Amicus Therapeutics Receives Positive CHMP Opinion for Opfolda® (miglustat) for Late-Onset Pompe Disease

European Commission Approval of Opfolda and Commercial Launch of Pombiliti® + Opfolda® Anticipated in 3Q 2023   Upon Approval, Pombiliti + O...

April 27, 2023 | Thursday | News
Roche's Columvi Gets CHMP Nod for Fixed-Duration Use in Diffuse Large B-cell Lymphoma

The recommendation is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete r...

April 27, 2023 | Thursday | Regulatory
Cytiva backs BioCina's first GMP facility for mRNA in Australia

Expanded facility to manufacture mRNA-based therapies and vaccines  Researchers at the University of Adelaide will address the design and manufacturi...

April 26, 2023 | Wednesday | News
Mass Spectrometry Explained: How LC/MS/MS Works

Triple quadrupole mass spectrometers (LC/MS/MS) are established in labs dealing with challenging matrices, as they offer very low detection limits with spe...

April 25, 2023 | Tuesday | News
Simcere Pharma on Fast Track to Becoming Innovation-Driven Global Company with Four New Drug Launches in Three Years

-The revenue from innovative drugs accounted for more than 65% of total revenue  -Simcere's total revenue and the revenue from in...

April 24, 2023 | Monday | News
Sanofi Launches AVAXIM® Junior in UK for Hepatitis A Virus Immunisation in Children

Sanofi (EURONEXT: SAN and NASDAQ: SNY) has today announced the launch of AVAXIM® Junior in the UK, an inactive hepatitis A vaccine indicated for use in...

April 24, 2023 | Monday | News
CPC Launches Biopharma's Largest Aseptic Connector

"Biopharma manufacturers continue to press the boundaries of single-use technologies (SUTs) in nearly all of their production processes, including the use ...

April 22, 2023 | Saturday | News
Daewoong Pharmaceutical and Sygnature Discovery announce drug discovery research collaboration

Daewoong Pharmaceutical has entered a research collaboration with Sygnature Discovery to expand its global open innovation for novel drug development. On ...

April 19, 2023 | Wednesday | News
HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer

Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED said, “The NMPA acceptance of our NDA for fruquintinib is a positive step towa...

April 18, 2023 | Tuesday | Regulatory
Adaptive Biotech, Takeda collaborate to measure disease with clonoSEQ® assay.

Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune sy...

April 14, 2023 | Friday | News
Initiation of New Patients on Evobrutinib Paused in the U.S.; Fully Enrolled Phase III Evobrutinib Studies Continue

Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the init...

April 14, 2023 | Friday | News
OM1 Unveils Patented, AI-powered Platform to Accelerate Personalized Medicine

OM1, a leading real-world data, outcomes and technology company with a focus on chronic conditions, today launched PhenOM™, its artificial intelligen...

April 13, 2023 | Thursday | News
ProMIS Neurosciences Announces Submission of Investigational New Drug (IND) Application for Lead Antibody PMN310

“This submission is an important milestone for the ProMIS team as we advance our lead compound, PMN310, toward the clinic. We are excited to continue...

April 11, 2023 | Tuesday | News
FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) fo...

April 09, 2023 | Sunday | News

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