Drugs
Attorneys Frank Sasinowski and Alexander Varond (Hyman, Phelps & McNamara) say that their analysis of the strength of scientific and clinical evidence for FDA’s 19 non-AIDS, non-cancer Subpart H approval determinations over the accelerated approval program’s 24 years shows that the agency “exercises extraordinary regulatory flexibility
Drugs
FDA has published a draft guidance on “Ulcerative Colitis: Clinical Trial Endpoints” that is intended to assist sponsors in their clinical development of drugs for treating the condition in adult and pediatric patients. The document addresses FDA’s current thinking on efficacy endpoints for ulcerative colitis clinical trials. “This draft
Drugs
FDA has granted Merck accelerated approval for Keytruda (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. The approval was based on tumor response rate and durability of
Drugs
FDA has cited Alfred I. duPont Hospital for Children after an inspection of its sterile drug compounding operations found significant GMP violations. A just-posted Form 483 said the inspection found that the hospital aseptic processing areas’ systems for maintaining any equipment are deficient. Specifically, it says the hospital’s
Drugs
Improved research and technology development, combined with general advances in biological and information technologies, should accelerate improvement in cardiovascular outcomes, opines FDA commissioner Robert Califf in an 8/8 Journal of the American College of Cardiology article. “But if we are to harness these technologies and apply them effectively, our
Drugs
FDA has issued Alexion Pharmaceutical a three-item Form-483 after inspecting its Smithfield, RI manufacturing facility. “These observations are inspectional, and do not represent a final FDA determination of compliance,” the company said in a financial disclosure filing. “The observations pertain to: completion and closure of certain investigations, validation
Drugs
The National Institutes of Health Clinical Center has “decommissioned” operations at its Pharmaceutical Development Section (PDS) after “serious manufacturing problems and lack of compliance with standard operating procedures” were uncovered in an FDA inspection last year. Previously, PDS operations were suspended while corrective actions were taken (see earlier story). PDS
Drugs
FDA has accepted a Merck NDA for MK-1293, an investigational follow-on biologic copy of Sanofi-Aventis’ Lantus (insulin glargine) for use in treating people with Type 1 and Type 2 diabetes. Because Lantus was not approved under the Public Health Service Act, there is no biosimilar approval pathway
Drugs
Bristol-Myers Squibb (BMS) has reported disappointing data from its CheckMate-026, a trial investigating the use of Opdivo (nivolumab) as monotherapy in advanced non-small cell lung cancer (NSCLC). The trial did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced NSCLC whose
Drugs
Pfizer’s Hospira drug unit has recalled one lot of 0.25% bupivacaine hydrochloride injection, USP (lot # 59-064-DK, expiry 11/1/2017) due to the presence of particulate matter within a single vial, according to an FDA recall notice. The product is indicated for local or regional anesthesia
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee have voted 18 to 1 to recommend that an Egalet NDA for Arymo ER (morphine sulfate extended-release tablets) be approved for managing pain severe enough to require daily, around-the-clock,
Drugs
FDA and Amarin have agreed to amend the company’s special protocol assessment (SPA) agreement for the REDUCE-IT cardiovascular outcomes study involving Vascepa (icosapent ethyl). Currently, the drug is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Earlier
Drugs
The Biotechnology Innovation Organization (BIO) has published a document with four “considerations” to provide the ethical foundation for any product communication. The group says that the considerations were drawn from application of relevant aspects of BIO’s Statement of Ethical Principles. “In the past,” the document says, “BIO has primarily
Drugs
FDA has denied a 10/17/13 petition from the American Herbal Products Association asking that it (1) formally rescind an agency policy prohibiting investigators from quoting or citing cGMP (current good manufacturing practice) regulations upon which they base inspection findings reported in FDA-483 issued to conventional food and
Drugs
CDER’s Larissa Lapteva says that clinical holds placed on INDs do not lead to “substantial” delays in drug development. Interviewed for a CDER Conversation, she said that the CDER Office of New Drugs’ rare diseases program began collecting data specifically related to rare disease applications in 2010. “At the
Drugs
Sunovion Pharmaceuticals has filed an NDA for SUN-101/eFlow (glycopyrrolate), an investigational treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Glycopyrrolate is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the eFlow nebulizer closed system. The submission is based
Drugs
Four CDER staffers say that the drug industry, academia, and regulatory agencies need to make a collaborative effort to develop new approaches and technologies for in vivo in vitro correlations (IVIVC) so they can be better used in drug development and post-approval manufacturing changes. Writing in the AAPS Journal,
Drugs
FDA has told Ocular Therapeutix that corrective actions detailed in a response to an inspection Form 483 appear to address the 10 observations that led to a complete response letter for its NDA on Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in treating ocular pain occurring after ophthalmic
Drugs
Par Sterile Products is asking FDA not to approve any ANDA for an epinephrine injection 1 mg/mL product in a 1 mL vial, ampule, pre-filled syringe or similar parenteral administration modality unless the generic product contains the same inactive composition as would the reformulated Par Adrenalin (epinephrine injection)
Drugs
Citizens Against Government Waste (CAGW) president Tom Schatz says that FDA decisions on biosimilar labeling could “create obstacles in biosimilars by both sending a signal that they are not as safe or effective as their corresponding brand-name biologics, and raising questions about the two types of drugs that are
Drugs
FDA has published a draft guidance, Insanitary Conditions at Compounding Facilities, to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. The document says it also is intended to assist state regulators in understanding some examples of what the agency considers to be insanitary conditions
Drugs
Nine healthcare advocacy organizations representing pharmacists, pharmacies, payers, pharmacy benefit managers, and other stakeholders have written to key members of both the House and Senate to express concern about an FDA proposal to exempt certain biologic products, including biosimilars, from requirements to adhere to U.S. Pharmacopeial (USP) public standards