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DEVICES FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on
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FDA has approved a BioMarin Pharmaceutical NDA for Palynziq (pegvaliase-pqpz) for adults with phenylketonuria (PKU), a rare and serious genetic disease where patients are born with an inability to break down phenylalanine, present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages.
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FDA has granted Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa (DEB). The company says that KB103 is the first topically-applied herpes simplex virus based gene therapy engineered to deliver a human collagen protein to patients suffering from DEB, which is a chronic and
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FDA has granted Pfizer a breakthrough therapy designation for tafamidis for treating patients with transthyretin cardiomyopathy, a rare and fatal condition associated with progressive heart failure. The designation was based on data from the tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, in which the drug demonstrated a statistically significant
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FDA has accepted for review an AcelRx Pharmaceuticals NDA resubmission for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain for adult patients in medically supervised settings. FDA has assigned a user fee review action target date of 11/3. In 10/2017, the agency issued
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The Supreme Court is refusing to hear an appeal of a 5th Circuit Court of Appeals decision to uphold summary judgment and award costs in favor of Solvay Pharmaceuticals in a False Claims Act case. Attorneys Jennifer Thomas and Andrew Hull (Hyman, Phelps & McNamara) write in their firm’s
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FDA has issued a complete response letter to Recro Pharma for the NDA on its IV meloxicam. The company reports that FDA said that although the pivotal Phase 3 trials demonstrated statistically significant outcomes on the primary endpoint, the agency is unable to approve the NDA in its current form.
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Pfizer will pay $23.85 million to resolve claims that it used a foundation to pay copays of Medicare patients taking three company drugs. A Justice Department news release on the settlement identifies the Pfizer drugs as Sutent and Inlyta, which both treat renal carcinoma, and Tikosyn, which treats arrhythmia
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A Senate Appropriations Committee 5/24 mark-up for FY 2019 has approved $2.97 billion in discretionary funding for FDA, which is $159 million (5%) over the FY 2018 enacted level, but about $150 million less than the House has approved (see earlier story). Both measures are now awaiting
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FDA has cleared a protocol amendment for Cotinga Pharmaceuticals’ ongoing clinical Phase 1b/2a trial of COTI-2. The amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers, the company says. Cotinga says it will initially evaluate COTI-2 combined with
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FDA has released the FDA-483 issued following a 4/11-4/26 inspection at Pine Pharmaceuticals, a Tonawanda, NY, outsourcing facility. The three observations listed on the form were: * employees engaged in the processing of a drug product lack the training required to perform their assigned functions; * procedures designed
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CDER director of nonprescription drug products Theresa Michele says that a new draft guidance on maximal usage trials (MUsT studies) will help industry design and conduct MUsT studies for topical active ingredients that are under consideration for inclusion in an OTC monograph. Writing in an FDA Voice blog post, Michele
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FDA is asking manufacturers to voluntarily withdraw from the market over-the-counter (OTC) oral health products containing the pain reliever benzocaine indicated for the temporary relief of sore gums due to teething in infants or children. If companies do not comply, the agency says in a statement, it will
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FDA has published a guidance, Anthrax: Developing Drugs for Prophylaxios of Inhalational Anthrax, to assist sponsors in developing drugs with an indication of prophylaxis to inhalational anthrax in persons who have or may have inhaled aerosolized Bacillus anthracis spores but who have not yet manifested clinical evidence of disease. The
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The U.S. Solicitor General says the Supreme Court should hear Merck’s appeal of an appeals court ruling in a failure-to-warn case involving its Fosamax. In an amicus brief, the government says the 3rd Circuit Court of Appeals erred in holding that a jury must determine whether
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FDA has approved an Eli Lilly supplemental NDA for a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. The product was first approved 3/2016 for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic
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FDA has issued a complete response letter (CRL) for Cosmo Pharmaceuticals’ NDA for Methylene Blue MMX, intended as a visualization aid to increase detection of colon lesions. The company says the CRL is consistent with preliminary feedback it announced 5/9 that FDA had identified unspecified deficiencies that preclude continuation
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FDA has accepted for review a Sanofi NDA for Zynquista (sotagliflozin), an oral treatment added to insulin therapy to improve blood sugar control in adults with Type 1 diabetes. The oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate
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A 9/18-9/22/17 FDA inspection at Nox Bellcow Cosmetics, Guandong Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/9 Warning Letter. Specific violations cited were: * failing to establish an adequate quality control unit with the responsibility
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An 11/13-11/17/17 FDA inspection at Cerno Pharmaceuticals, Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations and misbranding regulations in the firm’s production of finished pharmaceuticals. A 5/15 Warning Letter says the violations were: * failing to withhold from use each lot
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FDA has released a seven-item Form 483 following a 5/1 inspection of Biocon’s Bangalore, India drug substance and drug product manufacturing facility. For example, FDA investigators cited the firm for not adequately demonstrating its disinfection efficacy. The firm was also cited for a deficient environmental monitoring effort
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Avadel Specialty Pharmaceuticals, which markets Noctiva (desmopressin acetate) nasal spray for treating nocturia due to nocturnal polyuria, is asking FDA to impose requirements on NDAs for desmopressin acetate products with that indication, including a resubmitted Ferring NDA for its Nocturna (desmopressin acetate). In its 5/18 petition, Avadel asks that