Company (location)

Product

Description

Indication

Status

Date

Cancer

Amgen Inc. (Thousand Oaks, Calif.)

Xgeva

Denosumab

Prevention of skeletal-related events with bone metastases from solid tumors

The FDA approved the supplemental BLA to expand the currently approved indication to include patients with multiple myeloma

1/8/18

Amgen Inc. (Thousand Oaks, Calif.)

Kyprolis

Carfilzomib

Relapsed or refractory multiple myeloma

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a label variation to include updated overall survival (OS) data from the head-to-head phase III ENDEAVOR trial

1/31/18

Amgen Inc. (Thousand Oaks, Calif.) and Allergan plc (Dublin)

Mvasi

Biosimilar to Avastin

Multiple types of cancer

The European Commission granted marketing authorization

1/22/18

Aspyrian Therapeutics Inc. (San Diego)

RM-1929

Conjugate of cetuximab and IRDye 700DX

Locoregional recurrent head and neck squamous cell carcinoma

Gained FDA fast track status

1/18/18

Astrazeneca plc (Cambridge, U.K.) and Merck & Co. Inc. (Kenilworth, N.J.)

Lynparza

Olaparib; PARP inhibitor

Deleterious or suspected deleterious germline BRCA-mutated HER2-negative, metastatic breast cancer

The FDA approved it for use in patients who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting

1/17/18

Astrazeneca plc (Cambridge, U.K.) and Merck & Co. Inc. (Kenilworth, N.J.)

Lynparza

Olaparib; PARP inhibitor

Platinum-sensitive relapsed ovarian cancer

Japan's Ministry of Health, Labour and Welfare (MHLW) approved it for use as a maintenance therapy for patients, regardless of BRCA mutation status, who responded to their last platinum-based chemotherapy

1/22/18

Berg LLC (Boston)

BPM-31510

Restores the metabolism of cancerous cells

Pancreatic cancer

Gained FDA orphan status

1/23/18

Biocon Ltd. (Bangalore, India) and Mylan NV (Canonsburg, Pa.)

Zedora

Biosimilar trastuzumab

Overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer

It was approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica, of Sao Paulo, Brazil

1/2/18

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Gilotrif

Afatinib

Metastatic non-small-cell lung cancer

The FDA approved the expanded use of it for the first-line treatment of patients whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations, including three additional EGFR mutations: L861Q, G719X and S768I

1/18/18

Bristol-Myers Squibb Co. (Princeton, N.J.)

Yervoy

Ipilimumab

Advanced melanoma

The European Commission expanded the indication to include treatment of pediatric patients 12 years of age and older

1/23/18

Cantex Pharmaceuticals Inc. (Weston, Fla.)

CX-01

Polysaccharide

Acute myeloid leukemia

The FDA granted orphan designation

1/4/18

Cascadian Therapeutics Inc. (Seattle)

Tucatinib

Tyrosine kinase inhibitor

HER2-positive metastatic breast cancer

Received a product-specific pediatric waiver from the EMA

1/3/18

Eisai Co. Ltd. (Tokyo) and Merck & Co. (Kenilworth, N.J.)

Lenvima

Lenvatinib

Advanced or metastatic renal cell carcinoma

Received breakthrough therapy designation from the FDA for it in combination with Keytruda

1/10/18

Eli Lilly Canada Inc. (Toronto)

Lartruvo

Olaratumab

Soft tissue sarcoma

Health Canada issued a notice of compliance with conditions for the chemotherapy used in combination with doxorubicin for the treatment of adults when treatment with radiation or surgery are not options

1/25/18

Genmab A/S (Copenhagen, Denmark)

Darzalex

Daratumumab

Multiple myeloma

The FDA granted priority review to the supplemental biologics license application (sBLA) for use in combination with bortezomib, melphalan and prednisone for the treatment of newly diagnosed patients who are ineligible for autologous stem cell transplant; a PDUFA target date of May 21 has been assigned

1/23/18

Hedgepath Pharmaceuticals Inc. (Tampa, Fla.) and Mayne Pharma Ltd. (Melbourne, Australia)

Suba-Itraconazole

Oral formulation of itraconazole

Basal cell carcinoma nevus syndrome

The EMA granted orphan designation

1/12/18

Helsinn Group (Lugano, Switzerland) and Mei Pharma Inc. (San Diego)

Pracinostat

HDAC inhibitor

Acute myeloid leukemia

The EMA granted orphan designation

1/12/18

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

Keytruda

Pembrolizumab

Radically unresectable urothelial carcinoma

The Japanese Ministry of Health, Labor and Welfare approved it

1/3/18

Myriad Genetics Inc. (Salt Lake City)

BRACAnalysis CDx with Lynparza

Companion in-vitro diagnostic device with olaparib

HER2-negative metastatic breast cancer

The FDA approved it for use as a companion diagnostic

1/16/18

Novartis AG (Basel, Switzerland)

Kisqali

Ribociclib

HR+/HER2- advanced breast cancer

The FDA granted breakthrough therapy designation to it for initial endocrine-based treatment in premenopausal women

1/4/18

Novartis AG (Basel, Switzerland)

Kymriah

Tisagenlecleucel

Relapsed or refractory diffuse large B-cell lymphoma

The sBLA for it as a treatment of adult patients who are ineligible for or relapse after autologous stem cell transplant was accepted and assigned a priority review by the FDA

1/18/18

Novartis AG (Basel, Switzerland)

Lutathera

Lutetium (177Lu) oxodotreotide

Gastroentero-pancreatic neuroendocrine tumors

The FDA approved it

1/29/18

Pharmamar SA (Madrid)

Aplidin

Plitidepsin

Relapsed and refractory multiple myeloma

Requested the EMA's Committee for Human Medicinal Products (CHMP) re-examine the MAA

1/4/18

Progenics Pharmaceuticals Inc. (New York)

Azedra

Iobenguane I 131

Malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma

The FDA accepted the NDA for review; the priority-review action date is April 30, 2018

1/2/18

Seattle Genetics Inc. (Bothell, Wash.)

Adcetris

Brentuximab vedotin

Advanced classical Hodgkin's lymphoma

The FDA accepted for filing a supplemental BLA for it in combination with chemotherapy, granted priority review and set the PDUFA target action date for May 1, 2018

1/3/18

Seattle Genetics Inc. (Bothell, Wash.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Adcetris

Brentuximab vedotin

CD30-positive cutaneous T-cell lymphoma

The European Commission extended the current conditional marketing authorization to include the treatment of adult patients after at least one prior systemic therapy

1/23/18

Synthon NV (Nijmegen, the Netherlands)

SYD-985

[Vic-] trastuzumab duocarmazine

HER2-positive metastatic breast cancer

Gained FDA fast track status

1/26/18

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Trisenox

Arsenic trioxide injection

Newly diagnosed low-risk acute promyelocytic leukemia (APL)

The FDA approved the use of it in combination with tretinoin for the treatment of adults whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

1/17/18

Cardiovascular

Anges Inc. (Tokyo)

HGF plasmid

Gene therapy

Critical limb ischemia

Submitted an application for marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan

1/24/18

Cardiome Pharma Corp. (Vancouver, British Columbia)

Aggrastat

Tirofiban hydrochloride

ST-segment elevation myocardial infarction(STEMI)

The Chinese Center for Drug Evaluation (CDE) approved an expansion of the indications to include patients with STEMI who are intended for primary percutaneous coronary intervention; the CDE also approved a high-dose bolus (HDB) regimen to be used on both indicated patient populations

1/24/18

Upsher-Smith Laboratories LLC (Maple Grove, Minn.)

Bumetanide

Diuretic tablets

Hypertension

The FDA approved its ANDA

1/31/18

Vifor Fresenius Medical Care Renal Pharma Ltd. (Zurich, Switzerland) and Chemocentryx Inc. (Mountain View, Calif.)

Avacopan

Selective inhibitor of the terminal effector complement C5a receptor

Anti-neutrophil cytoplasmic antibody associated vasculitis

Its conditional marketing authorization (CMA) was accepted by the EMA

1/5/18

Dermatologic

Abbvie Inc. (North Chicago)

ABT-494

Upadacitinib

Moderate to severe atopic dermatitis

The FDA granted breakthrough therapy designation

1/9/18

Abeona Therapeutics Inc. (New York and Cleveland)

EB-101

Gene-corrected autologous cell therapy

Recessive dystrophic epidermolysis bullosa

The FDA granted regenerative medicine advanced therapy (RMAT) designation, making it eligible for priority review and accelerated approval

1/30/18

Perrigo Co. plc (Dublin)

Soolantra

Ivermectin cream, 1%

Inflammatory lesions of rosacea

The FDA gave tentative approval

1/31/18

Pharming Group NV (Leiden, the Netherlands)

Ruconest

Recombinant C1 esterase inhibitor

Hereditary angioedema

The FDA accepted the sBLA for it as a routine prophylaxis to prevent attacks in adult and adolescent patients; the PDUFA date is Sept. 21, 2018

1/18/18

Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.)

Dupixent

Dupilumab

Atopic dermatitis

The Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for treatment of adults not adequately controlled with existing therapies

1/23/18

Shire plc (Dublin)

Cinryze

C1 esterase inhibitor (human)

Hereditary angioedema

Gained FDA approval for the technology transfer of the manufacturing process to its Vienna manufacturing site

1/25/18

Endocrine/Metabolic

3Sbio Inc. (Shenyang, China)

Bydureon

Exenatide microsphere for injection

Type 2 diabetes

The CFDA approved it

1/5/18

Alnylam Pharmaceuticals Inc. (Cambridge, Mass.)

Patisiran

RNAi therapeutic targeting transthyretin

Hereditary ATTR amyloidosis

The EMA accepted the marketing authorization application and initiated its review; the U.K. Medicines and Healthcare Products Regulatory Agency granted Promising Innovative Medicine status

1/29/18

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

Galafold

Migalastat

Fabry disease

The Canadian Drug Expert Committee offered a positive recommendation to list in provincial drug formularies for long-term treatment of adults with confirmed diagnosis and who have an amenable mutation

1/30/18

Chiesi Farmaceutici SpA (Parma, Italy)

Lamzede

Velmanase alfa

Mild to moderate alpha-mannosidosis

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

1/29/18

Clarus Therapeutics Inc. (Northbrook, Ill.)

Jatenzo

Oral testosterone undecanoate capsule

Primary hypogonadism and hypogonadotropic hypogonadism

The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-10 on it; no votes were mostly based on clinically significant cardiovascular (CV) events associated with patients who took it vs. another testosterone replacement therapy; committee members who voted yes said many patients who are in desperate need of therapy options would be willing to take on the increased CV risk

1/11/18

Dauntless Pharmaceuticals Inc. (San Diego)

DP-1038

Octreotide acetate

Acromegaly

The FDA granted orphan drug designation for intranasal administration

1/31/18

Ionis Pharmaceuticals Inc. (Carlsbad, Calif.)

Inotersen

Antisense drug

Hereditary TTR amyloidosis

The new drug application was accepted for priority review by the FDA

1/9/18

Lipocine Inc. (Salt Lake City)

Tlando

Oral testosterone undecanoate capsule

Primary hypogonadism and hypogonadotropic hypogonadism

Six members of the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee supported approval of it while 13 panelists said the overall benefit/risk profile was not acceptable and were concerned about the risks for patients who are older, obese, diabetic and prone to cardiovascular issues

1/12/18

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

Segluromet

Ertugliflozin/metformin

Type 2 diabetes

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

1/29/18

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

Steglatro

Ertugliflozin

Type 2 diabetes

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

1/29/18

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

Steglujan

Ertugliflozin/sitagliptin

Type 2 diabetes

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

1/29/18

Mylan NV (Hertfordshire, U.K.) and Biocon Ltd. (Bengaluru, India)

Semglee

Insulin glargine

Diabetes

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

1/30/18

Novo Nordisk (Bagsvaerd, Denmark)

Ozempic

Semaglutide injection

Type 2 diabetes

Health Canada approved it as an adjunct to diet and exercise to improve glycemic control when metformin is not tolerated or contraindicated

1/10/18

Orphazyme ApS (Copenhagen)

Arimoclomol

Small molecule that activates molecular chaperones

Niemann-Pick disease

The FDA granted rare pediatric disease designation

1/22/18

Repros Therapeutics Inc. (The Woodlands, Texas)

Encyzix

Enclomifene

Hypogonadotrophic hypogonadism

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

1/29/18

The Medicines Co. (Parsippany, N.J.)

Inclisiran

RNAi targeting PCSK9

Homozygous familial hypercholesterolemia

The FDA granted orphan drug designation

1/26/18

Vifor Fresenius Medical Care Renal Pharma Ltd. (Zurich, Switzerland)

Veltassa

PatiromerAvacopan

Hyperkalemia

Swissmedic approved it

1/5/18

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

Stannsoporfin

Heme oxygenase inhibitor

Infantile hyperbilirubinemia

Completed the rolling submission of a new drug application to the FDA

1/8/18

Spruce Biosciences Inc. (San Francisco)

SPR-001

Small molecule

Congenital adrenal hyperplasia

The EMA granted orphan drug designation

1/8/18

Gastrointestinal

Acacia Pharma Group Ltd. (Cambridge, U.K.)

Baremsis

Amisulpride injection

Postoperative nausea and vomiting

Its NDA was accepted for filing by the FDA with a PDUFA date of Oct. 5, 2018

1/5/18

Albireo Pharma Inc. (Boston)

Elobixibat

IBAT inhibitor

Chronic constipation

Japan's Ministry of Health, Labor and Welfare approved it

1/22/18

Cour Pharmaceuticals Inc. (Chicago)

TIMP-GLIA

Nanoparticle-based therapeutic

Celiac disease

The FDA granted fast track designation

1/12/18

Lyric Pharmaceuticals Inc. (South San Francisco)

LP-101

Ulimorelin

Enteral feeding intolerance in critical illness

The FDA granted fast track designation

1/18/18

Synergy Pharmaceuticals Inc. (New York)

Trulance

Plecanatide

Irritable bowel syndrome with constipation

The FDA approved a 3-mg tablet for the once-daily treatment in adults

1/26/18

Genitourinary/Sexual Health

Achaogen Inc. (South San Francisco)

Plazomicin

Aminoglycoside

Complicated urinary tract infections

The FDA classified the outcome of its fourth quarter 2017 reinspection of Pfizer Inc.'s McPherson facility as voluntary action indicated (VAI); the PDUFA date is June 25

1/31/18

Endoceutics Inc. (Quebec)

Intrarosa

Prasterone

Vulvar and vaginal atrophy

The European Commission approved it

1/17/18

Mylan N.V., of Canonsburg, Pa.

Estradiol

Vaginal cream 0.01%

Vulvar and vaginal atrophy

Received final approval from the FDA for its abbreviated NDA

1/2/18

Omeros Corp. (Seattle)

OMS-721

Human monoclonal antibody

Primary immunoglobulin A nephropathy

The EMA's Committee for Orphan Medicinal Products (COMP) issued a positive opinion on its application for orphan drug designation

1/23/18

Therapeuticsmd Inc. (Boca Raton, Fla.)

TX-001HR

Estradiol and progesterone in a single, oral softgel

Moderate-to-severe vasomotor symptoms due to menopause

Submitted the NDA to the FDA

1/2/18

Hematologic

Baxter International Inc. (Deerfield, Ill.)

Bivalirudin

Thrombin inhibitor

Percutaneous coronary intervention

Won FDA approval for a frozen, premixed, ready-to-use formulation (0.9 % sodium chloride injection) for use as an anticoagulant

1/23/18

CTI Biopharma Corp. (Seattle)

Pacritinib

Oral tyrosine kinase inhibitor

Myelofibrosis

The EMA's Committee for Medicinal Products for Human Use granted the three-month extension the company sought for submitting response to a day 120 list of questions regarding its marketing authorization application

1/29/18

Global Blood Therapeutics Inc. (South San Francisco)

Voxelotor

Hemoglobin modifier

Sickle cell disease

Received breakthrough therapy designation from the FDA

1/10/18

Novartis AG (Basel, Switzerland)

Promacta

Eltrombopag

Severe aplastic anemia

The FDA designated it a breakthrough therapy when combined with standard immunosuppressive therapy

1/5/18

Roche Holding AG (Basel, Switzerland) and Chugai Pharmaceutical Co. Ltd. (Tokyo)

Hemlibra

Emicizumab

Hemophilia A factor with VIII inhibitors

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

1/29/18

Shire plc (Dublin)

Adynovi

Extended half-life recombinant factor VIII treatment

Hemophilia A

The European Commission granted marketing authorization for on-demand and prophylactic use in patients 12 and older

1/17/18

Immune

Eli Lilly and Co. (Indianapolis)

Taltz

Ixekizumab

Active psoriatic arthritis

The European Commission granted marketing authorization for it, alone or in combination with methotrexate, for the treatment in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drug therapies

1/26/18

Momenta Pharmaceuticals Inc. (Cambridge, Mass.)

Glatopa

Glatiramer acetate injection

Relapsing forms of multiple sclerosis

The FDA classified the outcome of its fourth quarter 2017 re-inspection of Pfizer Inc.'s McPherson facility as "voluntary action indicated" (VAI); the abbreviated NDA remains under regulatory review

1/31/18

Nohla Therapeutics Inc. (Seattle)

NLA-101

Hematopoietic stem and progenitor stem cell therapy

Hematopoietic stem cell transplantation

The European Commission granted orphan drug designation

1/24/18

Infection

60 Degrees Pharmaceuticals LLC (Washington)

Tafenoquine

8-aminoquinoline

Malaria

Received FDA fast track designation

1/5/18

Achaogen Inc. (South San Francisco)

Plazomicin

Aminoglycoside

Complicated urinary tract infections

The FDA accepted for review its new drug application with a PDUFA date of June 25

1/3/18

Armis Biopharma Inc. (Fort Collins, Colo.)

Ximycin

Localized antimicrobial agent

Surgical site infections

The FDA designated it as a qualified infectious disease product, or QIDP, for prophylactic treatment in high-risk patients undergoing nonemergent colorectal surgery

1/30/18

Cutispharma Inc. (Wilmington, Mass.)

Firvanq

Vancomycin hydrochloride oral solution

Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus

The FDA approved it

1/30/18

Glaxosmithkline plc (London)

Fluarix Quadrivalent

Vaccine

Influenza

The FDA granted an expanded approval to include children ages 6 months to 3 years of age

1/16/18

Glaxosmithkline plc (London)

Shingrix

Recombinant, adjuvanted Herpes zoster vaccine

Herpes zoster and post-herpetic neuralgia

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

1/29/18

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

Doravirine

Non-nucleoside reverse transcriptase inhibitor

HIV-1 infection

The FDA accepted for review two new drug applications and set the PDUFA date for Oct. 23, 2018

1/9/18

Paratek Pharmaceuticals Inc. (Boston)

Omadacycline

Antibiotic

Acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia

Started the rolling submission of an NDA to the FDA

1/4/18

Sato Pharmaceutical Co. Ltd. (Tokyo)

Nailin

Oral antifungal agent

Onychomycosis

Obtained marketing and manufacturing approval for it

1/22/18

Shire plc (Dublin)

SHP-620

Maribavir

Cytomegalovirus (CMV) infection and disease

The FDA granted breakthrough therapy designation for it in transplant patients resistant or refractory to prior therapy

1/5/18

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

TAK-426

Inactivated, alum-adjuvanted, whole Zika virus vaccine

Zika virus

The FDA granted fast track designation

1/30/18

Tetraphase Pharmaceuticals Inc. (Watertown, Mass.)

Eravacycline

IV antibiotic

Complicated intra-abdominal infections

Submitted an NDA to the FDA

1/4/18

Venatorx Pharmaceuticals Inc. (Malvern, Pa.)

VNRX-5133

Beta-lactamase inhibitor

Complicated urinary tract infections and complicated intra-abdominal infections

The FDA granted qualified infectious disease product and fast track designations

1/4/18

Inflammatory

Centrexion Therapeutics Corp. (Boston)

CNTX-497

Injection of trans-capsaicin

Pain associated with knee osteoarthritis

The FDA granted fast track designation

1/17/18

Sandoz (Basel, Switzerland, unit of Novartis AG)

Adalimumab

Biosimilar to Humira

Inflammatory diseases

The FDA accepted its BLA, submitted under the 351(k) pathway

1/17/18

Sonoma Pharmaceuticals Inc. (Petaluma, Calif.)

Sinudox

Antimicrobial nasal irrigation

Chronic sinusitis

The United Arab Emirates Ministry of Health & Prevention approved it

1/10/18

Musculoskeletal

Amgen Inc. (Thousand Oaks, Calif.) and UCB SA (Brussels)

Evenity

Romosozumab

Osteoporosis

The EMA accepted the marketing authorization application

1/9/18

Benitec Biopharma Ltd. (Sydney)

BB-301

Gene therapy

Oculopharyngeal muscular dystrophy

The FDA granted orphan designation

1/17/18

Ipsen Biopharmaceuticals Canada Inc. (Mississauga, Ontario)

Dysport Therapeutic

AbobotulinumtoxinA

Lower limb spasticity

Health Canada approved it for pediatric patients 2 years of age and older

1/10/18

Santhera Pharmaceuticals Holding AG (Liestal, Switzerland)

Raxone

Idebenone

Duchenne muscular dystrophy

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

1/29/18

Neurology/Psychiatric

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

Clobazam

Oral soluble film

Seizures associated with Lennox-Gastaut syndrome

The FDA accepted for review its new drug applications for adjunctive treatment in patients 2 or older

1/19/18

Avadel Pharmaceuticals plc (Dublin)

FT 218

Formulation of sodium oxybate

Narcolepsy

The FDA granted orphan drug designation

1/11/18

Ensysce Biosciences Inc., of San Diego

PF-614

Extended-release oxycodone prodrug

Moderate to severe chronic pain

The FDA granted fast track designation for pain management when a continuous, around-the-clock analgesic is needed for an extended period of time

1/30/18

GW Pharmaceuticals plc (London)

Epidiolex

Cannabidiol

Seizures associated with Lennox-Gastaut syndrome and Dravet syndrome

Submitted its marketing authorization application to the EMA as adjunctive treatment

1/2/18

Janssen Pharmaceuticals, Inc. (Titusville, N.J.; unit of Johnson & Johnson)

Invega Sustenna

Paliperidone palmitate

Schizophrenia

The FDA approved data from the PRIDE study to be included on the label, showing it demonstrated superior effectiveness in delaying time to relapse vs. a group of seven oral antipsychotics in adults with schizophrenia in real-world circumstances

1/4/18

Trevena Inc. (Chesterbrook, Pa.)

Olinvo

Oliceridine

Poderate to severe acute pain

The FDA accepted its NDA

1/4/18

Vistagen Therapeutics Inc. (South San Francisco)

AV-101

L-4-chlorokyurenine

Major depressive disorder

The FDA granted fast track designation

1/4/18

Ocular

Alimera Sciences Inc. (Atlanta)

Iluvien

Fluocinolone acetonide intravitreal implant

Recurrent and persistent non-infectious uveitis affecting the posterior segmen

Received validation of a type II variation submitted with the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K.; the submission seeks to add the indication to the label in Europe

1/5/18

Kala Pharmaceuticals Inc. (Waltham, Mass.)

KPI-121

1%, a twice-per-day corticosteroid

Inflammation and pain following ocular surgery

The NDA was accepted for review by the FDA with a PDUFA date of Aug. 24, 2018

1/8/18

Psivida Corp. (Watertown, Mass.)

Durasert

Three-year microinsert

Posterior segment uveitis

Submitted its NDA to the FDA

1/9/18

Shire plc (Dublin)

Xiidra

Lifitegrast

Dry eye disease

Approved in Canada for the treatment of the signs and symptoms in adults

1/4/18

Sonoma Pharmaceuticals Inc. (Petaluma, Calif.)

Acuicyn

Antimicrobial solution

Blepharitis on the eyelid and eyelash

The United Arab Emirates Ministry of Health & Prevention approved it

1/10/18

Other/Miscellaneous

Sinclair Pharma plc (London)

Ellanse

Bioresorbable collagen stimulator

Facial wrinkles and folds

Received regulatory approval by ANVISA in Brazil

1/17/18

Sonoma Pharmaceuticals Inc. (Petaluma, Calif.)

Microsafe

Antiseptic mouth and throat rinse

Pain and inflammation caused by mucositis

The United Arab Emirates Ministry of Health & Prevention approved it

1/10/18

Respiratory

Aradigm Corp. (Hayward, Calif.)

Linhaliq

Liposomally encapsulated ciprofloxacin

Non-cystic fibrosis bronchiectasis chronic lung infections with Pseudomonas aeruginosa

FDA Antimicrobial Drugs Advisory Committee (ADAC) voted 12-4 against approval; received a CRL recommending a third-party verification of its phase III results and an additional phase III trial, plus a human factors study

1/30/18

Astrazeneca plc (Cambridge, U.K.)

Daliresp

Roflumilast

Severe COPD associated with chronic bronchitis and history of exacerbations

The FDA approved 250 mcg as a starting dose once daily for the first four weeks of treatment followed by 500 mcg thereafter to help reduce the rate of treatment discontinuation in some patients

1/26/18

Astrazeneca plc (Cambridge, U.K.) and Merck & Co. Inc. (Kenilworth, N.J.)

Fasenra

Benralizumab

Bronchial asthma

Japan's Ministry of Health, Labour and Welfare (MHLW) approved it as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite other asthma treatments, including high-dose inhaled corticosteroid

1/22/18

Astrazeneca plc (London)

Fasenra

Benralizumab

Severe eosinophilic asthma

The European Commission approved it as an add-on maintenance treatment in adult patients

1/11/18

Faron Pharmaceuticals Ltd. (Turku, Finland)

Traumakine

Recombinant human interferon beta-1

Acute respiratory distress syndrome

The FDA granted fast track status

1/30/18

Theravance Biopharma Inc. (Dublin) and Mylan NV (Hertfordshire, U.K.)

TD-4208

Revefenacin

Chronic obstructive pulmonary disease

The FDA accepted their NDAand indicated that it doesn't plan to convene an advisory committee meeting to discuss it; the PDUFA goal date is Nov. 13, 2018

1/30/18

Vertex Pharmaceuticals Inc. (Boston)

Orkambi

Lumacaftor/ivacaftor

Cystic fibrosis

The European Commission granted an extension of its marketing authorization to include children ages 6 through 11 with two copies of the F508del mutation

1/11/18

Toxicity/Intoxication

Braeburn Pharmaceuticals Inc. (Princeton, N.J.)

CAM-2038

Buprenorphine weekly and monthly depot injection

Opioid use disorder

Received a complete response letter (CRL) from the FDA regarding the new drug application (NDA); the agency requested additional information in order to progress the application forward; it has not asked for additional clinical studies to be conducted

1/23/18

Enzychem Lifesciences Corp. (Fort Lee, N.J.)

EC-18

Oral, small-molecule candidate

Acute radiation syndrome

The FDA granted orphan designation

1/22/18


Notes

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

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

 

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