Drugs
FDA has cleared an Allergan 510(k) for TrueTear Intranasal Tear Neurostimulator, a handheld device developed to temporarily increase tear production during neurostimulation in adult patients. The device comes with daily disposable tips that are inserted into the nasal cavity to induce the production of tears. Clearance was based on
Drugs
In announcing a record first quarter, Lonza says it was issued an FDA Warning Letter 4/24 after an inspection at the firm’s Walkersville, MD “bioscience solutions” manufacturing plant. The letter raised concerns with validation and the company’s aseptic operations — issues the company says it is currently addressing.
Drugs
FDA has accepted for review a Santen Pharmaceutical NDA for intravitreal (IVT) sirolimus for treating non-infectious uveitis of the posterior segment (NIU-PS). Uveitis is a leading cause of preventable blindness in working-age adults. The agency has set a user fee review target date of 12/24. IVT
Drugs
Critics of Scott Gottlieb’s nomination as FDA commissioner question the role he played in 2006 in helping Cephalon secure more fentanyl for its opioid lollipop used by some cancer patients. The Washington Post reports that at the time that Gottlieb (who was then an FDA deputy commissioner) and other
Drugs
A Massachusetts federal judge has allowed an argument that FDA acted recklessly in its oversight of the New England Compounding Center (NECC) and thus bears some liability for damages incurred by two medical practices that used contaminated sterile drugs from NECC to go forward. The judge ruled on a motion
Drugs
Hospira has recalled one lot of 25% dextrose injection, USP, (infant) pre-filled syringe due to the presence of particulate matter, identified as human hair, found within an internal sample syringe. The affected lot is NDC: 0409-1775-10, Lot 58382EV, expiry date 10/1/2017, according to a recall
Drugs
Eli Lilly says it will file an NDA for abemaciclib based on data from a Phase 3 breast cancer study called MONARCH 3 that met its primary endpoint of demonstrating statistically significant improvement in progression-free survival, according to an interim analysis. The study evaluated abemaciclib, a cyclin-dependent kinase
Drugs
Apotex has petitioned FDA to impose stricter requirements for applicants seeking approval for a biosimilar product referencing Amgen’s Neulasta (pegfilgrastim). The petition wants applicants to “conduct their comparative clinical efficacy studies (including pharmacokinetics (PK) and pharmacodynamics (PD) studies and immunogenicity studies) in at least one intended patient population.” Apotex
Drugs
FDA has approved Sanofi’s Thymoglobulin [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression to prevent acute rejection in patients receiving a kidney transplant. Approval was based on data from two randomized multicenter studies comparing Thymoglobulin to interleukin-2 receptor antagonists (il2ra:basiliximab or daclizumab) in deceased
Drugs
FDA has cited Sun Pharmaceuticals with an 11-item Form 483 after completing a week-long inspection 4/13 at the firm’s Dadra, India finished-dosage drug manufacturing facility. For example, FDA said the firm’s laboratory records do not include all calculations and graphs associated with a test.
Drugs
Becton Dickinson (BD) has reached an agreement to acquire medical device firm C.R. Bard for $24 billion. BD says the transaction would improve its ability to offer products that reduce the chance of hospital-acquired infections. Bard is a leader in vascular, urology and oncology treatments. DePuy Synthes says
Drugs
FDA has issued Vernalis a complete response letter for CCP-07, an extended release equivalent product to an undisclosed prescription cough-cold treatment. The letter “did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07 but did identify outstanding items that need to be addressed prior
Drugs
FDA has released a draft guidance on generic naloxone hydrochloride nasal spray entitled “Draft Guidance on Naloxone Hydrochloride.” The document provides product-specific recommendations on bioequivalence study designs to support ANDAs for naloxone hydrochloride (Narcan) nasal spray, indicated for treating opioid overdose.
Drugs
FDA and Basilea Pharmaceutica have reached agreement on Special Protocol Assessments (SPAs) for two planned Phase 3 clinical studies evaluating the company’s antibiotic ceftobiprole. for treating Staphylococcus aureus bacteremia (bloodstream infections) and acute bacterial skin and skin structure infections. If successful, the company believes studies would be cross-supportive
Drugs
Rep. Steve Stivers (R-OH) has reintroduced the “Speeding Access to Already Approved Pharmaceuticals Act that would require FDA to expedite the review of pharmaceuticals that are approved by the European Union (EU). The bill is co-sponsored by Tim Ryan (D-OH). Specifically, the measure requires the agency to
Drugs
FDA has granted Aldeyra Therapeutics an orphan drug designation for ADX-102 and its use in treating congenital ichthyosis, a severe skin disease characteristic of Sjögren-Larsson Syndrome (SLS). “The skin disease associated with SLS is physically and emotionally debilitating, leading to considerable social stigma and requiring significant daily care
Drugs
CytRx Corp. and FDA have reached an agreement to allow the company to submit a rolling 505(b)(2) NDA for aldoxorubicin in soft tissue sarcomas (STS). The company says it is planning to complete the submission in the fourth quarter. Previously, the agency granted aldoxorubicin an orphan drug designation
Drugs
FDA and the European Medicines Agency (EMA) say a five-year joint pilot program for parallel assessment of applications containing Quality by Design (QbD) elements showed “solid alignment between both agencies regarding implementation of multiple International Conference on Harmonization Q8, Q9, and Q10 concepts. The FDA/EMA QbD pilot program
Drugs
FDA says it is restricting the use of codeine and tramadol medicines in children due to ongoing concern about serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years. The medicines should also be limited in some older
Drugs
AbbVie says that two Phase 3 trials of its veliparib, an investigational oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints. A company statement says the studies evaluated veliparib in combination with carboplatin and paclitaxel in patients with squamous non-small cell lung cancer and
Drugs
CDER director of professional affairs and stakeholder engagement John Whyte says the agency has taken steps to promote patient diversity in clinical trials. Writing in a Clinical Leader guest column, Whyte references a 2014 action plan with 27 recommendations in three broad categories: improving the completeness and quality of the
Drugs
Pfizer says it has received grand jury subpoenas from the Justice Department about an antitrust probe into drug makers that market intravenous saline solutions. Reuters reports that subpoenas also were received by ICU Medical, which acquired Pfizer’s global infusion therapy business, and Baxter International. ICU Medical said the probe