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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.
Working Towards Zero Emissions
Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.
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.
Summa Equity Acquires Majority Stake in Axion BioSystems
Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.
908 Devices and Transcenta Partnership Leads to Workflow Innovations
Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.
Artificial Intelligence Facilitates Empty Well Detection
Through a partnership with the University of Hertfordshire, Ziath discovers means of using AI to detect empty wells in sample tube racks.
J.T.Baker Robotic Tips from Avantor Offer Precision Workflow
Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.
FDA Under Pressure to Restore “Normal” Drug Inspections
FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.
