Industry News

Pharma Headline News (Drugs.com)

• FDA Requests Removal of Opana ER for Risks Related to Abuse
  June 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is...
• FDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)
  June 8, 2017 - The U.S. Food and Drug Administration has approved the first generic version of Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex...
• Monthly News Roundup - May 2017
  Actemra: First Drug Approved to Treat Giant Cell Arteritis Actemra (tocilizumab) from Hoffman La Roche has gained a new indication as the first drug approved to treat adults with giant cell arteritis, a specific type of vasculitis. Vasculitis is...
• FDA Approves First Generic Strattera for the Treatment of ADHD
  May 30, 2017 -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals...
• FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests
  May 17, 2017 -- The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in...
• FDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies
  May 12, 2017 -- The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their...
• Monthly News Roundup - April 2017
  Takeda Announces FDA Accelerated Approval of Alunbrig The US Food and Drug Administration (FDA) has approved once-daily oral Alunbrig (brigatinib) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small...
• FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients
  April 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were...
• FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions
  April 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA...
• FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr
  March 31, 2017 -- The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency...
• Monthly News Roundup - March 2017
  Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed...
• Monthly News Roundup - February 2017
  FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl...
• FDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis
  February 23, 2017 -- The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory...
• FDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity Results
  February 23, 2017 -- The U.S. Food and Drug Administration today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about...
• Louisiana Drug and Dietary Supplement Maker Ordered to Cease Operations Due to Federal Violations
  February 21, 2017 -- On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and...
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New Drug Approvals (Drugs.com)

• FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema
  June 22, 2017 -- The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients....
• FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers
  South San Francisco, CA -- June 22, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan Hycela (rituximab and hyaluronidase human) for...
• FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD
  Lexington, Mass., USA – June 20, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment...
• Neos Therapeutics Announces FDA Approval of Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets for the Treatment of ADHD in Patients 6 to 17 Years Old
  DALLAS and FORT WORTH, Texas, June 19, 2017 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary...
• Melinta Therapeutics Announces FDA Approval of Baxdela (delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
  NEW HAVEN, Conn, June 19, 2017 – Melinta Therapeutics, a privately held company focused on discovering, developing, and commercializing novel antibiotics to treat serious bacterial infections, announced today that the U.S. Food and Drug...
• Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
  Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today the U.S. Food and Drug Administration (FDA) has approved the use of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the...
• Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults
  June 16, 2017 -- Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen) today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of Dysport (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based...
• Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe
  SAN DIEGO, June 15, 2017 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg...
• FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas
  June 6, 2017 - The U.S. Food and Drug Administration (FDA) has approved Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on...
• FDA Approves Two-Month Aristada for Treatment of Schizophrenia
  DUBLIN--(BUSINESS WIRE)--Jun. 6, 2017-- Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of...
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NDAs (Drugs.com)

• FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP
  SOUTH SAN FRANCISCO, Calif., June 19, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced the U.S. Food and Drug Administration (FDA) has filed its New Drug Application (NDA) for the use of Tavalisse (fostamatinib...
• Pfizer Receives FDA Fast Track Designation for Tafamidis for Transthyretin Cardiomyopathy
  Tuesday, June 6, 2017 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to tafamidis, the company’s investigational treatment for transthyretin cardiomyopathy (TTR-CM). This...
• Puma Biotechnology Receives FDA Advisory Committee Support for Neratinib
  LOS ANGELES, Calif., May 24, 2017 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 - 4 to recommend...
• Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA
  Paris, France and Tarrytown, New York - April 28, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the resubmission of Biologics License Application for Kevzara (sarilumab) as...
• Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States
  SOUTH SAN FRANCISCO, Calif., April 27, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Tavalisse™ for the company's...
• Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment
  April 25, 2017, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter, “Santen”), a specialized ophthalmology company headquartered in Osaka, Japan, today announced that the U.S. Food and Drug Administration (FDA) has accepted...
• PTC Therapeutics Completes Acquisition of Emflaza for the Treatment of Duchenne Muscular Dystrophy in the U.S.
  SOUTH PLAINFIELD, N.J., April 20, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced it has completed its acquisition of all rights to Emflaza™ (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD) in the...
• TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update
  BOCA RATON, Fla.--(BUSINESS WIRE)--Apr. 19, 2017-- TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced that, based on continued correspondence with the U.S. Food and Drug Administration (FDA), the...
• Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL
  Basel, April 18, 2017 - Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult...
• Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
  LOS ANGELES, Calif., April 17, 2017 - Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by...
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Clinical Trial Results (Drugs.com)

• Pfizer Begins Phase 1 Clinical Trial to Evaluate Investigational Group B Streptococcus Vaccine
  June 19, 2017 Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1 trial in healthy volunteers of PF-06760805, an investigational vaccine designed to help protect against Group B Streptococcus (GBS) infection. An estimated 10 to 30...
• Genmab Announces Preliminary Cervical Cancer Data from Tisotumab Vedotin Phase I/II Study
  Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the...
• Threshold Pharmaceuticals Announces First Patient Dosed in Immunotherapy Clinical Trial of Evofosfamide and Ipilimumab
  MENLO PARK, Calif., June 13, 2017 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (NASDAQ:THLD) a clinical-stage biopharmaceutical company developing novel therapies for cancer, today announced that the University of Texas MD Anderson Cancer...
• Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab
  Tuesday, June 13, 2017 - Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with...
• Adamas Announces Publication of ADS-5102 Phase 3 EASE LID Clinical Trial in JAMA Neurology
  EMERYVILLE, Calif., June 12, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that results of its Phase 3 EASE LID clinical trial of ADS-5102 were published online in JAMA Neurology. A New Drug Application...
• Lilly's Galcanezumab Significantly Reduces Number Of Migraine Headache Days For Patients With Migraine: New Results Presented At AHS
  INDIANAPOLIS, June 10, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today positive results from three Phase 3 studies of galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine, including...
• Merck and Pfizer Announce that Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies
  Saturday, June 10, 2017 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE:PFE), today announced that two Phase 3 studies (VERTIS MET and VERTIS SITA) of ertugliflozin, an investigational...
• Inovio Begins Phase 3 Clinical Trial of VGX-3100 for the Treatment of HPV-Related Cervical Pre-Cancer
  PLYMOUTH MEETING, Pa., June 08, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it has commenced its phase 3 clinical program to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat...
• Cascadian Therapeutics' Lead Candidate, Tucatinib, Receives Orphan Drug Designation from FDA for Treatment of Breast Cancer Patients with Brain Metastases
  SEATTLE, June 08, 2017 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for...
• Teva's Fremanezumab Meets all Primary & Secondary Endpoints Across Both Monthly and Quarterly Dosing Regimens in Phase III Study in Episodic Migraine Prevention
  JERUSALEM--(BUSINESS WIRE)--Jun. 7, 2017-- Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced positive results from the second Phase III HALO study of fremanezumab (TEV-48125), an investigational treatment for the prevention of...
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