News

The new LabVantage Enterprise SaaS adds full configurability and custom interfacing capabilities.

NewAge Industries has completed a plant expansion that added new cleanrooms to its headquarters in Southampton, Pa.

Gyros’ new titer kit identifies adeno-associated virus serotype 9 in vector-based cell and gene therapy manufacturing.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.

FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.

USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.

CuriRx’s CuriLytics platform is a mass spectrometry instrument that will support complex biotherapeutics development.

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

KSL Biomedical announced their expansion into Canada with the acquisition of Pulse Scientific and the incorporation of KSL Biomedical Canada.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

Biden outlines a plan to end the pandemic in a virtual global conference.

GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

The first part of the 2021 CPhI Annual Report has been published and predicts a strong outlook for CDMOs over the next few years.

The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS).

ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

The research collaboration between AstraZeneca and VaxEquity aims to discover and develop self-amplifying RNA therapeutics.

The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.

Celularity and Oncternal’s collaboration will focus on therapeutics targeting Orphan Receptor 1, which is linked to aggression and survival in solid tumor cells.

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

Novartis’ acquisition of Arctos Medical could lead to significant advancements in optogenetic therapies for patients with vision loss.

Metrion’s new 12,000 ft² headquarters will significantly expand its range of services and cell lines.