Industry News

Pharma Headline News (Drugs.com)

• Prescribing of Gluten-Free Foods Declining in England
  THURSDAY, April 19, 2018 -- Recent policy changes have led to a decline in the prescribing of gluten-free foods in England, according to research published online April 16 in BMJ Open. Alex J. Walker, Ph.D., from the University of Oxford in the...
• Opioids Tied to Adverse Outcomes in Hemodialysis Patients
  THURSDAY, April 19, 2018 -- For patients on hemodialysis, opioids are associated with adverse outcomes, according to a study published online April 19 in the Clinical Journal of the American Society of Nephrology. Julie H. Ishida, M.D., from the...
• First Opioid Lawsuit Targeting Pharmacy Benefit Managers
  THURSDAY, April 19, 2018 -- A first opioid lawsuit is targeting pharmacy benefit managers (PBMs), according to a report published in Managed Healthcare Executive. Noting that until now, PBMs have not been sued for the opioid crisis, in February, a...
• Most Smokers With Head and Neck Cancer Have Tried to Quit
  THURSDAY, April 19, 2018 -- Most active smokers with head and neck squamous cell carcinoma (HNSCC) have made one or more quit attempts, according to a study published online April 12 in JAMA Otolaryngology-Head & Neck Surgery. Samir S....
• Adults Using Benzodiazepines More Likely to Receive Opioid Rx
  THURSDAY, April 19, 2018 -- New opioid prescriptions for U.S. adults using benzodiazepines stopped increasing in 2010, although the likelihood of receiving a prescription is still elevated versus the general population, according to a study...
• AAN: Erenumab Shows Promise for Hard-to-Treat Migraine
  THURSDAY, April 19, 2018 -- For patients with episodic migraine who have failed prior preventive migraine treatments (PMTs), erenumab is associated with an increase in the proportion of patients achieving a ≥50 percent reduction in mean monthly...
• Small Link for Cannabis Use, Reduced Cognitive Functioning
  THURSDAY, April 19, 2018 -- For adolescents and young adults, frequent or heavy cannabis use has a small association with reduced cognitive functioning, according to research published online April 18 in JAMA Psychiatry. J. Cobb Scott, Ph.D., from...
• Artificial Pancreas Treatment Efficacious for Type 1 Diabetes
  THURSDAY, April 19, 2018 -- For patients with type 1 diabetes, artificial pancreas treatment is efficacious, increasing the proportion of time spent in the near normoglycemic range, according to a study published online April 18 in The BMJ. Eleni...
• Less Pain Post TKA With Addition of Peripheral Nerve Blocks
  THURSDAY, April 19, 2018 -- Addition of an interspace between the popliteal artery and capsule of the posterior knee (IPACK) block and adductor canal block (ACB) to periarticular injection (PAI) is associated with less pain after total knee...
• Gene Therapy Found to Be Promising for β-Thalassemia
  THURSDAY, April 19, 2018 -- For patients with severe β-thalassemia, the need for red-cell transfusions can be reduced or eliminated by transducing cells with the LentiGlobin BB305 vector, according to a study published in the April 18 issue of the...
• Number of Cigarettes Smoked Daily Tied to Stroke Risk
  THURSDAY, April 19, 2018 -- There is a strong dose-response relationship between the number of cigarettes smoked daily and ischemic stroke risk among men younger than 50 years of age, according to a study published online April 19 in Stroke. Janina...
• Hearing Aids May Mitigate Cognitive Decline, Memory Loss
  THURSDAY, April 19, 2018 -- Using hearing aids may slow cognitive decline in later life, according to a study published online April 10 in the Journal of the American Geriatrics Society. Asri Maharani, Ph.D., from the University of Manchester in the...
• Delayed Coronary Obstruction Rare After TAVR
  THURSDAY, April 19, 2018 -- Delayed coronary obstruction (DCO) after transcatheter aortic valve replacement (TAVR) is a rare phenomenon but is associated with a high in-hospital mortality rate, according to a study published in the April 10 issue...
• AAN: New Drug May Help Infants With Spinal Muscular Atrophy
  THURSDAY, April 19, 2018 -- For infants with type 1 spinal muscular atrophy who have two copies of the survival motor neuron (SMN) 2 gene, RG7916 can increase SMN protein levels in the blood, according to a study presented at the annual meeting of...
• Time-Related Deployment Factors Predict Suicide Attempt Risk
  THURSDAY, April 19, 2018 -- For soldiers who have been deployed twice, suicide attempt (SA) risk is associated with timing of first deployment and dwell time (DT; i.e., length between deployments), according to a study published online April 18 in...
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New Drug Approvals (Drugs.com)

• FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
  April 17, 2018 -- The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH...
• FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia
  SOUTH SAN FRANCISCO, Calif., April 17, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved Tavalisse (fostamatinib disodium hexahydrate) for the treatment of...
• FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures
  April 11, 2018 -- On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and...
• Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
  PARSIPPANY, N.J., April 06, 2018 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to broaden the use of Exparel...
• Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
  BOULDER, Colo.--(BUSINESS WIRE)--Apr. 6, 2018-- Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with...
• FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control
  April 3, 2018 AstraZeneca today announced the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with...
• FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
  March 29, 2018 -- The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal...
• Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.
  HERTFORDSHIRE, England and PITTSBURGH, March 28, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug...
• FDA Approves Toujeo (insulin glargine) Max SoloStar
  BRIDGEWATER, N.J., March 27, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the...
• Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia
  Basel, March 22, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with...
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NDAs (Drugs.com)

• Antares Pharma Provides Xyosted Regulatory Update
  EWING, N.J., April 05, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) (the Company) today announced that the U.S. Food and Drug Administration (FDA or the Agency) acknowledged receipt of the Company’s March 29, 2018 resubmission to...
• Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA
  BOSTON, April 04, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline, an...
• US FDA Accepts Biologics License Application for Moxetumomab Pasudotox in Hairy Cell Leukemia
  April 3, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an...
• Alkermes Receives Refusal to File Letter From FDA for ALKS 5461
  DUBLIN, April 2, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461, a once-daily, oral...
• FDA Advisory Committee Votes in Favor of Lucemyra (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms
  LOUISVILLE, Ky., March 27, 2018 /PRNewswire/ -- US WorldMeds today announced that the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine for mitigating opioid...
• Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes
  The Woodlands, Texas, March 26, 2018 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that its collaborator, Sanofi, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing...
• Loxo Oncology Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancer
  STAMFORD, Conn., March 26, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the...
• Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
  CRANBURY, N.J., March 26, 2018 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical...
• Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for Azedra (iobenguane I 131)
  NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced today that the Company has...
• Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53
  CAMBRIDGE, Mass., March 12, 2018 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases,...
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Clinical Trial Results (Drugs.com)

• Inventiva Announces a U.S. Phase II Investigator-Initiated Study with Lanifibranor on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes
  Daix (France), April 4th, 2018 - Inventiva, a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that Dr. Kenneth Cusi, Chief of...
• Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy
  SOUTH SAN FRANCISCO, Calif., April 3, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today announced topline data from its proof-of-concept Phase 2 study of fostamatinib in patients with IgA nephropathy (IgAN), an orphan autoimmune...
• Phase III data in The Lancet Show Novartis Siponimod Significantly Improves Outcomes in Patients with Secondary Progressive MS
  Basel, March 23, 2018 - Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet....
• Fennec Pharmaceuticals Receives Fast Track Designation by FDA for Pedmark
  RESEARCH TRIANGLE PARK, N.C., March 21, 2018 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique...
• Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial
  IRVING, Texas, March 22, 2018 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, today announced positive top-line data from the Phase 2 LARIAT trial evaluating bardoxolone...
• AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer
  NORTH CHICAGO, Ill., March 22, 2018 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, today announced that after consulting with the U.S. Food and Drug Administration (FDA), it will not seek...
• Cidara Therapeutics Provides Clinical Data Updates for its Lead Antifungal Rezafungin
  SAN DIEGO, March 21, 2018 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today is providing additional details from the positive safety and efficacy...
• Trillium Therapeutics' TTI-621 Receives Orphan Drug Designation for the Treatment of Cutaneous T-Cell Lymphoma
  Toronto, March 20, 2018 — Trillium Therapeutics Inc. (Nasdaq/TSX: TRIL), an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan...
• Cellectar Biosciences Granted Orphan Drug Designation for CLR 131 to Treat Neuroblastoma
  MADISON, Wis., March 19, 2018 (GLOBE NEWSWIRE) -- Cellectar Biosciences (Nasdaq:CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that...
• Heron Announces Positive Topline Results From Pivotal Phase 3 Clinical Trials of HTX-011 in Bunionectomy and Hernia Repair
  SAN DIEGO--(BUSINESS WIRE)--Mar. 19, 2018-- Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important...
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