Drugs
A Nelson Hardiman blog post says that the 21st Century Cures Act would weaken FDA oversight of new drugs and new uses for existing drugs. The post says that the bill would allow “evidence from clinical experience” to substitute for evidence gathered from clinical trials. “Essentially, doctors’ anecdotes would be
Drugs
FDA has published a draft guidance, Quality Attribute Considerations for Chewable Tablets, to give manufacturers of chewable tablets for human use CDER’s current thinking on the critical quality attributes that should be assessed during product development. The guidance also provide recommendations about submitting developmental, manufacturing, and labeling information for
Drugs
Two University of California, Irvine, researchers are asking whether it is possible to have better, more complete, data on drug shortages at little additional costs. Writing in Health Affairs, the two describe the significant differences they found between the FDA shortage database and the data from the University of Utah’
Drugs
The Generic Pharmaceutical Association (GPhA) says it supports the bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) act introduced by Sen. Chuck Grassley (R-IA). An association statement says the bill “improves patient access to safe and affordable medicines by taking steps to curb abuses of Risk Evaluation
Drugs
Former FDA Office of Generic Drugs deputy director and now consultant Gordon Johnston has pled guilty and admitted his role in an insider trading scheme that obtained highly confidential and material nonpublic information from a senior FDA official about the status and impending approval of generic enoxaparin (Sanofi-aventis’ blockbuster
Drugs
FDA says that its review of several Web sites owned by Focus Laboratories, North Little Rock, AR, indicates that the company is marketing items that the agency has determined are unapproved new drugs and are misbranded. A 6/3 Warning Letter from the agency’s Dallas District Office refers to
Drugs
Three Fish & Richardson attorneys say that Janssen’s Massachusetts federal court suit against Celltrion is of interest because it is one of the few currently pending litigations related to biosimilars and the Biologics Price Competition and Innovation Act (BPCIA). Writing in an online blog post, the attorneys says that
Drugs
A 5/28-29/15 FDA inspection at Austin Biotechnology, Taipei, Taiwan, found significant violations of current good manufacturing practice for finished pharmaceuticals, according to a 6/2 Warning Letter. Specific violations cited in the letter included: * failing to establish a quality control unit with the responsibility and authority to
Drugs
FDA has denied, without comment on whether it will take the requested action, a United Therapeutics 1/15 petition asking that the agency not approve any ANDA for a treprostinil inhalation solution drug-device combination product referencing Tyvaso unless certain conditions are met. The petition said the ANDA should: * request
Drugs
Marathon Pharmaceuticals has submitted an NDA for the investigational drug deflazacort for treating patients with Duchenne muscular dystrophy (DMD), the most common and most severe form of muscular dystrophy. The submission is supported by preclinical and clinical study data, including two pivotal clinical efficacy trials exclusively licensed by Marathon in
Drugs
Novo Nordisk says its diabetes drug Victoza (liraglutide) injection 1.2 mg or 1.8 mg reduced the risk of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo in a recent trial involving 9,340 adults. “Victoza is the only approved
Drugs
FDA has strengthened an existing warning about the risk of acute kidney injury for Type 2 diabetes medicines canagliflozin (Janssen’s Invokana and Invokamet) and dapagliflozin (AstraZeneca’s Farxiga and Xigduo XR). “Based on recent reports, we have revised the warnings in the drug labels to include information about acute
Drugs
The Washington Legal Foundation says that many state attorneys general view drug companies as “their own private cash cow.” A Legal Opinion Letter by two Arnold & Porter attorneys outlines a recent South Carolina Supreme Court decision against Janssen over its Risperdal marketing. In 2003, FDA required all drugs in
Drugs
Teva Pharmaceuticals has suspended marketing of its battery-powered Zecuity (sumatriptan iontophoretic transdermal system) patch, indicated for treating acute migraines, while FDA and the company investigate reports of serious burns and potential permanent scarring in product users. A recall has also been initiated, according to the company. Earlier this month,
Drugs
FDA has released a draft guidance on “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment” that provides recommendations for designing a nonclinical development program to support approval for such drugs. “In addition to the pharmacology and toxicology studies required to support development of a new drug or biologic, long-term
Drugs
House Energy and Commerce Committee chairman Fred Upton (R-MI) and ranking member Frank Pallone, Jr. (D-NJ) have introduced The FDA Cross-Center Collaboration Act of 2016, legislation to encourage collaboration between product centers at the agency. The bill would require FDA to establish one or more “Intercenter Institutes”
Drugs
Former Insys Therapeutics district manager Jonathan Roper and former sales rep Fernando Serrano have been arrested and charged with two counts each of violating the anti-kickback statute involving the painkiller Subsys (fentanyl). After their arrest, they were brought before U.S. magistrate judge Kevin N. Fox in Manhattan. The
Drugs
FDA has issued KemPharm a complete response letter for its NDA for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The letter is in response to an NDA amendment that the company filed last week (see story) that seeks to
Drugs
FDA has approved a ViiV Healthcare supplemental NDA for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages six to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Dolutegravir is indicated for
Drugs
A 6/10 FDA public meeting on the potential development of a user fee program for over-the-counter (OTC) monograph drugs drew criticism from some stakeholders who called for the agency to be more transparent and upfront on what kind of program it is seeking. FDA presenters provided no
Drugs
FDA has granted tentative approval to Upsher-Smith Laboratories for its supplemental NDA for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults. Company chief scientific officer William Pullman says that there are no extended-release topiramate formulations approved for migraine prophylaxis in the
Drugs
Salix Pharmaceuticals has agreed to pay $54 million to the U.S. government to settle a civil fraud lawsuit that alleged the company had violated the federal Anti-Kickback Statute and False Claims Act by using its “speaker programs” as a mechanism to pay kickbacks to doctors to induce them