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FDA Regulation of Nonprescription Drugs in Spotlight
Application for OTC contraceptive highlights efforts to broaden access to medicines.
Merck Digital Sciences Studio Supports Early-Stage Startups
Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.
Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA
Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.
Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center
Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.
Coya Therapeutics Secures Rights to Exosome Engineering Technology from Carnegie Mellon University
Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.
Bio-Rad Launches CFX Opus Deepwell Real-Time PCR Detection System
Bio-Rad’s CFX Opus Deepwell Real-Time PCR Detection System is designed to support researchers in developing nucleic acid detection assays.
Bio-Rad Launches New Chromatography Column Packs
Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.
FDA Drug Regulation Challenged by Anti-Abortion Campaign
Some states look to block access to approved drugs.
US Government to Support Expansion of Croda Lipid Systems Capability
Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.
VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies
VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.
LG Chem Renews License with Avacta for IND Studies
LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.
FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.
Getinge Launches New DPTE-EXO with Sleeveless DPTE-BetaBag for Aseptic Transfer
Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.
Ipsen Expands Oncology Portfolio with $247 Million Epizyme Acquisition
Ipsen will acquire Epizyme, who recently had their lead medicine Tazverik (tazemetostat) approved by FDA for treatment of relapsed or refractory follicular lymphoma.
Inceptor Bio Collaborates with University of Minnesota to Develop Cell Therapy Platform
Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.
MilliporeSigma to Supply Lotte Biologics with Biologics Manufacturing Capabilities in US
MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.
Avantor Partners with GeminiBio on Custom Hydrated Solutions and Cell Culture Media
Under the collaboration, Avantor and GeminiBio will offer custom cGMP solutions to enhance process efficiency and accelerate speed-to-market of novel emerging therapy modalities.
Cosentyx Receives Expanded Approvals in EU for Use in Childhood Arthritic Conditions
The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.
Xenpozyme Approved by EC for the Treatment of ASMD
The European Commission has approved Xenpozyme as the first treatment for ASMD.
FDA Releases Action Plan for Rare Neurodegenerative Diseases
The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.
MilliporeSigma Intensifies Upstream Processing with New BioContinuum Seed Train Platform Offering
MilliporeSigma’s new BioContinuum Seed Train Platform offering enables a fully closed bioprocessing environment for both fed-batch and perfusion N-production.
Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation
Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.
ImmunoGen Partners with Oxford BioTherapeutics to Develop Novel ADCs
ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.
First Successful Efficacy Study Against Omicron With COVID-19 Vaccine
The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.
Pierre Fabre and Lonza Enter Manufacturing Agreement
Lonza will produce drug product for Pierre Fabre’s monoclonal antibody W0180.
Echosens and Novo Nordisk Announce Partnership to Combat NASH
The partnership between Echosens and Novo Nordisk is intended to increase awareness and early diagnosis of non-alcoholic steatohepatitis (NASH).
MHRA Updates Guidance on Handling of Approved or Pending DCP and MRP
The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.
Novartis to Invest $250 Million for R&D of Neglected Tropical Diseases
Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D.
GSK Announces £1 Billion R&D Investment in Fighting Infectious Diseases in Lower-Income Countries
GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.
Kindeva Drug Delivery Completes Acquisition of iPharma Labs
Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.