Algeta ASA and partner Bayer AG disclosed FDA approval Wednesday for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, with the agency's nod coming three months ahead of the Aug. 14 PDUFA date

One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily maintenance therapy for relieving airflow obstruction in patients with chronic obstructive pulmonary disease (COPD

One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily maintenance therapy for relieving airflow obstruction in patients with chronic obstructive pulmonary disease (COPD

In March Dako, of Glostrup, Denmark, part of Agilent Technologies Co., received FDA approval for the addition of Kadcyla (ado-trastuzumab emtansine) to the labeling of two Dako companion diagnostic assays

Company Drug Indication BioAlliance Pharma SA Sitavig Recurring herpes labialis Sucampo Pharmaceuticals Inc. Amitiza Opioid-induced constipation Tris Pharma Inc. Karbinal ER Seasonal and perennial allergic rhinitis

Hours after reporting its first quarterly earnings as a commercial entity following FDA approval of Kynamro (mipomersen) in January and subsequent launch of the antisense drug, Isis Pharmaceuticals Inc...Kynamro, an injected apolipoprotein B synthesis inhibitor, became the first systemic antisense drug to win FDA approval, initially in homozygous familial hypercholesterolemia (HoFH

Clinical success rates – the percentage of investigational compounds that eventually obtain FDA approval – for cancer therapeutics rose from 9.9 percent for drugs that entered the clinic in the mid-1990s to 19.8 percent for those that entered human studies in the early 2000s, with an overall success rate of 13 percent across the study period...I would expect these findings to carry forward," he said, noting that progress in cancer drug development is accelerating, with 10 FDA approvals of cancer

The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib prior to FDA approval

Apligraf is a living-cell-based product for the treatment of chronic wounds, and is the only product with FDA approval to treat both VLUs and diabetic foot ulcers

received FDA approval for Procysbi for nephropathic cystinosis

Arena's drug made headlines when it became the first of the top three obesity drugs to gain FDA approval last June...The DEA requirement meant that the second obesity drug to win FDA approval, Vivus Inc.'s Qsymia (phentermine/topiramate extended-release), got a head start on the commercialization front, though sales have been slower than expected, possibly due to physician prescribing patterns

FDA approval was based on a new drug application comprising data from six clinical trials, including a randomized, multicenter, active-controlled Phase III trial of 43 patients with NC and extension data from that trial...Leerink Swann LLC analyst Joseph Schwartz predicted FDA approval in a research update last month

Trimel Pharmaceuticals Corp., of Toronto, said it submitted a new drug application to the FDA for approval of its bioadhesive intranasal gel testosterone product, indicated for the treatment of testosterone deficiency in men

Collaboration with pharma on integrating data would be a first step in creating a more powerful bloc, and would lead to improved cohesion on data issues toward FDA approvals

Total Value in 2013: $5,960.77M* Number of Deals in 2013: 93 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date FEBRUARY Ablynx NV (Ghent, Belgium) Spirogen Ltd. (London) ND Research collaboration to evaluate the potential of a cancer drug conjugate combining Spirogen's cytotoxic drugs, pyrrolobenzodiazepines and associated linker technology, with Nanobodies generated Ablynx will provide access to Nanobodies against an undisclosed target, and Spirogen will

Funding for biodefense has gone through changes over the years, starting with Project BioShield in 2004 to stockpile products that were close to FDA approval

Since the beginning of the year the FDA Office of Orphan Drug Products has granted 69 compounds orphan drug designation (ODD), with drugs intended to treat rare diseases or conditions affecting fewer than 200,000 people in the U.S. That designation confers special incentives to the drug developer, including tax credits toward the cost of clinical trials, prescription drug user fee waivers and may entitle a period of seven years U.S market exclusivity upon FDA approval

For instance, there's the "tale of two adcoms," as Russo Partners' David Schull referred to the two adcom meetings prior to FDA approval of Arena Pharmaceuticals Inc.'s obesity drug Belviq (lorcaserin

It is more often the case that biomarkers identified in early development aren't up to snuff as an FDA-approval companion diagnostic, or that diagnostic test results are approved and available, but not of much use to physicians