Company (location)

Product

Description

Indication

Status

Date

Cancer

Adgero Biopharmaceuticals Holdings Inc. (Princeton, N.J.)

REM-001

Photosensitizer drug

Basal cell carcinoma nevus syndrome

The FDA granted orphan designation

2/23/18

Advaxis Inc. (Princeton, N.J.)

Axalimogene filolisbac

Targeted Listeria monocytogenes-based immunotherapy

Persistent, recurrent or metastatic carcinoma of the cervix

Submitted a conditional marketing authorization application to the EMA

2/14/18

Agios Pharmaceuticals Inc. (Cambridge, Mass.)

AG-120

Ivosidenib

Relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation

The FDA accepted its new drug application, granted priority review and set a PDUFA date of Aug. 21

2/16/18

Amgen Inc. (Thousand Oaks, Calif.)

Denosumab

RANK ligand inhibitor

Skeletal events associated with cancer

The EMA's Committee for Human Medicinal Products issued a positive recommendation to relax the conditions from those with bone metastases resulting from solid tumors to any cancer patient with advanced malignancies involving bone; the extension also includes patients with unresectable giant cell tumor of bone

2/26/18

Astrazeneca Canada (Mississauga, Ontario, part of Astrazeneca plc)

Tagrisso

Osimertinib

Locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer

Health Canada has granted full approval for Tagrisso (osimertinib) for the treatment of patients whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy

2/1/18

Astrazeneca plc (Cambridge, U.K.)

Imfinzi

Durvalumab

Stage III non-small-cell lung cancer

Received FDA approval for the treatment of patients whose tumors are unresectable and whose cancer has not progressed after treatment with chemotherapy and radiation

2/21/18

Astrazeneca plc (Cambridge, U.K.)

Lynparza

Olaparib

Ovarian, fallopian tube and primary peritoneal cancers

The EMA's Committee for Human Medicinal Products issued a positive recommendation for new dose forms

2/26/18

Astrazeneca plc (London), and Merck & Co. Inc. (Kenilworth, N.J.)

Selumetinib

MEK 1/2 inhibitor

Neurofibromatosis type 1

The FDA granted orphan drug designation

2/16/18

Aveo Oncology Inc. (Cambridge, Mass.)

Foivda

Tivozanib

Advanced renal cell carcinoma

The U.K.'s National Institute for Health and Care Excellence has published a final appraisal determination recommending it for the first line treatment of adult patients

2/13/18

Celltrion Inc. (Incheon, South Korea)

Herzuma

Biosimilar trastuzumab

Early breast cancer, metastatic breast cancer or metastatic gastric cancer

The European Commission approved it for the treatment of patients whose tumors have either HER2 overexpression or HER2 gene amplification

2/15/18

Cormedix Inc. (Berkeley Heights, N.J.)

Taurolidine

Antibiotic

Neuroblastoma

The FDA granted orphan drug designation

2/27/18

Eli Lilly and Co. (Indianapolis)

Verzenio

Abemaciclib

Breast cancer

The FDA approved it in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer

2/28/18

Gilead Sciences Inc. (Foster City, Calif.)

Zydelig

Idelalisib

Chronic lymphocytic leukemia

Withdrew an application from the EMA's Committee for Human Medicinal Products

2/26/18

Ipsen Biopharmaceuticals Canada Inc. (Mississauga, Ontario; Canadian affiliate of Ipsen SA)

Somatuline Autogel

Lanreotide injection

Carcinoid syndrome

Health Canada approved it (120 mg)

2/14/18

Janssen Pharmaceutical Companies (Johnson & Johnson; New Brunswick, N.J.)

Zytiga

Abiraterone acetate

Newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer

Health Canada has approved the marketing of it in combination with prednisone and androgen deprivation therapy (ADT) for the treatment of patients who may have received up to three months of prior ADT

2/16/18

Janssen Research & Development LLC (Raritan, N.J.)

Erleada

Apalutamide

Non-metastatic castration-resistant prostate cancer

The FDA approved it

2/15/18

Janssen-Cilag International NV (Beerse, Belgium)

Apalutamide

Oral androgen receptor inhibitor

High-risk non-metastatic castration-resistant prostate cancer

Submitted a marketing authorization application to the EMA

2/12/18

Kazia Therapeutics Ltd. (Sydney)

GDC-0084

PI3K inhibitor

Glioblastoma multiforme

The FDA granted orphan drug designation

2/26/18

Pfizer Inc. (New York)

Lorlatinib

Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor

ALK-positive metastatic non-small cell lung cancer

Gained FDA acceptance and priority review for its new drug application with a PDUFA goal date of August; the EMA and Japan's PMDA have also accepted marketing applications

2/13/18

Pfizer Inc. (New York)

Mylotarg

Gemtuzumab ozogamicin

CD33-positive acute myeloid leukemia

The EMA's Committee for Human Medicinal Products issued a positive recommendation and covers previously untreated patients ages 15 or older

2/26/18

Pfizer Inc. (New York)

Bosulif

Bosutinib

Philadelphia-chromosome-positive chronic myelogenous leukemia (Ph+ CML)

The EMA's Committee for Human Medicinal Products recommended granting an extension of indication to include newly diagnosed chronic-phase Ph+ CML and accelerated-phase or blast-phase Ph+ CML in patients refractory to imatinib, nilotinib and dasatinib

2/26/18

Pfizer Inc. (New York)

Sutent

Sunitinib

Kidney cancer

The EMA's Committee for Human Medicinal Products issued a negative recommendation for the extension of the indication to delay or prevent the postsurgical recurrence of in high-risk patients

2/26/18

Puma Biotechnology Ltd. (Los Angeles)

Nerlynx

Neratinib

Breast cancer

The EMA's Committee on Human Medicinal Products issued a negative opinion on it because of an unfavorable risk-benefit profile

2/26/18

Verastem Inc. (Boston)

Duvelisib

Oral dual inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma

Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL)

Submitted an NDA to the FDA seeking full approval for the treatment of relapsed or refractory CLL/SLL and accelerated approval for the treatment of relapsed or refractory FL

2/8/18

Yisheng Biopharma Co. Ltd. (Beijing)

YS-ON-001

Immunomodulator

Pancreatic cancer

The FDA granted orphan status

2/27/18

Cardiovascular

ATXA Therapeutics Ltd. (Dublin)

NTP-42

Inhibitor of the T prostanoid receptor

Pulmonary arterial hypertension

The EMA granted orphan drug designation

2/26/18

Daiichi Sankyo Co. Ltd. (Tokyo)

Esaxerenone

Non-steroidal, selective antagonist of the mineralocorticoid receptor

Hypertension

Submitted its regulatory application to the Japanese Pharmaceutical and Medical Devices Agency

2/28/18

Dermatologic

Genentech Inc. (South San Francisco; unit of Roche Holdings AG)

Rituxan

Rituximab

Pemphigus vulgaris

The FDA accepted the supplementary BLA and assigned a priority review

2/15/18

Novartis AG (Basel, Switzerland)

Cosentyx

Secukinumab

Moderate to severe plaque psoriasis

The FDA has approved a label update effective in the U.S. immediately

2/9/18

Ortho Dermatologics (unit of Valeant Pharmaceuticals International Inc., Laval, Quebec)

Jemdel

Halobetasol propionate

Plaque psoriasis

The FDA accepted an NDA and assigned a PDUFA date of Oct. 5, 2018

2/15/18

Pfizer Inc. (New York)

PF-04965842

Janus kinase 1 inhibitor

Moderate-to-severe atopic dermatitis

The FDA granted breakthrough therapy designation

2/15/18

Shire plc (Dublin)

SHP-643

Lanadelumab

Hereditary angioedema

Health Canada accepted its request for priority review for the new drug submission

2/14/18

Shire plc (Dublin)

Cinryze

C1 esterase inhibitor (human)

Hereditary angioedema

Sthe FDA accepted the supplemental biologics license application for the treatment of children 6 and older, granted priority review and set a June 20 PDUFA date

2/16/18

Shire plc (Dublin)

SHP-643

Lanadelumab

Hereditary angioedema

The EMA's Committee for Medicinal Products for Human Use granted an accelerated assessment

2/28/18

Shire plc (Dublin)

SHP-643

Lanadelumab

Hereditary angioedema

The FDA accepted the biologics license application and granted priority review

2/26/18

Endocrine/Metabolic

Akcea Therapeutics Inc. (Cambridge, Mass.)

Volanesorsen

Antisense molecule targeting ApoC-III

Familial chylomicronemia syndrome

The FDA will hold an advisory committee meeting to review the data for it on May 10, 2018; the PDUFA date is Aug. 30

2/20/18

Alnylam Pharmaceuticals Inc. (Cambridge, Mass.)

Patisiran

RNAi therapeutic targeting transthyretin

Hereditary ATTR amyloidosis

The FDA accepted for filing its NDA, granted a priority review and set a PDUFA date of Aug. 11; at this time, the FDA is not planning to hold an advisory committee meeting to discuss the application

2/5/18

Amicus Therapeutics Inc. (Cranbury, N.J.)

Migalastat HCl

Chaperone therapy

Fabry disease with amenable mutations

The FDA has accepted the new drug application for filing under priority review; the PDUFA goal date for the FDA decision has been set for Aug. 13

2/13/18

Ammtek (Paris)

Amglidia

Glibenclamide

Neonatal diabetes

The EMA's Committee for Human Medicinal Products issued a positive recommendation

2/26/18

Audentes Therapeutics Inc. (San Francisco)

AT-342

AAV8 vector containing a functional copy of the UGT1A1 gene

Crigler-Najjar syndrome

The FDA granted rare pediatric disease and fast track designations

2/13/18

Diurnal Group plc (Cardiff, U.K.)

Alkindi

Hydrocortisone granules in capsules

Pediatric adrenal insufficiency

The European Commission granted a pediatric use marketing authorization for it as a replacement therapy for infants, children and adolescents

2/14/18

Ferring Pharmaceuticals Inc. (Parsippany, N.J.)

Zomacton

Somatropin

GH deficiency

The FDA approved it for the replacement of growth hormone in adults

2/2/18

Mallinckrodt plc (Staines-upon-Thames, U.K.)

Stannsoporfin

Heme oxygenase inhibitor

Severe hyperbilirubinemia

The FDA has accepted its NDA

2/26/18

Novo Nordisk A/S (Bagsværd, Denmark)

Ozempic

Semaglutide

Type 2 diabetes

The European Commission granted marketing authorization

2/12/18

Protalix Biotherapeutics Inc. (Carmiel, Israel)

PRX-102

Pegunigalsidase alfa

Fabry disease

The FDA granted fast track designation

2/1/18

Swedish Orphan Biovitrum AB (Stockholm)

Orfadin

Nitisinone

Hereditary tyrosinemia type-1

The Canadian Agency for Drugs and Technologies in Health Canadian Drug Expert Committee issued a conditional positive reimbursement recommendation for the treatment of adult and pediatric patients in combination with dietary restriction of tyrosine and phenylalanine, if certain conditions and criteria are met

2/28/18

Xeris Pharmaceuticals Inc. (Chicago)

Glucagon

Teady-to-use, liquid-stable formulation

Hyperinsulinemic hypoglycemia

Gained FDA orphan status

2/12/18

Gastrointestinal

Prometic Life Sciences Inc. (Laval, Quebec)

Inter-alpha-inhibitor-proteins

Endogenous proteins that control excessive inflammatory responses

Necrotizing enterocolitis

The FDA granted orphan drug designation

2/16/18

Salix Pharmaceuticals Ltd. (Bridgewater, N.J.) and Norgine BV (Amsterdam)

Plenvu

Bowel cleansing preparation

Colonoscopy preparation

The FDA extended the PDUFA action date for its review of the new drug application by three months to May 13, 2018

2/12/18

Shire plc (Dublin)

SHP-647

Fully human IgG2 monoclonal antibody

Moderately to severely active Crohn's disease

The FDA granted orphan drug designation

2/14/18

Genitourinary/Sexual Health

Achillion Pharmaceuticals Inc. (New Haven, Conn.)

ACH-4471

Small-molecule factor D inhibitor

C3 glomerulopathy

The EMA's Committee for Orphan Medicinal Products issued a positive opinion for orphan status in the European Union

2/27/18

Allergan plc (Dublin)

Liletta

Levonorgestrel-releasing intrauterine system (52 mg)

Prevention of pregnancy

The FDA accepted for filing the supplemental NDA aiming to extend the duration of use for the prevention of pregnancy from up to four years to up to five years

2/23/18

Amag Pharmaceuticals Inc. (Waltham, Mass.)

Prefilled Makena auto-injector

Hydroxypro-gesterone caproate

Preterm birth

The FDA approved it as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past

2/16/18

Apricus Biosciences Inc. (San Diego)

Vitaros

Alprostadil, DDAIP.HCl

Erectile dysfunction

The FDA issued another complete response letter for the resubmitted NDA

2/20/18

Hematologic

Amag Pharmaceuticals Inc. (Waltham, Mass.)

Feraheme

Ferumoxytol injection

Iron deficiency anemia (IDA)

The FDA approved its application to broaden the existing label to include all eligible adult IDA patients who have intolerance to oral iron or have had unsatisfactory response to oral iron

2/6/18

Amgen Inc. (Thousand Oaks, Calif.)

Neulasta

Pegfilgrastim

Neutropenia

Received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending a label variation for the product to include the Neulasta Onpro Kit, which combines Neulasta with an on-body injector delivery system

2/28/18

Novo Nordisk A/S (Bagsvaerd, Denmark)

N8-GP

Turoctocog alfa pegol

Hemophilia A

Submitted a BLA to the FDA and a marketing authorization application to the EMA

2/28/18

Shield TX Ltd. (London)

Feraccru

Ferric maltol

Iron deficiency in inflammatory bowel disease

The EMA's Committee for Human Medicinal Products recommended granting an extension of indication

2/26/18

Shionogi & Co. Ltd. (Osaka, Japan)

S-888711

Lusutrombopag

Thrombocytopenia associated with chronic liver disease

The NDA was accepted for filing and granted priority review by the FDA; the PDUFA date is Aug. 26

2/27/18

Immune

Adamis Pharmaceuticals Corp. (San Diego)

Symjepi

Epinephrine

Anaphylaxis

The FDA has accepted for review the supplemental NDA and indicated it is targeting Sept. 3, 2018, to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests

2/13/18

Hansa Medical AB (Lund, Sweden)

Ides

Imlifidas

Guillain-Barré syndrome

The FDA granted orphan drug designation

2/20/18

Hoffmann-La Roche Ltd. (Mississauga, Ontario)

Ocrevus

Ocrelizumab

Early primary progressive multiple sclerosis

Health Canada approved it

2/16/18

Sandoz Inc. (Holzkirchen, Germany; unit of Novartis AG)

Glatopa

Glatiramer acetate injection

Relapsing forms of multiple sclerosis

The FDA approved it

2/14/18

Shionogi & Co. Ltd. (Osaka, Japan)

Actair

Allergy immunotherapy sublingual tablet

House dust mite induced allergic rhinitis

Received expanded approval to treat patients younger than 12 years of age in Japan

2/20/18

Torii Pharmaceutical Co. Ltd. (Tokyo)

Miticure

Sublingual allergy immunotherapy tablet

Allergic rhinitis

Gained approval from the Japanese Ministry of Health, Labour and Welfare to expand the use to include treating pediatric patients

2/20/18

Infection

60 Degrees Pharmaceuticals Inc. (Washington)

Tafenoquine

8-aminoquinoline analogue of primaquine

Malaria

Received priority review designation from the FDA for prevention in adults; it also has been given fast track designation for adults traveling to areas where the disease is prevalent

2/9/18

Abbvie Inc. (North Chicago)

Maviret

Glecaprevir/pibrentasvir tablets

Chronic hepatitis C virus infection

The Canadian Agency for Drugs and Technologies in Health Canadian Drug Expert Committee issued a positive recommendation

2/7/18

Allecra Therapeutics GmbH (Lörrach, Germany)

AAI101

Extended spectrum beta-lactamase inhibitor

Serious hospital-acquired infections

The FDA granted fast track designation to it when given in fixed dose combination with the antibiotic cefepime

2/15/18

Allergan plc (Dublin)

Avycaz

Ceftazidime and avibactam

Pneumonia

The FDA approved its supplemental NDA to expand the approved use to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa and Haemophilus influenzae in patients 18 years of age or older

2/5/18

Biocryst Pharmaceuticals Inc. (Durham, N.C.)

Alpivab

Peramivir

Influenza

The EMA's Committee for Human Medicinal Products issued a positive recommendation

2/26/18

Contravir Pharmaceuticals Inc. (Edison, N.J.)

TXL

Tenofovir exalidex

Chronic hepatitis B infection

The FDA granted orphan designation for the treatment in a pediatric patient population (0 to 11 years old); Contravir is developing it via the agency's 505(b)(2) registration pathway

2/23/18

Eurofarma Laboratórios Ltda. (Brazil)

Baxdela

Delafloxacin

Acute bacterial skin and skin structure infections

Submitted a marketing authorization application in Argentina

2/21/18

Evofem Biosciences Inc. (San Diego)

Amphora

L-lactic acid, citric acid and potassium bitartrate vaginal gel

Urogenital chlamydia

The FDA granted fast track designation

2/22/18

Gilead Sciences Inc. (Foster City, Calif.)

Biktarvy

Bictegravir, emtricitabine and tenofovir alafenamide

HIV-1

The FDA approved it

2/9/18

Grifols SA, of Barcelona, Spain

Hyperrab

Rabies immune globulin (human)

Rabies postexposure prophylaxis

The FDA approved a higher potency formulation

2/7/18

Merck & Co. Inc. (Kenilworth, N.J.)

Prevymis

Letermovir

Cytomegalovirus

The European Commission approved it

2/1/18

Merck & Co. Inc. (Kenilworth, N.J.)

Isentress

Raltegravir

HIV

The EMA's Committee for Human Medicinal Products recommended granting an extension of indication for children ages 4 weeks and upward and adults to neonates

2/26/18

Mylan NV (Hertfordshire, U.K.)

DTG/FTC/TAF

Dolutegravir, emtricitabine and tenofovir alafenamide

HIV/AIDS

Received tentative approval from the FDA under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its new drug application

2/21/18

Paratek Pharmaceuticals Inc. (Boston)

Omadacycline

Broad-spectrum antibiotic

Community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections

Completed the submission of two NDAs for its once-daily oral and intravenous formulations of broad-spectrum antibiotic omadacycline

2/6/18

Sanofi SA (Paris)

Fexinidazole

Antiparasitic

Trypanosoma brucei gambiense human African trypanosomiasis

The company and the Drugs for Neglected Diseases Initiative have asked the EMA to review it under "Article 58" in which the EMA gives its scientific opinion in cooperation with the World Health Organization for treatments to be sold outside the EU

2/1/18

Siga Technologies Inc. (New York)

Tpoxx

Tecovirimat

Smallpox infection

The FDA accepted its NDA; the marketing application will receive a priority review with a PDUFA date of Aug. 8, 2018

2/8/18

Tetraphase Pharmaceuticals Inc. (Watertown, Mass.)

Eravacycline

Fully-synthetic fluorocycline antibiotic

Complicated intra-abdominal infections

The FDA accepted the NDA and assigned an Aug. 28 PDUFA date, reflective of a priority review

2/28/18

Inflammatory

Swedish Orphan Biovitrum AB (Stockholm, Sweden)

Kineret

Anakinra

Still's disease

The EMA's Committee for Human Medicinal Products recommended granting an extension of indication, including systemic juvenile idiopathic arthritis and adult-onset Still's disease

2/26/18

Musculoskeletal

Aquestive Therapeutics Inc. (Warren, N.J.)

Riluzole

Oral soluble film

Amyotrophic lateral sclerosis

The FDA has granted orphan drug designation

2/1/18

Capricor Therapeutics Inc. (Los Angeles)

CAP-1002

Cell therapy

Duchenne muscular dystrophy

The FDA granted regenerative medicine advanced therapy designation

2/6/18

Kyowa Hakko Kirin Co. Ltd. (Tokyo), Kyowa Kirin International plc (London) and Ultragenyx Pharmaceutical Inc. (Novato, Calif.)

Crysvita

Burosumab

X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease

It received a positive European Commission decision granting a conditional marketing authorization to Kyowa Kirin for treatment in children 1 year of age and older and adolescents with growing skeletons

2/26/18

PTC Therapeutics Inc. (South Plainfield, N.J.)

Ataluren

Oral small-molecule compound

Nonsense mutation Duchenne muscular dystrophy

The FDA's Office of New Drugs affirmed the agency's prior position on the NDA and denied the company's appeal of the complete response letter

2/21/18

Neurology/Psychiatric

Abeona Therapeutics Inc. (Cleveland)

ABO-202

AAV-based gene therapy

Infantile Batten disease

The FDA granted orphan drug designation

2/13/18

Acorda Therapeutics Inc. (Ardsley, N.Y.)

Inbrija

Inhaled levodopa treatment

Parkinson's disease

The FDA accepted for filing its NDA and set a PDUFA target date of Oct. 5, 2018

2/21/18

Alkermes plc (Dublin)

ALKS-5461

Buprenorphine and samidorphan

Major depressive disorder

Submitted an NDA to the FDA as adjunctive treatment

2/1/18

Emerald Health Pharmaceuticals Inc. (San Diego)

EHP-102

Cannabigerol derivative

Huntington's disease

The FDA granted orphan designation

2/27/18

GW Pharmaceuticals plc (London)

Epidiolex

Cannabidiol

Seizures associated with Lennox-Gastaut syndrome and Dravet syndrome

The EMA accepted for review the marketing authorization application

2/7/18

GW Pharmaceuticals plc (London)

Epidiolex

Cannabidiol

Tuberous sclerosis

The EMA granted orphan drug designation

2/28/18

Kempharm Inc. (Coralville, Iowa)

Apadaz

Prodrug of benzhydrocodone/acetaminophen

Short-term management of acute pain

The FDA approved it

2/26/18

Osmotica Pharmaceutical US LLC (Bridgewater, N.J.)

Osmolex ER

Amantadine extended-release tablet

Parkinson's disease and drug-induced extrapyramidal reactions

The FDA approved it

2/21/18

Pacira Pharmaceuticals Inc. (Parsippany, N.J.)

Exparel

Bupivacaine liposome injectable suspension

Nerve block to produce regional analgesia

The FDA's Anesthetic and Analgesic Drug Products Advisory voted 6 to 4 against recommending approval of the additional indication for use; the company will continue to work with the FDA before the April 6 PDUFA date

2/16/18

Pain Therapeutics Inc. (Austin, Texas)

Remoxy ER

Abuse-deterrent, extended-release capsule formulation of oxycodone

Pain

Resubmitted the NDA and expects a six-month review cycle for it

2/14/18

Sage Therapeutics Inc. (Cambridge, Mass.)

SAGE-217

GABAA positive allosteric modulator

Major depressive disorder

The FDA granted breakthrough therapy designation

2/8/18

Teva Pharmaceutical Industries Ltd. (Petah Tikva, Israel)

Remanezumab

Anti-calcitonin gene-related peptide antibody

Prevention of episodic and chronic migraine

The EMA accepted its marketing authorization application

2/5/18

Zogenix Inc. (Emeryville, Calif.)

ZX-008

Low-dose fenfluramine

Seizures associated with Dravet syndrome

The FDA granted breakthrough designation

2/7/18

Ocular

Icon Bioscience Inc. (Newark, Calif.)

Dexycu

Dexamethasone intraocular suspension

Inflammation associated with cataract surgery

Gained FDA approval

2/13/18

Knight Therapeutics Inc. (Montreal) and Società Industria Farmaceutica Italiana S.p.A. (Sicily)

Netildex

Netilmicin and dexamethasone

Inflammatory ocular conditions of the anterior segment of the eye

Its new drug submission was accepted for review by Health Canada

2/16/18

Meiragtx Ltd. (London and New York)

A-002

AAV2/8-hCARp.hCNGB3

Achromatopsia due to mutations in the CNGB3 gene

The FDA granted rare pediatric disease designation

2/2/18

Other/Miscellaneous

Arrowhead Pharmaceuticals Inc. (Pasadena, Calif.)

ARO-AAT

Knocks down the hepatic production of the mutant alpha-1 antitrypsin protein

Alpha-1 antitrypsin deficiency

The FDA granted orphan drug designation

2/16/18

Respiratory

Astrazeneca Canada (Mississauga, Ontario; unit of Astrazeneca plc)

Fasenra

Benralizumab

Severe eosinophilic asthma

Health Canada approved it as an add-on maintenance treatment for adults

2/27/18

Chiesi Farmaceutici SpA (Parma, Italy)

Trydonis

Beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium bromide

Chronic obstructive pulmonary disease

The EMA's Committee for Human Medicinal Products issued a positive recommendation

2/26/18

Glaxosmithkline plc (London) and Innoviva Inc. (Brisbane, Calif.)

Trelegy Ellipta

Fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI

Moderate to severe chronic obstructive pulmonary disease

Submitted a type II variation to the EMA to support an expanded label as a maintenance treatment

2/15/18

Sandoz GmbH (Holzkirchen, Germany; unit of Novartis AG)

Generic version of Advair

Fluticasone propionate/salmeterol

Asthma and chronic obstructive pulmonary disease

Received a complete response letter from the FDA

2/9/18

Vertex Pharmaceuticals Inc. (Boston)

Symdeko

Tezacaftor/ivacaftor and ivacaftor

Cystic fibrosis

The FDA approved it for patients ages 12 and older with two copies of the F508del mutation in the CF transmembrane conductance regulator gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor

2/14/18


Notes

The date indicated refers to the BioWorld Today issue in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

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