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Pharmaceutical
As we soon head into the first-quarter financial results reporting period, German family-owned pharma major Boehringer Ingelheim came to the fore, reporting its achievements for 2016. Also in the news were positive late-stage clinical results for Paratek Pharmaceuticals’ omadacycline, Astellas Pharma’s buy of Belgian firm Ogeda, lack of investor excitement despite a US approval for Teva Pharmaceutical Industries Huntington’s drug and questions over Tesaro’s PARP inhibitor. 8 April 2017
Biotechnology
US-based biotech firm IsoPlexis has presented findings from research using the company’s precision engineering platform, called IsoCode. 7 April 2017
Biotechnology
Australian biotech firm Novogen has announced it will not continue development of its preclinical program ATM-3507 (anisina), causing stocks to tumble more than 20%. 7 April 2017
Pharmaceutical
Japanese drugmaker Takeda Pharmaceutical has announced that it has entered into an agreement to hive off a newly-established wholly-owned subsidiary, which will be called Takeda Development. 7 April 2017
Biotechnology
APAC Biotech has been granted with a commercial license by India’s Central Drugs Standard Control Organization (CDSCO) to market product, Apcedene, a dendritic cell-based autologous Immuno-oncology product for four cancer indications. 5 April 2017
Biotechnology
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to extend the use of Opdivo (nivolumab). 5 April 2017
Pharmaceutical
Heptares Therapeutic says it has achieved an important milestone in its immuno-oncology collaboration with AstraZeneca, which is focused on the development of AZD4635 (HTL-1071) as a potential new treatment for a range of cancers. 5 April 2017
Biotechnology
The Chinese biopharma startup Ascentage Pharma, which focuses on developing apoptosis -targeted small-molecule therapeutics, is likely to be the next Chinese target in the US market as soon as in this year, notes The Pharma Letter’s correspondent Wang Fangqing. 4 April 2017
Biotechnology
Amgen has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for Xgeva (denosumab). 4 April 2017
Biotechnology
The Phase III ALUR study met its primary endpoint, demonstrating that Alecensa (alectinib) significantly improved progression-free survival (PFS) in people with anaplastic lymphoma kinase (ALK)-positive advanced (metastatic) non-small cell lung cancer (NSCLC) who had progressed following treatment with one prior line of both platinum-based chemotherapy and crizotinib, compared with chemotherapy. 3 April 2017
Biotechnology
Bristol-Myers Squibb’s week started on a high note as the latest data on its immune-oncology asset Opdivo (nivolumab) sent the company’s share price up by 1% to $54.88 in the first hour of trading. 3 April 2017
Pharmaceutical
Swiss pharma giant Novartis has received EU approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib) in non-small cell lung cancer (NSCLC). 3 April 2017
Pharmaceutical
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib). 3 April 2017
Pharmaceutical
Most of the headline grabbing news last week focussed on approvals of new medicines and some exciting clinical trial results. Among these were the approvals of Roche’s Ocrevus for multiple sclerosis, Tesaro’s Zejula for treatment of recurrent ovarian cancer and Sanofi’s Dupixent for atopic dermatitis. Also stirring interest was clinical data on Vertex’ combination of tezacaftor and ivacaftor. 2 April 2017
Biotechnology
Additional details have been announced of the clinical development program investigating the combination of epacadostat, Incyte Corp’s investigational oral selective IDO1 enzyme inhibitor, with Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy. 31 March 2017
Biotechnology
French cancer-focused drug developer Erytech Pharma has announced positive topline results from its Phase IIb clinical study evaluating Graspa (eryaspase) in combination with chemotherapy for second-line metastatic pancreatic cancer. 31 March 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has fully approved AstraZeneca’s non-small cell lung cancer (NSCLC) treatment Tagrisso (osimertinib), the company announced today. 31 March 2017
Pharmaceutical
UK-based Mundipharma has received the green light from Japanese regulators to market Mundesine (forodesine hydrochloride), the first regulatory approval for the novel therapy. 30 March 2017
Biosimilars
International expansion and bringing affordable biosimilars to patients are two of the stated aims of privately-held Russian biotech company Biocad, and the company has taken a step forward on both fronts with news on one of its products. 30 March 2017
Biotechnology
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous injection was favorable for the treatment of certain blood cancers. 30 March 2017
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
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
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