Drugs
FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. The expanded approval is intended for patients experiencing disease progression on or after two
Drugs
FDA has issued Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active rheumatoid arthritis. The agency letter indicated that additional clinical data are needed to further evaluate the therapy’s safety, according to the company. Janssen plans to have
Drugs
Aegerion Pharmaceuticals has agreed to plead guilty in the Massachusetts federal court to two misdemeanor misbranding charges involving Juxtapid (lomitapide), indicated as an adjunct therapy to treat homozygous familial hypercholesterolemia (HoFH), a rare disorder that that causes high cholesterol levels and early cardiovascular disease. According to the government, Aegerion failed
Drugs
The 5th Circuit Court of Appeals has upheld a Texas federal court grant of summary judgment to Solvay Pharmaceuticals in a False Claims Act (FCA) case brought by two whistleblowers alleging that the company induced false Medicaid claims through off-label marketing and kickbacks to promote Luvox, Aceon, and AndroGel.
Drugs
FDA has published a draft guidance, Statistical Approaches to Evaluate Analytical Similarity, with agency advice on the evaluation of analytical similarity for sponsors interested in developing biosimilar products under the Biologics Price Competition and Innovation Act of 2009. Specifically, the document says, it describes the type of information a sponsor
Drugs
An FDA safety alert warns that Intercept Pharmaceuticals’ liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. “Ocaliva may also be associated with liver injury in some
Drugs
Public Citizen has filed suit against FDA in DC federal court over the agency’s failure to rule on the advocacy group’s three-year-old petition asking that it address life-threatening health risks associated with benzocaine, an ingredient common in certain infant teething and other medicines. The suit
Drugs
FDA has cleared a ClaroNav 510(K) for NaviENT, a computer-assisted surgical navigation system for surgical procedures inside a patient’s skull. The device provides three-dimensional visualization and assists surgeons in navigating patient sinuses while avoiding areas like the optic nerve and brain, the company says. The system
Drugs
Four FDA officials say that in the period FY 2010-2014, FDA allowed 98% of individual patient expanded-access requests to proceed. Writing in The Journal of Clinical Pharmacology, the four say that for individual expended access requests, FDA must determine that: * the patient to be treated has a serious
Drugs
The FDA request for stakeholder views on ensuring a balance between innovation and access in the Waxman-Hatch amendments has brought diverse views. In its response, Vifor Pharma says that generic forms of non-biological complex drugs (NBCDs) should not be approved via the ANDA pathway. It asks the agency
Drugs
An FDA safety alert says that opioid addiction medications buprenorphine and methadone should continue to be given to patients taking benzodiazepines or other drugs that depress the central nervous system, even though their combined use increases the risk of serious side effects. The agency contends that the harm caused by
Drugs
FDA has told Lipocine that the agency’s Bone, Reproductive and Urologic Drugs Advisory Committee plans to discuss the company’s NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). The advisory committee meeting
Drugs
Pfizer has filed suit in Pennsylvania federal court against Johnson & Johnson and its Janssen Biotech unit for antitrust violations in blocking competition from Pfizer’s biosimilar Inflectra (infliximab-dyyb) to protect Janssen’s Remicade (infliximab). The suit says the case is about J&J “imposing a web of
Drugs
FDA says that opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other central nervous system depressants. An agency drug safety communication says the “combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction
Drugs
The CDER Office of Drug Security, Integrity, and Response has sent Warning Letters to 13 Internet-based companies operating scores of individual Web sites that the agency says are offering unapproved new drugs and misbranded drugs for sale in U.S. commerce. The 13 companies are 247Med, Pharm Cash, Glay
Drugs
An 11/3-11/11/16 FDA inspection at Firson Company, Chungcheongnam-do, Korea, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to an 8/31 Warning Letter. Specific violations noted in the letter were: * failing to establish and follow appropriate written procedures designed to
Drugs
FDA has approved a GlaxoSmithKline and Innoviva NDA for a once-daily, single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), indicated for long-term maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis or emphysema. The therapy is intended for patients who are on a
Drugs
A 3/6-3/10 FDA inspection at Wuxi Medical Instrument Factory, Wuxi City, Jiangsu, China, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 9/7 Warning Letter. Specific violations noted in the letter were: * failing to establish written procedures for production and
Drugs
FDA has denied a Boehringer Ingelheim petition seeking to have FDA impose conditions for approving any NDA for a fixed-dose, triple-combination, inhaled drug product intended to treat patients with chronic obstructive pulmonary disease (COPD). In its denial letter, the agency said it was approving GlaxoSmithKline’s Trelegy Ellipta
Drugs
FDA’s Oncologic Drug Advisory Committee has voted six in favor and six against the benefit-risk profile for Pfizer’s Sutent (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after surgical removal of the cancer-containing kidney. FDA has set a
Drugs
The Post-Finasteride Syndrome Foundation is asking FDA to immediately withdraw marketing approval for Merck’s Propecia and generic formulations of finasteride 1 mg for androgenic alopecia “because the risk of serious injury from the drug outweighs its limited benefits.” The foundation says that an alternative request would be to
Drugs
The Association for Accessible Medicines (AAM) says that a draft FDA guidance on “Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions,” represents a fundamental departure from the GDUFA 2 comment letter and may unintentionally discourage ANDA sponsors from submitting a priority review request. In its comment