Biologics
FDA has approved a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older. The approval follows a June Vaccines and Related Biological Products Advisory Committee meeting that supported the vaccine’s approval. "The FDA approval of mFLUSIVA, our fourth
Biologics
FDA has granted accelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with Bristol Myers Squibb's Opdivo (nivolumab), for treating adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)
Biologics
FDA has accepted for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults. “MMP can contribute to the appearance of a wider or more square lower
Biologics
A new FDA draft guidance is outlining how sponsors should develop and evaluate container closure systems and device components used with biosimilar and interchangeable biosimilar products, providing a clearer framework for demonstrating that design differences from reference products do not compromise safety or effectiveness. The document focuses on therapeutic protein
Biologics
Sen. Ron Johnson (R-WI), chairman of the Senate Permanent Subcommittee on Investigations, has requested that former CBER director Peter Marks, former CDER officials Narayan Nair, Steven Anderson, and Manette Niu, and former National Institute of Allergy and Infectious Diseases director Anthony Fauci appear for transcribed interviews about their roles
Biologics
FDA has accepted for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma. If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy
Biologics
A 5/5 FDA guidance on chemistry, manufacturing, and controls flexibilities for developing human cellular and gene therapy (CGT) products is changing the landscape of regulatory approval for such products. A BioProcess International online column analyzing the guidance, which is being implemented immediately, says FDA has abandoned its long-standing
Biologics
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee has voted 10 to 3 to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's Opdivo for patients with advanced melanoma, despite FDA reviewers' conclusions that the application lacked
Biologics
An FDA advisory committee voted 9 to 3 against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD), dealing a significant setback to the company's approval bid ahead of an 8/22 user fee review decision target date.
Biologics
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well before a BLA filing to help avoid delays and common regulatory pitfalls. According to a just posted transcript, officials from CBER's Office of
Biologics
Johnson & Johnson is reporting positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqyv) plus Talvey (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and Talvey plus pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received
Biologics
FDA has accepted for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The company says it has requested accelerated approval based on dystrophin as a surrogate endpoint. The agency set a user fee review action target
Biologics
HHS aide Stefanie Spear, a close associate of HHS secretary Robert F. Kennedy Jr. for many years, has been asking FDA to provide access to its Sentinel and BEST surveillance system data to help the HHS staff conduct studies, including into rates of autism and other conditions among vaccinated versus
Biologics
Former CDC chief medical officer Debra Houry said she left the agency after concluding she could no longer defend its scientific integrity, citing widespread political interference in vaccine policy, communications, and data operations, according to a 7/5 CBS News interview aired on Face the Nation. The interview provides a
Biologics
FDA has published a guidance, Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral, and Blood Product Management in Response to an Ebola Disease Outbreak, notifying blood collection establishments of the agency’s determination of Ebola to be a transfusion-transmitted infection. The document includes the agency’s recommendations for
Biologics
CBER has published a Standard Operating Policy and Procedure (SOPP) to guide staff in implementing and maintaining Risk Evaluation and Mitigation Strategies (REMS). The document says the SOPP applies to an initial REMS as part of an original BLA or NDA, or a new REMS needed as part of an
Biologics
FDA has told Capricor Therapeutics that it has scheduled a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee to review the company's BLA resubmission for deramiocel, an investigational cell therapy for treating Duchenne muscular dystrophy. The panel will meet on 7/29, less than a month
Biologics
The European Commission has opened a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misleading campaign against a rival influenza vaccine marketed by CSL Seqirus. The investigation centers on Sanofi's promotion of its enhanced influenza vaccine, Efluelda, which competes in Europe
Biologics
FDA has accepted for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma, the company announced Friday. The agency classified the filing as a Class 1 resubmission and set a review action target date of 8/
Biologics
A Covid-19 vaccine effectiveness study that was previously blocked from publication in a Centers for Disease Control and Prevention (CDC) journal has now been published in JAMA Network Open, reigniting a debate over both vaccine policy and the methods used to evaluate vaccine performance. The study found that the
Biologics
FDA has given Beam Therapeutics the green light in its IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for phenylketonuria (PKU). The clearance enables the launch of a Phase 1/2 trial evaluating BEAM-304, an in vivo gene-editing therapy
Biologics
The FDA Vaccines and Related Biologic Products Advisory Committee has voted to recommend approval of Moderna’s mFlusiva mRNA flu shot. The Associated Press reports the company is seeking approval for the vaccine’s use in people ages 50-64, along with authorization for use in those aged 65 and