Drugs
FDA published 10/6 a Federal Register notice with final regulations to implement some of the provisions of the 2003 Medicare Modernization Act. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the final rule “will forever alter the Waxman-Hatch landscape and
Drugs
Novartis reportedly has paid over $35 million to settle a whistleblower’s false claims case over off-label marketing of its eczema cream Elidel. Corporate Crime Reporter says that a former Novartis sales representative alleged that he was instructed to tell doctors that Elidel was safe and effective for use
Drugs
Nurse Assist has recalled all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections. The recall was conducted after the company became aware of patients that developed the infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist, a recall
Drugs
FDA has issued a guidance, Tropical Disease Priority Review Vouchers, discussing implementation of part of the FDA Amendments Act of 2007 that authorized the agency to award priority review vouchers to sponsors of certain tropical disease product applications that meet specified criteria. The agency says it has received numerous inquiries
Drugs
FDA has released a guidance on “Head Lice Infestation: Developing Drugs for Topical Treatment” to assist sponsors in the clinical development of such drugs. Specifically, the document gives the agency’s current thinking on the overall development program and clinical trial designs, and is intended to help sponsors plan clinical
Drugs
Collegium Pharmaceutical has submitted a supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment. The sNDA includes comparative oral pharmacokinetic data from a recently completed clinical
Drugs
Pfizer is petitioning FDA to grant five-year exclusivity for bazedoxifene, a new active moiety that is in its fixed-dose combination drug Duavee (conjugated estrogens/bazedoxifine). The 9/30 petition says that Duavee has already been granted a three-year exclusivity period that expired 10/3, making time of
Drugs
Senior leaders from drug companies, government agencies, and academia convened by the Tufts Center for the Study of Drug Development for a roundtable discussion say that companies need to prioritize where to place resources to help pediatric oncology drug development. The center’s latest R&D Management Report (subscription
FDA Policy/General
A Pew Charitable Trusts analysis says that one-third of animal antibiotic drug labels will not meet judicious use requirements that are part of an agency voluntary guidance intended to ensure the judicious use of antibiotics that are important to humans in the production of food animals. The report says
Drugs
FDA has granted Breakthrough Therapy designation to Roche’s Actemra/RoActemra (tocilizumab) for giant cell arteritis (GCA), described as a chronic, potentially life-threatening autoimmune condition. The company says the disease is caused by inflammation of large and medium-sized arteries, most often in the head but also in the
Drugs
FDA has granted Chugai Pharmaceutical a breakthrough therapy designation for Actemra /RoActemra (tocilizumab), a Chugai-originated drug that is currently under development by Roche and Genentech for treating giant cell arteritis (GCA). The designation was based on the GiACTA study, a global Phase 3 study assessing the efficacy and safety
Drugs
FDA has warned patients and healthcare providers about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (see listing below). In
Drugs
Lilly associate senior consultant for global quality laboratories Mark Newton says there is the potential for adverse pharmaceutical data integrity impact when companies uses a layered approach, such as a data entry forms layer, business rules layer, and database layer. Writing in an online blog post, Newton references a recent
Drugs
FDA says it recently completed its 20th patient-focused drug development meeting held as part of the PDUFA 5 agreement. CDER Office of Strategic Programs director Theresa Mullin writes in an FDA Voice blog post that under PDUFA 5 FDA committed to obtain patients’ views in at least 20 disease
Drugs
FDA says that Nippon Fine Chemical Co., Takasago City, Hyogo, Japan, limited and/or refused an FDA inspection when an investigator came to the company on 12/14/15. A 9/15 Warning Letter says that under the Federal Food, Drug, and Cosmetic Act, drugs produced by the company are
Drugs
In its report on potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System between April and June, the agency says it is evaluating the need for regulatory action on 22 separate signals in products or classes of products. The report also shows action
Drugs
A new CDER drug safety report has outlined ongoing research priorities to improve drug safety. For example, one priority is to use electronic health care data to better determine suicide risks associated with approved drug products. “CDER must enhance its ability to determine if suicide is a potential adverse event
Drugs
FDA has denied a Haner & Kuo (New York) citizen petition, which was filed on behalf of an unnamed client, that asked FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. Like several others still pending at the agency, this petition
Drugs
CDER director Janet Woodcock is “unfit to serve as CDER director,” Public Citizen Health Research Group director Michael Carome says in a Huffington Post blog posting. Her decision last month to approve Sarepta’s Duchenne muscular dystrophy drug eteplirsen while overruling several agency experts, “represents a dangerous, unparalled capitulation to
Drugs
Jazz Pharmaceuticals has begun a rolling NDA submission for Vyxeos (cytarabine and daunorubicin liposome injection), an investigational agent for treating acute myeloid leukemia (AML). The company expects to complete the submission of the NDA by early next year, and will request a priority review. Vyxeos was granted breakthrough therapy designation
Drugs
Par Pharmaceutical has filed a lawsuit in DC federal court against FDA seeking reversal of an agency decision that revoked Par’s eligibility for 180-day exclusivity for a generic copy of Takeda’s gout drug Colcrys (colchicine) tablets. On 9/28, the agency informed Par for the first time
Drugs
The Securities and Exchange Commission (SEC) has charged the former senior director of regulatory affairs for Puma Biotechnology with insider trading based on clinical trial data to which he was privy. The SEC alleges that Robert Gadimian gained more than $1.1 million in illicit profits by secretly purchasing Puma