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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
Pharmaceutical
Promacta (eltrombopag), a drug from Swiss pharma giant Novartis that is marketed as Revolade in most countries outside the USA, has had its label expanded by the US Food and Drug Administration (FDA). 19 November 2018
Pharmaceutical
Clinical trials news last week included Amarin’s presentation of new data on its Vascepa, showing strong cardiovascular risk reduction which caused controversy. Also, Merrimack announced that it would discontinue its cancer drug MM-121 following disappointing results, and AstraZeneca suffered a setback with another MYSTIC trial of lung cancer drug Imfinzi. On the deal making front, AstraZeneca featured as it continues to sell off non-core assets, this time its respiratory drug Synagis to Swedish Orphan Biovitrum (Sobi), while Arena Pharmaceuticals inked a licensing deal with United Therapeutics for its pulmonary arterial hypertension (PAH) drug ralinepag worth a potential $1.2 billion. 18 November 2018
Biotechnology
Hutchison China MediTech (AIM: HCM) lost 19% of its market value on Friday following the Phase III failure of a drug that has just been approved to treat advanced colorectal cancer. 16 November 2018
Pharmaceutical
Shares in Seattle Genetics are up nearly 5% and climbing today after the firm announced a new approval for Adcetris (brentuximab vedotin), shortly after revealing the US regulator had granted the therapy Breakthrough Designation in the same indication. 16 November 2018
Pharmaceutical
The European Medicines Agency’s Committee for Products for Human Use (CHMP) recommended four medicines for approval, including one for use in countries outside the European Union, at its November 2018 meeting, as well as two re-examinations and four indication extensions. 16 November 2018
Pharmaceutical
Seattle Genetics has been given Breakthrough Designation from the US Food and Drug Administration for Adcetris (brentuximab vedotin) for certain peripheral T-cell lymphomas (PTCL). 16 November 2018
Biotechnology
In an Expert View column, Stephen Bennett (pictured) and Mary Foord-Weston, from UK-based law firm Hogan Lovells, consider the questions that new oncology treatments raise around the current intellectual property (IP) system. 16 November 2018
Biotechnology
Swedish biotech Immunicum has announced a collaboration to test its lead product, ilixadencel, an off-the-shelf cell-based cancer immune primer, alongside the anti-PD-L1 monoclonal antibody, Bavencio (avelumab). 16 November 2018
Biotechnology
The UK’s National Health Service (NHS) will pay for eligible English children and young people with pediatric acute lymphoblastic lymphoma (ALL) to be treated with Novartis’ CAR-T therapy Kymriah (tisagenlecleucel). 16 November 2018
Biotechnology
German family-owned drugmaker Boehringer Ingelheim and Epizyme today announced a new global collaboration which could be worth more than $300 million. 15 November 2018
Biotechnology
In a second deal within a matter of weeks, privately-held Cambridge, USA-based Dragonfly Therapeutics has entered into a new agreement with Celgene to discover, develop and commercialize innovative immunotherapies for patients with solid and hematological cancers. 15 November 2018
Biotechnology
Following the recent spate of approvals in both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), the treatment landscape is becoming increasingly difficult to navigate for both physicians and patients, highlighting the need for better education, access, and infrastructure to support physicians’ and patients’ choices of the optimal therapies. 15 November 2018
Pharmaceutical
German science and tech company Merck KGaA was trading nearly 4% higher late on Wednesday as markets digested its third-quarter financial results. 14 November 2018
Pharmaceutical
Bayer’s Stivarga (regorafenib) will be subject to a new trial run by The Global Coalition for Adaptive Research (GCAR), called GBM AGILE. 14 November 2018
Biotechnology
Merck & Co’s Keytruda (pembrolizumab) has now been approved in a remarkable 14 indications. 12 November 2018
Pharmaceutical
Big things are happening in oncology at the moment. Considering all stages of clinical development, there are thought to be up to 8,000 anticancer candidates being tested by drugmakers globally. 12 November 2018
Pharmaceutical
The Chinese subsidiary of Japan’s Eisai has launched the kinase inhibitor Lenvima (lenvatinib mesylate) in China. 12 November 2018
Pharmaceutical
Although the glioblastoma (GBM) treatment market is small with many unmet needs, it is expected to grow from $662.0 million in 2017 to $1.4 billion in 2027 across the eight major markets (8MM) at a compound annual growth rate (CAGR) of 7.5%. 12 November 2018
Pharmaceutical
Food and Drug Administration decisions of note last week included approval of AcelRx’ opioid analgesic Dsuvia but rejection of Trevena’s Olinovo (oliceridine) and also approval of Pfizer’s Lorbrena, which puts the company all along the continuum for ALK-positive lung cancer. On the political front, US mid-term elections resulted in a split Congress, which has implications for the pharma industry. Among deal-making news, it seems that Nektar has convinced another big pharma – Pfizer –on the promise of its cancer immunotherapy NKTR-214. 11 November 2018
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca is calling for a change of heart at England’s medicines cost regulator after it failed to consider its cancer drug Lynparza (olaparib) as cost-effective. 9 November 2018
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