Drugs
FDA has accepted for review an Alexion Pharmaceuticals supplemental BLA seeking to expand the indication for Soliris (eculizumab) as a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive. Soliris is described as a first-in-class terminal complement inhibitor, and is approved
Drugs
Three generic drug companies have notified FDA that they have reviewed the GDUFA 2 Program Fee List of Abbreviated New Drug Application Sponsors and Application numbers issued by the agency 1/9 and want some listing changes for purposes of a single GDUFA 2 program fee. Responses came from Mallinckrodt,
Drugs
A Texas federal judge has rejected an effort to use Buckman preemption to eliminate an entire Texas tort reform statute that created a presumption in drug cases that a drug’s warning is adequate if FDA approved it. Attorney John Sullivan (Cozen O’Conner) writes in an online blog post
Drugs
Intersect ENT has submitted an NDA for the company’s investigational Resolve steroid releasing implant, which it says is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, including polyps, who might otherwise warrant a repeat surgical procedure. The submission is based on data
Devices
Attorney Michelle Yeary (Reed Smith) says that federal courts in Ohio and California both found that all claims brought against Medtronic’s PMA-approved pain pump device were completely preempted, although they reached their conclusions through different means. Writing in an online blog post, she compares the two decisions: * Manufacturing
Devices
FDA has accepted a Keryx Biopharmaceuticals supplemental NDA for Auryxia (ferric citrate) tablets, which seeks an expanded indication to include the treatment of iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). Auryxia is currently approved for use in the U.S. for the control
FDA Policy/General
A study conducted by FDA researchers found that the location of risk information on prescription drug Web sites can affect consumer knowledge of drug risks. However, they found, signals and special formatting may not be necessary to adequately inform consumers about drug risks. In the research, reported in the Journal
Devices
FDA has cleared an Intellijoint Surgical 510(k) for the intellijoint Hip Anterior, a 3D mini-optical navigation solution that provides quantifiable, intraoperative measurements for cup position, leg length, and offset to orthopedic surgeons performing direct anterior approach total hip arthroplasty. The device’s use could eliminate fluoroscopy verification for
Biologics
FDA has granted DynPort Vaccine Co. an orphan drug designation for a plague vaccine being developed on behalf of the Defense Department. The recombinant rF1V product is intended to be used for pre-exposure prophylaxis to combat infection with Yersinia pestis, the causative agent of plague. The vaccine is being
Drugs
In response to criticism of a Republican bill to replace ObamaCare, president Trump tweeted early 3/7 that he is formulating a plan to lower drug prices through increased competition. “I am working on a new system where there will be competition in the Drug Industry. Pricing for the American
FDA Policy/General
HHS secretary Tom Price 3/6 hinted on Hugh Hewett’s talk radio show (view transcript) that an FDA commissioner nomination could be announced as early as this week. Law professor Hewett’s radio show is heard in more than 120 cities across the U.S., with an audience of
Drugs
FDA now considers seven of 12 India-based Wockhardt drug manufacturing sites to be out of compliance with current good manufacturing practice regulations (CGMP), according to a 2/17 Warning Letter from the agency’s Chicago District Office. The letter focuses on a 1/4-2/5/16 inspection at
Drugs
A 9/19-9/23/16 FDA inspection at Megafine Pharma, Mumbai, India, found significant deviations from current good manufacturing practice (CGMP) for drugs, along with data integrity concerns. A 2/24 Warning Letter says specific deviations included: * failure of the quality unit to exercise its responsibility to ensure that
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Denttio, Inc. Los Angeles, CA (2/23): FDA inspected the firm 8/2016 and documented GMP deficiencies related to its manufacture of digital x-ray image receptors and intraoral
Drugs
Recordati Rare Diseases (RRD), which is the NDA sponsor for NeoProfen (ibuprofen lysine) injection, 10 mg/ml, is asking FDA to require that any ANDA that references NeoProfen include measures to mitigate the risk of precipitate formation, such as using vials inert to the complexing of aluminum with ibuprofen, and
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its new DxC 700 AU chemistry analyzer. The new device combines the capabilities of two Beckman Coulter products – the “simple intuitive design of the DxC analyzer and the robust throughput and workhorse capabilities of the AU analyzer – into one standardized
Drugs
In denying a 11/19/16 Ferring petition asking that it not approve a Serenity Pharmaceuticals NDA for SER 120, a desmopressin nasal spray to treat nocturia in adults, until certain conditions are met, FDA said it approved the NDA 3/3 because it “is satisfied that Serenity presented substantial
Devices
Information prepared by FDA for the 3/6 MDUFA 3 quarterly performance meeting shows that the percentage of PMA originals and panel track supplements with major deficiency letters in the first FDA review cycle was 81%, as high as it was in 2010 and 2007. The meeting agenda covered guidances
Drugs
CDER director Janet Woocock says that the Center’s top priority for 2017 is improving and implementing informatic process management across the whole center. Speaking in a Director’s Corner podcast, she said that a tremendous amount of effort is going into the program. “We have set up a governance
Drugs
FDA has accepted for review three Merck and Pfizer NDAs for medicines containing ertugliflozin, an investigational SGLT2 inhibitor under development to help improve glycemic control in adults with Type 2 diabetes — one for monotherapy, one for a fixed-dose combination of ertugliflozin and Januvia (sitagliptin), and one for a fixed-
Drugs
FDA has accepted for review a PTC Therapeutics NDA that was filed in protest for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy (DMD). The move follows the company’s loss in October of an appeal after receiving a refuse-to-file letter (see story) issued by the Division
Drugs
FDA has lifted clinical holds against several Seattle Genetics Phase 1 trials of vadastuximab talirine (SGN-CD33A; 33A) in acute myeloid leukemia. “The clinical hold on our early-stage vadastuximab talirine clinical trials has been resolved through a comprehensive analysis of the clinical data from over 300 patients treated to