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Pharmaceutical
Apalutamide is the first medicine to be registered on the Australian Register of Therapeutic Goods (ARTG) that has been evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Chemical Entities Work Sharing Pilot. 5 July 2018
Pharmaceutical
French biotech Ipsen has published full results from the Phase III CELESTIAL trial of cabozantinib, as a second-line treatment against advanced hepatocellular carcinoma (HCC). Originally presented at ASCO GI in January 2018, the data are now published in the New England Journal of Medicine (NEJM). 5 July 2018
Biotechnology
Since it first received US approval for thyroid cancer in February 2015, excitement around Eisai’s Lenvima (lenvatinib mesylate) as one of the hottest properties in oncology has steadily been growing. 4 July 2018
Pharmaceutical
French biopharma titan Sanofi indicated at its Vision In Oncology conference that the company intends to become a leading player in pharma's most crowded therapy area. 4 July 2018
Biotechnology
Celgene yesterday announced promising results from the OPTIMISMM study, a Phase III, randomized, open-label, international clinical trial of the investigational combination regimen of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one prior treatment including lenalidomide 4 July 2018
Biotechnology
East Coast, USA-based firm Athenexhas announced several key strategic deals focused on China, aimed at furthering its oncology developments. 3 July 2018
Biotechnology
US clinical-stage oncology drug developer MabVax Therapeutics has granted to Denmark-based Y-mAbs Therapeutics an exclusive sublicense to a bi-valent ganglioside based vaccine intended to treat neuroblastoma, a rare pediatric cancer. 3 July 2018
Biotechnology
French company OSE Immunotherapeutics is cracking on with its Atalante 1 Phase III trial of Tedopi for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients who have not responded to immune checkpoint inhibitors. 3 July 2018
Biotechnology
Chugai Pharma Europe, a wholly-owned subsidiary of Chugai Pharmaceutical and its majority owner Roche, has announced the hiring of Troy Robinson as managing director of its UK operations. 3 July 2018
Pharmaceutical
There was good news for Anglo-Swedish pharma major AstraZeneca and its partners, with fast-track approval from Japan’s regulator for their breast cancer and lung cancer drugs. 2 July 2018
Pharmaceutical
Last week’s clinical trial news included good and bad results. Roche’s latest data on Tecentriq was impressive in lung cancer, but Summit Therapeutics had a huge disappointment with its ezutromid in Duchenne muscular dystrophy (DMD). The US Food and Drug Administration’s approval of the first cannabinoid drug, GW Pharmaceuticals’ Epidiolex for rare forms of epilepsy caused a bit of s stir, while on the negative side, Pain Therapeutics looks set for another FDA rejection for pain drug Remoxy ER. On the M&A front, Novartis has at long last made a decision on the future of its eye care division Alcon. 1 July 2018
Pharmaceutical
Tokyo-based drugmaker Astellas Pharma has published full data from the Phase III PROSPER trial, which evaluated Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in prostate cancer. 29 June 2018
Pharmaceutical
The UK’s reimbursement agency, the National Institute for Health and Care Excellence (NICE), has loosened the purse strings for Roche’s cancer drug Alecensa (alectinib) as a first-line therapy for certain lung cancer patients. 28 June 2018
Biosimilars
As Swiss pharma giant Roche starts facing up to biosimilars competition for some of its mega-selling biological drugs, yet another copy version has emerged. 28 June 2018
Biotechnology
The US Food and Drug Administration has awarded New York-based Pfizer Priority Review designation for glasdegib, an oral smoothened (SMO) inhibitor. 28 June 2018
Pharmaceutical
Colorado, USA-based biotech firm Array BioPharma has been granted approval from the US regulator to market Braftovi (encorafenib) in combination with Mektovi (binimetinib) for certain metastatic melanoma patients. 28 June 2018
Biotechnology
Development and commercialization partners AstraZeneca and Merck & Co have clocked up a potentially important milestone with Lynparza (olaparib) that could expand its reach considerably. 27 June 2018
Biotechnology
Tilos Therapeutics, a biotech firm developing anti-LAP antibodies for the treatment of cancer, fibrosis and autoimmune diseases, today announced the appointment of Jessie English as chief scientific officer. 27 June 2018
Pharmaceutical
The US Supreme Court yesterday granted Swiss drugmaker Helsinn’s petition for certiorari to review a Federal Circuit Panel decision, holding that certain patent claims covering Aloxi (palonosetron hydrochloride) injection are not valid and are not infringed by Israeli generics drug giant Teva Pharmaceutical Industries’ generic palonosetron product. 26 June 2018
Pharmaceutical
US pharma company Merrimack Pharmaceuticals lost 44% of its value on Monday. 26 June 2018
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
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
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