Drugs
Public Citizen says that the number and size of federal and state settlements in criminal and civil cases against drug companies decreased significantly in 2014 and 2015. “It remains to be seen whether this decline represents a longer-term trend,” the advocacy group says in a report updating a 2012
Drugs
FDA has published a draft guidance, Labeling for Biosimilar Products, to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products. The recommendations for prescription drug labeling in the document pertain only to the package insert, except for recommendations that pertain to FDA-approved patient labeling
Drugs
Cancer Moonshot Task Force executive director Greg Simon says there are very few unknown problems that are holding back cancer research. In a National Public Radio interview, he says what is important is to take action to address the barriers that are known “because the overarching goal of this initiative
Drugs
The Biosimilars Council, a division of the Generic Pharmaceutical Association, is asking the Supreme Court to hear Sandoz’ appeal of its biosimilars patent dance case against Amgen. The council’s amicus brief says that the decision by the Court of Appeals for the Federal Circuit requiring “patent dance” notification only
Drugs
The International Council on Harmonization (ICH) has reached the adoption phase (Step 4) on an Electronic Common Technical Document v4.0 Implementation Package for Modules 2 through 5. Step 4 enables each regulatory region to start the implementation process. As part of the implementation process, FDA says it is providing
Drugs
Opko Health has received an FDA complete response letter (CRL) on an NDA for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The letter cited manufacturing deficiencies at Opko’s third-party contract manufacturer found during
Drugs
The FTC has filed suit in eastern PA federal court alleging that Endo Pharmaceuticals and several other drug companies violated antitrust laws by using pay-for-delay settlements to block generic versions of Opana ER and Lidoderm. The agency says this is the first FTC case challenging an agreement not
Drugs
Republican leaders of the House Energy and Commerce Committee say that even with intensified FDA efforts to protect heparin, “serious challenges remain to significantly reduce risks for heparin from economically-motivated adulteration.” In a 3/29 letter to FDA commissioner Robert Califf, the congressmen lay out five key problems identified
Drugs
The Justice Department says Novartis has violated a Corporate Integrity Agreement it signed following the $422.5 million settlement of a 2010 case against the company over its drug promotional practices, and should now be hit with each tougher penalties. The government says the company engaged in a nationwide kickback
Drugs
FDA has approved a supplemental NDA for Danco Laboratories’ abortifacient Mifeprex (mifepristone) to relax label requirements for administering the drug. The approval expands on-label usage to 70 days after a woman’s last menstrual period. Previously, the label recommended the drug be used within 49 days of the last
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after receiving a hematopoietic stem cell transplantation (HSCT). Hepatic VOD can occur in patients who receive chemotherapy and HSCT, according to
Drugs
FDA says that during Fiscal Year 2015, it met or exceeded many of the goals established for the Generic Drug User Fee Amendments (GDUFA) program. The program’s FY 2015 performance report says the agency met or exceeded its hiring goal, exceeded the commitment to respond to 70% of GDUFA
Drugs
The Securities and Exchange Commission (SEC) has brought fraud charges against Aveo Pharmaceuticals and three of its former executives for misleading investors about company efforts to obtain FDA approval for its kidney cancer drug tivozanib. The SEC says the company hid the level of FDA concern about the drug in
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee has voted 12 to 2 to support approval of an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) and its use in treating psychosis associated with Parkinson’s Disease (PDP). Agency reviewers had noted that data submitted showed that pimavanserin 40 mg was more efficacious than
Drugs
A 9/15-10/7/14 FDA inspection at Leiter’s Compounding, San Jose, CA, found current good manufacturing practice and other violations in the firm’s work as an outsourcing facility and determined that the company is producing drugs that violate the Federal Food, Drug, and Cosmetic Act, according
Drugs
FDA has issued Newron Pharmaceuticals a complete response letter on an NDA for safinamide, indicated for treating patients with Parkinson’s disease. The letter requests “clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects” as required by CDER’s Controlled Substance
Drugs
B. Braun Medical has recalled one lot of 5% dextrose injection USP 100/150mL container (Lot #J5J706) after it identified an adverse quality trend in customer complaints reporting that some containers exhibited leakage. The company also says it has received complaints about visible particulate matter identified as microbial growth. “To
Drugs
Pain Therapeutics has resubmitted to FDA an NDA for Remoxy (oxycodone) extended-release capsules, an abuse-deterrent formulation for treating pain. The submission was made despite Pfizer deciding in 2014 to discontinue its agreement to develop and commercialize Remoxy due to unresolved issues outlined in a 2011 complete response letter
Drugs
FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Stiolto Respimat (tiotropium bromide and olodaterol) that adds to the label data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD). Approval is based on data from the OTEMTO 1 and 2 clinical
Drugs
FDA has issued Takeda Pharmaceutical Co. and H. Lundbeck A a complete response letter for a supplemental NDA for Brintellix (vortioxetine) that sought to include new data in the drug’s clinical trials labeling section for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The
Drugs
Since 2010, FDA has issued Warning Letters to an increasing number of companies for data integrity violations, according to an analysis by the PricewaterhouseCoopers Health Research Institute, reported in a March Regulatory Spotlight. From 2010 to 2012, it says, five drug manufacturers were cited for data integrity violations, while from
Drugs
Recent cases have produced differing results when courts have considered requests to stay litigation of drug patent disputes during inter partes review (IPR) proceedings authorized under the 2012 America Invents Act. WilmerHale attorneys Andrea Jeffries and Nancy Schroeder say that the litigation stay requests raise questions about the 30-month