FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The COVID-19 pandemic has further impacted ongoing drug shortage issues; essential action is needed to avoid repeating previous mistakes.

There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation.

Repligen and Navigo’s novel ligand could be the first to address antibody aggregation in low pH elution buffers.

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

The memorandum of understanding between ABITEC and Luca AICell will work to advance ultra-high purity lipidic chemistries.

Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.

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.

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, has successfully closed a £3.5 million (US$4.9 million) pre-initial public offering (IPO) funding round.

NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

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's proof of concept project evaluating the application of the nanoforming process has been successful.

Avantor has acquired the Masterflex bioprocessing business and related assets of Antylia Scientific.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.

The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.

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.

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’s new single-dose vaccine will be a booster for both COVID-19 and the flu.

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 Scientific plans to expand its Nashville, Tenn., site by establishing a dedicated single-use technology manufacturing facility at the site, doubling capacity.

Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.