BDSI

Pharma

BDSI’s cancer pain product preps for Europe, triggers $2.5M milestone

The breakthrough cancer pain treatment developed by BioDelivery Sciences (NASDAQ:BDSI) International is making progress toward entering the European market, triggering a $2.5 milestone payment from BDSI’s drug partner Meda Pharmaceuticals. The milestone was triggered by registration and pricing approval of the drug Breakyl in Europe. Raleigh, North Carolina-based BDSI is due another $2.5 million upon […]

Pharma

Patent award to BDSI triggers $15M milestone payment from Endo Pharma

A drug delivery technology patent awarded to BioDelivery Sciences International (NASDAQ:BDSI) has triggered a $15 million milestone payment from drug partner Endo Pharmaceuticals (NASDAQ:ENDP). Raleigh, North Carolina-based BDSI said today that the U.S. Patent and Trademark Office has formally awarded a patent for the company’s “Transmucosal Delivery Devices with Enhanced Uptake,” a patent that covers […]

Pharma

FDA concerns delay relaunch of BDSI cancer pain product Onsolis

Plans to relaunch breakthrough cancer pain treatment Onsolis are now delayed indefinitely until BioDelivery Sciences International (NASDAQ:BDSI) can work out manufacturing issues raised by the U.S. Food and Drug Administration. Over Onsolis’ two-year shelf life, the product’s pink appearance can fade. The FDA told the Raleigh, North Carolina company that the color change could confuse […]

Pharma

Patent decision favors BDSI; USPTO rejects 222 MonoSol Rx claims

Specialty pharmaceutical company BioDelivery Sciences International (NASDAQ:BDSI) can now claim patent victories against all three patent challenges levied by a rival in a long-running patent dispute. The U.S. Patent and Trademark Office has rejected all claims made by MonoSol Rx in the third MonoSol patent that the New Jersey company alleged BDSI had infringed. In […]

Pharma

Drug delivery technology from BDSI withstands MonoSol patent challenge

Drug delivery technology developed by BioDelivery Sciences International (NASDAQ:BDSI) has withstood another patent challenge from competitor MonoSol Rx. Specialty pharmaceutical company BDSI said that the U.S Patent and Trademark Office has rejected all of the claims asserted by MonoSol in the latest patent claim. Both companies have technologies that deliver drugs via a small piece […]

sponsored content

A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Pharma

$40M stock offering filed by BioDelivery Sciences International

A month after licensing a clinical-stage chronic pain treatment to Endo Pharmaceuticals (NASDAQ:ENDP) in a deal worth up to $180 million, BioDelivery Sciences International (NASDAQ: BDSI) is now preparing an additional $40 million financial cushion. The Raleigh, North Carolina specialty pharmaceutical company has filed a shelf registration that would allow BDSI to raise up to […]

Pharma

Chronic pain treatment from BDSI licensed to Endo Pharma in $180M deal

The investigational chronic pain treatment from BioDelivery Sciences International (NASDAQ:BDSI) that failed in a late-stage clinical trial now has a partner and a plan that salvages the drug program and infuses the biopharmaceutical company with cash at a critical time. Endo Pharmaceuticals (NASDAQ:ENDP) has licensed pain treament candidate BEMA Buprenorphine in a deal that pays […]

Pharma

How FDA changes to ‘REMS’ rules helps BioDelivery Sciences

Some opioid painkillers used by cancer patients are governed by U.S. Food and Drug Administration plans to manage possible health risks. The FDA is changing how it manages these drugs and these changes should help Raleigh, North Carolina company BioDelivery Sciences International (NASDAQ:BDSI). Here’s how. BDSI’s product Onsolis delivers the painkiller fentanyl through a small […]

Pharma

Patent ruling favors BDSI; MonoSol still claims infringement on other patents

BioDelivery Sciences International (NASDAQ:BDSI) has a patent victory against a competitor who claims the North Carolina pharmaceutical company’s drug delivery platform infringes on its technology. The United States Patent and Trademark Office rejected all 191 claims made by New Jersey-based MonoSol Rx as unpatentable. The dispute centers on the technology that forms BDSI’s drug-delivery platform. […]

Pharma

BDSI opioid dependence drug NDA planned for late 2012

BioDelivery Sciences International (NASDAQ:BDSI) has started testing how its experimental opioid dependence treatment is handled by the human body as it moves forward with its plans to break into the billion-dollar market for opioid dependence drugs. Based on the pharmacokinetic testing results, Raleigh, North Carolina-based BDSI will choose doses of its BEMA Buprenorphine/Naloxone to compare […]

Pharma

BDSI pain drug fails in phase 3 trials but company plans new study

A pain drug candidate from BioDelivery Sciences International (NASDAQ:BDSI) failed to perform better than a placebo in phase 3 clinical trials, according to preliminary trial results released by the biopharmaceutical company after the close of the financial markets Wednesday. But Raleigh, North Carolina-based BDSI is not giving up on BEMA Bupenorphine, which the company was […]

Pharma

BDSI’s opioid-addiction drug candidate aims to challenge market leader RB

An opioid-dependence treatment being developed by BioDelivery Sciences International (NASDAQ:BDSI) is on track for a New Drug Application filing in the second half of 2012, making it a contender to compete against current market leader Reckitt Benckiser (LSE:RB). Raleigh, North Carolina-based specialty pharmaceutical company BDSI announced positive preliminary results from a clinical trial  that studied […]