Pharma/Biotech – USA, UK, Asia and ROW Regulatory News – Aug 2024

USA

FDA Approves First Nasal Spray for Emergency Treatment of Anaphylaxis

The FDA has approved neffy (epinephrine nasal spray) for emergency treatment of Type I allergic reactions, including life‑threatening anaphylaxis, in adults and children weighing at least 30 kg.

Updated mRNA COVID‑19 Vaccines Receive FDA Approval and EUA

The FDA has approved and authorized updated 2024–2025 mRNA COVID‑19 vaccines from ModernaTX Inc. and Pfizer Inc. The vaccines now contain a monovalent component targeting the Omicron KP.2 strain to better protect against circulating variants and reduce risks of severe illness, hospitalization, and death.

FDA Approves First Nalmefene Hydrochloride Auto‑Injector for Opioid Overdose

The FDA has approved Zurnai, the first nalmefene hydrochloride auto‑injector for emergency treatment of known or suspected opioid overdose in adults and adolescents aged 12 and older. Nalmefene and naloxone remain key options for reversing opioid overdose amid ongoing public health concerns driven largely by illicit fentanyl.

FDA Approves Gene Therapy for Metastatic Synovial Sarcoma

The FDA has approved Tecelra (afamitresgene autoleucel), a gene therapy for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for specific HLA A*02 alleles, and whose tumors express the MAGE‑A4 antigen as confirmed by an FDA‑authorized companion diagnostic.

AUSTRALIA

New Semaglutide Product (Wegovy) Available

Novo Nordisk has announced that Wegovy, a semaglutide‑based medication for chronic weight management in adults and adolescents meeting specific criteria, will be available in Australia starting early August 2024. Semaglutide is the same active ingredient used in Ozempic, which has experienced intermittent shortages since 2022.

Quality Standards Published for MDMA and Psilocybine

New national quality standards for MDMA and psilocybine have been released to establish minimum requirements for both active pharmaceutical ingredients (APIs) and finished products.

Safety Concerns with Garcinia gummi‑gutta (Garcinia cambogia) and HCA‑Containing Products

Medicines and herbal supplements containing Garcinia gummi‑gutta or hydroxycitric acid (HCA) may, in rare cases, cause liver injury. Similar risks apply to related ingredients such as Garcinia quaesita and various hydroxycitrate salts.

CANADA

International Overdose Awareness Day Message

Canadian health ministers released a joint statement recognizing International Overdose Awareness Day, honoring lives lost to overdose and emphasizing the need for community action to reduce stigma, promote awareness, and expand access to essential health and social services.

CHINA

COVID‑19 Infection Levels Stable and Manageable

Experts report that fluctuations in COVID‑19 case numbers across China remain within manageable levels and do not strain healthcare resources. Fever clinic visits declined from 125,000 on July 1 to 92,000 on July 31 and remained below peak levels seen earlier in the year. Critical cases have also decreased significantly.

PHILIPPINES

Training on PIC/S GMP Guide Version 14

A new training program will cover the current PIC/S Good Manufacturing Practice Guide (PE 009‑14) and other regulatory requirements to support compliance with pharmaceutical GMP standards.

SINGAPORE

TelCentris + Avastin Not Approved as Adjuvant Therapy for HCC

Roche Singapore has issued a Dear Healthcare Professional Letter stating that Tecentriq (atezolizumab) combined with Avastin (bevacizumab) is not approved as adjuvant therapy for hepatocellular carcinoma following resection or ablation. Updated data show that earlier recurrence‑free survival benefits were not maintained with longer follow‑up. The approved indication for unresectable HCC remains unchanged.

Retail Recall of YSP Prednisolone Tablet 5 mg

A retail‑level recall has been initiated for one batch of YSP Prednisolone Tablet 5 mg due to discovery of blister packaging intended for the Malaysian market.

UK

MHRA Approves Zolbetuximab for Stomach and Gastro‑Esophageal Junction Cancers

Zolbetuximab (Vyloy), a monoclonal antibody that targets specific cancer cells, has been approved for use with standard chemotherapy in treating adults with gastric or gastro‑oesophageal junction cancer.

Lecanemab Approved for Early‑Stage Alzheimer’s Disease

The MHRA has granted product licensure for lecanemab (Leqembi) for adults in the early stages of Alzheimer’s disease. This marks the first Alzheimer’s treatment authorized in Great Britain that demonstrates evidence of slowing disease progression. The approval follows expert evaluation by the Commission on Human Medicines.