Drugs
FDA has issued a guidance, Elemental Impurities in Drug Products, with recommendations regarding the control of elemental impurities of human drug products marketed in the U.S. consistent with implementation of the International Council for Harmonization Q3D Elemental Impurities guidance. The document also is to assist manufacturers of compounded drug
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The Biotechnology Industry Organization (BIO) is asking FDA to clarify how its draft guidance on considerations for inclusion of adolescent patients in adult oncology clinical trials relates to provisions in the Pediatric Research Equity Act (PREA) and the FDA Reauthorization Act of 2017. The association’s comment letter says that
Drugs
FDA has issued Pain Therapeutics a complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to the company, the letter said data submitted in the company’s NDA do not support the conclusion that the benefits of Remoxy outweigh the risks. “This is a bizarre
Drugs
FDA has released a draft guidance entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” The document addresses the clinical endpoints acceptable to demonstrate the effectiveness of such drugs. For advice on specific drug development programs, sponsors are encouraged to contact CDER’s Division of
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FDA has granted Alteogen an orphan drug designation for ALT-P7 and its use in treating gastric cancer. The antibody-drug conjugate (ADC) uses a trastuzumab (Genentech’s Herceptin) variant form of an antibody. ALT-P7, which is being investigated for treating gastric and breast cancers, utilizes the company’s
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FDA has granted Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allogeneic cord blood transplant. The designation was based on efficacy and safety data from a Phase 2 single arm study in patients with hematologic malignancies who underwent a myeloablative
Drugs
FDA has approved an Indivior NDA for Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for treating schizophrenia in adults. Approval was based on data showing that clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental
Drugs
An FDA safety alert warns that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. “Results of a clinical trial found an increased rate
Drugs
FDA has granted PharmaMar an orphan drug designation for lurbinectedin and its use in treating small cell lung cancer. Lurbinectedin is described by the company as an inhibitor of RNA polymerase II, an enzyme that is essential for the transcription process that is over-activated in tumors with transcription addiction.
Drugs
FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replacement therapy (NRT) drugs to market. “We know that about 70% of adult smokers in the U.S. want to quit,” he says in an online post. “In fact, nearly half try
Drugs
Federal Register notice: FDA has announced that it has revoked an Emergency Use Authorization issued to Zalgen Labs for the ReEBOV Antigen Rapid Test, intended for use in detecting the Ebola virus. The authorization was revoked 5/18 as requested by the company in March after performance validation data were
Drugs
Members of the FDA Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products advisory committees will be asked 8/3 to review data from the most recent assessment of the REMS (Risk Evaluation and Mitigation Strategy) with Elements to Assure Safe Use for transmucosal immediate-
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Attorney Michelle Yeary (Dechert) says a Florida federal court rendered a mixed decision in a failure-to-warn case against Novartis involving a drug used to treat leukemia. Writing in a Drug & Device Law blog post, Yeary says the court didn’t agree that the suit was preempted by
Drugs
FDA says it has awarded nearly $6 million in grants to three research institutions to study how cutting-edge manufacturing technologies can be implemented in a way that leads to more innovative, consistent, and dependable manufacturing of drug and biological products. Grant recipients were Rutgers University, Massachusetts Institute of Technology,
Drugs
AuroMedics Pharma has recalled two lots of piperacillin and tazobactam for injection, USP 3.375 g due to concerns that vials may contain particulate matter, identified as glass and silicone material. “The administration of glass or silicone particulates may result in local irritation or swelling in response to the foreign
Drugs
FDA has approved a Shionogi NDA for Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist for treating thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Approval was based on safety and efficacy data from two Phase 3 clinical
Drugs
A 1/31-2/27 FDA inspection at BioDiagnostic International, Brea, CA, found significant violations of the Federal Food, Drug, and Cosmetic Act and of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Specific violations cited in a 7/12 Warning Letter were: * failing to have separate or defined
Drugs
FDA has granted Daiichi Sankyo a breakthrough therapy designation for quizartinib, an investigational FLT3 inhibitor for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia, a very aggressive form of the disease associated with poor prognosis. Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as
Drugs
FDA has released the FDA-483 issued following a 7/10-7/13 inspection at Sharp Drugs, a West Hampton Beach, NY, producer of sterile and non-sterile drugs. The inspection observations were: * ISO 5 classified aseptic processing area located within a non-classified room (segregated production area); * disinfecting agents,
Drugs
An 11/13-11/17/17 FDA inspection at the Yuki Gosei Kogyo drug manufacturing facility in Fukushima, Japan, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API), according to a 7/17 Warning Letter. The significant deviation cited in the letter was failure
Drugs
Americans for Homeopathic Choice and three of its top leaders are challenging an FDA draft guidance on homeopathy that says it intends to treat all homeopathic medicines as if they are “new drugs.” In a citizen petition, the group says it believes that homeopathic medicines fall under the 1938 definition
Drugs
A 12/7-12/27/17 FDA inspection at Milbar Laboratories, East Haven, CT, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/23 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility and authority to