Drugs
Furloughed FDA employees are expected to return to work early next week under a 1/25 tentative agreement reached between President Trump and Congress to re-open the government for three weeks while negotiations continue on border security issues. A short term budget resolution gives FDA some breathing room, according
Drugs
FDA has issued two draft guidances to help improve the agency’s ability to ensure that risk mitigation programs that are put in place for certain drugs and biologics as a requirement of their approval are working. The first guidance, REMS Assessment: Planning and Reporting, describes how to develop a
Drugs
Based on recent discussions with FDA, Bristol-Myers Squibb has withdrawn a supplemental BLA for an indication in metastatic first-line non-small cell lung cancer for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden (TMB) greater or equal to 10 mutations/megabase. The agency
Drugs
The chairman of the FDA Anesthetic and Analgesic Drugs Advisory Committee, anesthesiologist Raeford Brown, says the agency is putting the interests of narcotic drug manufacturers ahead of public health. In an explosive interview with The Guardian, Brown took particular aim at the recent FDA approval of AcelRx’ Dsuvia (sufentanil sublingual
Drugs
FDA has approved an Amerigen Pharmaceuticals ANDA for a generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Amerigen is currently selling an “authorized generic” version
Drugs
FDA has approved Sanofi Pasteur’s 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Approval is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children, which demonstrated that one or two doses
Drugs
FDA has placed a partial clinical hold on Advaxis’ Phase 3 AIM2CERV trial of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer. The company says the hold is related to FDA requests for additional information on certain AXAL chemistry, manufacturing, and controls matters. The agency did not cite
Drugs
FDA has approved a Teligent ANDA for a generic copy of Fougera Pharmaceuticals’ Temovate (clobetasol propionate ointment USP) 0.05%. The topical steroid is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. Annual sales of clobetasol propionate
Drugs
The Supreme Court unanimously refused to reinstate Helsinn Healthcare’s patent for its anti-nausea drug Aloxi, thereby supporting Teva, which launched a generic version of the drug last year. Reuters reports that Aloxi is indicated to prevent nausea and vomiting in patients receiving chemotherapy. According to the report, the
Drugs
Torrent Pharmaceuticals has expanded its recall from 10 lots of losartan potassium tablets to include six lots of losartan potassium and hydrochlorothiazide tablets due to the detection a suspected carcinogenic impurity, N-nitrosodiethylamine (NDEA) in an active pharmaceutical ingredient manufactured by Hetero Labs Limited. NDEA occurs naturally in certain foods,
Drugs
FDA has accepted for review two Merck supplemental NDAs for Pifeltro (doravirine, 100 mg) and Delstrigo (doravirine 100 mg, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg). The applications seek approval for Pifeltro (in combination with other antiretroviral medicines) and Delstrigo for use in people living with HIV-1
Drugs
FDA has denied an 8/2/17 American Dental Association petition asking the agency to open the rulemaking process to review and update five over-the-counter oral health drug product monographs. The petition said many of the monographs had not kept pace with the latest science-based testing standards,
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it spent a record $27.5 million on lobbying in 2018. Bloomberg News reports that the “surge in spending … came as the industry failed to win a last-minute legislative fix that would have reduced its share of outlays in a popular
Drugs
The Senate Finance Committee has announced a 1/29 hearing on “Drug Pricing in America: A Prescription for Change, Part I.” The 10:15 a.m. hearing will be chaired by chairman Chuck Grassley (R-IA). It is the first in a series of hearings “scrutinizing prescription drug pricing and
Drugs
FDA has placed on clinical hold a Translate Bio IND submission for MRT5201 for treating ornithine transcarbamylase (OTC) deficiency, due to additional clinical and nonclinical questions. The company submitted the IND in December to support the initiation of a Phase 1/2 clinical trial in patients with OTC deficiency. It
Drugs
FDA has cleared a United Imaging 510(k) for the uExplorer total-body scanner, which is described as the world’s first medical imaging scanner that can capture a 3D picture of the whole human body at one bed position. The device is a combined positron emission tomography and x-
Drugs
Janssen Biotech has submitted the first part of a supplemental BLA for a label expansion to include the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant. The
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 8 to 8 on whether to recommend approval for Lexicon Pharmaceuticals Inc and Sanofi’s sotagliflozin for treating Type 1 diabetes as an add-on to insulin therapy. Panel members were concerned about a safety signal that FDA raised in
Drugs
FDA has issued a guidance, Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway, to assist applicants in developing the Indications and Usage section of labeling for human prescription drug and biological products approved under the accelerated approval regulatory pathway. More specifically, the document
Drugs
FDA has released a draft International Council for Harmonization guidance, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines, recommending international standards for, and promoting harmonization of, the nonclinical safety studies recommended to support development of pediatric medicines. The document recommends an approach for the nonclinical safety evaluation
Drugs
FDA has granted Albireo Pharma an orphan drug designation for A4250, an ileal bile acid transporter inhibitor for treating biliary atresia, a rare and life-threatening liver disease with no approved pharmacologic treatment option. The company describes A4250 as a first-in-class product candidate being developed to treat rare
Drugs
FDA oncology researchers say that patient-reported outcome (PRO) assessments can contribute important information about the patient experience during treatment with anticancer products and use of such assessments is likely to increase. Writing in JAMA Oncology, the researchers say randomized oncology trials are increasingly open-label, and the accelerated approval