Drugs
Pfizer CEO Albert Bourta says that payers are trapped and can’t cover biosimilars because they would lose the benefit of rebates offered by the innovator companies. “Unless we resolve this big issue,” he said on a third quarter conference call, “we will never be able to see tremendous progress
Drugs
IQVIA (formerly IMS Health and Quintiles) says an FDA draft guidance on general pharmacology considerations for neonatal studies for drugs and biological products provides a helpful explanation of the agency’s current thinking on the topic. The firm’s comment letter says it strongly advocates that generation of data in
Drugs
The CDER Office of Hematology and Oncology Products (OHOP) has been reorganized as the Office of Oncologic Diseases (OOD). An agency announcement says that OHOP director Richard Pazdur has been named acting director of OOD. Pazdur also directs the FDA Oncology Center of Excellence that was established in 2017 to
Drugs
FDA has posted on its Web site a draft document, “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff,” as required by the 21st Century Cures Act. The document was released for comment within the next 60 days. In an executive summary, FDA says the draft
Drugs
FDA has approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen’s Neulasta (pegfilgrastim) for decreasing the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant
Drugs
Six CDER staff members say that in the Center’s Office of Hematology and Oncology Products, less than 10% of INDs went on hold or were withdrawn within the 30-day safety review period. In an article to be published in Regulatory Toxicology and Pharmacology, the researchers report that of
Drugs
An FDA 5/7-5/10 inspection at Bingbing Pharmaceutical Co., Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a just-released 10/3 Warning Letter. Specific violations were: * failing to maintain written production, control, or distribution records specifically associated with
Drugs
A lengthy Kaiser Health News online story details instances in which FDA has approved branded drugs for marketing despite manufacturing issues raised by agency inspectors. The story says the pressure on the agency to get innovative drugs to market quickly is considerable, because they offer new treatments for desperate patients
Drugs
A McKinsey white paper says a “holistic” transformation of the drug development process could result in accelerating the development timeline by 500 days and reducing cost by 25%. “While there is no silver bullet,” the report says, “drug developers can make a concerted effort to apply and integrate multiple innovations
Drugs
FDA has awarded AnaBios an “Indefinite Delivery, Indefinite Quantity” contract to access its adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function. The company says it has worked for a decade to develop a translational ex-vivo human heart platform. “We anticipate
Drugs
A recent FDA-requested clinical trial did not alleviate an “overall survival (OS) trend” that the agency was concerned with in an earlier Aveo Oncology study of tivozanib in highly refractory metastatic renal cell carcinoma (RCC) patients, according to a company update. FDA told the company that it was premature
Drugs
Aquestive Therapeutics, which is testing Libervant (diazepam) buccal oral film for seizure clusters, is asking FDA to stay approval of Neurelis’ 505(b)(2) NDA for Valtoco (diazepam intranasal solution) until additional clinical studies have been conducted that would allow for adequate labeling as requested by Aquestive. An Aquestive 11/
Drugs
Tonix Pharmaceuticals says that for its Phase 3 study of Tonmya (cyclobenzaprine sublingual tablets) to treat post-traumatic stress disorder (PTSD), the timing of the primary endpoint analysis has been changed from week 4 to week 12. The company also says it plans to add an interim analysis that allows
Drugs
Fagron has recalled its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products. The packs are used as a topical anesthetic and packaged in boxes containing lidocaine hydrochloride, epinephrine bitartrate, tetracaine hydrochloride, sodium metabisulfite, suturagel methylcellulose base, an adapter cap and syringes, according to a
Drugs
FDA has approved a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg /250 mg/12.5 mg for treating Helicobacter pylori (H. pylori) infection in adults. The company says Talicia is the only rifabutin-based therapy approved for treating the infection and is
Drugs
Novartis says its EXCEED head-to-head trial comparing Cosentyx (secukinumab) to AbbVie’s Humira (adalimumab) in patients with active psoriatic arthritis (PsA) “missed statistical significance for superiority” in the composite measure ACR 20, but Cosentyx did show numerically higher results versus Humira. “Statistically significant advantages of Cosentyx versus Humira
Drugs
An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine (NDMA) found in ranitidine (Zantac) says that preliminary testing on numerous ranitidine products has found NDMA levels that are similar to levels consumers would normally be exposed to in foods like grilled or smoked meats. “We
Drugs
FDA has issued a draft guidance, Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, to give stakeholders information on the agency’s implementation of GDUFA 2. “Because GDUFA 2 created changes to the user fee program,” the document says, “this guidance serves to provide an explanation
Drugs
FDA has issued a guidance, Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment, to assist sponsors in clinical development of drugs to treat chronic hepatitis D virus (HDV) infection. The document specifically addresses the agency’s current recommendations for the overall development program and clinical trial designs for the
Drugs
FDA has granted a Recro Pharma appeal of the agency’s complete response letter issued for the NDA seeking approval for intravenous meloxicam. The company says the FDA letter said the appeal was granted “specific to the request … that the NDA provides sufficient evidence of effectiveness and safety to support
Drugs
ICU Medical has recalled one single lot of lactated ringer’s injection, USP, and one single lot of 0.9% sodium chloride injection, USP, due to the presence of particulate matter. “Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the
Drugs
FDA has granted CARsgen Therapeutics a Regenerative Medicine Advanced Therapy designation for its investigational CT053 CAR-T cell therapy and its use in treating relapsed and refractory multiple myeloma. The designation for the drug, a human anti-B cell maturation antigen, was based on clinical data from an ongoing Phase