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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
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
The inventors of a new and unique cancer immunotherapy developed at Roswell Park Comprehensive Cancer Center have announced a major step forward with that therapy, known as SurVaxM. 20 November 2019
Biotechnology
In a third deal with a pharma major, US biotech firm Dragonfly Therapeutics today announced a multi-target research collaboration with AbbVie designed to advance a number of Dragonfly's novel NK cell engager-based immunotherapies for autoimmune and oncology indications. 20 November 2019
Biotechnology
Janssen has received European Commission (EC) marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT). 20 November 2019
Biotechnology
US pharma major Bristol-Myers Squibb has announced that its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has failed to meet a primary endpoint in the CheckMate -915 Phase III melanoma trial. 20 November 2019
Biotechnology
Shares of US biotech CNS Pharmaceuticals gained 4.1% to $4.33 yesterday, after revealing that it has completed an agreement with Houston Pharmaceuticals Inc (HPI) to obtain the rights to a worldwide, exclusive royalty-bearing, license for the chemical compound commonly known as berubicin. 20 November 2019
Generics
India's war on drug prices has been pushed up another notch. Given that the list of drugs under price control has steadily expanded from 74 in 1995 to nearly 860 by 2019, the prevailing mood of the government is to further bring down prices. The price of drugs used to treat cancer and cardiac issues could soon face the axe, reports The Pharma Letter’s India correspondent. 19 November 2019
Biotechnology
The market value of Myovant Sciences was up 160% within the opening minutes of trading on Tuesday. 19 November 2019
Pharmaceutical
At its November 11-14 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five novel medicines for marketing approval. 16 November 2019
Pharmaceutical
Japanese drugmaker Takeda closed 2% up on Friday in Tokyo, after the company staged an R&D showcase in New York on Thursday. 15 November 2019
Pharmaceutical
A little over five years ago, British drugmaker GlaxoSmithKline was riding high, following multiple years of strong sales and related year-on-year share price gains. 15 November 2019
Biotechnology
On Thursday, the US Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 15 November 2019
Pharmaceutical
As discussed in last month’s column, The FDA’s take on Medical Innovation, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) strives to support the innovation and development of novel drugs and biological products. 1 15 November 2019
Pharmaceutical
Growing sales in the Healthcare and Life Science business units cancelled out declines in the Performance Materials arm to keep revenue and earnings on the up at Germany’s Merck KGaA in its quarterly financial results. 14 November 2019
Biotechnology
Continuing its battle with the Japanese pharma company, US biotech Seattle Genetics today announced that it has submitted an arbitration demand to the American Arbitration Association to resolve its dispute with Daiichi Sankyo. 13 November 2019
Biotechnology
Genome editing company Editas Medicine has extended a strategic research collaboration with Celgene. 12 November 2019
Biotechnology
Japan’s NEC Corporation and Vaximm, a Swiss biotech company focused on developing oral T-cell immunotherapies, today announced the signing of a strategic clinical trial collaboration and an equity investment agreement to develop novel personalized neoantigen cancer vaccines. 12 November 2019
Pharmaceutical
Russia may start large-scale of drugs on the African continent, that may take place within the next several years, according to recent statements made by the Russian Minister of Industry and Trade Denis Manturov as a result of the recent Russia-Africa forum, reports The Pharma Letter’s local correspondent. 12 November 2019
Biotechnology
One year after achieving landmark approval in China for the first ever China-discovered and developed targeted oncology drug to receive unconditional approval (fruquintinib, for colorectal cancer), the Hong Kong-headquartered and Nasdaq-listed Chi-Med is on the way to commercializing its second China-developed drug, this time for advanced non-pancreatic neuroendocrine tumors (NETs). 11 November 2019
Biotechnology
Merck KGaA and Pfizer’s hopes of advancing their PD-L1 antibody Bavencio (avelumab) in the challenging gastric cancer space were dealt a blow by the topline results of the Phase III JAVELIN Gastric 100 study. 11 November 2019
Pharmaceutical
Last week’s noteworthy news included China’s medicines regulator, the NPMA, approving the first new Alzheimer’s therapy in 17 years, but questions are raised on Green Valley’s oligomannate. There was a series disappointment on Monday for Halozyme Therapeutics with the failure of its pancreatic cancer candidate PEGPH20. Israel’s RedHill Biopharma had good news last week with the US Food and Drug Administration approval of its Helicobacter pylori treatment Talicia, and AstraZeneca announced a major expansion of its presence in China, which is now the Anglo-Swedish pharma major’s second largest market. 10 November 2019
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