Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

USA

FDA Authorizes Neoadjuvant and Adjuvant Nivolumab for Respectable NSCLC

The FDA has approved Nivolumab (Opteva, Bristol Myers Squibb) in combination with platinum-based chemotherapy as a neoadjuvant option, followed by single‑agent Nivolumab post‑surgery, for adults with respectable non‑small cell lung cancer (NSCLC) measuring ≥4 cm and/or with nodal involvement and without EGFR mutations or ALK rearrangements.

New FDA Approval for Hemophilia A and B Treatment

The FDA has approved Hympavzi (marstacimab‑hncq) for routine prophylaxis to prevent or reduce bleeding in adults and patients aged 12 or older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.

FDA Clears First Non‑Prescription Home Test for Flu and COVID‑19

The FDA granted marketing authorization for the Halogen Rapid Check COVID‑19/Flu A&B Antigen Test. This over‑the‑counter test provides results in about 15 minutes using a nasal swab and detects antigens from SARS‑CoV‑2 and influenza A/B.

FDA Approves Inavolisib Combination for PIK3CA‑Mutated Breast Cancer

The FDA has approved inavolisib (Itovebi, Genentech), used with palbociclib and fulvestrant, for adults with endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative advanced or metastatic breast cancer identified through an FDA‑approved diagnostic test.

EUROPE

EMA Upholds Decision Not to Renew Translarna Authorization

The EMA reaffirmed its non‑renewal of authorization for Translarna, a treatment for ambulatory patients aged 2 and older with Duchenne muscular dystrophy caused by a nonsense mutation in the dystrophin gene.

AUSTRALIA

TGA Declines Approval of Lecanemab (LEQEMBI)

The TGA has decided not to register lecanemab for patients with mild cognitive impairment or mild Alzheimer’s disease.

Updated Nitrosamine Acceptable Intake Limits

The TGA released updated acceptable intake (AI) values for nitrosamine impurities, aligning with recent EMA guidance. Changes include clearer expectations for manufacturers, editorial updates, increased AI limits for selected impurities, and adoption of new internationally agreed‑upon limits.

CANADA

Acrobat‑i Stabilizer Z and Positioner Z Recall Notice

A manufacturing deviation involving repeated tray sealing has prompted concerns regarding long‑term sterility, leading to recall action despite initial sterility testing.

Ak98 Hemodialysis Machine Safety Update

Baxter Healthcare has issued an urgent correction due to risks associated with peroxide‑cured silicone tubing potentially linked to nondioxin‑like PCB contaminants. The Ak98 device is used for chronic or acute renal failure treatments.

Adult Nasal Cannula Recall

Following reports of partial prong blockages reducing oxygen flow, CHS Ltd. confirmed the defect and issued a Type II recall, though no patient injuries have been reported.

JAPAN

PMDA Risk Communication Update

The PMDA has released updated risk information based on accumulated adverse drug reaction reports and Early Post‑marketing Phase Vigilance data. These findings may lead to updates to product precautionary statements following ongoing review.

SINGAPORE

Gavrilo® (Pralsetinib) – New Warning on Severe and Fatal Infections

A notice to healthcare providers highlights reports of severe and fatal infections, including opportunistic infections, in patients treated with Gavrilo®. Providers are advised to monitor for infection, interrupt treatment during active infection, and discontinue permanently for life‑threatening cases.

Q‑No Care Whitening Underarm Cream Found to Contain Harmful Ingredients

HSA testing revealed the product contains very high mercury levels, a potent steroid (betamethasone valerate), and triclosan—ingredients not permitted in cosmetic creams.

Recall of Apo‑Amitriptyline Tablets

Several batches of Apo‑Amitriptyline 10 mg and 25 mg tablets are being recalled after an impurity was detected above acceptable thresholds.

UK

Sugemalimab Approved for NSCLC Treatment

The MHRA has approved sugemalimab (Equip) for adults with non‑small cell lung cancer.

MHRA Issues Reminder on GLP‑1 Agonist Side Effects

The agency urges clinicians to ensure patients understand common gastrointestinal risks associated with GLP‑1 receptor agonists, used for type 2 diabetes and obesity management.

Donanemab Authorized for Early Alzheimer’s Disease

The MHRA approved donanemab (Kisunla) for adults in early‑stage Alzheimer’s disease with zero or one APOE4 allele. The treatment removes beta‑amyloid plaques and has shown potential to slow disease progression in clinical studies.