Drugs
FDA has issued Sun Pharmaceutical Industries an eight-observation Form 483 after a December inspection at its Gujarat, India drug manufacturing facility. According to the form, the company was cited for not having written procedures for production and process controls designed to assure that its drug products have the identity,
Drugs
Incyte says its pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD) did not meet the primary endpoint of improving overall response rate compared to placebo plus corticosteroids. Itacitinib added to corticosteroids improved the overall response
Drugs
Several stakeholders are asking FDA to clarify elements in its draft guidance on methods to identify what is important to patients that is part of the agency’s series of guidances on patient-focused drug development. The National Organization for Rare Disorders says it appreciates that the emphasis of the
Drugs
Authors from FDA and several other organizations and academic centers analyze progress and challenges in developing new therapies for rare diseases. A Nature drug discovery review article says that addressing the translational gap is a multifaceted challenge for which a key aspect is the selection of the optimal therapeutic modality
Drugs
Kaiser Permanente says that expanding the scope of circumstances when postmarketing requirements (PMRs) can apply could increase available scientific evidence about drugs, which will support evidence-based treatment decisions and improve the quality of care. The company strongly encourages FDA “to apply and enforce meaningful PMRs to assess serious risks
Drugs
FDA has again issued Correvio Pharma a complete response letter on its NDA for Brinavess (vernakalant IV), an anti-arrhythmic drug for converting atrial fibrillation, due to safety concerns. The agency letter provided recommendations needed for resubmission, according to the company. “FDA stated that while the submitted data provides substantial
Drugs
Washington Legal Foundation (WLF) says the HHS Office of Inspector General (OIG) should reverse its decision to exclude drug and medical device manufacturers from the protection of proposed anti-kickback statute safe harbors. In a 12/31/19 comment, WLF praised the OIG’s removal of regulatory barriers to care
Drugs
FDA has approved an Eisai NDA for Dayvigo (lemborexant) 5 mg and 10 mg for treating adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The approval was based on data from two pivotal Phase 3 studies, which evaluated the drug versus placebo for up
Drugs
FDA says that dropping the exclusion of chemically synthesized polypeptides from the March opening of most protein products that were approved as drugs, including all currently marketed insulins, to biosimilar and interchangeable competition “will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein
Drugs
FDA has given accelerated approval to Astellas Pharma’s Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody and microtubule inhibitor conjugate, for treating adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death ligand-1 inhibitor and platinum-containing
Drugs
FDA says it will use information in a National Academies of Science, Engineering, and Medicine report it contracted on framing opioid prescribing guidelines for acute pain as it implements the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. That act requires FDA to
Drugs
Rep. Jan Schakowsky (D-IL) and Sen. Elizabeth Warren (D-MA) have reintroduced their Affordable Drug Manufacturing Act (H.R. 5501), described as an “ambitious proposal to address the skyrocketing price of prescription drugs.” A statement issued by Schakowsky (includes links to bill text and summary) says the measure would
Drugs
President Donald Trump and HHS are proposing a rule that, if finalized, would allow the importation of certain prescription drugs from Canada. The administration also announced a draft guidance with procedures drug manufacturers could follow to facilitate importation of prescription drugs, including biologics, that are FDA-approved, manufactured abroad, authorized
Drugs
FDA says that serious breathing difficulties may occur in patients using gabapentin (Pfizer's Neurontin, Assertio’s Gralise, Arbor’s Horizant) or pregabalin (Pfizer’s Lyrica and Lyrica CR) who have respiratory risk factors. In a drug safety communication, the agency said its evaluation showed that the use of
Drugs
Attorney James Beck (Reed Smith) says that with its announcement of the availability of CURE ID, an Internet-based repository of physician information on off-label success stories, FDA appears to be getting into the off-label promotion business itself. Writing in the Drug and Device Law blog, Beck says
Drugs
A new FDA analysis based on two sources shows that greater generic drug competition is linked to lower generic drug prices. An FDA statement says the analysis updates and expands on a 2005 analysis and includes two different sources of wholesale drug prices. It looked at all drug products that
Drugs
A bipartisan group of four House members has introduced the Lower Insulin Costs Now Act to increase access to affordable, generic insulin options. The bill was introduced by Reps. Lauren Underwood (D-IL), Jan Schakowsky (D-IL), Brett Guthrie (R-KY), and Mike Kelly (R-PA). A statement issued by
Drugs
A very strong final quarter in 2019 led to CDER approving 48 new molecular entities in 2019. While this number is 20% off of last year’s record 59 approvals, it is well above the 10-year average of 35 annual approvals. The Center approved 44% (21 submissions) during October,
Drugs
Aurobindo Pharma has recalled one lot of mirtazapine due to a label error on declared strength; bottles labeled as mirtazapine 7.5 mg may contain 15 mg tablets. “Taking a higher dose than expected may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation
Drugs
Some drug manufacturers, including Bristol-Myers Squibb, Gilead, Pfizer, GlaxoSmithKline, Sanofi and Biogen have started the new year with higher prices on more than 250 drugs. Reuters reports on data analyzed by 3 Axis Advisors, a healthcare research firm, showing that nearly all of the increases were less than 10%
Drugs
FDA has issued a draft guidance, Bridging for Drug-Device and Biologic-Device Combination Products, with recommendations for approaching bridging in NDAs or BLAs for drug-device or biologic-device single entity or co-packaged combination products. The document covers: * bridging of information related to a combination product that employs
Drugs
FDA has issued a draft guidance, Demonstrating Substantial Evidence of Equivalence for Human Drug and Biological Products, to guide applicants planning to file NDAs or BLAs or supplemental applications on the evidence to be provided to demonstrate effectiveness. The document complements and expands on a 1998 guidance. The guidance says