Industry News

Pharma Headline News (Drugs.com)

• Monthly News Roundup - September 2017
  FDA Approves Lilly’s Verzenio: Targeted Breast Cancer Treatment Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex)...
• FDA Improves Access to Reports of Adverse Drug Reactions
  September 28, 2017 -- The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System...
• FDA Approves First Continuous Glucose Monitoring System for Adults Not Requiring Blood Sample Calibration
  September 27, 2017 -- The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions...
• FDA Conducts Major Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
  September 25, 2017 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved...
• Teva Announces Reintroduction of Generic Depo-Provera in the United States
  JERUSALEM--(BUSINESS WIRE)--Sep. 25, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the reintroduction of the generic equivalent to Depo-Provera1 Contraceptive Injection (medroxyprogesterone acetate injectable suspension,...
• Criminal and Civil Actions Filed Against Aegerion Pharmaceuticals Inc.
  September 22, 2017 -- Today, Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
• Monthly News Roundup - August 2017
  Kymriah from Novartis Approved as First U.S. CAR-T Cell Therapy History was made this month as the U.S. Food and Drug Administration (FDA) approved the first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR)...
• FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
  August 17, 2017 -- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to...
• FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
  August 11, 2017 -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby...
• Monthly News Roundup - July 2017
  FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of...
• FDA Clears First Neonatal Magnetic Resonance Imaging Device
  July 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI...
• Endo Provides Update On Opana ER
  DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes...
• FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
  July 3, 2017 -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in...
• Monthly News Roundup - June 2017
  New Fluoroquinolone Baxdela Approved for Certain Skin Infections Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and...
• FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
  June 29, 2017 -- The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas,...
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New Drug Approvals (Drugs.com)

• Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis
  Horsham, Pa., October 13, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Stelara (ustekinumab) for the treatment of adolescents (12 years of age or older) with...
• FDA Approves Lyrica CR (pregabalin) Extended-Release Tablets for Neuropathic Pain Conditions
  October 12, 2017 - Pfizer Inc. (NYSE: PFE) announced today that the United States Food and Drug Administration (FDA) has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain...
• Flexion Therapeutics Announces FDA Approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis Knee Pain
  BURLINGTON, Mass., Oct. 06, 2017 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) approved Zilretta (triamcinolone acetonide extended-release injectable suspension), the...
• FDA Approves Botox Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines
  DUBLIN, Oct. 3, 2017 /PRNewswire/ -- Today Allergan plc (NYSE: AGN) announced the FDA approval of Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis...
• FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy
  Santa Ana, California October 3, 2017 -- McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, Inc. announces the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection,...
• Novo Nordisk Receives FDA Approval for Fiasp (insulin aspart injection), a New Fast-Acting Mealtime Insulin
  PLAINSBORO, N.J., Sept. 29, 2017 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic...
• FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
  September 28, 2017 -- The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast...
• FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
  KENILWORTH, N.J.--(BUSINESS WIRE) September 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s...
• Bristol-Myers Squibb’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib
  PRINCETON, N.J.--(BUSINESS WIRE) September 22, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients...
• BioCryst's Rapivab (peramivir injection) Receives FDA Approval for a Pediatric Indication
  RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2017 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced today...
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NDAs (Drugs.com)

• AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA NDA
  REDWOOD CITY, Calif., Oct. 12, 2017 /PRNewswire/-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx), a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration...
• Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
  HORSHAM, PA, October 11, 2017 – Janssen Biotech, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor...
• Rigel Provides Update on FDA Review of Fostamatinib for ITP
  SOUTH SAN FRANCISCO, Calif., Oct. 2, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that during the company's mid-cycle meeting with the U.S. Food and Drug Administration (FDA) the FDA indicated that, at this point,...
• Kitov Announces Filing by FDA of New Drug Application for KIT-302
  TEL AVIV, Israel, October 2, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) filed the Company's New Drug...
• INSYS Therapeutics Files New Drug Application (NDA) for Buprenorphine Sublingual Spray with FDA
  PHOENIX, Sept. 29, 2017 (GLOBE NEWSWIRE) -- In advancing its pipeline of innovative medicines, INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”), announced today that it filed a New Drug Application (NDA) for a novel...
• Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA
  TORONTO, Sept. 25, 2017 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and...
• Aradigm Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status
  HAYWARD, Calif.--(BUSINESS WIRE) September 25, 2017 -- Aradigm Corporation (NASDAQ: ARDM) (the "Company") today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA)...
• Janssen Receives Complete Response Letter From U.S. FDA for Sirukumab Biologics License Application
  HORSHAM, PA, September 22, 2017 – Janssen Biotech, Inc. (Janssen) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of...
• FDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease
  CRANBURY, N.J., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the oral precision medicine migalastat for the treatment of...
• Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder
  Lund, Sweden – 18 September 2017 — Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for weekly and monthly CAM2038 buprenorphine depots for the treatment of adults...
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Clinical Trial Results (Drugs.com)

• Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer
  October 16, 2017 - Pfizer Inc. (NYSE:PFE) today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and...
• Merck Provides Update on Anacetrapib Development Program
  KENILWORTH, N.J.--(BUSINESS WIRE) October 11, 2017 --Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, today announced that the company will not submit applications for regulatory approval for anacetrapib, Merck’s investigational...
• FDA Grants Fast Track Designation to Astellas for Development of Gilteritinib in Relapsed or Refractory Acute Myeloid Leukemia
  TOKYO, Oct. 10, 2017 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of...
• Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens
  FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 4, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from a Phase 3 study (Study 1878) evaluating the efficacy and safety of switching virologically suppressed HIV-1...
• Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome
  EMERYVILLE, Calif., Sept. 29, 2017 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its...
• Cascadian Therapeutics Announces FDA Orphan Drug Designation Granted to Tucatinib for the Treatment of HER2+ Metastatic Colorectal Cancer
  SEATTLE, Sept. 27, 2017 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to tucatinib...
• Axovant Announces Negative Topline Results of Intepirdine Phase 3 MINDSET Trial in Alzheimer's Disease
  BASEL, Switzerland, Sept. 26, 2017 /PRNewswire/ -- Axovant Sciences (NASDAQ: AXON) today announced that the Phase 3 MINDSET clinical trial of its investigational drug intepirdine in patients with mild to moderate Alzheimer's disease (AD) who were...
• Acer Therapeutics Reports Positive Results From Pivotal Clinical Trial of Edsivo (celiprolol) for Treatment of Vascular Ehlers-Danlos Syndrome
  Cambridge, MA – September 25, 2017 -- Acer Therapeutics Inc., (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical...
• Arbutus Announces Topline Results for ARB-1467 Phase II Cohort 4
  VANCOUVER, British Columbia and WARMINSTER, Pa., Sept. 25, 2017 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, announced topline results of the bi-weekly...
• Sanofi and Alnylam Report Positive Topline Results from APOLLO Phase 3 Study of Patisiran in Hereditary ATTR (hATTR) Amyloidosis Patients with Polyneuropathy
  Paris, France and Cambridge, MA - September 20, 2017 - Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company announced today that the APOLLO Phase 3...
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