Bio/Pharma News
MilliporeSigma Invests $286 Million in US Drug Safety Testing Capacity
The $286 million investment ability is designed to elevate MillioporeSigma’s ability to conduct biosafety testing and analytical development services.
Regeneron and Cytomx Announce $2 Billion Oncology Collaboration
The collaboration will see the companies develop investigational next-generation bispecific immunotherapies for cancer.
FDA Approves Injection Designed to Delay Onset of Type 1 Diabetes
Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.
FDA Committee Recommends Ardelyx Kidney Disease Drug
Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.
Sanofi and Insilico Medicine Ink $1.2 Billion Drug Development Deal
The deal will see Sanofi use Insilico’s AI drug discovery platform to advance up to six new drug development candidates.
Indivior Acquires Opiant for $145 Million
Indivior’s acquisition of Opiant grants them access to the company’s portfolio of investigational opioid overdose reversal agent, OPNT003.
Salipro Biotech Enters into Collaboration with Sanofi
Salipro Biotech has entered into a collaboration and license agreement with Sanofi to advance discovery programs.
UK MHRA Expands Cosentyx License
The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.
FDA Publishes Draft Guidance Concerning Sameness in ANDAs
The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.
Shimadzu and UMG Göttingen Enter Analytics Collaboration
The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.
Scorpion Biological Services Opens San Antonio Biologics Facility
Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.
Gerresheimer and Nelson Labs NV Announce E&L Partnership
Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.
Merck and Veeva Ink 10-Year Partnership Agreement
Under this deal, Merck, known as MSD outside of the United States and Canada, will select Veeva products for industry-specific software and data.
J&J to Acquire Abiomed for $16.6 Billion
Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.
Lonza and Singzyme Enter Bioconjugates Partnership
Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.
Purolite and Repligen Announce Ligand Partnership
Purolite and Repligen have extended their existing ligand partnership through 2032.
Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program
FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.
FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
GSK Expands Precision Medicine Collaboration with Tempus to Accelerate R&D
Under the new collaboration with Tempus, GSK will have access to de-identified patient data to accelerate drug discovery, improve clinical trial design, and speed up enrollment.
Aragen to Invest in New Formulation Manufacturing Facility in Hyderabad, India
Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.
Recipharm to Add High-Speed Filling Line to Wasserburg Facility
Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.
Aenova and Microcaps Enter Strategic Collaboration
Aenova Group and Microcaps are partnering to enable new customized formulations for product development and life cycle management solutions.
Gilead and MacroGenics Enter $1.7 Billion Oncology Collaboration
Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.
Post-Transplant Lymphoproliferative Disease Treatment Receives Marketing Authorization Recommendation from EMA
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
EMA Announces Positive Indication for Takeda’s Dengue Vaccine
Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.
Merck and Moderna Enter $250 Million Cancer Vaccine Partnership
Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.
Alexion, AstraZeneca Acquire Genomic Medicines Company
Alexion’s acquisition of LogicBio is designed to accelerate the company’s growth in genomic medicines.
Lilly and Schrödinger Ink $425 Million Small Molecule Partnership
Eli Lilly and Company will partner with Schrödinger to develop and optimize small molecule compounds.
Amphista Therapeutics Enters Targeted Protein Degradation Partnership with Domainex
Amphista Therapeutics and Domainex will work together to develop treatments focusing on targeted protein degradation.
