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Health Highlights: Dec. 8, 2017
Posted 2 days ago in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Large Study Will Compare 3-D and Regular X-Ray Mammograms A large study will try to determine whether 3-D mammograms are better than regular X-ray mammograms at finding the most dangerous breast tumors. The U.S. National Cancer Institute-funded study will include 165,000 healthy women, ages 45-74, at about 100...
Read moreNew Gene Therapy May Be Cure for 'Bubble Boy' Disease
Posted today in Medical
SATURDAY, Dec. 9, 2017 -- Babies born with the immune-system ravaging "bubble boy" disease have had to spend their too-often-short lives in germ-free isolation, lest something as simple as a common cold virus fell them with a fatal infection. But after decades of research, doctors now believe they have created a cure for severe combined immunodeficiency (SCID). Six out of seven infants treated using a newly crafted...
Read moreAnother Gene Therapy Breakthrough Against Hemophilia
Posted yesterday in Medical
SATURDAY, Dec. 9, 2017 -- Coming just days after reports of a gene therapy that pushed the bleeding disorder hemophilia B into remission, new research suggests the same could be true for adults with the "A" form of the disease. That's significant because, due to the complexities of the gene responsible for hemophilia A, experts had thought it might be far more resistant to gene-based treatment. But in the new...
Read moreGot Scabies? Here's What to Do
Posted yesterday in Medical
FRIDAY, Dec. 8, 2017 -- If you or a family member develops scabies, you need to take immediate action, a dermatologist advises. Scabies is a common skin condition caused by the human itch mite. Symptoms include an itchy rash, sores and a thick crust on the skin. "Most people get scabies from direct skin-to-skin contact, although it's possible to get scabies from infested bedding, clothes and furniture," said Dr....
Read moreAre Women With Parkinson's at a Disadvantage?
Posted yesterday in Medical
FRIDAY, Dec. 8, 2017 -- Women with Parkinson's disease appear to face a disadvantage: They're much less likely than men to have caregivers, a new study finds. That's probably because women often outlive their most likely potential caregiver -- their husband, according to researchers at the University of Pennsylvania School of Medicine. "Care provided by family and friends to people with Parkinson's disease is an...
Read moreNovo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
Posted 4 days ago in New Drug Approvals
December 5, 2017 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 Ozempic is administered once weekly, on the same day each...
Read moreSunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD
Posted 4 days ago in New Drug Approvals
MARLBOROUGH, Mass.--(BUSINESS WIRE) December 5, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary ...
Read moreFDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
Posted 8 days ago in New Drug Approvals
December 1, 2017 -- The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer...
Read moreMonthly News Roundup - November 2017
Posted 9 days ago in Pharma Industry News
FDA Approves Juluca, a Novel 2-Drug Regimen for HIV-1 Infection In November, the U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Juluca (dolutegravir and rilpivirine), a single-tablet, two-drug regimen of dolutegravir (Tivicay) and rilpivirine (Edurant). Juluca is the first complete treatment regimen containing only two drugs, instead of three or more, for HIV maintenance. Juluca is used in c...
Read moreFDA Approves Sublocade (buprenorphine) Once-Monthly Injection for Opioid Use Disorder
Posted 10 days ago in New Drug Approvals
November 30, 2017 -- The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine...
Read moreFDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep
Posted 10 days ago in New Drug Approvals
Parsippany, NJ – November 29, 2017 – The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. approval to market Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of the colon in adults undergoing a colonoscopy. With availability planned in Q1 2018, Clenpiq will be the only FDA-approved prescription colonoscopy prep that comes “re...
Read moreDova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review
Posted 13 days ago in New Drug Applications
DURHAM, N.C., Nov. 27, 2017 (GLOBE NEWSWIRE) -- Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) today announced the New Drug Application (NDA) for avatrombopag has been accepted for filing and has been granted Priority Review by the United States Food and Drug Administration (FDA). Dova is seeking FDA approval of avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are...
Read moreU.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine
Posted 2 weeks ago in New Drug Applications
LOUISVILLE, Ky., Nov. 21, 2017 /PRNewswire/ -- US WorldMeds today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) for lofexidine, an investigational product to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. Priority Review is granted to submissions for medications...
Read moreU.S. Food and Drug Administration (FDA) Grants Alnylam Breakthrough Therapy Designation (BTD) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis with Polyneuropathy
Posted 2 weeks ago in New Drug Applications
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 20, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated ATTR amyloidosis...
Read moreAlnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis
Posted 3 weeks ago in New Drug Applications
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 16, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR), for the treatment of hereditary ATTR (hATTR) amyloidosis....
Read moreFDA Grants Marketing Authorization of the First Device for Use in Helping to Reduce the Symptoms of Opioid Withdrawal
Posted 3 weeks ago in Pharma Industry News
November 15, 2017 -- Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. “Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs ...
Read moreAkcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS
Posted 3 weeks ago in New Drug Applications
CAMBRIDGE, Mass., Nov. 15, 2017 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced that all of its marketing applications for volanesorsen have been accepted for review in the U.S., EU and Canada for the...
Read moreFDA Warns Companies Marketing Unproven Products, Derived From Marijuana, that Claim to Treat or Cure Cancer
Posted 5 weeks ago in Pharma Industry News
November 1, 2017 -- As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of t...
Read moreMonthly News Roundup - October 2017
Posted 5 weeks ago in Pharma Industry News
Yescarta CAR T-Cell Therapy Approved for Lymphoma Novel chimeric antigen receptor T cell (CAR T) therapy allows patients with certain blood cancers -- but limited treatment options -- to achieve remission. The U.S. Food and Drug Administration (FDA) has cleared Kite Pharma/Gilead’s Yescarta (axicabtagene ciloleucel), the first CAR T-cell treatment for adults with large B-cell lymphoma after failing at least two o...
Read moreMonthly News Roundup - September 2017
Posted 10 weeks ago in Pharma Industry News
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) in patients with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy; or as monotherapy for patients who previously rec...
Read moreKadmon Presents Encouraging Data on Tesevatinib in EGFR-Mutated Non-Small Cell Lung Cancer with Brain Metastases and/or Leptomeningeal Metastases
Posted 4 days ago in Clinical Trials
NEW YORK--(BUSINESS WIRE) December 6, 2017 -- Kadmon Holdings, Inc. (NYSE: KDMN) (“Kadmon” or the “Company”) today announced encouraging data from its ongoing Phase 2 clinical study of tesevatinib, the Company’s blood-brain barrier penetrant oral tyrosine kinase inhibitor, for the treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) that has metastasized to the bra...
Read moreBiohaven Completes Enrollment in Second Pivotal Phase 3 Clinical Trial of Oral CGRP-Receptor Antagonist Rimegepant
Posted 12 days ago in Clinical Trials
NEW HAVEN, Connecticut, November 27, 2017 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced today completion of enrollment in Study BHV3000-302, the Company’s second pivotal Phase 3 clinical trial examining the efficacy and safety of rimegepant in the acute treatment of migraine. The trial began shortly after the commencement of rimegepant’s first efficac...
Read moreMenlo Therapeutics Begins Phase 2 Clinical Trial for Serlopitant for Pruritus Associated with Psoriasis
Posted 2 weeks ago in Clinical Trials
REDWOOD CITY, Calif., November 21, 2017 /PRNewswire/ — Menlo Therapeutics Inc., a late- stage biopharmaceutical company developing a neurokinin 1 (NK‐1) receptor antagonist (serlopitant) for the treatment of pruritus (itch) and refractory chronic cough, has initiated enrollment in a new Phase 2 clinical trial evaluating serlopitant for the treatment of pruritus associated with psoriasis. The PSORIXA study, MTI...
Read moreFDA Grants Orphan Drug Designation for TRM-201 (rofecoxib) for the Treatment of Hemophilic Arthropathy
Posted 2 weeks ago in Clinical Trials
CAMBRIDGE, Mass.--(BUSINESS WIRE) November 21, 2017 --Tremeau Pharmaceuticals, Inc., a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation, on a first cycle review, for TRM-201 (rofecoxib), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), for the treatment...
Read moreAcorda Discontinues Tozadenant Development Program
Posted 2 weeks ago in Clinical Trials
ARDSLEY, N.Y.--(BUSINESS WIRE)--November 20, 2017 -- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the ...
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