FDA

The FDA has granted accelerated approval to the first-in-class antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) from Genmab and Seagen to treat adults with recurrent or metastatic cervical cancer. Specifically, the approval covers cancer with disease progression on or after chemotherapy. The drug targets protein tissue factor (TF), which is abnormally expressed in cervical cancer. Historically, physicians…

The Global Institute of Stem Cell Therapy and Research (GIOSTAR) has announced that the FDA has authorized emergency use of its stem cell therapy for hospitalized COVID-19 patients. The San Diego–based organization has offered stem cell therapy for COVID-19-related symptoms since April 2020. The compassionate use authorization will enable GIOSTAR to offer stem cell therapy…

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…

FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis. Earlier in the year, federal authorities had counseled against the use of the  monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351). Meanwhile, demand for…

In recent years, regulators including FDA have increased their focus on the potential of drugs to cause blood pressure increases. To that end, the agency asked Urovant (Irvine, California) to study the impact of the beta-3 adrenergic receptor agonist vibegron on blood pressure. The study, recently published in the Journal of Urology, found no significant change…

Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.  But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.  Two departing senior FDA vaccine officials recently co-wrote…

The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations. To get a clearer sense of what the ramifications of this accelerated development will…

FDA leaders have issued a statement regarding the agency’s plan for authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner…

FDA determined it couldn’t conclude that the benefits of lenzilumab from Humanigen (NSDQ:HGEN) outweigh the risks for patients hospitalized with COVID-19.  Lenzilumab is the company’s lead product candidate.  The drug works by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF), which is implicated in the so-called cytokine storm.  The drug is the subject of 16 clinical trials spanning…

Traditionally, one of the most challenging aspects of treating schizophrenia is medication adherence. Patients who neglect to take their medicine have an elevated risk of relapse, hospitalization and suicide. “There’s a higher likelihood of an exacerbation of the illness occurring,” said Dr. Gustavo Alva, medical director at ATP Clinical Research (Costa Mesa, California).  The problem…

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by…

Novartis (NYSE:NVS) has received FDA fast track designation for LNA043, a potential treatment for osteoarthritis of the knee. LNA043 is a modified version of the human angiopoietin-like 3 (ANGPTL3). The drug would be a potential first-in-class disease-modifying osteoarthritis therapy. Osteoarthritis is a common joint disorder. In 2017, more than 300 million people internationally had either hip…

The FDA has scheduled a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss Pfizer’s supplemental application for a COVID-19 vaccine booster.  While President Biden has embraced the concept of boosters as early as five months post-second dose, other experts within the government have recommended a more cautious approach. In addition, WHO has…

Janssen (NYSE:JNJ) has won FDA approval for the long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), which will be the first six-month injectable on the U.S. market. Titusville, New Jersey–based Janssen announced that patients who intend to obtain Invega Hafyera must receive Invega Sustenna (one-month paliperidone palmitate) four at least four months beforehand. Alternatively, they can…

Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News citing a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within…

Pfizer (NYSE: PFE) recently announced that its once-daily oral Janus kinase 1 (JAK1) inhibitor abrocitinib bested Sanofi’s Dupixent (dupilumab) in a Phase 3 study focused on moderate to severe atopic dermatitis (AD). Meanwhile, Sanofi (EPA:SAN) announced that a Dupixent pivotal trial met its primary and secondary endpoints, making it the first biologic to demonstrate significant…

Novartis (NYSE:NVS) has announced that the FDA has granted priority review for its application for allosteric inhibitor asciminib (ABL001) in chronic myeloid leukemia (CML). The drug targets the ABL myristoyl pocket (STAMP). The priority review status could trim four months off the review time, dropping the review period to eight months from 12 months under a…

The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age…

Jazz Pharmaceuticals (NSDQ:JAZZ) has announced that its Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution has won FDA approval for treating idiopathic hypersomnia in adults. Idiopathic hypersomnia is a rare chronic disorder involving chronic excessive daytime sleepiness. Previously, the drug was FDA approved for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years…

The panel joined FDA in endorsing a third dose of Pfizer-BioNTech and Moderna vaccines for moderately to severely immunocompromised patients. The Advisory Committee on Immunization Practices (ACIP) concluded there was insufficient evidence to recommend an additional dose for immunocompromised recipients of Janssen’s COVID-19 vaccine. The ACIP panel described the third dose of vaccine as part…

The FDA has authorized boosters for certain vaccinated individuals, but the agency believes there is insufficient evidence to recommend boosters to the broader population. The amended EUA applies to the Pfizer-BioNTech or Moderna vaccines. The individuals covered in the EUA include solid organ transplant recipients and people with other medical conditions leading to a moderate…

The case for boosters has gained ground amidst the surge in COVID-19 infections over the past month. BioNTech CEO Özlem Türeci recently recommended that health officials administer a third dose six to 12 months after the second dose to “maintain the highest level of protection.” Pfizer CEO Dr. Albert Bourla has made similar recommendations.  Pfizer…

Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week. In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods…

Regeneron’s (NSDQ:REGN) REGEN-COV remains one of the most effective monoclonal antibody therapies in reducing the risk of serious COVID-19 infections and resulting hospitalizations and deaths. A study recently published in the New England Journal of Medicine found that the drug effectively prevented COVID-19 disease in household contacts of individuals infected with the novel coronavirus. When…

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. …