Industry News

Pharma Headline News (Drugs.com)

• 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,...
• FDA Unveils Plan to Eliminate Orphan Designation Backlog
  June 29, 2017 -- Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm...
• FDA Tackles Drug Competition to Improve Patient Access
  June 27, 2017 -- Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent,...
• Sonar Products Ordered to Cease Operations, Stratus Pharmaceuticals Ordered to Cease Distributing Unapproved Drugs
  June 15, 2017 -- Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc....
• 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...
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New Drug Approvals (Drugs.com)

• FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
  August 17, 2017 -- The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell...
• CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension
  Farmville, NC. August 7, 2017 – CMP Pharma today announced that the US Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir (Spironolactone Oral Suspension, 25 mg/5mL), the first...
• FDA Approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years
  August 6, 2017 -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and...
• FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
  August 3, 2017 -- The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes...
• FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
  August 3, 2017 -- The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including...
• FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
  August 2, 2017 -- The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the...
• FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV
  FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 1, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first...
• FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
  August 1, 2017 -- The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for...
• Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
  PRINCETON, N.J.--(BUSINESS WIRE) August 1, 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 adult and...
• Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension Approved by the U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
  Valby, Denmark and Tokyo, Japan, 28 July 2017 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced Abilify Maintena® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and...
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NDAs (Drugs.com)

• Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission
  SALT LAKE CITY, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the U.S. Food & Drug Administration ("FDA") has acknowledged receipt of the Company's New Drug Application...
• Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
  FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an...
• Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism
  SALT LAKE CITY, Aug. 09, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced the resubmission of a New Drug Application ("NDA") for LPCN 1021, its oral testosterone product candidate for...
• Valeant Pharmaceuticals Receives Complete Response Letter from the FDA for Latanoprostene Bunod Ophthalmic Solution, 0.024% NDA
  LAVAL, Quebec, Aug. 7, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug...
• Dynavax Provides U.S. Regulatory Update on Heplisav-B Following FDA Advisory Committee Meeting
  BERKELEY, CA -- (Marketwired) -- 08/03/17 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) has requested more detailed information about the company's proposed post-marketing study...
• FDA Advisory Committee Does Not Recommend Approval of Sirukumab for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
  HORSHAM, Pa., Aug. 2, 2017 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) did not recommend approval of sirukumab (proposed trade name PLIVENSIA™) for the...
• US FDA Accepts Regulatory Submission for Acalabrutinib and Grants Priority Review
  August 2, 2017 -- AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA)...
• Dynavax Announces FDA Advisory Committee Vote in Favor of Heplisav-B
  BERKELEY, CA -- (Marketwired) -- 07/28/17 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that...
• Aradigm Submits New Drug Application (NDA) to FDA for U.S. Marketing Approval of Linhaliq in Non-Cystic Fibrosis Bronchiectasis
  HAYWARD, Calif.--(BUSINESS WIRE) July 27, 2017 -- Aradigm Corporation (NASDAQ: ARDM) (the "Company") today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Linhaliq™ for the treatment of...
• Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla
  PRINCETON, N.J., July 27, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a forward-thinking women's healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug...
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Clinical Trial Results (Drugs.com)

• ARCA Biopharma Announces Completion of Enrolment for GENETIC-AF Phase 2B Clinical Trial Evaluating Gencaro (bucindolol hydrochloride)
  WESTMINSTER, Colo., Aug. 16, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced...
• Spectrum Pharmaceuticals Announces Initiation of the Registrational Phase 3 Trial of Qapzola (apaziquone) in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
  HENDERSON, Nev.--(BUSINESS WIRE) August 14, 2017 -- Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced...
• Anthera Announces FDA Orphan Drug Designation for Blisibimod for the Treatment of IgA Nephropathy
  HAYWARD, Calif., Aug. 09, 2017 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals (Nasdaq:ANTH) today announced that blisibimod has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A...
• Amylyx Pharmaceuticals Doses First Patient in Phase II Clinical Trial of AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis
  Cambridge, MA, August 8, 2017 – Amylyx Pharmaceuticals, Inc., in collaboration with The ALS Association, ALS Finding a Cure®, and the Massachusetts General Hospital, today announced that the first patient was dosed in the CENTAUR study, a Phase...
• Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma
  SANTA MONICA, Calif.--(BUSINESS WIRE) August 8, 2017 -- Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA)...
• Zynerba Pharmaceuticals Announces Top-Line Results from Phase 2 STAR 1 Trial of ZYN002 in Adult Epilepsy Patients with Focal Seizures
  Devon, PA, August 7, 2017 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative transdermal pharmaceutically-produced cannabinoid treatments, today...
• Rebiotix Announces First Patient Enrolled in Phase 3 Clinical Trial of RBX2660 for the Prevention of Recurrent Clostridium difficile Infection
  ROSEVILLE, MN (August 07, 2017) — Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that it has enrolled the first patient in a Phase 3...
• Gemphire Announces Top-Line Data from ROYAL-1 Phase 2b Clinical Trial in Hypercholesterolemic Patients
  LIVONIA, Mich., Aug. 07, 2017 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP) today announced top-line data based upon the Company’s preliminary review of the limited top-line data set from the completed double-blind,...
• Polaryx Therapeutics Receives Orphan Drug Designation From the U.S. FDA for PLX-200 for Rare Pediatric Disease
  PARAMUS, N.J., Aug. 7, 2017 /PRNewswire/ -- Polaryx Therapeutics, Inc, a biotech company developing oral small molecule therapeutics for Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and for other forms of NCL, commonly known as Batten...
• Lilly Announces Positive Results For Second Phase 3 Study Of Lasmiditan For The Acute Treatment Of Migraine
  INDIANAPOLIS, Aug. 4, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, met its primary endpoint in SPARTAN, a second Phase...
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