Drugs
FDA has issued Alkem Laboratories a three-item Form-483 after an inspection (12/5-9) recently concluded at the firm’s Ankleshwar, India active pharmaceutical ingredient manufacturing plant. The company said in a financial release that it is preparing a detailed response with “adequate corrective and preventive measures” to
Drugs
FDA officials writing in the 12/8 New England Journal of Medicine express caution about “real world evidence” and its potential to contribute efficiently to current knowledge gained from traditional clinical trials, “whose well-known limitations make it difficult to generalize findings to larger, more inclusive populations of patients, providers,
Drugs
Several former pharmaceutical executives and managers at Insys Therapeutics were arrested 12/8 on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. The indictment alleges that former CEO Michael L. Babich, former sales VP Alec
Drugs
FDA has denied a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, 4 mg, indicated for treating opioid overdose, asking that it publish a guidance for all naloxone products to identify the “optimal fixed initial dose for each route of administration as well as the required exposure
Drugs
FDA has accepted for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum-based regimen. The agency has set a user fee review target for
Drugs
Gilead Sciences has submitted an NDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for treating direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The submission is based on data from two
Drugs
Bristol-Myers Squibb has entered into a settlement agreement with 43 states to resolve allegations the company used false and misleading representations to promote its antipsychotic drug Abilify. Under the agreement, Bristol-Myers Squibb will pay $19.5 million and implement marketing, sales, disclosure and other reforms aimed at avoiding
Drugs
The Health Industry Distributors Association says that a delay in issuing federal licensure regulations for pharmaceutical wholesale distributors has led to state inspectors and state boards developing varying interpretations and requirements, many of which the association says are not only inconsistent with the Drug Supply Chain Security Act but also
Drugs
FDA has issued a guidance, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, to aid “trading partners” (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined in the Drug Supply Chain Security Act (DSCSA) and terminating notifications. The document says that as
Drugs
FDA has cleared an Exact Imaging 510(k) for its ExactVu micro-ultrasound system for urological procedures. The device provides a resolution down to 70 microns, which is a 300% improvement in imaging resolution compared to traditional standard-of-care urological ultrasound systems, according to the company. Urologists now have
Drugs
The Association of Clinical Research Organizations (ACRO) says it welcomes and supports creation of an International Conference on Harmonization guideline on multi-regional clinical trials (MRCTs). “ACRO’s view is that the draft guideline represents a very well-considered approach to the issues raised by MRCTs and is an excellent
Biologics
The U.S. acting solicitor general is recommending that the Supreme Court hear appeals by Amgen and Sandoz on the implementation of portions of the Biologics Price Competition and Innovation Act (BPCIA). In an amicus brief, the acting solicitor general says that a Federal Circuit Court of Appeals conclusion that
Drugs
FDA associate commissioner for global regulatory policy Dana Corrigan says a Mutual Reliance Initiative (MRI) with the European Union (EU) allows FDA and EU inspectors to work together, relying on each other’s inspections, avoiding duplication, and conducting more inspections. Writing in an FDA Voice blog post, Corrigan says the
Drugs
Pharmaceutical Research and Manufacturers of America says the reauthorization of the Biosimilar User Fee Act for FY 2018-2022 (BsUFA 2) “provides the resources and support needed for FDA to achieve its core mission of protecting and promoting public health.” The association says the reauthorization agreement will continue to build
Drugs
President-elect Donald Trump may want to shake FDA up and reform its outdated approval programs, and maybe that is why his transition team reportedly is considering a Silicon Valley investor close to billionaire Peter Thiel to lead the agency. Jim O’Neil, a managing director of one of Theil’
Drugs
An FDA inspection at the Sun Pharmaceutical facility in Halol, India, resulted in a 14-page FDA-483 list of observations, Bloomberg News reports. A Mumbai securities analyst told the news service that the length of the report gives it a negative connotation. “We don’t know if it will
Drugs
Kitov Pharmaceuticals Holdings says it has completed FDA-required stability testing on nine pivotal batches of KIT-302, three in each dosage form (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg). The testing met the criteria demonstrating stability for six months,
Drugs
A former FDA official is calling out the agency over a couple of recent approvals that he says defy common sense and lack scientific proof that they are safe and effective. Writing in a Stat News opinion piece, former FDA medical officer and now Georgetown University pharmacology professor David Gortler
Drugs
A 5/2-5/6 FDA inspection at Interquim, Barcelona, Spain, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/22 Warning Letter. Specific deviations included: * failing to have adequate cleaning procedures that define and justify acceptance criteria for residues; * failing to
Drugs
As the Senate prepares for a floor vote Wednesday (12/7) on the 21st Century Cures Act, Senate Judiciary Committee members led by ranking member Patrick Leahy (D-VT) have introduced a bipartisan amendment to prevent pharmaceutical companies blocking cheaper generic alternatives from entering the marketplace. The Creating and Restoring
Drugs
The 1st Circuit Court of Appeals has upheld a district court decision allowing a 2012 payment of $700 million from AstraZeneca to Ranbaxy for abandoning its challenge to patents covering Nexium, delaying market entry of a generic Nexium. Attorneys Eric Furman and Caleb Bates (Knobbe Martens Olson & Bear) say
Drugs
CDER Office of New Drugs associate director for therapeutic biologics Leah Christl says that her agency and other major regulators are working toward attaining scientific alignment on biosimilar regulation rather than harmonization. Speaking at the 2016 DIA biosimilars conference, Christl said FDA “avoids using the word harmonization, because harmonization often