Drugs
Medtronic says it has enrolled the first patient in its Embrace TDD (targeted drug delivery) study to evaluate using the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain, with or without leg pain. The company says
Drugs
FDA has granted Bridge Biotherapeutics an orphan drug designation for BBT-877, an autotaxin inhibitor that deregulates ATX, an enzyme found to be associated with inflammation and fibrosis. The early-stage compound of BBT-877 had been originally discovered by LegoChem Biosciences and Bridge Biotherapeutics acquired the worldwide exclusive rights
Drugs
As a result of a meeting with FDA staff, Omeros and the agency have finalized the company’s clinical plan for its OMS721 submission and approval in immunoglobulin A nephropathy (IgAN). The company says OMS721 is its lead human monoclonal antibody targeting MASP-2, the effector enzyme of the complement
Drugs
FDA has released a final guidance, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, to assist drug or medical device sponsors who are planning to develop new drugs and test devices and want to coordinate development of the products so that the test device could be cleared either
Drugs
UCLA Anderson School of Management researchers say they have developed a quantitative framework that FDA could use to assess candidate drugs based on severity and prevalence as well as characteristics of the drug development process and existing market. “Such a model could augment the complex decision-making and statistical analyses
Devices
As part of an agreement to resolve all long-standing patent disputes between the two companies, Edwards Lifesciences is making a one-time payment of $180 million to Boston Scientific. The two firms have been involved for several years in litigation over heart valve replacement systems, including transcatheter aortic valves,
Biologics
FDA has approved an expanded use for Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria, and pertussis. The company says Adacel is the first and only Tdap vaccine in the U.S. approved for
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