Drugs
Merck says that the C-EDGE comparative Phase 3 study of Zepatier (elbasvir and grazoprevir) versus a regimen of Gilead’s Sovaldi (sofosbuvir) plus peginterferon and ribavirin showed Zepatier superiority in treatment-experienced patients with chronic hepatitis C genotype 1 or 4 infection. FDA approved the drug 1/28 based
Drugs
FDA has issued a draft guidance, Data Integrity and Compliance with CGMP, to clarify the role of data integrity in current good manufacturing practice for drugs. The document says that the agency expects that data will be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based
Drugs
FDA has posted the results of five drug safety evaluations completed between 10/1 and 12/31/15. For four of the five — Wyeth’s Duavee (conjugated estrogens/bazedoxifene) tablet, film-coated; Medicis’ Luzu (luliconazole) cream; zoledronic acid injection; and Iroko’s Zorvolex (diclofenac) capsule — no new safety issues were
Drugs
Researchers say that doctors often don’t understand the meaning of FDA approval of a drug. A report in the Journal of the American Medical Association says the researchers surveyed board-certified internists and specialists and found “substantial deficits in knowledge of the meaning of FDA approval. Physicians tended to
Drugs
CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that the office is on track to meet the goals set for it under the 2012 Generic Drug User Fee Act (GDUFA). Writing in an FDA Voice blog post, Uhl says that 2015 was the first full year of operation
Drugs
FDA has accepted for review a Pain Therapeutics NDA resubmission for Remoxy (oxycodone) extended-release capsules in an abuse-deterrent formulation for treating pain. The agency has set a user fee review target date of 9/25. The submission was made despite Pfizer deciding in 2014 to discontinue its agreement
Drugs
FDA has accepted for review an sBLA for Merck’s Keytruda (pembrolizumab) for treating patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Merck says that its application seeks approval for Keytruda as a single agent at a dose
Drugs
An 8/17-8/21/15 FDA inspection at the Pikeville Medical Center Institutional Review Board (IRB) Pikeville, KY, found that the IRB did not adhere to applicable FDA regulations governing the protection of human subjects. A just-released 3/1 Warning Letter says that violations shown on an FDA-
Drugs
CDER Office of Pharmaceutical Quality deputy director Lawrence Yu says that while it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards and FDA is encouraging companies to consider making the effort. Writing in an FDA Voice blog post, Yu says that
Drugs
A Utah federal court has agreed with Aventis that there was “clear evidence,” as required under Wyeth v. Levine, that FDA would not have approved labeling changes for its Clomid to include a warning against using the drug before pregnancy. The case was brought by a woman who used Clomid
Drugs
Some 15 healthcare stakeholders led by the Generic Pharmaceutical Association and including managed care companies, pharmaceutical benefits managers, and leading drug companies have told FDA that a proposed rule to change generic drug labeling requirements could permit multiple, potentially conflicting labels for therapeutically equivalent products that would create provider and
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/12 voted 12 to 1 to not recommend accelerated approval for a Clovis Oncology NDA for rociletinib tablets and its use in treating patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an
Drugs
Biosimilar products are unlikely to have federal preemption protection from state product liability claims like generic drugs under PLIVA v. Mensing, according to an analysis by Reed Smith attorney James Beck. Traditional generic preemption “depends on the impossibility of making an immediate change to a product (including its labeling) as
Drugs
Durect Corp. is amending its PERSIST Phase 3 trial for Posimir, an extended-release depot utilizing the company’s SABER technology designed to continuously deliver bupivacaine, based on recommendations in an FDA advice letter. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. “This change
Drugs
FDA has approved an AbbVie NDA for Venclexta (venetoclax) and its use in treating patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one prior therapy. An FDA release says the drug is the first agency-approved
Drugs
FDA has published a guidance on Safety Considerations for Product Design to Minimize Medication Errors that provides a set of principles for using a systems approach to minimize errors relating to product and container closure designs for all prescription and nonprescription drugs and biologic products. The guidance also provides examples
Drugs
FDA is requiring changes to labeled recommendations on metformin-containing medicines for diabetes to expand the drug’s use in certain patients with reduced kidney function. The current labeling strongly recommends against metformin’s use in some patients whose kidneys do not work normally. The agency says it was asked
Drugs
FDA has granted orphan drug designation to Anavex Life Sciences Corp. for its drug candidate Anavex 3-71 for treating frontotemporal dementia (FTD), described as a syndrome associated with progressive shrinking of the frontal and temporal anterior lobes of the brain, causing a decline in language skills and/or behavioral
Drugs
FDA has created its first Combination Products Policy Council, a senior-level, agency-wide forum for discussing, resolving, and implementing product and policy issues. “Because of the multiple FDA organizations involved, this council will have decisional authority on issues relating to combination products, cross-labeled products, and medical product classification,
Drugs
The European Medicines Agency (EMA) has started a review involving approved drugs that relied on studies that were conducted at Alkem Laboratories Ltds in Taloja, India. The regulator says its action is the result of a good clinical practice inspection of this site which raised concerns regarding study data used
Drugs
FDA’s Gastrointestinal Drug Advisory Committee has unanimously (17 to 0) voted to recommend approval for an Intercept Pharmaceuticals NDA for obeticholic acid (OCA) for treating primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable
Drugs
Is FDA looking for some wiggle room to skirt its obligation under current law to approve generic opioids in the face of unprecedented public alarm about the current abuse epidemic? Addressing the recent Rx Opioid and Drug Abuse Summit in Atlanta, FDA commissioner Robert Califf acknowledged calls for the agency