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2023-08-28|

GeneOnline’s Weekly News Highlights: Aug 21-25

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GeneOnline’s editorial team has compiled a digest of top international biotechnology and healthcare news of the week to help readers keep abreast of global biomedical industry updates.

Pfizer’s RSV Vaccine Becomes First FDA-Approved Shot for Pregnant Individuals

On August 21, U.S. FDA approved Abrysvo, the respiratory syncytial virus (RSV) vaccine developed by Pfizer, as the first vaccine for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age. Being administered as a single dose injection into the muscle, Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. As the only company to date that has filed regulatory applications for both the RSV vaccine for pregnant women and adults 60 years of age or older, Pfizer already secured FDA approval for Abrysvo in May for the prevention of LRTD caused by RSV in older adults. In addition, it is noteworthy that Abrysvo was also granted marketing authorization from the European Commission (EC) three days after its latest FDA approval, 

U.S. Government Awards $1.4 Billion to Advance COVID Therapies and Vaccines 

On August 22, the U.S. Department of Health and Human Services (HHS) announced that they have awarded $1.4 billion to accelerate and support the development of new therapies and vaccines against COVID-19. The awards are part of the Project NextGen initiative, which aims to advance the development of COVID-19 vaccines and therapeutics through collaboration with the industry. They include $1 billion allocated to supporting vaccine clinical trials and $326 million awarded to Regeneron for the development of their COVID-19 monoclonal antibody therapy. The funding represents a significant step forward in the development of new vaccines and therapies that will hopefully bridge the current gaps in COVID therapeutics. 

RayzeBio Plans Potential IPO to Advance Phase 3 Radiotherapy Drug Candidate

Based in San Diego, California, RayzeBio is a biotech company that develops targeted radiopharmaceutical drugs for cancer. On August 24, the company filed for an initial public offering (IPO) to the Securities and Exchange Commission. Though the company did not specify how much it hoped to raise from the public offering or how many shares it intended to sell, some related information indicated a maximum amount of $100 million. The San Diego-based company intends to use some of the proceeds to advance RYZ101, its lead candidate that is currently undergoing phase 3 trials in patients with gastroenteropancreatic neuroendocrine tumors that express the somatostatin receptor (SSTR).

Novo Nordisk’s Weight Loss Medication Reduces Cardiovascular Risk

As part of the European Society of Cardiology (ESC) Congress, Novo Nordisk announced on August 25 that its blockbuster GLP-1 receptor agonist Wegovy (once-weekly semaglutide 2.4 mg self-injection) has demonstrated cardiovascular benefits, this time in a Phase 3 STEP HFpEF trial, spurring significant reductions in heart failure-related symptoms, physical limitations and improvements in exercise function, and resulting in greater weight loss in adults with obesity and heart failure with preserved ejection fraction (HFpEF), a potentially fatal condition that comprises roughly half of all heart failure cases.

FDA Approves Sandoz’s Antibody Medication as the First Biosimilar Treating Multiple Sclerosis

Sandoz, Novartis’ division of generic and biosimilar medicines, announced on August 25 that the U.S. FDA has approved its biosimilar Tyruko (natalizumab-sztn), an anti-α4 integrin monoclonal antibody, for the treatment of adults with relapsing forms of multiple sclerosis (MS). As a biosimilar to Tysabri injection, Biogen’s monotherapy for MS, it is the first and only FDA-approved biosimilar for relapsing forms of this chronic autoimmune disease. It is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD).

AstraZeneca Challenges IRA’s Drug Price Negotiation Program

On August 25, AstraZeneca joined other pharmaceutical companies in opposition to the Inflation Reduction Act’s (IRA) drug price negotiation program. The IRA is an initiative that aims to address inflation by lowering drug prices, promoting environmental sustainability, and deficit reduction. Furthermore, it gives Medicare the ability to negotiate prices for high-priced medications. The filed legal challenge claims that the drug price negotiation program conflicts with the Orphan Drug Act (ODA). Furthermore, they believe the program will restrict the development of new drugs and access to medicines for patients with rare diseases.

Introducing Veopoz: A Breakthrough Treatment for CHAPLE Disease

Regeneron Pharmaceuticals announces the FDA approval of Veopoz (pozelimab-bbfg) injection as the first treatment for both children and adults dealing with CHAPLE disease, an ultra-rare inherited immune disorder referred to as CD55-deficient protein-losing enteropathy. Regeneron’s remarkable achievement marks the first and only FDA-approved treatment tailored specifically for CHAPLE disease, giving patients and their families newfound hope.

Royalty Pharma acquires a stake in Ferring’s cancer treatment in its first-ever gene therapy transaction.

In its debut gene therapy arrangement, Royalty Pharma is set to invest $300 million initially to secure a 5% royalty based on the U.S. sales of Ferring’s recently sanctioned gene therapy designed for a specific kind of bladder cancer. Royalty Pharma is extending its established strategy of procuring drug royalty privileges to the realm of gene therapy, as evidenced by its recent pact to acquire a portion of forthcoming proceeds from Ferring Pharmaceuticals’ novel bladder cancer treatment, Adstiladrin. This marks Royalty Pharma’s first foray into gene therapy agreements and reflects its confidence in Adstiladrin’s potential to emerge as a highly successful product in the upcoming decade.

 

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