Industry News

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

MHRA has awarded Promising Innovation Medicine (PIM) designation to rezafungin for the treatment of invasive candidiasis.

Evonik has increased its global supply of plant-derived cholesterol used for mRNA vaccines and gene therapies.

TFF Pharmaceuticals and Catalent will collaborate to develop TFF's platform for manufacturing dry powder particles.

In a goal to boost local pharmaceutical production, the World Health Organization has established a global manufacturing training hub in the Republic of Korea through which Bangladesh, Indonesia, Pakistan, Serbia, and Vietnam will receive mRNA technology.

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

As Russia’s invasion of Ukraine continues, industry leaders speak out in condemnation of the actions taking place and pledge to provide aid to those in need.

FDA has approved Vonjo (pacritinib) capsules to treat adults with a rare form of bone marrow disorder.

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

Califf will face challenges that include COVID-19, opioids, and user fees.

FDA has revised the Emergency Use Authorization for sotrovimab.

BioMed X and Boehringer Ingelheim have announced the start of a new research project in brain sensor development.

Hovione has announced that Jean-Luc Herbeaux will take over for Guy Villax as CEO on April 1, 2022.

UCB has announced that it is extending its tender offer to acquire Zogenix.

EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.

EMA has recommended approval of Spikevax for children aged 6 to 11.

Johnson & Johnson has confirmed advancement of the nationwide opioid settlement agreement.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.

FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.

TFF Pharmaceuticals announces findings that inhaled niclosamide significantly inhibits viral replication of the Omicron variant of SARS-CoV-2.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.

Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.

MHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.

The Center for Breakthrough Medicines and BioAnalysis LLC have formed a strategic alliance to offer novel analytical testing services for CGT clients.

Semarion raises £2.14 million GBP (US$2.89 million) seed funding to support the commercial development of Semarion’s SemaCyte cell assaying platform.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.