colorectal cancer could benefit from taking the drug cetuximab, reports EurekAlert. 16 May 2016
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