Drugs
Continuing FDA safety concerns involving PD-1/PD-L1 inhibitors have spread to two Roche clinical trials. A Phase 1b and Phase 1b/2 involving Tecentriq have been placed on partial clinical hold, according to Roche. Last month, CDER director Janet Woodcock said the agency was stepping up its safety
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FDA has approved a Symbiomix Therapeutics NDA for Solosec (secnidazole) 2g oral granules for treating bacterial vaginosis (BV) in adult women. The next-generation, 5-nitroimidazole antibiotic is designed with enhanced pharmacokinetic properties that enable delivery in a single dose, according to the company. Approval was based on data from
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FDA has posted 10 annex guidance documents developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The documents describe the evaluations and recommendations by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as
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Sanofi and Regeneron Pharmaceuticals have announced positive results from the Phase 3 CAFÉ study of Dupixent (dupilumab) in adults with moderate-to-severe atopic dermatitis who are inadequately controlled with or intolerant to the broad immunosuppressant drug cyclosporine A, or when this treatment is medically inadvisable. In the study, according
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FDA has issued a seven-item Form 483 after inspecting U.S. Specialty Formulations last month. According to the just-posted document, the firm was cited for personnel gowning for aseptic operations in non-classified areas, and the gowning area is not supplied with HEPA-filtered air. The investigator also
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The U.S. government has stepped into an ongoing Biologics Price Competition and Innovation Act (BPCIA) dispute (Amgen v. Sandoz) involving biosimilar-related disclosure provisions. According to the U.S. amicus brief, the BPCIA “preempts any state-law remedies for an applicant’s decision not to make the disclosures identified
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FDA has approved CSL Behring’s Privigen [immune globulin intravenous (human), 10% liquid] for treating adults with chronic inflammatory demyelinating polyneuropathy to improve neuromuscular disability. The rare autoimmune disorder affects peripheral nerves and may cause permanent nerve damage. Approval was based on data from two Phase 3 clinical studies, PATH
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FDA has approved a Nesher Pharmaceuticals ANDA for the first generic version of Genentech’s Tamiflu (oseltamivir phosphate) for oral suspension, 6 mg (base)/mL, indicated for patients that are not able to ingest capsules for treating influenza A and B in those two weeks of age and older. The
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FDA has approved a UCB supplemental NDA for Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Briviact is already approved in the U.S. as adjunctive treatment for POS in patients in this age group. It is in the “racetam”
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FDA says the International Conference on Harmonization (ICH) E18 guidance Guideline on Genomic Sampling and Management of Genomic Data, reached Step 4 of the ICH process this month and moves now to implementation. The document is intended to provide harmonized principles of genomic sampling and management of genomic data in
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FDA has approved Amgen’s Mvasi (bevacizumab-awwb), a biosimilar to Genentech’s Avastin (bevacizumab), for treating multiple types of cancer. It is the first biosimilar approved in the U.S. to treat cancer. An agency news release says Mvasi is approved to treat adult patients with certain colorectal, lung,
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FDA has approved AstraZeneca’s asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 micrograms to reduce exacerbations of chronic obstructive pulmonary disease (COPD). Expanded approval was based on data from two Phase 3 studies of six-month (Trial 3 — The RISE Study) and 12-month (Trial
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FDA has permitted under its de novo process the marketing of the first mobile medical application to help treat substance use disorders (SUDs). Pear Therapeutics Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs, according to an agency notice. The mobile
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FDA has granted accelerated approval to Bayer Healthcare Pharmaceuticals’ Aliqopa (copanlisib) for treating adults with relapsed follicular lymphoma who have received at least two prior systemic therapy treatments. The kinase inhibitor works by blocking several enzymes that promote cell growth, according to the agency. Approval was based on data from
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Two Hyman, Phelps & McNamara attorneys say that the recent FDA approval of Chemo Research’s NDA for benznidazole to treat children with Chagas disease, that included giving the sponsor a tropical disease priority review voucher, is the latest approval demonstrating how flexible the agency has become in applying evidence
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The FDA Office of Criminal Investigations and the Justice Department say that three Chipley, FL, residents have been arrested for their involvement in a steroid and fake prescription pill lab. The three had been indicted by a federal grand jury in August for conspiracy to import, manufacture, and distribute anabolic
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FDA has accepted for review an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In the U.S., Myrbetriq (mirabegron) and VESIcare (solifenacin succinate)
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Amicus Therapeutics says that top-line data from the Phase 3 ESSENCE study assessing the safety and efficacy of its novel topical wound-healing agent SD-101 show that it failed to meet the primary or secondary endpoints in participants with epidermolysis bullosa (EB). The study involved 169 patients with
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Representatives of Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) are attacking as inaccurate a study published in JAMA Internal Medicine on the research and development cost of bringing a new cancer drug to market, and revenues after approval. The researchers from a number of
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Several drug companies and their trade association are raising concerns about an FDA “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminology” document. Sanofi says it feels strongly that the effort will have a significant impact on underlying data systems within the industry as well as
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FDA’s Medical Imaging Drugs Advisory Committee has voted 13 to 1 to recommend a warning about gadolinium retention for gadolinium-based contrast agents (GBCAs) when used during magnetic resonance imaging (MRI) scans. Panel members said product labels should be updated to warn that gadolinium may be retained in certain
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CDER director Janet Woodcock told a House Energy and Commerce Health Subcommittee hearing 9/13 that the current monograph system for over-the-counter (OTC) drug products is outdated and reforms are needed to “improve the timeliness of review activities, spur innovation on behalf of consumers, and enable the agency