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HUTCHMED Receives Breakthrough Therapy Designation from China’s NMPA
HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.
Former FDA Scientists Dispute Need for Booster Vaccines
Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.
ABITEC Enters into Memorandum of Understanding with Luca AICell
The memorandum of understanding between ABITEC and Luca AICell will work to advance ultra-high purity lipidic chemistries.
Boehringer Ingelheim and Twist Bioscience Team Up for Therapeutic Antibody Discovery
Boehringer Ingelheim and Twist Bioscience will use Twist’s antibody libraries to discover therapeutic antibody candidates.
FDA Approves Janssen’s Invega Hayfera for Schizophrenia Treatment
Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.
Vector Laboratories Closes $124 Million Buyout
Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.
Eight Patient Leaders Join ABPI Advisory Council
ABPI has announced that eight leaders from the patient and health charity sector have been chosen to join its new Patient Advisory Council.
ILC Therapeutics Successfully Closes Pre-IPO Funding Round
ILC Therapeutics, has successfully closed a £3.5 million (US$4.9 million) pre-initial public offering (IPO) funding round.
Janssen’s Erleada is Reconsidered by NICE, Gaining a Positive Recommendation
NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.
NICE Issues Recommendation for Pfizer’s Juvenile Idiopathic Arthritis Treatment
NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.
Sterling Pharma Solutions Set to Create Center of Excellence in Continuous Flow Chemistry in UK
Sterling Pharma Solutions has invested in a center of excellence for research into commercial applications of continuous flow chemistry at its site in Dudley, UK.
Nanoform and Herantis Pharma Announce Successful Results from PoC Project
Nanoform and Herantis Pharma's proof of concept project evaluating the application of the nanoforming process has been successful.
Avantor Strengthens Bioprocessing Position with Acquisition of Masterflex
Avantor has acquired the Masterflex bioprocessing business and related assets of Antylia Scientific.
Biden Bolsters Vaccine Production in Pandemic Preparedness Plan
The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.
Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1
Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.
Ardena Acquires Idifarma From Suanfarma
Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.
TCR² Therapeutics Receives FDA Orphan Drug Designation for Gavo-cel
The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.
AstraZeneca and European Commission Reach Settlement Agreement Over COVID-19 Vaccine Supply
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria.
CEPI Says Approved COVID-19 Vaccines Must Be Available for Clinical Trials
The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.
Moderna to Develop Combined COVID-19/Flu Vaccine
Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.
FDA Places Clinical Hold on BioMarin’s Phase I/II Gene Therapy Study
FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.
Thermo Fisher to Establish Single-Use Technology Site in US
Thermo Fisher Scientific plans to expand its Nashville, Tenn., site by establishing a dedicated single-use technology manufacturing facility at the site, doubling capacity.
Impel NeuroPharma Gets FDA Approval for Nasal Spray Migraine Treatment
Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.
FDA Launches Novel Excipient Review Pilot Program
The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.
Polaryx Therapeutics Receives FDA Orphan Drug Designation for PLX-200 for Treatment of Krabbe Disease
Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.
Thermo Fisher Scientific to Expand Pipette Tip Manufacturing Under $192.5 Million Government Contract
The US government has granted Thermo Fisher Scientific a $192.5 million contract that the company will use to expand domestic manufacturing for pipette tips.
Setting a Clear Strategy for Primary Packaging
Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.
Getting a Nose for Vaccines
The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.
Diffusion Pharmaceuticals Announces FDA Clearance of IND Application for TSC
FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.
Element Acquires Impact Analytical
Element’s acquisition of Impact Analytical expands their life sciences footprint in North America.
