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Vertex launches phase 3 trials of VX-445/Tezacaftor/Ivacaftor combo in cystic fibrosis
Vertex Pharmaceuticals has initiated two phase 3 studies of VX-445, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF).
Contract Research & Services > Clinical Trials > News
Endo to buy Somerset Therapeutics for $190m
Endo International has agreed to acquire New Jersey-based Somerset Therapeutics, that develops and markets sterile injectable and ophthalmic drugs, and the business of its India-based affiliate Wintac, which operates as Somerset's contract developer and manufacturer.
Production & Manufacturing > Manufacturing > News
ValiRx secures EU patent grant for VAL201 prostate cancer treatment
By PBR Staff Writer
ValiRx has secured a patent grant from the European Union (EU) for its prostate cancer treatment, VAL201, which is currently under clinical studies.
Regulatory Affairs > News
ADC Therapeutics terminates ADCT-502 program targeting HER2 expressing solid tumors
ADC Therapeutics (ADCT) has terminated the phase I clinical trial to assess its antibody drug conjugate (ADC) ADCT-502 in patients with advanced solid tumors with HER2 expression.
Contract Research & Services > Clinical Trials > News
Corvidia Therapeutics raises $60m funding to speed up clinical work
Corvidia Therapeutics has secured $60m in a Series B funding round to accelerate growth of its ongoing clinical programs, expand scientific and market access capabilities and explore new treatment areas.
Drug Research > Drug Discovery & Development > News
AbbVie seeks US approval for psoriasis drug risankizumab
By PBR Staff Writer
AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration seeking approval of risankizumab for the treatment of moderate to severe plaque psoriasis.
Production & Manufacturing > Process & Production > News
FDA expands GSK’s Trelegy Ellipta indication in COPD
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.
Regulatory Affairs > News
AstraZeneca’s lung cancer combo fails in phase III trial
AstraZeneca’s lung cancer combo of Imfinzi (durvalumab) plus tremelimumab has failed to deliver desired results in a phase III trial, called ARCTIC, in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who had more than two prior treatments.
Contract Research & Services > Clinical Trials > News
Shire considers Takeda's revised £46bn takeover offer
By PBR Staff Writer
Shire’s board said that it is willing to recommend Takeda Pharmaceutical’s revised acquisition offer of £46bn to its shareholders.
Production & Manufacturing > Manufacturing > News
Prothena scraps development of AL amyloidosis drug
By PBR Staff Writer
Prothena is stopping the development of AL amyloidosis treatment NEOD001 following unfavorable results in the phase 2b Pronto study.
Contract Research & Services > Clinical Trials > News
Celgene expands bispecific antibody collaboration with Zymeworks
Zymeworks said that Celgene has exercised its right to expand its collaboration agreement for the research, development, and commercialization of bispecific antibody therapeutics using the former’s Azymetric platform.
Drug Research > Drug Discovery & Development > News
Scientists develop new method to make drugs smarter
Scientists from the University of Lincoln in the UK have created a new technique using nanotechnology which can make drugs more effective at reaching their target.
Drug Research > Drug Discovery & Development > News
Pfizer biosimilar of Roche's cancer drug fails to get FDA approval
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to approve Pfizer’s proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab) and asked for more technical information.
Regulatory Affairs > News
Biogen to pay Ionis $1bn for neurological drugs development
By PBR Staff Writer
Biogen has entered into a new ten-year collaboration agreement with Ionis Pharmaceuticals for the development of antisense drug candidates to treat a range of neurological diseases.
Drug Research > Drug Discovery & Development > News
Alnylam signs settlement agreement with Dicerna to resolve trade secret misappropriation claims
Alnylam Pharmaceuticals has entered into a settlement agreement with Dicerna Pharmaceuticals to resolve trade secret misappropriation claims against Dicerna, and counterclaims asserted by Dicerna, in pending litigation in the Superior Court of Middlesex County, Massachusetts.
Regulatory Affairs > News
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