Drugs
FDA has issued Immunomedics a complete response letter (CRL) on its BLA for sacituzumab govitecan for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. “The issues related to approvability in the CRL were exclusively focused on chemistry, manufacturing and
Drugs
Eli Lilly says results from ANNOUNCE, a Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the therapy’s clinical benefit, which is a requirement for a product to demonstrate post approval under FDA’s accelerated
Drugs
Prinston Pharmaceutical Inc. (dba Solco Healthcare) has recalled one lot of irbesartan and seven lots of irbesartan hydrochlorothiazide tablets due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals. “Prinston is only recalling lots of irbesartan-containing products
Drugs
FDA has issued Johnson & Johnson's Actelion Pharmaceuticals a complete response letter for its supplemental NDA for Opsumit (macitentan) for treating adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve pulmonary vascular resistance (PVR) and exercise capacity. The agency said that additional data are needed to evaluate
Drugs
FDA has approved a Nexus Pharmaceuticals ANDA for busulfan injection, the company’s AP-rated therapeutic equivalent to Otsuka’s Busulfex 60 mg/10 mL (6 mg/1 mL). “Busulfan is currently on the American Society of Health System Pharmacists drug shortage list,” Nexus notes. It is indicated for use
Drugs
In an effort to encourage drug companies to enter the over-the-counter market and increase access to the opioid overdose reversing drug naloxone, FDA has developed a model drug facts label (DFL) with easy-to-use pictograms on how to use the drug. A statement from FDA commissioner Scott
Drugs
FDA says it has approved a modification to the Risk Evaluation and Mitigation Strategy (REMS) for clozapine (Novartis’ Clozaril), an antipsychotic drug used to help improve symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. The changes take effect 2/28 and include a requirement
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
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
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
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
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
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