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Merck KGaA Acquires CDMO Exelead
The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.
Pfizer and Acuitas Therapeutics Collaborate on Lipid Nanoparticle Delivery System
The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.
Novartis and Alnylam Announce Liver Therapy Collaboration
The collaboration will leverage Alynlam’s proprietary small interfering RNA (siRNA) technology to inhibit a target discovered by Novartis.
FDA Grants Oncolyze Orphan Drug Designation for Leukemia Treatment
FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).
Bio-Rad Introduces SARS-CoV-2 Variant Neutralization Antibody Assays
Bio-Rad’s new assays are designed to measure neutralizing antibodies against wild-type and significant variants of COVID-19.
FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine
FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.
FDA Accepts IND for Poseida Therapeutics’ Allogeneic CAR-T Cell Therapy Candidate
FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.
Insightful Science Completes Acquisition of Protein Metrics
The acquisition of Protein Metrics expands Insightful Science’s R&D solutions to include proteomics.
AstraZeneca and Neurimmune Ink Collaboration Deal Worth Up to $760 Million
Neurimmune will receive up to $760 million for NI006, an investigational human monoclonal antibody in development for the treatment of transthyretin amyloid cardiomyopathy.
Piramal Pharma Invests Minority Stake in India-Based CDMO, Yapan Bio
With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.
FDA Keeps New Drugs Coming
FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.
New High Fidelity CRISPR Cas9 Protein Reduces Off-Target Effects
Thermo Fisher Scientific’s Invitrogen TrueCut HiFi Cas9 Protein offers the advantage of significantly minimizing off-target events while aiming to retain maximum on-target editing efficiency.
OpenEye Scientific and Specifica Partner to Launch Orion Antibody Discovery Suite
The partnership between OpenEye Scientific and Specifica has generated AbXtract, an antibody discovery model that is included in the Orion Antibody Suite.
FDA Expands Use of Pfizer-BioNTech COVID-19 Vaccine
The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.
Here Come the COVID-19 Treatment Options
FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.
Moderna Releases New Vaccine Data Concerning Omicron Variant
Moderna’s vaccine is weaker against the Omicron variant, but boosters can increase neutralizing antibody levels by as much as 83-fold.
Sanofi Acquires Amunix Pharmaceuticals for $1 Billion
Sanofi’s acquisition will grant access to Amunix's promising immuno-oncology pipeline.
FDA Approves AstraZeneca and Amgen’s Tezpire
Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.
EMA Recommends Conditional Authorization for Novavax’s COVID-19 Vaccine
The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.
Amgen Extends Collaboration with Syngene International
Amgen and Syngene International have extended their research collaboration to 2026.
Genezen Starts Up Operations at Lenti- and Retroviral Vector Process Development Lab
Genezen has opened its new process development and analytical lab for viral vector production.
Asahi Kasei Medical Acquires Bionique
Bionique Testing Laboratories has been acquired by Asahi Kasei Medical and will join the company’s biosafety testing services unit.
FDA Approves American Regent’s Injectafer for Pediatric Patients
FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.
Lonza to Incorporate Agilent Analytics Technology Into Cocoon Platform
Lonza plans to ensure consistent product quality by incorporating Agilent’s analytics technology into its Cocoon platform.
Pfizer Opens Gene Therapy Clinical Manufacturing Facility
Pfizer invested $68.5 million in a facility in Durham, NC.
FUJIFILM Irvine Scientific Opens New European Manufacturing Facility
FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.
FUJIFILM Diosynth Biotechnologies to Create Major Biopharma Manufacturing Site in United Kingdom
FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.
Califf Gains Bipartisan Support for FDA Confirmation
General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.
EMA Accepts MAA for Sanofi’s Rare Disease Therapy
The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.
Pfizer Acquires Arena Pharmaceuticals for $6.7 Billion
Pfizer’s $6.7 billion acquisition of Arena will give them access to a portfolio of immuno-inflammatory therapies.