Company (Location)

Product

Description

Indication

Status

Date


Almirall SA (Barcelona, Spain)

Eklira Genuair

Aclidinium

Chronic obstructive pulmonary disease

CHMP issued a positive opinion

5/30/12

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Jentadueto

Combines DPP-4 inhibitor linagliptin and metformin

Type II diabetes

Received a positive opinion from the CHMP

5/29/12

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Olodaterol

A long-acting beta2-agonist

Chronic obstructive pulmonary disease

Data showed that it provided a significant and identical increase in the lung function parameter FEVI over a 24-hour period compared to twice-daily treatment

5/22/12

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Tiotropium

Delivered once daily via the Respimat inhaler

Asthma

Phase II data showed it produced greater lung function at all doses tested, compared to placebo

5/23/12

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Tradjenta

Linagliptin

Type II diabetes

Phase III data showed significant hemoglobin A1c reduction of 0.88% compared with 0.24% in the placebo group at 24 weeks

5/25/12

CSL Behring Ltd. (King of Prussia, Pa.)

Human 4-factor prothrombin

Complex concentrate

To reverse vitamin K-anta-gonist therapy in patients with acute major bleeding

FDA accepted for review its BLA

5/30/12

Dainippon Sumitomo Pharma Co. Ltd. (Osaka, Japan)

Latuda

Lurasidone HCL

Bipolar I depression

It met its key primary and secondary endpoints in two Phase III trials

5/8/12

Eisai Inc. (Woodcliff Lake, N.J.)

Fycompa

Perampanel

Partial-onset seizures

CHMP issued a positive opinion

5/30/12

Eli Lilly and Co. (Indianapolis)

Dulaglutide

Long-acting glucagon-like peptide 1 analogue

Type II diabetes

Met its primary endpoint of noninferiority for mean 24-hour systolic blood pressure after 16 weeks

5/23/12

Galleon Pharmaceuticals Inc. (Horsham, Pa.)

GAL-021

Product for improving breathing

To improve breathing in those receiving opioids

Was safe and well tolerated in a Phase I trial in 30 healthy adults

5/8/12

Janssen Pharmaceuticals Inc. (Raritan, N.J.)

Nucynta ER

Tapentadol extended-release tablets

Chronic moderate to severe pain in diabetic peripheral neuropathy

Phase III study demonstrated significantly greater benefit than placebo

5/18/12

Janssen Therapeutics (Titusville, N.J.)

Prezista

Darunavir; protease inhibitor

HIV

FDA issued a complete response letter

5/30/12

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

Simponi

Golimumab; subcutaneous induction regimens of anti-TNF-alpha therapy

Ulcerative colitis

Induced clinical response in a majority of patients who had previously failed or were intolerant to conventional agents

5/22/12

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

Xarelto

Rivaroxaban; an oral anticoagulant

Deep-vein thrombosis or pulmonary embolism

Submitted a supplemental NDA; FDA's Cardiovascular and Renal Drugs Advisory Committee voted against approval to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome

5/3/12

Meda AB (Goteborg, Sweden)

Dymista

A nasal spray formulation of azelastine hydrochloride and fluticasone propionate

Seasonal allergic rhinitis

FDA approved it

5/3/12

Merck & Co. Inc. (Whitehouse Station, N.J.)

Isentress

Raltegravir; film-coated tablets

HIV

FDA approved a labeling update showing that the integrase inhibitor in combination therapy demonstrated long-term viral suppression, a greater immunologic response and a good safety and tolerability profile

5/22/12

Merck & Co. Inc. (Whitehouse Station, N.J.)

Rotateq

Rotavirus vaccine, live, oral, pentavalent

Rotavirus

Launched in Rwanda

5/29/12

Mylan Inc. (Pittsburgh)

Atorvastatin

Generic version of Lipitor

To lower cholesterol

Launched it in France, Belgium, the UK, the Netherlands and Ireland

5/14/12

Novo Nordisk A/S (Princeton, N.J.)

Levemir

Insulin detemir [rDNA origin] injection

Type I diabetes

FDA approved it for use in children, ages 2 to 5

5/23/12

Otsuka Pharmaceutical Co. Ltd. (Tokyo) and H. Lundbeck A/S (Copenhagen, Denmark)

Aripiprazole

Intramuscular depot formulation

Schizophrenia

Phase III data showed it significantly delayed time-to-impending relapse compared to placebo

5/8/12

Pfizer Inc. (New York)

Axitinib

Oral kinase inhibitor

Advanced renal cell carcinoma

CHMP recommended marketing authorization

5/29/12

Pfizer Inc. (New York)

Lyrica

Pregabalin

Painful diabetic peripheral neuropathy; fibromyalgia

Phase IIIb withdrawal design study for Lyrica did not meet its primary endpoint; decreased connectivity between various parts of the brain involved in pain processing in fibromyalgia patients

5/7/12; 5/21/12

Pfizer Inc. (New York)

Pristiq

Desvenlafaxine

Major depressive disorder

Showed significant increases in time to relapse over six months compared to placebo

5/8/12

Pfizer Inc. (New York)

Tofacitinib

JAK inhibitor

Rheumatoid arthritis

FDA advisory committee voted 8-2 to recommend approval

5/10/12

Pfizer Inc. (New York)

Torisel

Temsirolimus

Advanced renal cell carcinoma

Phase III data showed it did not meet the primary endpoint of prolonging progression-free survival when compared to Nexavar

5/17/12

Pfizer Canada Inc. (Kirkland, Quebec)

Xyntha Solfuse

Preloaded device that delivers recombinant Factor VIII intravenously after reconstitution of a freeze-dried powder

Hemophilia A

Launched it in Canada to prevent and control hemorrhagic episodes

5/18/12

Pfizer Inc. (New York)

Vyndaqel

Tafamidis meglumine

Transthyretin familial amyloid polyneuropathy

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 4-13 against approval, saying the study was not well controlled or sufficiently powered to produce robust results

5/25/12

Roche AG (Basel, Switzerland)

Dalcetrapib

Heart disease therapy

Stable coronary heart diseases

Data safety monitoring board recommended stopping the Phase III trial due to a lack of efficacy

5/8/12

Sanofi SA (Paris)

QIV

Quadrivalent influenza vaccine

Influenza

Phase III data from a pediatric study in children 6 months through 8 years of age supported results in prior adult studies; the addition of a fourth influenza strain does not adversely affect the safety and immunogenicity profiles of QIV compared to those of Sanofi's Fluzone

5/2/12

Shire plc (Dublin, Ireland)

LDX

Lisdexmfetamine dimesylate

Attention deficit hyperactivity disorder

Phase III data demonstrated the long-term maintenance efficacy in children and adolescents, ages 6 to 17

5/24/12

Stiefel (Research Triangle Park, N.C.)

Fabior

Tazarotene foam 0.1%

Acne vulgaris

FDA approved the NDA

5/15/12

Sunovion Pharmaceuticals Inc. (Marlborough, Mass.)

Latuda

Lurasidone HCl

Schizophrenia

The proportion of patients who met pre-specified criteria for treatment failure was 6.9% on 40 mg/day, 9.2% on 40/80 mg/day and 7.4% on 80 mg/day

5/10/12

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

MLN0002

Vedolizumab

Crohn's

disease; ulcerative colitis

Phase III data showed a statistically significant improvement with vedolizumab in the primary endpoint of clinical remission compared to placebo; Phase III data showed 47.1% of patients experienced clinical response vs. 25.5% in the placebo group

5/14/12

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Alogliptin

A selective dipeptidyl peptidase IV inhibitor

Type II diabetes

EMA accepted the submission of a marketing authorization application

5/24/12

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

Generic

Version of Auxilium Pharmaceuticals Inc.'s Testim 1% testosterone gel

Testosterone deficiency

Filed an abbreviated NDA seeking to market a generic version

5/29/12


Notes:

This chart includes clinical news from pharmaceutical companies as it relates to biotech products and/or fields of interest.

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