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1139 News Found

Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding
News | May 19, 2022

Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding

A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study


Synexa Life Sciences acquires Finnish CRO Syrinx Bioanalytics
News | May 19, 2022

Synexa Life Sciences acquires Finnish CRO Syrinx Bioanalytics

Expansion of leading biomarker and bioanalysis company enhances bioanalytical solutions for targeted radiopharmaceuticals


WHO validates Convidecia vaccine for Covid-19
News | May 19, 2022

WHO validates Convidecia vaccine for Covid-19

The vaccine was found to have 64% efficacy against symptomatic disease and 92% against severe Covid-19


Piramal Pharma Solutions new API plant in Canada goes online
Biotech | May 19, 2022

Piramal Pharma Solutions new API plant in Canada goes online

It is part of the company's CAD $30 million capital investment in the Aurora, Canada site


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series


BDR Pharma receives Rs. 685 crore of PE investment
News | May 17, 2022

BDR Pharma receives Rs. 685 crore of PE investment

Multiples is the first private equity (PE) investor in the company


Boehringer Ingelheim’s treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis
Biotech | May 16, 2022

Boehringer Ingelheim’s treatment slowed lung function decline in people living with idiopathic pulmonary fibrosis

Potential new treatment for progressive pulmonary fibrosis (PPF) builds on Boehringer Ingelheim’s leadership in lung fibrosis and will be further investigated in a phase III clinical trial program


AbbVie and Cugene announce collaboration in autoimmune diseases
News | May 16, 2022

AbbVie and Cugene announce collaboration in autoimmune diseases

AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology


Tirzepatide has potential to drive weight loss market dramatically, observes GlobalData
Biotech | May 15, 2022

Tirzepatide has potential to drive weight loss market dramatically, observes GlobalData

Tirzepatide is primarily indicated for the treatment of T2D and is expected to receive its decision from the FDA in Q2 2022


LOTTE to purchase Bristol Myers Squibb manufacturing facility in East Syracuse, New York
News | May 14, 2022

LOTTE to purchase Bristol Myers Squibb manufacturing facility in East Syracuse, New York

East Syracuse site to serve as the LOTTE Center for North America Operations for LOTTE’s biologics contract development and manufacturing organization (CDMO) business