Daria G. Husni

The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.

With the acquisition, AstraZeneca will gain a potential RSV and hMPV combination vaccine.

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

Under the agreement, the companies will discover and develop drug candidates targeting two ion channels linked to neurological disorders.

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.

The report indicates a rise in biotech funding and subsequent growth for pharma contract services.

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

The spinal muscular atrophy treatment, currently marketed by Roche, generated $1.2 billion in sales in 2022.

Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price.

This approval builds on a previous approval of the combination therapy for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.

Mirati’s focus on breakthrough cancer treatments will bolster Bristol Myers Squibb’s oncology portfolio.

Spinning off Sandoz allows Novartis to focus on the areas of cardiovascular, immunology, renal and metabolic, and oncology.

Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones.

The BioIndustry Association reports that with a strong foundation in research and development in mRNA the United Kingdom will be a major player in this rapidly growing industry.

The Japanese biotech company plans to make good use of Orchard’s portfolio, furthering its goal of providing life-changing medical care through cell and gene therapy.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

The contract is part of US Department of Health and Human Services’ ‘Project NextGen’ initiative, aimed at pushing forward new and stronger COVID-19 vaccines and therapies.

The collaboration will provide easy access and transfer between data in Torx and CDD Vault, upping the efficiency of the small-molecule discovery process.

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

The AstraZeneca rare disease group hopes to use these new gene therapy programs to bolster its work on genomic medicine.

Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

Topiramate can cause serious birth defects if exposed to children in the womb.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

The updated vaccine will be ready to ship following a positive European Commission review.