Devices
FDA has granted Grünenthal an expedited access pathway designation for Vivo, a surgical sealant proposed for being an adjunct to standard closure techniques in gastrointestinal procedures to reduce intestinal leakage. The company says the designation recognizes the “high unmet medical need in preventing intestinal leakages after gastrointestinal surgeries — life-threatening
Drugs
FDA has approved B. Braun Medical’s 0.9% sodium chloride injection, USP in the Ecoflac Plus 500 mL container. Over the past few years, B. Braun has worked with the agency to temporarily import Ecoflac Plus under regulatory discretion from an FDA inspected sterile injectable facility in Melsungen, Germany.
Drugs
The former head pharmacist at New England Compounding Center (NECC) has been sentenced to eight years of imprisonment for his role in the 2012 nationwide fungal meningitis outbreak that killed 64 and caused infections in 793 patients. Glenn Chin (Canton, MA) was also sentenced to two years of supervised release,
Drugs
The American Heart Association’s first scientific statement on the relationship between cardiovascular disease (CVD) and breast cancer says that with the evolving intersection of the cardiovascular and oncologic fields, “comprehensive care is an essential element in the management of cancer patients to maximize gains in cancer treatment while minimizing
Drugs
President Donald Trump again has urged Congress to pass “right-to-try” legislation to allow patients with terminal conditions to have access to unapproved experimental treatments. Speaking at a 2/1 Republican retreat in West Virginia, Trump echoed remarks he made during his State of the Union address 1/30
Drugs
FDA commissioner Scott Gottlieb says FDA is working closely with companies that manufacture saline to limit and improve the shortage issues, using all of its tools and resources. In an update, Gottlieb says the agency expects supplies of saline to increase over the next month. He notes that having adequate
Drugs
FDA has accepted for priority review an Alnylam Pharmaceuticals NDA for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for treating hereditary ATTR (hATTR) amyloidosis. The inherited, progressively debilitating, and often fatal disease is caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and
Drugs
A 6/2017 conference convened by the Yale Collaboration for Research Integrity and Transparency that brought together concerned academics, patient advocates, legal and medical experts, and leaders from international organizations to talk about serious problems and dysfunctions in how medicines are developed, tested, reviewed, marketed and used, developed seven points
Drugs
FDA has placed a clinical hold on Bellicum Pharmaceuticals’ U.S. studies of its BPX-501 after reports of three cases of encephalopathy possibly related to the drug. The company says it is awaiting formal FDA communication on the requirements for resuming studies, and will work closely with the agency
FDA Policy/General
A recent Justice Department directive requires that civil litigators who bring affirmative civil enforcement (ACE) cases not convert other agency guidance documents into binding rules. Attorneys Anne Walsh and Rachel Hunt (Hyman. Phelps & McNamara) write in their firm’s FDA Law Blog that associate attorney general Rachel Brand said
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Merck’s Keytruda (pembrolizumab) to be 1,338 days. Of this time, 1,148 days occurred during the testing phase and 190 days occurred during the approval phase. Keytruda is a programmed death receptor-1
FDA Policy/General
Federal Register notice: FDA has announced a 4/16 public meeting on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to improve enrollment
Drugs
President Donald Trump acknowledged FDA and its record approvals last year in his 1/30 State of the Union address. “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history,” he
Drugs
Alkermes has filed an NDA for ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder (MDD). The submission is based on data from more than 30 clinical trials and more than 1,500 patients with MDD. Buprenorphine is a partial
Devices
The Justice Department (DoJ) says the South Dakota federal court accepted 1/31 a guilty plea entered by Robert Lytle to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt. The pleas came in
Devices
FDA says that Physicians Products Inc. is selling its Sterile PRP Separation Kit online in violation of the Federal Food, Drug, and Cosmetic Act since it does not have a PMA approval or IDE in effect. “On your Web site, you market the product as ‘FDA approved,’ and offer it
Drugs
FDA has granted Aquestive Therapeutics an orphan drug designation for riluzole oral soluble film (OSF) for treating amyotrophic lateral sclerosis (ALS), which affects about 30,000 Americans. Riluzole OSF is currently in late-stage clinical development. Patients suffering from ALS often have difficulty swallowing. Riluzole film was developed to dissolve
Drugs
FDA has approved a Ferring Pharmaceuticals supplemental NDA for Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH), indicated for hormone replacement in adults with GH deficiency. The drug was previously approved for treating pediatric patients who have growth failure due to an inadequate secretion
Drugs
A Massachusetts federal judge sentenced Aegerion Pharmaceuticals for improperly marketing its Juxtapid cholesterol drug and ordered that some of the $40.1 million it agreed to pay as part of a plea bargain be divided among some of the company’s victims. A Reuters report says that prosecutors had charged
Devices
Masimo has received 510(k) clearance to sell its next-generation SedLine brain function monitoring device for use in anesthetized and sedated patients. The device acquires and processes electroencephalogram (EEG) signals, providing physicians brain function data on anesthetized patients. The revised SedLine “benefits from work to improve the patient state
Devices
A 10/21-11/17/17 FDA inspection at Light Age, Inc., Somerset, NJ, found 12 Quality System Regulation violations in the firm’s manufacturing of Class 2 medical lasers, including EpiCare and Q-Clear. A 1/24 Warning Letter says specific violations listed on an FDA-483 were: * failing
Drugs
A 7/18-7/21/17 FDA inspection at Daito Kasei Kogyo, Okayama, Japan, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 1/18 Warning Letter. Specific deviations were: * failing to ensure that appropriate laboratory tests are conducted for each batch