Drugs
Horsham, PA-based contract manufacturer Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA to revoke all indications for use of any opioids in management of chronic pain, saying there is insufficient evidence to support such an indication. Specifically, the group is asking that the agency: * revoke approval of OxyContin’s
Drugs
An analysis by the Tufts Center for the Study of Drug Development and Sakai Regulatory Consulting found multiple issues with the 505(b)(2) drug regulatory pathway, including longer approval times than for new molecular entities (NMEs) and fewer expedited review designations than NMEs. As reported in the center’s
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
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
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
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
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
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
Drugs
Consumer advocacy group Public Citizen is urging Congress to reject three “right to try” bills (S 204, HR 878 and HR 1020) because they would “put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely
Drugs
Former FDA commissioner Mark McClellan has weighed in on President Trump’s address to Congress last week where he criticized the agency’s approval process (see story) as “slow and burdensome.” In an interview with NPR reporter Audie Cornish, McClellan noted that the approval process takes only eight and a
Drugs
Sen. Chuck Grassley (R-IA) has expanded his inquiry into potential misuses of FDA’s orphan drug program in the wake of the agency’s recent approval of Marathon Pharmaceuticals’ orphan drug Emflaza (deflazacort) tablets and oral suspension to treat patients age five and older with Duchenne muscular dystrophy (see
Drugs
FDA has granted aTyr Pharma an orphan drug designation for Resolaris for treating limb girdle muscular dystrophy (LGMD) patients. The company is developing Resolaris as a potential first-in-class intravenous protein therapeutic for treating rare myopathies with an immune component. It says Resolaris is derived from a naturally occurring
Drugs
FDA has granted EnGeneIC an orphan drug designation for its epidermal growth factor receptor-targeted, doxorubicin-loaded EDV nanocells for treating glioblastoma multiforme. The clinical stage biopharmaceutical company says it is focused on developing its proprietary bacterially-derived EDV nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform
Drugs
FDA has awarded Biogen a priority review voucher (PRV)for gaining approval of rare disease drug Spinraza (nusinersen), indicated for treating spinal muscular atrophy in pediatric and adult patients. FDA has approved Biogen’s Spinraza (nusinersen) for treating children and adults with spinal muscular atrophy. Spinraza, the first drug indicated
Drugs
FDA has approved a Serenity Pharmaceuticals NDA for Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Approval was based on data from two 12-week trials in