media – Page 479 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Calquence tops Imbruvica in chronic lymphocytic leukaemia study

AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) hit the primary endpoint in a Phase III study in chronic lymphocytic leukaemia (CLL). In the ELEVATE-RR trial, Calquence demonstrated non-inferior progression-free survival (PFS) compared to Janssen’s BTK inhibitor Imbruvica (ibrutinib) in adult patients with previously-treated, high risk CLL – the primary endpoint of the study. AZ’s drug also met a key secondary endpoint for safety, with Calquence-treated patients demonstrating a statistically significant lower incidence of atrial fibrillation compared to patients treated with Imbruvica. In a statement, AZ added that there was also a ‘descriptive’ trend for numerically favourable overall survival for Calquence. “With over forty months of follow-up, today’s results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said José Baselga, executive vice president, Oncology R&D at AZ/ “The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence,” ...
- Source: drugdu
- 294
- January 26, 2021
Calquence
Servier and MiNA Therapeutics ink neurology pact

French pharma company Servier has entered into a research partnership with UK biotech MiNA Therapeutics to develop small activating RNA (saRNA) therapies for the treatment of neurological diseases. Under the terms of the deal, MiNA will engage its saRNA platform to identify new potential treatments with the aim of restoring normal cell function in neurological disorders. Meanwhile, Servier will be responsible for preclincial and clinical development of the lead candidates and will retain the rights for the commercialisation of any products resulting from the partnership. Although details of the specifics of the deal are sparse, the companies disclosed that MiNA would receive an upfront payment and exclusivity fee for certain ‘targets of interest’. MiNA will also be entitled to research and development, regulatory and commercial milestones and royalties. “MiNA’s innovative approach to activate gene expression through small activating RNAs is an exciting opportunity to unlock potential for the treatment of ...
- Source: drugdu
- 233
- January 25, 2021
neurology
Ridgeback Biotherapeutics’ Ebola treatment scores FDA approval

Ridgeback Biotherapeutics’ Ebanga has been approved by the US Food and Drug Administration (FDA) for the treatment of Ebola in adult and paediatric patients. Ebanga (ansuvimab-zykl), formerly mAb114, is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit in the Democratic Republic of Congo (DRC). The development of the treatment has been funded in whole or in part with funds from the US Department of Health and Human Services, as well as the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority. The PALM study conclusively demonstrated Ebanga’s safety and efficacy in a randomised controlled trial conducted during the second largest and longest Ebola outbreak in DRC history. “The devoted Ridgeback team embarked on this mission with one goal in mind – to stop the spread of Ebola and stop the devastation created by this aggressive ...
- Source: drugdu
- 275
- December 24, 2020
Ridgeback Biotherapeutics
Vicore Pharma’s C21 med shows promise in COVID-19 study

Vicore Pharma’s lead candidate drug C21 has scored some promising results in a study evaluating the medicine in hospitalised COVID-19 patients. The ATTRACT study recruited a total of 106 hospitalised patients with a confirmed COVID-19 diagnosis and signs of an acute respiratory infection without the need for mechanical ventilation. The patients were randomised to receive either oral treatment with C21 or placebo for seven days, on top of standard-of-care. In an expanded data analysis of this study, the data showed a restoration of lung function in COVID-19 patients treated with C21. In a statement, Vicore said that these results suggest “C21 can become an important complement to vaccines to combat the COVID-19 pandemic”. In a subgroup analysis of patients requiring supplemental oxygen, C21 also produced a greater reduction of C-reactive protein (CRP) compared to the placebo arm. In previously reported results, C21 treatment reduced the number of patients needing mechanical ...
- Source: drugdu
- 499
- December 23, 2020
Covid-19
Aimmune’s peanut allergy med Palforzia wins EU approval

The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm. Following the EC approval, Palforzia will be available to patients aged four to 17 years with a confirmed diagnosis of peanut allergy. It is not, however, indicated for the treatment of allergic reactions – including anaphylaxis – and must be used in conjunction with a peanut-avoidant diet. The drug can also be continued in patients aged 18 years or older, Aimmune added in a statement. The EC approval was based on a data package including two phase III clinical trials – PALISADE and ARTEMIS. Across both studies, Palforzia treatment led to a significant increase in the amount of peanut protein tolerated in participants with peanut allergy, compared to placebo. “Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, ...
- Source: drugdu
- 409
- December 22, 2020
Peanut allergy
Albireo submits rare liver disease med odevixibat to FDA and EMA

Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The US-based biopharmaceutical company has previously received fast track, rare paediatric disease and orphan drug designations for odevixibat in the US for PFIC. The drug also has orphan drug designations for the treatment for Alagille Syndrome, biliary atresia and primary biliary cholangitis. Odevixibat is a one-daily non-systemic ileal bile acid transport inhibitor (IBATi) currently being developed for the treatment of a number of rare paediatric liver diseases, such as PFIC, biliary atresia and Alagille syndrome. In a phase III trial evaluating the efficacy and safety of odevixibat in PFIC, the drug met two primary endpoints, demonstrating the ability to reduce serum bile acid responses and improve pruritus assessments with a single digit diarrhoea rate. “With randomised, placebo-controlled PEDFIC data, ...
- Source: drugdu
- 262
- December 13, 2020
Albireo
CRUK researchers develop new early-stage rectal cancer treatment

Cancer Research UK (CRUK) researchers have developed a new treatment for early-stage rectal cancer which they say could provide patients with an improved quality of life. In a pilot study of the new treatment option, which combines local keyhole surgery and radiotherapy, researchers found that they could prevent debilitating side effects such as diarrhoea and the need for a permanent colostomy bag. This study, dubbed TREC, enrolled 123 patients with early-stage rectal cancer, with 61 patients receiving the newly-developed treatment approach. In addition, 55 patients were randomised to two treatment approaches – 28 received major surgery and 27 received the new organ preserving treatment. Within the patient population who received the new treatment, 70% were treated successfully, meaning their tumour was removed while preserving the rest of their rectum and the cancer did not return during the three to five-year follow-up period. Patients who received the new treatment also reported ...
- Source: drugdu
- 697
- December 12, 2020
cancer
Janssen eyes US approval for EGFR-targeting NSCLC therapy

4th December 2020 Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab. Amivantamab is a bispecific antibody designed to target EGFR and mesenchymal epithelial transition factor (MET) mutated tumours. The FDA submission is based on results from the monotherapy arm of Janssen’s phase I CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a third generation EGFR tyrosine kinase inhibitor (TKI). An overall response rate (ORR) of 36% was observed in all NSCLC patients and 41% in patients with previously treated with platinum-based chemotherapy. In addition, the median duration of response for all evaluable patients was ten months and seven months for patients previously treated with platinum-based chemoterhapy. The median progression-free survival was 8.3 months for all patients and ...
- Source: drugdu
- 252
- December 11, 2020
NSCLC therapy
Janssen buys rights to Hemera’s eye disease gene therapy candidate

3rd December 2020 Johnson & Johnson’s pharmaceuticals division Janssen has purchased rights to acquire an investigational gene therapy asset for geographic atrophy from Hemera Biosciences. Geographic atrophy is an advance and severe form of age-related macular degeneration (AMD) which affects five million people globally. Hemera’s investigational gene therapy, HMR59, is administered as a one-time intravitreal injection to aid vision preservation in patients with geographic atrophy. HMR59 is designed to increase the ability of retina cells to produce a soluble form of CD59, a protein that protects the retina from damage. Patients with wet AMD often have low levels of this protein, which is an essential component of the body’s natural immune response. “Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & ...
- Source: drugdu
- 340
- December 9, 2020
Gene therapy
Genentech’s Gavreto scores US approval for RET thyroid cancer

4th December 2020 Roche’s Genentech division and its partner Blueprint Medicines have scored a new approval for Gavreto in the US for the treatment of RET-altered thyroid cancer. The US Food and Drug Administration (FDA) has cleared Gavreto (pralsetinib) for the treatment of adult and paediatric patients with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancer. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. This newest approval is based on results from the phase I/II ARROW study, in which treatment with Gavreto led to an overall response rate (ORR) of 60% in 55 people with previously-treated RET-mutant metastatic medullary thyroid cancer (MTC). In addition, Gavreto treatment led to an ORR of 66% in 29 people with RET-mutant advanced MTC who had not been previously treated with cabozantinib and vandetanib. Around 10-20% of people with papillary thyroid cancer have RET-fusion positive ...
- Source: drugdu
- 336
- December 8, 2020
RET thyroid cancer

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.