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Bioiberica Obtains CSR Management System Certification Aligned with UN Sustainable Development Goals
Bioiberica has received certification of its CSR management system as aligned with the United Nations Sustainable Development Goals.
University of Sheffield and CGT Catapult Launch Innovative Gene Therapy Program
The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.
Analysis Demonstrates No Increased Incidence of Thrombosis with TTS After Vaxzevria Second Dose
A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.
Sanofi Acquires Translate Bio for $3.2 Billion
Sanofi has acquired Translate Bio in a bid to further their mRNA research.
CMA Fines Advanz for Over-Pricing Liothyronine Tablets
CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.
FDA Approves Expanded Label of Allergan’s Botox to Treat Upper Limb Spasticity
FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.
Nitric Oxide Nasal Spray for COVID-19 to Be Distributed to India and Other Asia Markets
Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.
Janssen Collaborates with BioMedX in Autoimmunity and Drug Delivery Research
BioMed X Institute and Janssen Research & Development to start two new research programs in the field of autoimmune diseases and drug delivery.
FDA Approves AstraZeneca’s Lupus mAb, Saphnelo
FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.
FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases
FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.
EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment
The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
DisperSol and Catalent Announce Manufacturing Collaboration
DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.
FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment
The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.
FDA Approves Interchangeable Biosimilar Insulin
FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.
Regeneron and AstraZeneca Partner to Create Small-Molecule Obesity Drug
Regeneron and AstraZeneca have entered an agreement to create a small-molecule medicine designed to treat obesity.
FDA Approves GSK’s Treatment for Chronic Rhinosinusitis with Nasal Polyps
GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.
Drug Pricing Scrutiny Increases in Europe
Excessive drug pricing is being scrutinized across Europe, as hefty fines are set to send out a clear message of intolerance to anti-competition conduct.
FDA Inspections Back on Track?
Congress questions FDA on plans to catch up and move forward with facility inspections.
FDA’s Pazdur Challenges Attack on Accelerated Approval Program
The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.
CMOs and CDMOs Adjust to Pandemic Response and Beyond
Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.
FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing
Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.
18th Annual CPhI Pharma Awards to Take Place in Milan, Italy
Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.
FDA Grants Orphan Drug Designation to VICO Therapeutics for Huntington’s Disease Drug
VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.
New Drug Approvals on Track at FDA
In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.
Thermo Fisher Expands Hematology Oncology NGS Portfolio
Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.
CHMP to Assess Extended Indication of Kineret for COVID-19
Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.
EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine
EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.
ERS Genomics Adds Japan SLC to List of Partners
ERS Genomics and Japan SLC have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ CRISPR/Cas9 patent portfolio.
Byondis and Glycotope Partner on Discovery and Development of Glyco-Epitope-Targeting Antibodies
Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.
