Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
Abbott (Abbott Park, Ill.) |
Humira |
Adalimumab |
Moderate to severely active ulcerative colitis |
The CHMP issued a positive opinion for its use in adults who have not responded to, cannot tolerate or have medical contraindications to conventional therapies (2/21) |
APP Pharmaceuticals Inc. (Schaumburg, Ill.) |
Methotrexate |
Preservative-free injection |
Psoriasis and rheumatoid arthritis |
Received FDA approval to market the injection (2/23) |
Baxter International Inc. (Deerfield, Ill.) |
Stem cells |
Adult autologous CD34-positive stem cells |
Chronic myocardial ischemia |
Started a pivotal Phase III study (2/29) |
Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis) |
Jentadueto |
Linagliptin/metformin hydrochloride |
Type II diabetes |
Won FDA approval (2/1) |
Eli Lilly and Co. (Indianapolis) |
Cialis |
Tadalafil |
Benign prostatic hyperplasia and erectile dysfunction |
Phase III data showed that both Cuialis and tamsulosin significantly improved scores on the International Prostate symptom Score, compared to placebo; Cialis improved erectile dysfunction in men with signs and symptoms of BPH and ED (2/8) |
Forest Laboratories Inc. (New York) |
RGH-188 |
Cariprazine |
Acute exacerbation of schizophrenia |
Top-line Phase III data showed that patients treated with the dopamine D3-preferring D3/D2 receptor partial agonist experienced significant symptom improvement compared to the placebo group (2/29) |
Forest Laboratories Inc. (New York) |
Colobreathe |
Dry powder colisthimethate sodium for inhalation |
Cystic fibrosis |
Received European approval to market it to treat CF patients, ages 6 and older, with chronic lung infections caused by P. aeruginosa (2/27) |
Forest Laboratories Inc. (New York) |
Aclidinium bromide |
Twice-daily inhaled treatment |
Bronchospasms associated with chronic obstructive pulmonary disease |
FDA committee voted to recommend approval (2/24) |
Grupo Ferrer International SA (Barcelona, Spain) |
Lorediplon |
A nonbenzodiazepine inhibitor of the gamma-aminobutyric acid A receptor |
Insomnia |
It was well tolerated and demonstrated efficacy comparable to or in excess of Ambien in a Phase I insomnia trial (2/10) |
Hospira Inc. (Lake Forest, Ill.) |
Generic Cubicin |
Daptomycin for injection |
Skin and other infections |
Hospira filed an abbreviated NDA for a generic version of Cubicin (2/10) |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Suvorexant |
Orexin receptor antagonist |
Insomnia |
Merck plans to file an NDA this year based on results from two pivotal Phase III trials (2/7) |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Vorapaxar |
Oral protease activated receptor 1 thrombin receptor antagonist |
Atherothrom-botic ischemic events |
Top-line data from the TRA-2P study showed the drug met the primary endpoint in preventing clot formation and reducing cardiovascular events (2/8) |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Victrelis |
Boceprevir; protease inhibitor |
Hepatitis C virus |
Company warned U.S. physicians that a recent pharmacokinetic study in healthy volunteers showed it may reduce the efficacy of ritonavir-boosted HIV protease inhibitors, as well as the efficacy of Victrelis, when they are used in combination (2/10) |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Zioptan |
Tafluprost ophthalmic solution |
To reduce elevated intraocular pressure in open-angle glaucoma or ocular hypertension |
FDA approved Zioptan (2/14) |
Novartis AG (Basel, Switzerland) |
Gilenya |
TDI132; fingolimod |
Amyotrophic lateral sclerosis |
The ALS Therapy Development Institute plans to launch a Phase II trial in ALS (2/15) |
Novartis AG (Basel, Switzerland) |
Gleevec |
Imatinib |
CD117-positive gastrointestinal stromal tumor |
FDA approved Gleevec for use in adult patients who have had surgery to remove a tumor (2/2) |
Pfizer Inc. (New York) |
Tafamidis meglumine |
Oral treatment |
Transthyretin familial amyloid polyneuropathy |
FDA accepted for review the NDA (2/16) |
Sandoz (unit of Novartis AG; Basel, Switzerland) |
Generic Remodulin |
Treprostinil injection |
Pulmonary arterial hypertension |
Sandoz submitted an abbreviated NDA for a generic version of the 10 mg/mL strength of Remodulin (United Therapeutics Corp.) (2/7) |
Shire plc (Dublin, Ireland) |
Vpriv |
Velaglucerase alfa |
Gaucher disease |
The European Committee for Medicinal Products for Human Use approved the production of Vpriv in the firm's new manufacturing facility in Lexington, Mass. (2/23) |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
TAK-875 |
A GPR40 agonist |
Type II diabetes |
Phase II data showed it met its primary endpoint of statistically significantly lowering HbA1c levels over a 12-week period vs. placebo (2/28) |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Vedolizumab |
Humanized monoclonal antibody against alpha4beta7 integrin |
Ulcerative colitis |
Top-line data from a Phase III study in 895 patients showing it met the primary endpoints (2/22) |
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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. | ||||