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2023-08-21|

GeneOnline’s Weekly News Highlights: Aug 14-18

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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.

Gilead Reaches $247M Settlement in Antitrust Lawsuit

In a significant development, KPH Healthcare Services, Inc., commonly known as Kinney Drugs, Inc., has successfully reached a settlement in an ongoing legal battle against pharmaceutical giant Gilead Sciences, Inc. The lawsuit, filed under the title “In Re: HIV Antitrust Litigation,” accused Gilead of engaging in anticompetitive practices related to its HIV drugs. The settlement, amounting to an impressive $246.75 million, is poised to benefit direct-payor plaintiffs (DPPs) and marks a pivotal moment in the fight against monopolistic tactics within the pharmaceutical industry.

PDUFA Date Extension for Valneva Chikungunya Vaccine 

On August 14, Valneva announced that the U.S. FDA has extended the PDUFA date for their Chikungunya vaccine candidate. Originally, they were expecting a decision by the end of August for the Biologics License Application for their Chikungunya vaccine. However, the DFA has extended the PDUFA date to the end of November. Valneva will continue to work closely with the FDA, and they remain confident that they could obtain approval for their vaccine before the new PDUFA date. 

Amazon Pharmacy Implements Automated Discount Coupons Which Improved Insulin Affordability

On August 15, Amazon announced that its online pharmacy will automatically apply manufacturer-sponsored coupons to more than 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. The manufacturers sponsoring these coupons are Novo Nordisk, Sanofi, Eli Lilly, Insulet, Dexcom. Patients can now purchase insulin vials, pens, pumps, and continuous glucose monitors for as little as $35 for a month’s supply. In addition to the discounted rate, Amazon Pharmacy will also offer free delivery to its customers.

FDA Approves First Treatment for Fibrodysplasia Ossificans Progressiva

On August 16, Ipsen announced that the U.S. FDA has granted approval for their fibrodysplasia ossificans progressiva (FOP) treatment, Sohonos (palovarotene). FOP is an ultra-rare disease that is characterized by the development of bones in areas where they are not normally found. The approval is based on the positive data from their phase III trial. Its use was approved in adults and pediatric patients, more specifically for males aged 10 or older and females aged 8 or older. Sohonos is the first treatment approved by the FDA for FOP, offering much-needed treatment to patients suffering from this debilitating disease. 

GSK Announces Release of RSV Vaccine at Pharmacies Across the U.S.

On August 17, GlaxoSmithKline (GSK) announced that AREXVY, its adjuvanted vaccine against respiratory syncytial virus (RSV), is now available at all major retail pharmacies in the U.S. In May, GSK defeated major rivals Pfizer and Moderna to secure the first-ever FDA approval for RSV vaccine preventing RSV-lower respiratory tract disease (LRTD) in individuals aged 60 years and older. Now, the British pharma giant also managed to make the vaccine available in the US market ahead of the fall and winter RSV season. Under the Inflation Reduction Act, patients with Medicare Part D will pay no out-of-pocket expenses. As part of the Affordable Care Act, AREXVY may be covered for commercially insured patients at no cost when administered in-network. 

Moderna Announces Positive Clinical Data Confirming Efficacy of its Updated COVID-19 mRNA Vaccine

On August 17, Moderna announced that preliminary clinical trial data confirming its updated COVID-19 mRNA vaccine for the fall 2023 vaccination season showed a significant boost in neutralizing antibodies against the latest EG.5 (Eris) and FL.1.5.1 (Fornax) variants. These results suggest that the updated version of COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season. On August 9, the World Health Organization (WHO) recently classified the EG.5 strain as a variant of interest. EG.5 is now the dominant variant in the U.S. according to the Centers for Disease Control and Prevention (CDC),1 while also accounting for a growing proportion of cases across the globe. The FL 1.5.1 variant is also beginning to surge in parts of the U.S.

Regeneron Wins 10th FDA Approval for Novel Antibody Medication Treating Ultra-rare Immune Disease

On August 18, Regeneron Pharmaceuticals announced that the FDA has approved Veopoz, a fully human monoclonal antibody medication, for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy, marking the 10th FDA-approved drug invented by the New York-based biotech company. CHAPLE is an ultra-rare and life-threatening hereditary immune disease driven by an overactivation of the complement system, possibly causing life-threatening gastrointestinal and cardiovascular symptoms. It has a global patient population of fewer than 100 people. In just the U.S., fewer than 10 patients have been diagnosed.

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