Drugs
FDA has expanded the approved use of Hoffman La Roche’s subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. Giant cell arteritis is a form of vasculitis and it causes the arteries to narrow or become irregular, impeding adequate blood flow. Approval was based on data from a
Devices
Respironics has begun a Class 1 recall of its V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor to the control board may become loose over time due to low frequency vibration, an FDA notice says. The loose pins may prevent
Devices
FDA has cleared a Soterix Medical 510(k) for its IontoDC device, which uses a direct current to introduce ions of soluble salts or other drugs into the body. “Iontophoresis is used for hyperhidrosis treatment, delivery of local anesthetic before emergent skin puncture or dermatological procedure to reduce pain, administration
Drugs
Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple sclerosis. The investigational oral, selective S1P 1 and 5 receptor modulator met the primary endpoint in reducing annualized relapse rate compared to weekly interferon (Avonex). The
Drugs
FDA has released a Form 483 after a January inspection cited significant GMP issues at Sancilio & Co.’s Riviera Beach, FL manufacturing facility. For example, FDA said laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process
Drugs
Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple sclerosis. The investigational oral, selective S1P 1 and 5 receptor modulator met the primary endpoint in reducing annualized relapse rate compared to weekly interferon (Avonex). The
Drugs
An ongoing FDA review of the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has not identified adverse health effects from gadolinium retained in the brain. “All GBCAs may be associated with some gadolinium retention in the brain and other
FDA Policy/General
AstraZeneca has sold the European commercial rights to its beta-blocker heart drug Seloken and the associated fixed-dose combination Logimax to Italy-based Recordati for $300 million. Seloken (metroprolol) is used to control conditions such as hypertension, angina pectoris, disturbances of cardiac rhythm, maintenance treatment after myocardial infarction and
FDA Policy/General
FDA Amends Animal Drug Regs to Reflect Approvals 05/17/2017 Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during January and February. FDA Withdrawing Approval of Sioux Bio Animal Drug 05/
Drugs
FDA has just released the FDA-483 form listing 10 observations from its 6/13-6/17/16 inspection at Sekisui Medical Co., Iwate, Japan. Deviations from CGMP regulations for active pharmaceutical ingredients noted on the form were: * failing to maintain and review all raw data; * failing to prevent unauthorized
FDA Policy/General
Newly sworn-in FDA commissioner Scott Gottlieb will visit Capitol Hill for his first testimony as the agency head 5/25 during a House budget hearing. FDA observers will closely watch for Gottlieb’s stance on the Trump Administration’s proposed budget for FDA in 2018, which cuts the agency’
Devices
FDA has classified as Class 1 an Abbott recall of specific lots of three catheters — NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. A recall notice says that affected products could cause difficulty when the protective balloon sheath is removed,
Drugs
FDA has granted a breakthrough therapy designation to GlycoMimetics for GMI-1271 and its use in treating adult relapsed/refractory acute myeloid leukemia (AML). The E-selectin antagonist is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. FDA previously
Devices
FDA has cleared an XpandOrtho 510(k) for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses “multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint during a full range of motion,” the company says. “The device
FDA Policy/General
In his first address to FDA staff, commissioner Scott Gottlieb 5/15 talked about scientific advances that will give employees “better tools to do our regulatory work. Many of these tools and resources are being developed right here at FDA, in our labs, and at places like NCTR. Twenty-first
Drugs
FDA has granted Octapharma USA an orphan drug designation for Octagam [immune globulin intravenous (human) 10% liquid] for treating dermatomyositis, a rare acquired disorder characterized by chronic inflammatory and degenerative changes of the muscles and skin. Octagam is currently approved for treating chronic immune thrombocytopenic purpura (ITP) in adults. It
Drugs
FDA has approved two new indications for Merck’s Keytruda (pembrolizumab) for treating certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. One indication is for first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
Biologics
Amgen has submitted a BLA for erenumab to prevent migraine. The human monoclonal antibody works by blocking the Calcitonin Gene-Related Peptide receptor. according to the company. The submission includes data from pivotal studies in patients with episodic and chronic migraine, it says. “The erenumab global clinical trial program has
Drugs
Attorney Stephen Wood (Chuhak & Tecson) says a stay of discovery should be mandatory to weed out frivolous False Claims Act cases before defendants have to bear the cost of discovery. Writing in a Washington Legal Foundation Legal Backgrounder, Wood says that the small percentage of whistleblower cases that succeed
Drugs
The Supreme Court has refused to hear the appeal of a Philadelphia law firm that wanted FDA to either withdraw its approval for use of Janssen’s Risperdal (risperidone) in children or require a Boxed Warning about the potential for side effects including gynecomastia. FDA rejected the petition from Sheller
Drugs
Seeking to reduce federal government expenditures on the National Institutes of Health (NIH), President Donald Trump reportedly is considering imposing a 10% cap on the NIH’s indirect costs, money it gives grantees to support administration, equipment, IT, lighting, heating, electricity, and other overhead. An NIH source who was briefed
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA to stay its approval of an Inspirion Delivery Sciences NDA for Roxybond (oxycodone HCl) tablets. The PMRS petition asks the agency stay the effective date of approval of the NDA with labeling claims pertaining to chronic use and abuse deterrence until FDA