Drugs
Eisai and Purdue Pharma have submitted an NDA for lemborexant for treating insomnia. The submission was based on data from two pivotal Phase 3 clinical studies in patients with insomnia — SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303) — that enrolled about 2,000 patients. SUNRISE 1 included the first
Drugs
FDA has issued a draft guidance, ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs, to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. The document says it provides recommendations on the timing and content of amendments to tentatively
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for the first generic version of Lundbeck’s Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. Teva had
Drugs
FDA has issued a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in conducting more efficient and successful drug development programs. “Although the statutory requirements for marketing approval for drugs to treat rare
Devices
FDA has cleared an Immuno Concepts 510(k) for the Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use. The indirect immunofluorescent test is used to detect anti-mitochondrial antibodies, anti-smooth muscle antibodies, and anti-parietal cell antibodies. These autoantibodies are associated with several autoimmune diseases, including
Drugs
The FDA 12/12/18 final guidance on data integrity and compliance with CGMP (current good manufacturing practice) says that management with executive responsibility has the role of creating a quality culture in which employees understand the importance of data integrity and are encouraged to identify and promptly report data
Devices
FDA has cleared an MIM Software Inc. 510(k) for its molecular radiotherapy (MRT) dosimetry. MRT uses radiopharmaceuticals such as Lutathera (Lu-177 DOTATATE) and Azedra (I-131 iobenguane) to target tumors based on certain receptors that these tumors express. Currently, the company says there has not been an effective
Drugs
FDA has approved an Exelixis supplemental NDA for Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the U.S., according to the company. Previously,
Drugs
Massachusetts attorney general Maura Healy has written a 274-page memo detailing the role that the Sackler family behind Purdue Pharma played in the nation’s opioid epidemic. Healy alleges that the Sacklers knew that OxyContin was causing overdoses but continued to push its sales as deaths mounted. Boston public
Devices
FDA has cleared an iSchemaView 510(k) for its RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy (clot removal). The additional clearance allows RAPID CT-Perfusion and RAPID MR-Perfusion to be used by physicians to aid in the selection of
Devices
AdvaMed says it has updated its Code of Ethics on Interactions with Health Care Professionals to “reflect evolving legal standards, care delivery models, and best practices over the last decade to ensure the code’s continued effectiveness as a premier foundational document for ethics and compliance.” An association announcement says
Drugs
FDA has accelerated the PDUFA review date for Nabriva Therapeutics’ Contepo (fosfomycin for injection) from 6/30 to 4/30. The company says the two-month acceleration is due to a clarification of the classification and subsequent expedited review period for the 10/2018 Contepo NDA. FDA has granted Contepo
FDA Policy/General
FDA has ordered about 400 inspectors and support professionals to return to their posts from furlough to re-initiate high-risk surveillance inspections across food and medical product programs. In a series of tweets, commissioner Scott Gottlieb said about 100 staff are focused on inspections of high-risk medical device
Biologics
FDA commissioner Scott Gottlieb and CBER director Peter Marks say the agency is seeing a surge in cell and gene therapy products entering early development, as shown by the large upswing in the number of IND applications. In a statement, the two project that by 2020 the agency will receive
Drugs
HHS secretary Alex Azar says there have been “positive developments in drug pricing behavior” since President Donald Trump released a 5/2018 drug pricing blueprint. “From the release of the president’s blueprint … through the end of 2018, drug companies took 57% fewer price increases on brand drugs compared with
Drugs
FDA has granted Menlo Therapeutics a breakthrough therapy designation for serlopitant for treating pruritus associated with prurigo nodularis (PN). The designation is based on data from a Phase 2 clinical trial in pruritus associated with PN, according to the company. In the 127-patient trial, serlopitant met its primary and
Drugs
Aimmune Therapeutics mistakingly paid a $2.5 million user fee with a BLA submission for AR101, an investigational biologic oral immunotherapy for treating peanut allergy that was submitted just before the partial government shutdown. Under the agency’s shutdown guidelines, such a submission could have been accepted for review because
Drugs
FDA medical reviewers are raising safety issues associated with Sanofi’s sotagliflozin that will be considered by the agency’s Endocrinologic and Metabolic Drugs Advisory Committee 1/17. A briefing document released in advance of the meeting says Sanofi is seeking approval for the drug as an adjunct to insulin
Drugs
FDA has accepted for review two Pfizer NDAs for tafamidis for treating transthyretin amyloid cardiomyopathy (ATTR-CM). The submission are based on two formulations of tafamidis — meglumine salt and free acid. The company says the tafamidis meglumine form (20 mg capsule) has been granted a priority review with a user
Drugs
A joint meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee has voted 19 to 2 that based on its benefit-to-risk profile there is a patient population with gout that exists for Takeda’s Uloric (febuxostat) for its current indication as
Drugs
FDA commissioner Scott Gottlieb says the agency is monitoring whether branded biologic companies are taking any steps to undermine the fledgling biosimilar product market. “FDA continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we’ll take action if we determine a
Drugs
An FDA Bone, Reproductive and Urologic Drugs Advisory Committee 1/16 will discuss an Amgen BLA for romosozumab, indicated for treating osteoporosis in postmenopausal women at high risk of fracture, and a cardiovascular safety issue that arose during the submission’s earlier review that led to a complete response letter.