Drugs
FDA has approved an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, an autoimmune disorder that presents with baldness patches. The Janus kinase (JAK) inhibitor works by blocking the “activity of one or more of a specific family of enzymes, interfering
Drugs
A new JAMA online study finds that FDA is approving new oncology therapies much faster and sooner than its European regulatory counterparts. According to its findings, the study found that 89 new oncology therapies were approved by both FDA and the EMA from 2010 to 2019, but the U.S.
Drugs
GSK has announced positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the company’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. The analysis found that the primary endpoint was exceeded with no unexpected safety concerns
Drugs
An FDA January inspection at Bioiberica (Barcelona, Spain) resulted in a five-item FDA-483 that cited significant GMP violations at the drug substance manufacturing facility. For example, the 483 said the firm’s cleaning procedures for manufacturing equipment were not validated to facilitate adequate cleaning and contamination prevention measures.
Drugs
CBER has updated its prioritization schedule for the remainder of 2022 to account for Covid-19-related work. For the remainder of the year, the Center will continue to prioritize resources for Covid-19 regulatory work over non-Covid work, as needed. “As we enter calendar year 2023, we plan
Drugs
Green Pharmaceuticals has recalled one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contamination identified as Providencia rettgeri. A recall notice says that while the microorganism is rarely associated with human illness, immunocompromised patients are at risk of severe or life-threatening adverse events,
Drugs
An FDA consumer update cautions that some products marketed for removing moles and other skin lesions can cause injuries and scarring. The online post says there currently are no FDA-approved prescription or over-the-counter drugs to treat moles, seborrheic keratoses, or skin tags. “But,” it says, “there are
Drugs
The International Society for Pharmaceutical Engineering (ISPE) says it recognizes and thanks FDA for applying the lessons learned from the pilot Quality Metrics Site Visit Program and the Quality Metrics Feedback Program in developing an agency quality metrics reporting program proposal. In a comment letter, ISPE raises issues relating to
Drugs
FDA has released the FDA-483 issued following a 4/19-4/30/21 inspection at BPI Labs, a Largo, FL, sterile drug manufacturer and outsourcing facility. The five inspection observations were: * equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to
Drugs
University of Kentucky researchers say FDA, large buying groups, and the Defense Department should consider alternative strategies the researchers have developed for monitoring drug quality. Writing in the Journal of Pharmaceutical Innovation, the researchers say that since FDA began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing
Drugs
A bipartisan group of eight senators is asking the U.S. Patent and Trademark Office (USPTO) to take steps to eliminate patent thickets — the many patents that cover a single product or minor variations on a single product. In a 6/8 letter, the senators say patent thickets “harm competition
Drugs
FDA has denied most of a 9/18/17 petition submitted by the Post-Finasteride Syndrome Foundation seeking immediate removal from the market of Propecia and all its generic forms or significant labeling changes. However, the agency did agree to order a few labeling changes. The 43-page denial letter
Drugs
CDER has published a Manual of Policy and Procedures (MAPP), Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA, to describe how the Office of Generic Drugs (OGD) and the Office of Surveillance and Epidemiology (OSE) will assess the
Drugs
Members of the Senate have introduced the Affordability is Access Act “to ensure that people across the country can access and afford over-the-counter birth control options and plan their own reproductive lives on their own terms.” Senate HELP Committee chair Patty Murray (D-WA) says the act would
Drugs
Writing for the Global Forum, authors from 12 major drug companies say it is time to apply the sense of urgency that was used to quickly develop Covid-19 vaccines and treatments to other diseases of significant public health burden. “Cardiovascular and neurological diseases are both associated with even greater
Drugs
The Association for Accessible Medicines (AAM) says FDA’s proposed potential new direction for a quality metrics reporting program may not align with five principles the association described in a 3/10/21 white paper submitted to FDA. In a 6/3 comment letter, AAM says it’s concerned that
Drugs
FDA has approved Sanofi’s Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not recommended. Approval is based on data that include a Phase 3 trial evaluating
Drugs
Outlook Therapeutics has withdrawn a BLA submitted in March for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). FDA has requested additional information before it will accept the filing, the company says, adding that it plans to resubmit the BLA in September. “If approved, Lytenava could
Drugs
FDA has granted Allogene Therapeutics a regenerative medicine advanced therapy designation for ALLO-501A in relapsed/refractory large B cell lymphoma. The designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies, the company says. “Data support the potential
Drugs
FDA has approved a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who are overweight with at least one weight-related condition (e.g., high blood pressure, Type 2 diabetes, or high cholesterol). FDA says the subcutaneous injection is the
Drugs
FDA has released the FDA-483 issued to Nephron Sterile Compounding Center, a West Columbia, SC, outsourcing facility, with seven observations from a 3/28-4/20 inspection. The specific observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Drugs
Sens. Susan Collins (R-ME), Tim Kaine (D-VA), Maggie Hassan (D-NH), and Rob Portman (R-OH) are introducing the Interchangeable Biologics Clarity Act that they say will strengthen the FDA approval process pipeline and increase transparency for critical medicines, thus lowering costs and increasing availability of key medications.