Biopharma News
Sandoz to Build New Biologics Production Facility in Slovenia
Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.
Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies
The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.
Pfizer to Acquire Seagen in $43 Billion Blockbuster Deal
Pfizer will acquire all outstanding shares of Seagen for a total of $43 billion.
Sumitovant Acquires Myovant for $1.7 Billion
Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.
Biotech Companies Deal with Silicon Valley Bank Collapse
Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.
Catalent Expands UpTempo AAV Platform
Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.
Merck Releases Data on Rare Blood Vessel Disorder Treatment
Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.
Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone
Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.
Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35
Lilly will cap insulin prices for patients with and without insurance at $35 per month.
AstraZeneca Strikes $1.16 Billion Licensing Deal for Gastric Cancer Candidate
AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.
Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA
Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.
Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden
Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.
Moderna and Life Edit Therapeutics Enter Gene Editing Collaboration
Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.
FDA Approves Sanofi Hemophilia Treatment
Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.
AbbVie and Capsida Strike $674 Million Gene Therapy Development Deal
AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.
Predictive Oncology and Cvergenx Enter Genomics-Based Personalized Therapy Collaboration
The goal of this collaboration is to develop an approach to personalized radiotherapy and drug discovery that is based in genomics and artificial intelligence.
FDA Approves First Treatment for Geographic Atrophy
Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.
LIfT BioSciences and Minaris Regenerative Enter Cell Therapy Partnership
LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.
GenScript PrioBio and Bio Immunitas Announce Platform Collaboration
GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.
Charles River Launches Novel IgY-based ELISA Kit
The kit is meant for use for the detection and quantitation of residual host cell protein.
Roche Reports Positive Data for Rare Blood Condition Treatment
Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.
Thermo Fisher Scientific Collaborates to Introduce Fully Automated Cell Line Automation Platform
Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.
BioNTech Strengthens Manufacturing Capabilities with First In-house Plasmid DNA Manufacturing Facility
The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.
Thermo Fisher Scientific Announces Founding Sponsorship of Momentum Labs
Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.
Gerresheimer Presents New Clinical Trial Kit at Pharmapack
Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.
Scientific Laboratory Supplies Acquires C&M Scientific
Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.
Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement
deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.
USPTO Issues Notice of Allowance for Zika Vaccine Patent
The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.
FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug
In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.
