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2023-08-07|

GeneOnline’s Weekly News Highlights: July 31-Aug 4

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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.

FDA Approves First Oral Treatment for Postpartum Depression

The U.S. FDA announced on August 4 that it had approved Zurzuvae (Zuranolone), manufactured by Biogen and Sage Therapeutics, as the first oral medication for treating severe depression related to childbirth or pregnancy (postpartum depression, PPD). Clinical trials showed the pill helped to significantly reduce depressive symptoms within 3 days. The effect of the medication was maintained at 4 weeks after the last dose, the FDA said. As per Biogen and Sage, the pill is expected to be available later this year. No price has yet been announced.

The FDA Expands Approval for Merck’s Ebola Vaccine to Children Aged 12 Months and Above

Merck (known as MSD outside of the U.S. and Canada), announced on August 3 that the FDA has approved an expanded indication for ERVEBO, a vaccine which is now indicated for the prevention of Ebola Virus Disease (EVD) caused by Zaire ebolavirus in children 12 months of age and older. The vaccine initially received approval in December 2019 for its usage in those aged 18 and above. Separately, in late July, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the same expansion of approval for ERVEBO to protect against EVD. The CHMP opinion is now being considered by the European Commission for amending the marketing authorization, and a final decision is expected in the third quarter of 2023.

FDA Approves GSK’s PD-1 Medicine for Early-Detected Endometrial Cancer

GSK announced that the U.S. Food and Drug Administration (FDA) has approved Jemperli in combination with chemotherapy for the treatment of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer.  Jemperli is a programmed death receptor-1 (PD-1) blocking antibody. It works by blocking the interaction between the PD-1 ligands with PD-L1 and PD-L2 by binding to the PD-1 receptor. The approval is supported by the positive results shown in the drug’s phase III trials, including a 71% reduction in the risk of disease progression for patients in the trial. Its approval emphasizes the potential of Jemperli as an immuno-oncology treatment, providing hope and new treatment options.

 

Advancing Antiviral Therapies With Viral Membrane Targeting Molecules

Scientists at New York University have discovered a new approach to targeting viruses and developing new antivirals. In their study published in ACS Infectious Diseases, the researchers focused on targeting the viruses’ membranes as opposed to the fast-mutating proteins on their surfaces. They used molecules called peptoids, which were inspired by the immune system’s antimicrobial peptides. These molecules were able to disrupt the viral membranes of the Zika, Rift Valley fever, and Chikungunya viruses. This novel approach presents a possible solution to the problem of antiviral resistance. Furthermore, it shows promise for the development of a new generation of antivirals. 

European Commission Revokes Approval for Novartis Sickle Cell Drug

On August 3, the European Commission endorsed the Medicinal Products for Human Use (CHMP) recommendation to revoke the marketing authorization (MA) for Novartis’s sickle cell drug, crizanlizumab. The decision is the result of their phase III study (STAND) not showing significant efficacy in preventing vaso-occlusive crises. Novartis has announced that, in accordance with the decision, they will be removing crizanlizumab from the European market. The drug retains its approval in the U.S. for its use in the reduction of vaso-occlusive crises in adults and patients over 16 with sickle cell disease.

Henrietta Lacks’ family settles lawsuit with Thermofisher over use of HeLa cells

The cells were taken without consent from Henrietta Lacks in the 1950’s and since then have been a big part of scientific research and many breakthroughs. HeLa cells were fundamental in many vaccine developments for polio, coronavirus, etc. It has also been a great contribution in AIDS treatment development and cancer treatment. Thanks to HeLa cells various studies didn’t need to be first experimented on humans. Thermo Fisher and Henrietta Lacks’ family have reached a settlement. The terms of said settlement are confidential between both parties. The family was glad they were able to settle the litigation outside of the courtroom. 

Strengthening Asia’s Vaccine Distribution: A Transformative Collaboration between Zuellig Pharma and GSK

Zuellig pharma, located in Singapore, announced its partnership to work with GSK to improve Asia’s vaccine distribution. Both pharma companies will work together to create a distribution hub, which would enhance availability, distribution, and affordability of vaccines. The new hub will be stationed in Singapore, and will be connected to 13 markets across Asia-Pacific.

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