Drugs
A Florida federal court has denied the latest motion filed by Apotex to dismiss Amgen’s complaint in a follow-on suit about Apotex’ pegfilgrastim and filgrastim biosimilar candidates. The two companies have been involved in multiple patent lawsuits over the two biosimilars since 2015. A Big Molecule Watch online
Drugs
Takara Bio has submitted a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade. The reagent is often used during the manufacturing of CAR T-cell therapies. “In the manufacturing of such therapies, a patient’s T cells — responsible for immune homeostasis — are extracted, modified to
Drugs
As part of FDA’s role in combatting the opioid crisis, CDER has developed a Public Health Assessment via Structural Evaluation (PHASE) methodology to provide a structure-based evaluation of a newly-identified opioid’s risk to public safety. Writing online in Clinical Pharmacology and Therapeutics, seven CDER staffers say
Drugs
FDA has announced a 5/16 public meeting entitled “Responsible Innovation in Dietary Supplements.” The meeting is intended to provide interested parties an opportunity to present ideas for facilitating responsible innovation in the dietary supplement industry while preserving and strengthening FDA’s ability to efficiently and effectively protect the public
Drugs
CDER researchers are developing microengineered human cellular systems that allow for replication of human physiology and better prediction of drug effects before clinical trials are started. An agency Regulatory Science Impact Story says limitations in detecting drug toxicity before clinical trials means that drug developers often conduct costly trials of
Drugs
FDA is expanding its RCT DUPLICATE demonstration project with Aetion and Brigham and Women’s Hospital to use real-world evidence (RWE) to predict the results of seven ongoing Phase 4 trials. An Aetion statement says it is the first time that researchers will estimate the results of randomized controlled
Drugs
FDA has cleared a Bedfont 510(k) for its ToxCO carbon monoxide (CO) breath analysis monitor which determines levels of carbon monoxide poisoning. The device measures exhaled carbon monoxide to give healthcare personnel an idea of the levels in the blood, allowing them to triage carbon monoxide poisoning cases. “Breath
Drugs
The Federal Trade Commission (FTC) says that 12 corporate and four individual defendants have settled charges that they deceptively marketed “cognitive improvement” supplements using sham news Web sites containing false and unsubstantiated efficacy claims, references to non-existent clinical studies, and fraudulent consumer and celebrity endorsements. An FTC news release
Drugs
A Virginia federal grand jury has indicted Invidior, Inc. (formerly Reckitt Benckiser Pharmaceuticals) for engaging in an illegal scheme to increase prescriptions of Suboxone Film, an opioid drug used to treat opioid addiction. A Justice Department news release says Invidior obtained billions of dollars in revenue from Suboxone Film prescriptions
Drugs
Braeburn is petitioning FDA to revoke the orphan drug designation for Invidior’s Sublocade (buprenorphine extended-release) injection for treating opioid use disorder. The company’s petition calls on FDA to refuse to grant a seven-year orphan drug exclusivity for Sublocade. Braeburn says the exclusivity would likely prevent approval
Drugs
FDA has issued Zogenix a “refusal to file” letter for its for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome. “Upon its preliminary review, the FDA determined that the NDA, submitted on 2/5/2019, was not sufficiently complete to permit a substantive review,” the company says. In
FDA Policy/General
Three DIA Piper attorneys write in an online post that FDA acting commissioner Norman (Ned) Sharpless, who has been National Cancer Institute director, inherits four high-profile, ongoing initiatives. “It is yet to be seen how commissioner Sharpless will seek to move these initiatives forward,” they write, “and whether his
Drugs
Regeneron says it welcomes FDA efforts to provide recommendations in a draft guidance regarding clinical trials for drugs and therapeutic biologics to treat eosinophilic esophagitis (EoE). “As a rare disease,” the company’s comment says, “eosinophilic esophagitis is currently without a clear precedent for requirements for regulatory approval. We understand
Drugs
FDA has approved Amgen/UBS’ Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of fracture. An agency statement says these are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.
Drugs
An FDA drug safety communication says the agency has received reports of serious harm in patients who are physically dependent on opioid medicines suddenly having the medicines discontinued or the dose rapidly decreased. Examples of the harm include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide, the communication says.
FDA Policy/General
FDA and the Federal Trade Commission (FTC) say Advanced Spine and Pain, Mount Laurel, NJ, which is doing business as Relieveus, is using the Internet to market its CBD Salve, CBD Oil, and CBD for Dogs, which FDA considers to be new, unapproved and misbranded human or animal drugs that
Drugs
FDA has released the FDA-483 issued following a 2/22-3/1 inspection at Aurobindo Pharma, Telangana, India. The 11 specific observations on the form were: * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to establish control procedures that monitor the output and
Drugs
Bellerophon Therapeutics and FDA have reached agreement on the regulatory approval pathway for INOpulse, a proprietary pulsatile nitric oxide delivery system for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Based on recent data and INOpulse’s safety profile, Bellerophon says FDA agreed that it can measure
Drugs
FDA has approved a ViiV Healthcare NDA for Dovato (dolutegravir and lamivudine), as a complete regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. The
Drugs
Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals have agreed to pay a total of $122.6 million to resolve allegations that they each violated the False Claims Act by illegally paying Medicare or Civilian Health and Medical Program co-pays for their own products through foundations that the companies used as
Drugs
FDA has posted a 24-page Form 483 from a 5/2018 inspection of Akorn’s Decatur, IL sterile drug manufacturing operation. The inspection documented “poor aseptic processing techniques” and the company’s inadequate system for monitoring environmental conditions in aseptic processing areas. Additionally, the inspection form cited Akorn for
Drugs
FDA has issued a guidance, REMS: FDA’s Application of Statutory Factors in Determining When a REMS is Necessary, to clarify how the agency applies the factors from the Federal Food, Drug, and Cosmetic Act to determine whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that