Drugs
Three FDA officials say the recent approval of Astellas’ Prograf (tacrolimus) in combination with other immunosuppressants for the new indication of preventing organ rejection in adult and pediatric patients receiving lung transplantation reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD), when
Drugs
FDA has sent a complete response letter to Ardelyx for its NDA for tenapanor for the control of serum phosphorous in adult patients with chronic kidney disease on dialysis. The company says FDA found that the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorous in
Drugs
Based on data from the Phase 3 KEYNOTE-716 trial of Merck’s Keytruda (pembrolizumab), FDA has accepted the company’s sBLA for the adjuvant treatment of adults and children age 12 and older with stage 2B or 2C melanoma following complete resection. The agency says it will give the
Drugs
The HHS Office of Inspector General (OIG) says its report assessing how FDA implements the accelerated approval pathway is expected to be issued in 2023. In an online notice, the OIG says FDA’s recent approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s patients “raised concerns due to
FDA Policy/General
A Spherix Global Insights survey of 252 specialists in dermatology, gastroenterology, nephrology, neurology, and rheumatology found that confidence in FDA is swiftly diminishing. The survey says only 36% of respondents expressed a high level of assurance in the agency, with nearly one-half saying their confidence in FDA has eroded
Drugs
An FDA complete response letter to Medexus Pharma and its medac licensor says the agency can’t approve their NDA for treosulfan in its present form. The NDA was submitted for treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The FDA letter provided
Drugs
The 14 life science companies that belong to the Rare Disease Company Coalition (RDCC) have written to House and Senate leaders to express their support for the FDA accelerated approval program. Their 7/29 letter also discusses concerns with policy recommendations from the Medicaid and CHIP Payment Access Commission (MACPAC)
Drugs
FDA’s orphan designation is based on data from the university that suggest ketamine has the potential to increase life expectancy of ALS patients at any stage and slow the progressive loss of muscle associated with poor outcomes, PharmaTher says. “Ketamine works by blocking the action of the ionotropic glutamate
Drugs
FDA has released the FDA-483 issued following a 2/18-3/16 inspection at the Eli Lilly sterile drug manufacturing facility in Indianapolis, IN. The seven inspection observations were: * failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas; * failing to thoroughly investigate any unexplained
Drugs
Bristol Myers Squibb has announced its decision to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (romidepsin), a histone deacetylase inhibitor, as monotherapy for treating peripheral T-cell lymphoma in adult patients who have received at least one prior therapy. This accelerated approval was based
Drugs
A 10/22-10/30/19 FDA inspection at Farmakeio Outsourcing, Southlake, TX, determined that the drug products produced at the outsourcing facility failed to meet the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify for
Drugs
FDA has accepted a Genentech sBLA and granted priority review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for specified people with non-small cell lung cancer. The company says FDA is reviewing the application under the real-time oncology review pilot program and is expected
Drugs
A 10/7-10/28/20 FDA inspection at Syntec Pharma, Farmingdale, NY, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A just-released 7/6 Warning Letter identifies the deviations as: * failing to perform repackaging, relabeling, or holding of API under appropriate CGMP
Drugs
FDA has lifted a partial clinical hold on Novartis’ investigational gene therapy OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA). The decision to lift the hold was based on data from Novartis’ comprehensive nonclinical toxicology study in non-human primates that addressed all issues identified, including questions
Drugs
FDA has approved an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Approval was based on data from the two TULIP Phase 3 trials and the MUSE Phase 2I trial. Data showed that “more patients treated
Drugs
FDA finds itself defending the accelerated approval process in the wake of Biogen’s controversial approval for its Alzheimer’s therapy Aduhelm (aducanumab), and a new BMJ report that since the program’s inception in 1992, nearly half (112) of the 253 drugs authorized have not been confirmed as clinically
Drugs
FDA has revised Regeneron’s emergency use authorization (EUA) for Regen-Cov (casirivimab and imdevimab expanding its emergency use as post-exposure prophylaxis (prevention) of Covid-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression
Drugs
FDA has approved GlaxoSmithKline’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with
Drugs
FDA has approved Mylan’s Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes and adults with Type 2 diabetes. An agency notice says Semglee is biosimilar to and interchangeable with Sanofi’s Lantus (insulin
Drugs
Four senators — Chuck Grassley (R-IA), Amy Klobuchar (D-MN), Angus King (I-ME), and Susan Collins (R-ME) — are calling on HHS secretary Xavier Becerra to support policies that would allow Americans to personally import certain prescription drugs from Canada. Their 7/26 letter follows a presidential executive order
Drugs
FDA has approved an Allergan label expansion for Botox to include eight new muscles for treating upper limb spasticity in adults. The company says the new muscles include those in the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus), as well as intrinsic hand muscles (lumbricals and interossei)
Drugs
FDA approved a modification to the clozapine REMS (risk evaluation and mitigation strategy) 7/29 to become effective 11/15. An agency notice says FDA continues to work with the Clozapine Product Manufacturing Group to ensure that patients relying on clozapine have continued access to the medication and appropriate management