Company
(location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Allergan plc (Dublin)

Aczone

Dapsone gel; topical

Acne

FDA approved it in patients 12 years of age and older

2/29/16

Eli Lilly and Co. (Indianapolis)

Ixekizumab

Targets IL-17A

Moderate to severe plaque psoriasis

EMA's Committee for Medicinal Products for Human Use issued a positive opinion for ixekizumab for the treatment of moderate to severe plaque psoriasis in adults in the European Union who are candidates for systemic therapy

2/29/16

Genentech (unit of Roche AG, of Basel, Switzerland)

Ocrevus

Ocrelizumab

Primary progressive multiple sclerosis

FDA has designated Ocrevus a breakthrough therapy

2/18/16

Pfizer Inc. (New York)

Xeljanz XR

JAK inhibitor; tofacitinib citrate extended-release 11-mg tablets

Moderate to severe rheumatoid arthritis

FDA approved it in patients who have had an inadequate response or intolerance to methotrexate

2/25/16

Promius Pharma LLC (Princeton, N.J.; subsidiary of Dr. Reddy's Laboratories Ltd.)

Sernivo

Betamethasone dipropionate spray, 0.05%

Mild to moderate plaque psoriasis

Was granted FDA approval to treat patients 18 and older

2/9/16

True North Therapeutics Inc. (South San Francisco)

TNT009

A monoclonal antibody designed to target C1s

Autoimmune hemolytic anemia

EMA granted orphan designation for TNT009

2/26/16

CANCER

Adaptimmune Ltd. (Oxford, U.K.)

T-cell therapy

Targets NY-ESO

Synovial sarcoma

FDA has granted breakthrough therapy designation

2/10/16

Astellas Pharma Inc. (Tokyo) and Medivation Inc. (South San Francisco)

Xtandi

Enzalutamide

Metastatic castration-resistant prostate cancer

FDA accepted for review a supplemental NDA seeking approval to market the therapy; the PDUFA date is Oct. 22.

2/24/16

Astrazeneca plc (London)

Tagrisso

AZD9291, osimertinib

Locally advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small-cell lung cancer

European Commission has granted conditional marketing authorization

2/4/16

Astrazeneca plc (London) and Acerta Pharma BV (Redwood City, Calif.)

ACP-196

Acalabrutinib

Chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma

EMA's Committee for Orphan Medicinal Products adopted three positive opinions recommending it for designation as an orphan medicinal product

2/26/16

Aveo Oncology Inc. (Cambridge, Mass.)

Tivozanib

VEGF tyrosine kinase inhibitor

Advanced renal cell carcinoma

A registration dossier seeking to obtain marketing authorization has been accepted by the Ministry of Health of the Russian Federation

2/23/16

Bristol-Myers Squibb Co. (New York)

Empliciti

Elotuzumab; humanized, IgG1 monoclonal antibody that specifically targets the SLAMF7 protein

Multiple myeloma

The CHMP recommended approval of Empliciti

2/1/16

Bristol-Myers Squibb Co. (New York)

Opdivo

Nivolumab; anti-PD-1 drug

Locally advanced or metastatic non-small-cell lung cancer, and advanced renal cell carcinoma

EMA's Committee for Medicinal Products for Human Use recommended the approval of Opdivo for two new indications: adults with locally advanced or metastatic non-small-cell lung cancer after prior chemotherapy, and adults with advanced renal cell carcinoma after prior therapy; Opdivo is already approved in Europe for advanced melanoma and previously treated advanced squamous NSCLC.

2/29/16

Epizyme Inc. (Cambridge, Mass.)

Tazemetostat

EZH2 inhibitor

Malignant rhabdoid tumors

FDA designated it an orphan drug

2/9/16

Exelixis Inc. (South San Francisco)

Cabozantinib

Multi-tyrosine kinase inhibitor

Advanced renal cell carcinoma

EMA accepted for review the MAA

2/1/16

Genentech (unit of Roche AG; Basel, Switzerland)

Gazyva

Obinutuzumab

Follicular lymphoma

FDA approved Gazyva plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment

2/29/16

Immunomedics Inc. (Morris Plains, N.J.)

IMMU-132

Antibody that targets the TROP-2 receptor

Triple-negative breast cancer

Received breakthrough therapy designation from the FDA

2/8/16

Kremers Urban Pharmaceuticals Inc. (subsidiary of Lannett Co. Inc.; Philadelphia)

Temozolomide

Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg; therapeutic equivalent to Temodar (Merck & Co. Inc.)

Cancer

Received FDA approval of the aNDA

2/12/16

Medimmune and Astrazeneca plc (London)

MEDI4736

Durvalumab; human monoclonal antibody directed against programmed death ligand-1

PD-L1 positive inoperable or metastatic urothelial bladder cancer

FDA granted breakthrough therapy

2/18/16

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

Emend

Fosaprepitant dimeglumine; substance P/neurokinin-1 receptor antagonist

To prevent delayed nausea and vomiting

FDA approved an sNDA for single-dose Emend in combination with other anti-emetic medicines for adults receiving initial and repeat courses of moderately emetogenic chemotherapy

2/5/16

Novartis AG (Basel, Switzerland)

PKC412

Midostaurin

Acute myeloid leukemia

Gained FDA breakthrough therapy status

2/22/16

Novartis AG (Basel, Switzerland)

Afinitor

Everolimus tablets

Progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic

FDA approved it

2/29/16

Oasmia Pharmaceutical AB (Uppsala, Sweden)

Apealea

Paclical; a new version of paclitaxel based on the excipient platform XR-17, which forms Cremophor-free micellar nanoparticles with paclitaxel

Epithelial ovarian cancer

Submitted a marketing authorization application (MAA) to the EMA for Apealea combined with carboplatin

2/9/16

Pfizer Inc. (New York)

Ibrance

Palbociclib

Metastatic breast cancer

Received expanded approval from the FDA for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer to be combined with fulvestrant in women with disease progression following endocrine therapy

2/23/16

Roche AG (Basel, Switzerland)

Cotellic

Cobimetinib

Unresectable or metastatic melanoma

Health Canada approved Cotellic in combination with Zelboraf (vemurafenib)

2/26/16

Sandoz Inc. (Holzkirchen, Germany)

Biosimilar

To Amgen's Neulasta (pegfilgrastim, a long-acting recombinant human granulocyte colony-stimulating factor

Chemo-induced neutropenia

EMA accepted the MAA

2/12/16

Spectrum Pharmaceuticals Inc. (Henderson, Nev.)

Eoquin

Apaziquone for intravesical instillation

Cancer

FDA accepted the NDA for review and set a target action date of Dec. 11

2/22/16

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Ixazomib

Oral proteasome inhibitor

Relapsed and/or refractory multiple myeloma

Health Canada accepted the new drug submission for ixazomib for priority review

2/17/16

Tapimmune Inc. (Jacksonville, Fla.)

TPIV200

Multiple-epitope folate receptor alpha peptide vaccine

Ovarian cancer

FDA granted fast track designation

2/4/16

CARDIOVASCULAR

Actelion Ltd. (Allschwil, Switzerland)

Uptravi

Selexipag

Pulmonary arterial hypertension

Added a positive EMA opinion to the FDA and Health Canada approvals

2/1/16

Astrazeneca plc (London)

Brilique

Ticagrelor

Heart attack

European Commission granted marketing authorization

2/22/16

Baxalta Inc. (Bannockburn, Ill.)

Adynovate

Antihemophilic factor (recombinant), pegylated

Hemophilia A

Submitted supplemental BLAs to the FDA for the use of Adynovate to treat children under the age of 12 with hemophilia A and for use in surgical settings

2/29/16

Eagle Pharmaceuticals Inc. (Woodcliff Lake, N.J.)

Ryanodex

Dantrolene sodium

Exertional heat stroke

FDA has granted fast track designation

2/2/16

Les Laboratoires Servier SAS (Neuilly-sur-Seine, France)

Viacoram

Perindopril arginine/amlodipine besylate

Mild to moderate hypertension

Its Canadian unit reported Health Canada approval as a first-line treatment

2/1/16

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

Zetia and Vytorin

Ezetimibe; and ezetimibe and simvastatin

To lower cholesterol

FDA issued a complete response letter to the supplemental NDA

2/17/16

Nuvox Pharma LLC (Tucson, Ariz.)

NVX-508

Designed to deliver oxygen to the diseased tissues

Sickle cell disease

Secured orphan designation from the FDA for vaso-occlusive crisis and acute chest syndrome

2/17/16

Pharming Group NV (Leiden, the Netherlands)

Ruconest

Conestat alpha

Hereditary angioedema

EMA's Committee for Medicinal Products for Human Use issued a positive opinion on the company's request to add the treatment of hereditary angioedema (HAE) attacks in adolescents with HAE to the Ruconest (conestat alpha) label and to remove the requirements for rabbit IgE testing that formed part of the EU label; the FDA's 2014 approval of the recombinant human C1 esterase inhibitor to treat acute HAE attacks did not require rabbit IgE testing

2/29/16

Portola Pharmaceuticals Inc. (South San Francisco)

Andexanet alfa

To reverse anticoagulant activity of direct and indirect factor Xa inhibitors

To reverse anticoagulation

FDA accepted for priority review the BLA

2/19/16

Remedy Pharmaceuticals Inc. (New York)

Cirara

A high-affinity inhibitor of Sur1-Trpm4 channels

Acute subarachnoid hemorrhage

FDA granted orphan status

2/17/16

Swedish Orphan Biovitrum AB (Stockholm) and Biogen Inc. (Cambridge, Mass.)

Alprolix

A recombinant factor IX Fc fusion protein therapy

Hemophilia B

Received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending that marketing authorization be granted

2/29/16

CENTRAL NERVOUS SYSTEM

Acadia Pharmaceuticals Inc. (San Diego)

Nuplazid

Pimavanserin

Psychosis associated with Parkinson's disease

A March 29 meeting of the FDA's Psychopharmacologic Drugs Advisory Committee will review data included in the company's new drug application (NDA)

2/2/16

Adapta Pharma Ltd. (Dublin)

Narcan

Naloxone hydrochloride nasal spray

Opioid overdose

Now available in the U.S. for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression

2/29/16

Allergan plc (Dublin)

GLYX-13

Rapastinel; intravenous NMDA receptor partial agonist

Major depressive disorder

Received breakthrough therapy designation from the FDA

2/1/16

Amarantus Bioscience Holdings Inc. (San Francisco)

Eltoprazine

A 5HT1a/1b partial agonist small-molecule drug

Parkinson's disease levodopa-induced dyskinesia

Received orphan drug designation from the FDA

2/11/16

Asterias Biotherapeutics Inc. (Fremont, Calif.)

AST-OPC1

An oligodendrocyte progenitor population derived from human embryonic stem cells

Acute spinal cord injury

FDA granted orphan designation

2/5/16

Dr. Reddy's Laboratories Ltd. (Hyderabad, India)

Zembrace Symtouch

Sumatriptan succinate injection; a drug-device combination product

Acute migraine episodes, with or without aura

FDA approved it in adults who are inadequately managed with existing treatment regimens

2/1/16

H. Lundbeck A/S (Valby, Denmark) and Otsuka Pharmaceutical Co. Ltd. (Princeton, N.J.)

Rexulti

Brexipiprazole

Schizophrenia

FDA accepted for review a supplemental new drug application (sNDA) for the proposed labeling update for the maintenance treatment of adults

2/9/16

Kempharm Inc. (Coralville, Iowa)

KP201/APAP

Abuse-deterrent immediate-release hydrocodone combination candidate

Acute pain

FDA accepted and granted priority review to the NDA

2/11/16

Lannett Co. Inc. (Philadelphia)

Sumatriptan

Nasal spray USP; therapeutic equivalent to Imitrex nasal spray (Glaxosmithkline plc; London)

Migraine

FDA approved the abbreviated NDA

2/23/16

Optinose A/S (Oslo, Norway) and Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.)

Onzetra Xsail

Sumatriptan nasal powder; formerly AVP-825

Migraine with or without aura

FDA approved it for acute treatment in adults

2/1/16

Otsuka Pharmaceuticals Co. Ltd. (Tokyo) and H. Lundbeck A/S (Valby, Denmark)

Abilify Maintena

Aripiprazole

Schizophrenia

CHMP released a positive opinion on updating the product's label for schizophrenia who have acutely relapsed and is intended as maintenance treatment of patients who have been stabilized with oral aripiprazole

2/4/16

Retrophin Inc. (San Diego)

RE-024

Phosphopanto-thenate replacement therapy

Pantothenate kinase-associated neurodegeneration

European Commission granted orphan drug designation

2/25/16

Shire plc (Dublin) and Shionogi & Co. Ltd. (Osaka, Japan)

S-877503

Guanfacine hydrochloride prolonged release tablets

Attention deficit hyperactivity disorder

Submitted an NDA in Japan

2/12/16

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Brintellix

Vortioxetine

Major depressive disorder

FDA's Psychopharmacologic Drugs Advisory Committee voted 8-2 Wednesday in support of an expanded label for Takeda's Brintellix that would recognize cognitive dysfunction in adults with major depressive disorder

2/4/16

Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals Inc.

Probuphine

Subdermal buprenorphine implant

Opioid dependence

FDA extended by three months the PDUFA date, which is now set for May 27; the agency requested additional changes to the risk evaluation and mitigation strategy portion of the NDA

2/23/16

Trevena Inc. (King of Prussia, Pa.)

TRV130

Oliceridine

Moderate-to-severe acute pain

FDA designated intravenous oliceridine a breakthrough therapy

2/23/16

UCB SA (Brussels, Belgium)

Briviact

Brivaracetam; high-affinity synaptic vesicle protein 2A (SV2A) ligand

Partial-onset seizures in epilepsy

FDA approved it as adjunctive therapy

2/19/16

Zynerba Pharmaceuticals Inc. (Devon, Pa.)

ZYN002

Cannabidiol gel

Fragile X syndrome

FDA granted orphan drug designation to ZYN002

2/26/16

DIABETES

Sanofi SA (Paris) and Zealand Pharma AS (Copenhagen)

Basal insulin glargine and lixisenatide

Fixed-ratio combination of basal insulin glargine 100 U/mL and lixisenatide

Type 2 diabetes

FDA accepted its NDA for a fixed-ratio combination of basal insulin glargine 100 U/mL and lixisenatide, a GLP-1 receptor agonist

2/23/16

GASTROINTESTINAL

Synergy Pharmaceuticals Inc. (New York)

Plecanatide

A uroguanylin analogue

Chronic idiopathic constipation

Filed an NDA with the FDA seeking approval in CIC

2/1/16

INFECTION

Abbvie Inc. (North Chicago)

Viekirax + Exviera

Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir) without ribavirin

Chronic hepatitis C virus genotype 1b with compensated cirrhosis

EMA's Committee for Medicinal Products for Human Use issued a positive opinion

2/29/16

Allergan plc (Dublin)

Avycaz

Ceftazidime and avibacatam

Complicated intra-abdominal infections

FDA accepted for filing the company's sNDA, which will add data to the current label from two phase III trials evaluating the safety and efficacy in combination with metronidazole for the treatment of cIAI, including patients with infections due to ceftazidime-nonsusceptible pathogens

2/25/16

Bristol-Myers Squibb Co. (New York)

Daklinza

Daclatasvir; an NS5A replication complex inhibitor

Chronic hepatitis C virus with HIV-1 co-infection

Approved by the FDA in combination with Sovaldi (sofosbuvir, Gilead Sciences Inc.), with or without ribavirin, in genotypes 1 and 3

2/8/16

Cidara Therapeutics Inc. (San Diego)

CD101 IV

Novel echinocandin

Candidemia and invasive candidiasis

FDA granted orphan drug designation

2/11/16

Cipher Pharmaceuticals Inc. (Mississauga, Ontario)

Sitavig

Acyclovir mucoadhesive buccal tablets

Recurrent herpes labialis

Its new drug submission was accepted for review by Health Canada

2/17/16

Conatus Pharmaceuticals Inc. (San Diego)

Emricasan

First-in-class, orally-active pan-caspase inhibitor

Liver cirrhosis caused by nonalcoholic steatohepatitis

FDA designated emricasan a fast track drug

2/4/16

Gilead Sciences Inc. (Foster City, Calif.)

Truvada

Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg

HIV-1 infection

Type II variation application of Truvada, in combination with safer sex practices to reduce the risk of sexually acquired HIV in uninfected adults at high risk, has been fully validated and is now under evaluation by the EMA

2/2/16

Gilead Sciences Inc. (Foster City, Calif.)

Harvoni

Ledipasvir/sofosbuvir

Chronic hepatitis C virus

FDA approved additional indications for Harvoni: in combination with ribavirin for 12 weeks in HCV genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis, and for HCV genotype 1-infected patients with decompensated cirrhosis, including those who have undergone liver transplantation

2/17/16

Gilead Sciences Inc. (Foster City, Calif.)

TAF

Tenofovir alafenamide; once-daily treatment

Chronic hepatitis B virus infection

EMA validated and is now assessing the MAA for TAF

2/26/16

Gilead Sciences Inc. (Foster City, Calif.)

Descovy

Emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF

HIV-1 infection

EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the MAA for the two doses

2/29/16

Immune Response Biopharma Inc. (New York)

Remune HIV-1 Immunogen

HIV vaccine

HIV-1 infection

Received a complete response letter

2/17/16

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

Zepatier

Elbasvir and grazoprevir

Hepatitis C virus

FDA approved it for genotype 1 and 4 infections

2/1/16

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

Zepatier

Elbasvir and grazoprevir

Chronic hepatitis C virus genotypes 1, 3 or 4

Received accelerated approval in Canada

2/4/16

Nimbus Therapeutics Inc. (Cambridge, Mass.)

NDI-010976

Liver-targeted allosteric inhibitor of acetyl-CoA carboxylase

Non-alcoholic steatohepatitis

FDA granted fast track status

2/3/16

INFLAMMATORY

Dr. Reddy's Laboratories Ltd. (Hyderabad, India)

Zenavod

Doxycycline capsules; a tetracycline-class drug

Inflammatory lesions of rosacea

FDA has given tentative approval for Zenavod, 40 mg, with a stay of final approval for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act

2/2/16

MISCELLANEOUS

AB Science SA (Paris)

Masitinib

Tyrosine-kinase inhibitor

Severe systemic mastocytosis

Following a pre-submission meeting with the EMA, the MAA has been accepted for review

2/2/16

Amag Pharmaceuticals Inc. (Waltham, Mass.)

Makena

Single-dose, preservative-free formulation; hydroxyprogesterone caproate injection

To reduce the risk of preterm birth

FDA approved it as an expansion of the Makena product line, indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered a preterm baby in the past

2/24/16

Amarantus Bioscience Holdings Inc. (San Francisco)

MANF

Mesencephalic-astrocyte-derived neurotrophic factor

Retinitis pigmentosa

Amarantus requested rare pediatric disease designation from the FDA; it was previously granted orphan drug designation

2/8/16

Atara Biotherapeutics Inc. (South San Francisco)

T-lymphocyte

Off-the-shelf allogeneic cellular therapy, activated against Epstein-Barr Virus

Post-transplant lymphoproliferative disorder following hematopoietic cell transplant or solid organ transplant

FDA granted orphan drug designation

2/9/16

Bellicum Pharmaceuticals Inc. (Houston)

BPX-501

Genetically modified T cells

Immunodeficiency and graft-vs.-host disease

FDA has granted orphan drug designation for the combination of BPX-501 and activator agent rimiducid

2/23/16

Catalyst Pharmaceuticals Inc. (Coral Gables, Fla.)

Firdapse

Amifampridine phosphate

Lambert-Eaton myasthenic syndrome and congenital myasthenic syndromes

FDA issued a refuse to file letter for the NDA

2/18/16

CTI Biopharma Corp. (Seattle)

Pacritinib

An oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R

Primary myelofibrosis and post-polycythemia vera myelofibrosis (MF) and post-essential thrombocythemia MF

The FDA placed a partial clinical hold, citing fatal and life-threatening safety issues in patients treated with the drug vs. those provided best available therapy other than JAK inhibitors in the control arm of PERSIST-1, a phase III study of primary myelofibrosis; the hold also impacts PERSIST-2, an ongoing study extending pacritinib treatment to patients with post-polycythemia vera MF and post-essential thrombocythemia MF; CTI withdrew its NDA after the FDA expanded a partial clinical hold on trials of the drug to a full hold

2/9/16; 2/11/16

Esteve SA (Barcelona, Spain)

EGT-201 and EGT-301

Gene therapies; EGT-301 consists of an adeno-associated viral vector of serotype 9 containing the human iduronate-2-sulfatase transgene

Sanfilippo B syndrome and Hunter syndrome

Added two new investigational gene therapies, both developed in collaboration with a group at the Universitat Autònoma de Barcelona; the FDA has granted orphan drug designation to EGT-301 for the treatment of Hunter syndrome or mucopolysaccharidosis II

2/26/16

LFB SA (Les Ulis, France)

Fibclot

Human fibrinogen

Congenital fibrinogen deficiency

Received the first three European marketing authorizations in Germany, Denmark and Hungary

2/23/16

Onl Therapeutics Inc. (Ann Arbor, Mich.)

ONL1204

A first-in-class small molecule peptide

Retinal diseases and conditions

FDA granted orphan drug designation

2/12/16

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

Translarna

Ataluren

Duchenne muscular dystrophy

FDA refused to accept the NDA with a refuse to file (RTF) letter, viewing both the phase IIb and phase III ACT DMD trials as negative and not providing substantial evidence of effectiveness

2/24/16

Sarepta Therapeutics Inc. (Cambridge, Mass.)

Exondys 51

Eteplirsen

Duchenne muscular dystrophy

The new PDUFA date for eteplirsen has been set for May 26, a month after the originally scheduled action date; a meeting of the FDA's Peripheral and Central Nervous System advisory committee, which is slated to consider the company's applications, was postponed from Jan. 22 for inclement weather; that meeting is rescheduled for April 25

2/29/16

Tarix Orphan LLC (Cambridge, Mass.)

TXA127

A pharmaceutical grade formulation of the naturally occurring peptide angiotensin (1-­7)

Laminin-deficient congenital muscular dystrophy

Gained FDA orphan status

2/18/16

RESPIRATORY

Actavis Laboratories FL Inc.

Generic Orenitram

Treprostinil extended-release tablets (United Therapeutics Corp.)

Pulmonary arterial hypertension

Actavis submitted an abbreviated NDA (ANDA) to the FDA

2/22/16

Alk-Abello A/S (Copenhagen) and Merck Sharp & Dohme Corp. (subsidiary of Merck & Co.; Kenilworth, N.J.)

SLIT-tablet

House dust mite sublingual allergy immunotherapy tablet

House dust mite allergy

Submitted a BLA

2/11/16

Arch Biopartners Inc. (Toronto)

AB569

A potential new treatment for respiratory Pseudomonas aeruginosa infections

Pseudomonas aeruginosa pulmonary infections in cystic fibrosis

Submitted an application for orphan drug designation to the EMA

2/4/16

Biota Pharmaceuticals Inc. (Atlanta)

BTA585

Antiviral compound

Respiratory syncytial virus infection

FDA granted fast track designation

2/17/16

Mylan NV (Hertfordshire, U.K.)

Fluticasone propionate 100 mcg, 250 mcg, 500 mcg and salmeterol 50 mcg inhalation powder

Generic version of Glaxosmithkline plc's Advair Diskus

Asthma and maintenance treatment for chronic obstructive pulmonary disease

FDA accepted for filing the abbreviated new drug application (ANDA)

2/22/16

Nivalis Therapeutics Inc. (Boulder, Colo.)

N91115

A stabilizer of the cystic fibrosis transmembrane conductance regulator protein; S-nitrosoglutathione reductase inhibitor

Cystic fibrosis

FDA granted fast track designation

2/22/16

Proteostasis Therapeutics Inc. (Cambridge, Mass.)

PTI-428

An orally bioavailable CF transmembrane conductance regulator modulator belonging to the amplifier class

Cystic fibrosis

Received fast track designation from the FDA

2/2/16

Vertex Pharmaceuticals Inc. (Boston)

Kalydeco

Ivacaftor

Cystic fibrosis

Received a complete response letter for its sNDA

2/8/16

Notes

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

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 Thomson Reuters Cortellis.