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Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Boehringer Ingelheim and partners to develop gene therapy for patients with cystic fibrosis
Biotech | October 21, 2021

Boehringer Ingelheim and partners to develop gene therapy for patients with cystic fibrosis

It has exercised intellectual property options from IP Group regarding research results generated by the UK Cystic Fibrosis Gene Therapy Consortium, and from Oxford Biomedica regarding their lentiviral vector technology


U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Drug Approval | October 18, 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting


Roche’s 8-year safety data of Ocrevus shows reduced risk in multiple sclerosis patients
Biotech | October 13, 2021

Roche’s 8-year safety data of Ocrevus shows reduced risk in multiple sclerosis patients

New safety data show a consistent benefit-risk profile across all Ocrevus clinical trials


PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel
Medical Device | October 07, 2021

PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel

RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus


Merck and Ridgeback’s molnupiravir offer hope to Covid-19 patients
Biotech | October 01, 2021

Merck and Ridgeback’s molnupiravir offer hope to Covid-19 patients

If cleared, Merck's drug would be the first pill shown to treat Covid-19, a potentially major advance in efforts to fight the pandemic


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer
Drug Approval | September 28, 2021

Positive results from Lynparza with abiraterone delays Metastatic prostrate cancer

Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low


Cardiovascular devices market to grow at a CAGR of 3.9 % up to 2027
News | September 28, 2021

Cardiovascular devices market to grow at a CAGR of 3.9 % up to 2027

One of the key factors driving the market growth is the rise in the occurrence of chronic cardiovascular diseases such as heart failure and coronary artery disease: Valuates Reports


SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment
Biotech | September 26, 2021

SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment

Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors