Drugs
A 9/14-9/15/17 FDA inspection at Quali-Controle & Quali-Controle C.E.BAC, Meru, France, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 3/5 Warning Letter. Specific violations cited were: * failing to establish and document the accuracy, sensitivity,
Drugs
The President’s Cancer Panel is calling on President Donald Trump to make the dramatic rise of cancer drug prices a national priority that requires a “concerted, immediate, bipartisan, and multilateral effort.” In a report to Trump, the three panel members say they propose balanced solutions aimed at growing a
Drugs
FDA has placed on clinical hold an Advaxis IND for a Phase 1/2 combination study of axalimogene filolisbac with AstraZeneca’s Imfinzi (durvalumab) for treating patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The company says the hold
Drugs
Rep. Frank Pallone (D-NJ) has introduced HR 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, to increase funding to and expand FDA authority to prevent illegally manufactured opioids, including heroin and fentanyl, from arriving through the mail from overseas.In a statement (includes link
Drugs
FDA has released the FDA-483 issued following a 2/6-2/15 inspection at Biocon Sdn Bhd, a Johor, Malaysia, sterile drug manufacturer. The inspection observations were: * failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failing to thoroughly review
Drugs
FDA has announced new research to be conducted on direct-to-consumer (DTC) ads — “Utilization of Adequate Provision Among Low to Non-Internet Users.” Agency regulations require that broadcast advertisements contain a brief summary of side effects and contraindications or that “adequate provision” be made for dissemination of the approved
Drugs
Federal Register notice: FDA has submitted a proposed collection of information to OMB for review and clearance — “Transfer of a Premarket Notification.” The information collection is related to a draft guidance on “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers,” which is intended to provide information on
Drugs
FDA has reaffirmed a 2017 complete response letter denying approval of a Hikma Pharmaceuticals ANDA for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). In a just-concluded dispute resolution action, FDA has upheld its complete response action that requested the completion of an
Drugs
A revised “Right to Try” bill has been introduced in the House to improve access to experimental treatments for patients. “This updated ‘Right to Try’ bill is the direct result of conversations with our colleagues, the administration, and stakeholders on all sides of the issue,” said House Energy and Commerce
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Proprietary Names for New Animal Drugs.” The document provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand
Drugs
FDA has approved two ANDAs from Cipla Limited and Aurobindo Pharma for the first generic versions of Amgen’s Sensipar (cinacalcet hydrochloride) tablets for treating a thyroid issue in certain patients on dialysis. The drug is also indicated for treating hypercalcemia in adult patients with parathyroid carcinoma, and severe hypercalcemia
Drugs
FDA’s Gastrointestinal Drugs Advisory Committee has voted unanimously (15-0) to support approval of a Pfizer supplemental NDA for Xeljanz (tofacitinib) to treat adults with moderately to severely active ulcerative colitis. The positive vote follows a data presentation that showed that after eights weeks of treatment a significantly greater
Drugs
FDA has granted MiMedx Group a regenerative medicine advanced therapy designation for micronized amniotic tissue, AmnioFix Injectable, and its use in treating osteoarthritis of the knee. In granting the designation, FDA acknowledged preliminary clinical evidence that the drug has the potential to address unmet medical needs for the condition, according
Drugs
FDA has released the FDA-483 issued following a 2/5-2/23 agency inspection at Pentec Health, a Boothwyn, PA, outsourcing facility. The five specific observations in the document were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * batch production and control records do not
Drugs
A petition submitted by the Haynes and Boone law firm asks FDA not to approve any ANDA for a mycophenolate mofetil oral suspension product that relies on only metabolite data to establish bioequivalence to the reference-listed drug (Roche’s CellCept). The firm’s 3/6 petition also asks the
Drugs
FDA has accepted for review a TherapeuticsMD NDA for TX-001HR, an investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for treating moderate-to-severe vasomotor symptoms due to menopause. The agency has set a user fee review action target of 10/28.
Drugs
FDA has given IDE approval to InVivo Therapeutics Holdings for a second pivotal clinical study involving the company’s Neuro-Spinal Scaffold in patients with acute spinal cord injury. The 20-patient, randomized, controlled trial is designed to complement existing clinical evidence from the company’s single-arm INSPIRE study.
Drugs
FDA commissioner Scott Gottlieb says he wants more agency investigators at international mail facilities to help intercept illegal drug shipments, particularly opioids disguised as other drugs and dietary supplements. Speaking to an Associated Press reporter 3/6, Gottlieb said he wants to more than double the number of packages his
Drugs
Addressing healthcare payors at the America’s Health Insurance Plans National Health Policy Conference, FDA commissioner Scott Gottlieb said payors are going to have to decide whether they want to continue to receive the short-term profit that comes with drug rebate programs or are willing to support a system
Drugs
A Tufts Center for the Study of Drug Development survey says that the clinical trial study initiation process remains highly inefficient with wide variation among companies, despite implementation of new technology solutions and practices. “The findings indicate that the site initiation process has become increasingly challenging for sponsors and contract
Drugs
Esperion has reported positive top-line results from a pivotal Phase 3 study (Study 4 or 1002-048) involving its investigational bempedoic acid 180 mg. The trial was designed to evaluate the LDL-C lowering efficacy and safety and tolerability of bempedoic acid versus placebo in patients with, or at
Drugs
FDA has cleared a Panther Orthopedics 510(k) for the Puma System, an implantable flexible fixation device indicated for syndesmosis fixation, hallux valgus reconstruction, and tarsometatarsal fixation. The device was designed to solve problems experienced with stiff metal screws, which serve as stress risers and prohibit normal physiological joint motion,