Drugs
FDA says data from two large clinical trials indicate that canagliflozin (Janssen’s Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) causes an increased risk of leg and foot amputations. An agency drug safety communication says that a Boxed Warning will be added to the drugs’ labeling describing the
Drugs
Ionis Pharmaceuticals says that primary endpoints were met in its Phase 3 NEURO-TTR study of Ionis-TTR (inotersen) in patients with familial amyloid polyneuropathy. “Over the 15-month period of the study, inotersen-treated patients achieved statistically significant benefit compared to placebo in the modified Neuropathy Impairment Score +7
Drugs
FDA has granted Imara a rare pediatric disease designation for IMR-687, the company’s lead product candidate for treating sickle cell disease. The company is conducting a Phase 1a clinical study to evaluate the safety and pharmacokinetics of IMR-687 in healthy volunteers. In addition, it will assess pharmacodynamic
Drugs
FDA has accepted for review an Aerie Pharmaceuticals NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, indicated for treating elevated intraocular pressure (IOP) in glaucoma. The agency has set a user fee review target date of 2/28/2018, and it has told the firm to expect an advisory committee
Drugs
CDER officials say expanded access decisions have not led to a negative regulatory decision regarding a drug application, and there was only one instance where safety events under expanded access had a potentially negative effect on product labeling. “Concern that expanded access will have a negative impact on drug development
Drugs
FDA has issued a Form 483 to Badrivishal Chemicals & Pharmaceuticals (Maharashtra, India) related to a 8/2016 facility inspection that cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators found that the firm’s water purification system was not adequately monitored and controlled. Additionally,
Drugs
Senators Amy Klobuchar (D-MN), John McCain (R-AZ), and Chuck Grassley (R-IA) have urged the Trump Administration to use existing executive authority to lower prescription drug costs, including a certification to allow importation of prescription drugs from Canada. The three have worked together on bipartisan legislation to allow
Drugs
Eli Lilly says it will file a BLA in the second half of this year after reporting positive Phase 3 data for galcanezumab, an investigational treatment for preventing episodic and chronic migraines. Three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) demonstrated “statistically significant reductions in the number of
Drugs
FDA has issued Torrent Pharmaceuticals a four-item Form 483 following an inspection last month at the firm’s drug manufacturing facility in Indrad, Gujarat, India. The observations are related to deficiencies with procedures and documentation practices. For example, the agency cited Torrent on its change control records that were
Drugs
FDA has granted Loxo Oncology an orphan drug designation for larotrectinib for treating solid tumors with NTRK-fusion proteins, which are genetic abnormalities that occur rarely in various adult and pediatric solid tumors. Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for treating
Drugs
AstraZeneca and MedImmune have announced positive results from their Phase 3 PACIFIC trial, a randomized, double-blinded, placebo-controlled trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent
Drugs
Alzheimer’s disease researchers have published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer's Disease,” that urges FDA to clarify and modernize its current approach for approving new treatments for Alzheimer’s. The analysis recommends that FDA approve new medicines that demonstrate a proven benefit on
Drugs
FDA has informed Exact-Rx that the labeling information for its Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser is inaccurate. The letter says the company must take prompt action to correct the deficiency, which involves not including the active ingredient sulfur in the structured product labeling listing information.
Drugs
The 3rd Circuit Court of Appeals has affirmed a New Jersey federal court’s dismissal of a whistleblower suit against Genentech, although the appeals court ruled that the suit should be dismissed for a reason other than that cited by the lower court. Attorney Armandeep Sidhu (McDermott Will & Emery)
Drugs
FDA has released the FDA-483 issued following a 3/27-4/7 agency inspection at Biocon Limited, Bangalore, India. Specific violations were: * discrepancies between information submitted in an undisclosed document and the manufacturing process at the facility; * the company quality assurance unit has approved and implemented documents that do
Drugs
Attorneys Bradley Davidsen and Elena Quattrone (Epstein Becker Green) say that now that Scott Gottlieb has been confirmed by the Senate as FDA commissioner, he faces three immediate priorities on mandates stemming from approval of the 21st Century Cures Act. Writing in an online blog post, the attorneys say that
Drugs
Coherus Biosciences says FDA must deny an Apotex petition that contains a misunderstanding about the role of clinical studies in a biosimilar application submitted under the regulatory pathway created by the Biologics Price Competition and Innovation Act. The Coherus response says that “Apotex’ misunderstanding has led the company to erroneously
Drugs
FDA has granted accelerated approval for Merck’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (Alimta) and carboplatin, for first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). The indication was approved based on tumor response rate and progression-free survival.
Drugs
A 10/11-11/10/16 FDA inspection at a clinical trial site operated by Merrill Benson at the Indiana University School of Medicine, Indianapolis, IN, found “objectionable conditions” at a trial of an investigational drug. The inspection was part of the agency’s Bioresearch Monitoring Program to ensure that
Drugs
FDA has published the FDA-483 issued to Aurobindo Pharma, Hyderabad, Telangana, India, following a 4/30-4/28 agency inspection. Specific violations noted on the form were: * failing to maintain in a good state of repair buildings used in the manufacturing of a drug product; * failing to include in
Drugs
Genentech says its Phase 3 study IMvigor211 that evaluated Tecentriq (atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did not meet its primary endpoint (overall survival) compared to chemotherapy. “The results observed in
Drugs
The Pharmaceutical Research and Manufacturers Association of America (PhRMA) says that biopharmaceutical companies will now have to meet new research and development requirements to be eligible to join the association. The trade group is positioning this change as a commitment to “doing the time-intensive, scientifically sound research it takes