Shares in BioDelivery Sciences International (NSDQ:BDSI) fell today after the pharmaceutical company beat sales estimates but missed earnings expectations on Wall Street with its second quarter results. The Raleigh, N.C.-based company posted a net loss of -$14.9 million on sales of $8.7 million for the 3 months ended June 30, paring losses by 9.7% on sales […]
Pharmaceuticals
Liposomes triggered by ultrasound enable targeted pain-relief
Researchers at Boston Children’s Hospital have developed a technology to non-invasively trigger the release of nerve-blocking agents, helping to provide targeted pain-relief to patients as an alternative to addictive opioids. The team’s work was published yesterday in Nature Biomedical Engineering. “Opioid abuse is a growing problem in healthcare,” senior author Dr. Daniel Kohane said in prepared […]
Ocular’s new CEO to ‘aggressively’ seek partnerships
Since the start of June, Ocular Therapeutix‘s (NSDQ:OCUL) stock price has fallen more than -45%. The company’s founder and chief executive, Amar Swahney, has stepped down, assuming the role of executive chairman, and the FDA has rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza. Amidst regulatory troubles, Ocular tapped former Mundipharma exec Antony Mattessich to […]
Clearside Biomedical misses EPS estimate in Q2
Shares in Clearside Biomedical (NSDQ:CLSD) fell slightly today after the biopharmaceutical company missed earnings expectations on Wall Street with its second quarter results. The Alpharetta, Ga.-based company posted a net loss of -$13.8 million on sales of $130,000 for the 3 months ended June 30, for bottom-line loss of -169% compared with the same period last year. […]
Allegro’s diabetic macular edema trial meets primary endpoint
Privately-held biotech Allegro Ophthalmics said today that its Del Mar Phase IIb stage 2 trial met its primary endpoint. The study assessed Luminate as a sequential therapy or combo therapy in 80 patients with diabetic macular edema. The San Juan Capistrano, Calif.-based company’s Luminate integrin peptide therapy treats neovascular retinal diseases by targeting integrin receptors, […]
Mylan tumbles on Q2 miss, lowered outlook
Mylan (NSDQ:MYL) shares fell more than -6% this morning after it posted second quarter results that missed analysts’ sales and earnings estimates. The generics-maker announced that it would not include any major U.S. product launches in its forecast for the full-year, citing uncertainty in the U.S. regulatory market. Other generic drugmakers, like Teva Pharmaceuticals (NYSE:TEVA), have posted […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Novo Nordisk shares rise on solid Q2 results
Diabetes drugmaker Novo Nordisk (NYSE:NVO) posted Street-beating second quarter results today, lifting its full-year sales forecast despite lingering concerns relating to U.S. drug pricing pressures. Last year, the Danish company saw shares drop more than 40% after it slashed its long-term operating profit forecasts, citing price pressures in the U.S. market. Today, Novo Nordisk raised its […]
Sanofi brings another insulin glargine patent suit against Merck
Sanofi Aventis (NYSE:SNY) yesterday filed another patent lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK), alleging that Merck’s product infringes upon two patents covering Sanofi’s insulin glargine product, Lantus. In July, Merck won tentative approval for its follow-on biologic version of Sanofi’s Lantus. The agency’s final regulatory nod is contingent upon the resolution of these patent infringement […]
MannKind posts mixed Q2
Shares in MannKind Corp. (NSDQ:MNKD) fell slightly this morning after the biopharmaceutical company missed earnings expectations but beat sales estimates on Wall Street with its second quarter results. The Valencia, Calif.-based company posted a net loss of -$35.4 million on sales of $2.2 million for the 3 months ended June 30, for bottom-line loss of -18% on […]