Biologics
FDA has granted BioMarin accelerated approval for Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achondroplasia, the most common form of disproportionate short stature, in those five years of age and older with open epiphyses (growth plates). The approval was based on data showing an
Biologics
FDA has told a Texas federal court that it will need 55 years to respond to a Freedom of Information Act (FOIA) request from Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The conservative Blaze News Website says
Biologics
CBER has issued NYC Regenerative Medicine an untitled letter over its Web site and Facebook page that markets its cellular product derived from human umbilical cord for treating kidney disease and other conditions. The agency says such products are considered biologics and require an approved BLA to be marketed in
Biologics
FDA has approved a PharmaEssentia BLA for Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease associated with red blood cell overproduction, which thickens blood and increases the risk of blood clots. The interferon therapy is believed to work by “attaching to certain receptors
Biologics
Novavax says it has requested a meeting with FDA as it moves to file for approval of its Covid-19 protein-based vaccine with the agency by the end of the year. Yahoo! Money reports the company has received authorization in Indonesia and says it could receive up to five
Biologics
FDA has authorized Inovio to proceed with the INNOVATE Phase 3 segment for its INO-4800 Covid-19 vaccine candidate. In authorizing the trial, FDA lifted a partial clinical hold after reviewing additional non-clinical, clinical, and device information submitted by the company. Inovio says the vaccine candidate is composed
Biologics
Children’s Health Defense (CHD) says Congress should investigate FDA’s failure to look into a whistleblower’s allegations about issues with a Pfizer contractor (Ventavia) testing the company’s Covid-19 vaccine. The allegations of poor research practices were aired in an 11/2 BMJ article. CHD president and
Biologics
A regional director at Ventavia Research Group, which provides Covid-19 vaccine research services to Pfizer, says she had many concerns about problems at Ventavia that she raised with FDA the same day she was fired after two weeks on the job. The whistleblower, Brook Jackson, told the BMJ (formerly
Biologics
Ongoing safety concerns with Moderna’s Covid-19 vaccine and its potential use in adolescents has led to a filing delay for an emergency user authorization (EUA) to use a smaller dose vaccine in the pediatric population (6-11 years of age). Last month, it was reported (see story) that
Biologics
FDA 10/29 authorized the emergency use of Pfizer-BioNTech’s Covid-19 vaccine in children ages five through 11 years. The agency’s decision follows a 10/26 vote by its Vaccines and Related Biological Products Advisory Committee to recommend the agency authorize the lower-dose vaccine in the
Biologics
An estimated 30 million to 50 million doses of Johnson & Johnson’s Covid vaccine made early this year are in storage at the Emergent BioSolutions facility in Baltimore waiting for FDA approval to ship, according to a Reuters report. The news service says it was informed by two sources
Biologics
A 10/27 Government Accountability Office oversight report on the federal government response to Covid-19 says FDA “may face challenges resuming routine surveillance inspections of vaccine and allergenic manufacturing establishments.” The agency told GAO that vaccine inspections are a priority, the report says. It says FDA significantly reduced inspections
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 0 to recommend the agency authorize the use of Pfizer’s Covid-19 lower-dose vaccine in children ages 5 to 11 years. Panel members agreed that the vaccine’s benefits outweighed the risks, but some seemed concerned
Biologics
Agenus has withdrawn a BLA for balstilimab, its PD-1 inhibitor that was seeking an accelerated approval for second-line treatment of cervical cancer. The decision to withdraw the submission was urged by FDA due to Merck’s recent full approval of Keytruda (pembrolizumab) for treating this patient population (see
Biologics
FDA has denied a 9/27 citizen petition submitted by the Informed Consent Action Network asking it to revoke the emergency use authorizations (EUAs) granted to the Moderna and Johnson & Johnson Covid-19 vaccines. FDA says the petition argued the EUAs should be revoked because Pfizer/BioNTech’s Comirnaty
Biologics
FDA has approved Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) as an add-on maintenance treatment for patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Approval is based on data from a Phase 3 randomized, double-
Biologics
CDC’s Advisory Committee for Immunization Practices 10/21 voted to recommend accepting FDA’s 10/20 amended emergency use authorizations (see earlier story) for booster doses of both Moderna and Johnson & Johnson’s Covid-19 vaccines. FDA also authorized the use of any available Covid-19 vaccine as
Biologics
Sens. Susan Collins (R-ME) and Richard Burr (R-NC) are asking FDA and the Centers for Disease Control (CDC) for more efficacy data on Covid-19 vaccines and breakthrough cases. In a 10/20 letter, the two say that while CDC has started to make some additional information available
Biologics
FDA 10/20 authorized Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals. Additionally, the agency authorized the use of any available Covid-19 vaccine as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different
Biologics
FDA says two physician researchers at Minneapolis’ Hennepin County Medical Center failed to submit INDs for the conduct of clinical investigations with investigational new drugs. The agency just released a 5/5 Warning Letter to Jon Cole and a 5/6 Warning Letter to Lauren Klein detailing issues with Cole’
Biologics
FDA has issued Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection and its use in treating moderate to severe glabellar (frown) lines. The letter, according to the company, said the agency was unable to approve the submission due to deficiencies related to an onsite inspection
Biologics
FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental BLA for Cyltezo (adalimumab-adbm), an interchangeable biosimilar that will allow pharmacy substitutions without prescribers’ concurrence. Cyltezo was originally approved 8/2017 as a biosimilar version of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. “Interchangeable biosimilar products can be expected to