Drugs
Advera Health Analytics has issued an evidence review on comparative safety of six HER2 antagonists indicated for treating breast and stomach cancers. The report (registration required) shows that based on FDA adverse event reporting data, Genentech’s Kadcyla (ado-trastuzumab emtansine) and Genentech’s Perjeta (pertuzumab) have multiple unlabeled adverse
Drugs
The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures, Product Quality Microbiology Information in the Common Technical Document—Quality (CTD-Q), to assist CDER product quality microbiology reviewers by providing the expected locations of product quality microbiology information in the CTD-Q format. The document
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says that FDA is receiving orphan drug designation requests at a record rate of 1.6 per day, up from 2.23 per work day in 2016, and is granting designation requests at a near-record rate of 0.9 per day, down
Drugs
Hospira has recalled one lot of vancomycin hydrochloride for injection due to a confirmed customer report of particulate matter within a single vial. “In the unlikely event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood
Drugs
The Federal Trade Commission has filed a federal court stipulated order resolving charges that Endo Pharmaceuticals and Endo International violated antitrust laws by using so-called pay-for-delay settlements to block consumer access to generic versions of its Lidoderm topical patch indicated to relieve post-herpetic neuralgia and Opana
Drugs
FDA plans to request data on pharmaceutical quality metrics and has proposed guidance on data collection and submission, according to the Deloitte Life Sciences Regulatory Outlook for 2017. The document says the proposed guidance would change how FDA schedules its inspections, helping to promote modernization of the drug industry and
Drugs
The Justice Department says that Baxter Healthcare Corp. has agreed to pay $18.158 million to resolve criminal and civil liability arising from its failure to follow current good manufacturing practice (cGMP) when manufacturing sterile drug products in North Carolina. A department statement says the resolution includes a deferred prosecution
Drugs
Hogan Lovells attorneys say that one of the features of the 21st Century Cures Act is an attempt to bring consistency and efficiency to the regulation of combination products. In an online blog post, the firm says that the new law brings two important clarifications to the process of determining
Drugs
Novartis says that its generic version of Amgen’s Enbrel (etanercept) will not go on sale until 2018 at the earliest due to Amgen’s patent protection challenge. FDA has approved Novartis’ biosimilar Erelzi (etanercept-szzs) with an indication for rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, and other diseases. Amgen
Drugs
FDA has released an FDA-483 issued following a 12/5-12/9/16 inspection at Granules Omnichem Private Limited, Visakhapatnarn, India. The document lists these deviations from current good manufacturing practice regulations for active pharmaceutical ingredients: * failure of the quality unit to ensure review of all deviations reported during
Drugs
FDA has issued Natco Pharma Ltd. a six-item Form 483 after a 1/16-24 inspection of its pharmaceutical formulations facility in Kothur, near Hyderabad, India. In an unprecedented move by the company, it released a redacted copy of the inspection report. The company says the observations are “correctable,
Drugs
Mucodel Pharma, which is developing a buccal naloxone product, has asked FDA not to approve any intranasal (IN) naloxone NDA or ANDA for the emergency treatment of a known or suspected opioid overdose until the agency considers whether such an application adequately addresses the reliability of IN naloxone in actual
Drugs
FDA has released the FDA-483 issued after a 12/7-12/16/16 agency inspection at Hetero Labs, Polepally Village, India. Inspection observations included: * failing to fully follow the responsibilities and procedures applicable to the quality control unit; * failing to prepare batch production and control records for each batch
Drugs
A Pennsylvania federal judge has ruled that Sanofi Aventis can’t cite the 1st Amendment as grounds for dismissing a whistleblower’s suit charging that it used fraudulent and misleading speech to promote its chemotherapy drug Taxotore. An online blog post by attorneys for Peitragallo Gordon says that the company
Drugs
A 3/7-3/18/16 FDA inspection at Porton Biopharma (formerly Public Health England), Salisbury, UK, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients. A 1/19 Warning Letter says that specific violations and deviations included:
Drugs
A case being appealed to the Supreme Court says the court should overturn two earlier decisions that are the foundation of what has come to be known as the “Park Doctrine” or the responsible corporate officer doctrine. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA
Drugs
Eagle Pharmaceuticals has submitted a 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke (EHS). The company has requested a priority review and, if granted, a user fee target date is expected in July. “Our innovative formulation of dantrolene sodium has unique properties that may allow
Drugs
BIOLOGICS Draft Guide on Biosimilar Interchangeability Federal Register Notice: FDA has made available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the
Drugs
After a flurry of end-of-the year enforcement letters and new guidance documents this month on product communications, it appears a dramatic shift in CDER’s Office of Prescription Drug Promotion (OPDP) enforcement approach is underway, according to an analysis posted on FDAlawblog.com. “After a string of First
Drugs
FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) for treating adults with chronic idiopathic constipation (CIC). The company says Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal peptide that is thought to stimulate fluid secretion which results
Drugs
FDA has granted Concert Pharmaceuticals an orphan drug designation for CTP-656, a next-generation CFTR (cystic fibrosis transmembrane conductance regulator) potentiator being developed for treating cystic fibrosis. Last month, Concert initiated a Phase 2 trial in the U.S. evaluating the drug in cystic fibrosis patients with gating mutations.
Drugs
FDA has named deputy commissioner for foods and veterinary medicine Stephen Ostroff acting commissioner after former commissioner Robert Califf resigned 1/20 as the Trump Administration assumed government responsibilities. Ostroff has served as deputy commissioner since 5/2016. He previously served as acting commissioner from 4/2015 to 2/2016.