FDA Review: Phanes, Pfizer, GSK and More


The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.  

Here’s a look at what kept the agency busy this week.

Oct. 14

Phanes Therapeutics was cleared to initiate a Phase I trial of PT217, an anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody for small cell lung cancer and other neuroendocrine cancers.

Prestige Biopharma submitted a request to the FDA for a pre-submission meeting to discuss its expected BLA application for a Herceptin biosimilar, HD201(Tuznue).

Oct. 13

Reata Pharmaceuticals announced the FDA informed the company it will not hold an advisory committee meeting related to its New Drug Application (NDA) for omaveloxolone for treatment of Friedreich’s ataxia.

Oct. 12

Eagle Pharmaceuticals submitted an Investigational New Drug (IND) application for a Phase II trial of CAL-02 for treatment of severe community-acquired bacterial pneumonia.

Galactin Therapeutics received the go-ahead for a Phase II trial of belapectin with Merck’s Keytruda (pembrolizumab) for first-line treatment of recurrent/metastatic PD-L1 positive squamous cell carcinoma of the head and neck.

Regeneron Pharmaceuticals reported the FDA accepted for Priority Review its supplemental Biologics License Application (sBLA) for Eylea (aflibercept) injection to treat Retinopathy of Prematurity (ROP) in preterm infants.

Pfizer and BioNTech received Emergency Use Authorization (EUA) for a 10-microgram dose of their Omicron BA.4/BA.5 bivalent COVID-19 vaccine for kids 5 through 11 years of age.

SiSaf initiated the FDA regulatory process to obtain Orphan Drug Designation for SIS-101-ADO, a siRNA therapeutic for Autosomal Dominant Osteopetrosis Type 2 (ADO2).

BridgeBio Pharma announced the FDA granted Fast Track designation for BBP-398 in combination with Amgen’s Lumakras (sotorasib) for adults with previously treated KRAS G12C-mutated, metastatic non-small cell lung cancer.

Oct. 11

Eligo Bioscience’s EB003 received Orphan Drug Designation and Rare Pediatric Disease designation for EB003 to treat Shiga-toxin producing bacterial infection as it relates to the prevention of hemolytic uremic syndrome.

Incannex Healthcare reported it completed a constructive pre-IND meeting with the FDA for its IHL-216A for treatment of traumatic brain injury and concussion.

Aquestive Therapeutics received positive written feedback from the FDA for its initial End-of-Phase II meeting request to discuss Chemistry, Manufacturing and Controls (CMC) for its AQST-109 epinephrine sublingual film for the treatment of severe allergic reactions, including anaphylaxis.

XACT Robotics’ ACE Xtend Remote Control Unit was granted FDA clearance, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from a control room.

Biomind Labs announced the FDA granted a Pre-IND meeting for its Triptax, a new chemical entity that could be used as an active pharmaceutical ingredient or chemical precursor to treat depression.

Gilead Sciences reported the FDA accepted an sBLA for Trodelvy (sacituzumab govitecan-hziy) for priority review for the treatment of adults with unresectable locally advanced or metastatic HR+/HER- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

TeraImmune received the go-ahead to initiate a Phase I/IIa trial of TI-168 in congenital Hemophilia A patients with refractory inhibitors. TI-168 is a next-generation, autologous FVIII TCR-Treg cell therapy.

Oct. 10

scPharmaceuticals’ Furoscix (furosemide injection) was approved for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

The FDA issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena, which was approved to reduce the risk of preterm birth in women with a singleton pregnancy with a history of spontaneous preterm birth.

IRadimed Corporation voluntarily withdrew its 510(k) application for its next-generation MR IV pump due to the need to supply additional information within a timeline the company could not manage.

Nanoscope Therapeutics received Fast Track Designation for MCO-0101, an ambient-light activatable Multi-Characteristic Opsinoptogenetic monotherapy to restore vision in blind patients for the treatment of retinitis pigmentosa by way of intravitreal injection.

Oct. 7

GlaxoSmithKline’s Boostrix, a vaccine against whooping cough, was approved by the FDA for infants under the age of two months.

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