Bio/Pharma News
Merck and MPP Enter Into License Agreement for Investigational Oral Antiviral COVID-19 Medicine
Merck’s agreement with the Medicines Patent Pool (MPP) aims to facilitate affordable global access for molnupiravir.
Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children
Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.
Pfizer and BioNTech Release Phase III Trial Data Supporting Efficacy of Booster Doses
Pfizer and BioNTech’s Phase III trial demonstrated 95.6% booster efficacy relative to participants who received placebo.
Bristol Myers Squibb Receives European Commission Approval for Opdivo
The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.
Cellectis Opens GMP Manufacturing Facility
A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.
Crystec, Biosidus Collaborate on Enhanced Delivery and Performance of Biotherapeutics
Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.
FDA Amends EUA to Allow Booster Shots for Moderna, J&J COVID-19 Vaccines
In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.
Jones Healthcare Group is Awarded EcoVadis Silver-Medal Ranking
The silver-medal ranking is given to companies who demonstrate sustainability practices that place them in the top 20% of companies rated by EcoVadis.
Aptar CSP Technologies Receives $19 Million Government Contract
The $19 million contract will expand production capacity of Aptar’s Activ-Film technology, which is used in COVID-19 testing kits.
FDA Approves Cyltezo as Interchangeable Biosimilar with Humira
Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.
Bionano Genomics Acquires BioDiscovery Inc. for $100 Million
This acquisition grants Bionano access to BioDiscovery’s clinical software solution for variant analysis.
Intellia Therapeutics and SparingVision Announce Strategic Collaboration to Develop Novel Ocular Therapies Using CRISPR/Cas9 Technology
The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.
FDA Approves Rethymic for Pediatric Congenital Athymia
Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.
Element Strengthens US Presence with Nanosyn Acquisition
Element’s acquisition of Nanosyn is the latest in a series of moves made to strengthen the company’s North American presence.
MHRA Awards ‘Innovation Passport’ to CellResearch for Stem Cell Therapy
MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.
Pacira BioSciences Acquires Flexion Therapeutics for $630 Million
Pacira’s acquisition grants them access to Flexion’s pain management portfolio.
AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint
AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.
Supernus to Acquire Adamas Pharmaceuticals in $400 Million Deal
Supernus will acquire Adamas’ Parkinson's disease treatment portfolio through a $400 million acquisition.
FDA Approves ChemoCentryx’s Tavenos
The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
FDA Grants AstraZeneca's Tezepelumab Orphan Drug Designation
AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.
Pfizer Agrees to License Agreement with Voyager Therapeutics
Pfizer may pay up to $630 million for access to Voyager’s novel AAV capsids in transgene research.
Pfizer, BioNTech Request EUA for COVID-19 Vaccine in Children Aged 5-11
Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.
Application for COVID-19 Treatment Submitted to EMA
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.
Sunovion, Sumitomo Dainippon, and Otsuka Enter Development and Commercialization Collaboration
The collaboration between Sunovion, Sumitomo Dainippon, and Otsuka will focus on four compounds designed to treat neuropsychiatric health conditions.
Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%
Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.
Selecta Biosciences and Takeda Announce Gene Therapy Platform Licensing Agreement
Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.
“Waive Vaccine Patents” is Projected onto Hotel Hosting UK’s Annual Conservative Conference
Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.
AstraZeneca Acquires Caelum Biosciences
AstraZeneca’s acquisition of Caelum Biosciences gives them access to CAEL-101, a promising light chain amyloidosis treatment.
Merck Acquires Acceleron for $11.5 Billion
Merck’s 11.5 billion acquisition of Acceleron gives them access to their lead therapeutic candidate, sotatercept.
REGEN-COV Shows Promising Results in Hospitalized COVID-19 Patients
Rengeron’s trial found that REGEN-COV significantly reduced viral load of patients with COVID-19.