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FDA Approved seal
Biopharma regulatory actions and approvals October 2024

Two Stelara biosimilars among 15 US FDA approvals in October

Nov. 22, 2024
By Amanda Lanier
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.
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U.S. FDA headquarters

Former FDA chief Hamburg notes ‘challenging’ times post-Trump win

Nov. 22, 2024
By Nuala Moran
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
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Celltrion wins Korea approvals of Prolia, Xgeva biosimilars

Nov. 22, 2024
By Marian (YoonJee) Chu
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe.
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BrightHeart software

Brightheart secures FDA clearance for software to detect fetal heart defects

Nov. 21, 2024
By Shani Alexander
The U.S. FDA granted Brightheart SAS 510(k) clearance for its artificial intelligence software which helps doctors detect congenital heart defects in fetuses. The software will transform prenatal ultrasound evaluations of the fetal heart and improve the outcomes for newborns, Cécile Dupont, Brightheart’s CEO, told BioWorld.
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NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 21, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
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Illustration of cancer in the bile ducts

FDA approves biliary tract cancer treatment from Jazz

Nov. 21, 2024
By Lee Landenberger
More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks. The treatment was designed to have a more favorable profile than competitors, where drugs targeting HER2 such as Astrazeneca plc’s Enhertu (trastuzumab deruxtecan) and Roche Holding AG’s Herceptin (trastuzumab) are options, as well as checkpoint inhibitors such as Merck & Co Inc.’s Keytruda (pembrolizumab).
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Hidradenitis suppurativa illustration

UCB chalks hidradenitis suppurativa as fifth indication for Bimzelx

Nov. 20, 2024
By Randy Osborne
The U.S. FDA added hidradenitis suppurativa to the label for UCB SA’s Bimzelx (bimekizumab-bkzx), throwing renewed light on the indication, a chronic disease that causes painful, boil-like lumps that appear under the skin. Regulators cleared the humanized IL-17A and IL-17F antagonist for adults with moderate to severe HS, marking the drug’s fifth approval.
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Hepatitis B virus rendering
Infection

Epigenic Therapeutics’ epigenetic inactivator cleared to enter clinic for chronic hepatitis B

Nov. 20, 2024
Epigenic Therapeutics Inc. has received clinical trial application (CTA) approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committees (HDEC) to initiate a clinical trial for EPI-003, an investigational, liver-targeting antiviral therapy for chronic hepatitis B virus (HBV) infection.
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Illustration of siRNA structure
Neurology/psychiatric

Ractigen Therapeutics’ RAG-21 designated orphan drug for ALS

Nov. 20, 2024
Ractigen Therapeutics Co. Ltd.’s RAG-21, a novel siRNA therapy targeting the FUS gene, has been awarded orphan drug designation by the FDA for the treatment of amyotrophic lateral sclerosis (ALS).
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Neurology/psychiatric

Sangamo’s ST-503 receives IND clearance for idiopathic small fiber neuropathy

Nov. 20, 2024
Sangamo Therapeutics Inc. has received IND clearance from the FDA for ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN).
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