Officials at Brazil’s Butantan Institute said, though, that Sinovac wants to run the numbers out of Turkey and Indonesia as well. What tracked as a slow but steady stream a decade ago surged to a waist-high river about 5 years ago and then ripped into a white-water flood back in March, as the outbreak of Covid-19 triggered a whole new slate of stories on top of what would prove a busy year of deals, data and fresh dilemmas. Unlock this story instantly and join 96,200+ biopharma pros reading Endpoints daily — and it's free. But in No­vem­ber, In­di­v­ior got the FDA’s OK for a buprenor­phine ex­tend­ed-re­lease month­ly in­jec­tion, which goes by the brand name Sublo­cade. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Find the latest historical data for Braeburn Pharmaceuticals, Inc. (BBRX) at Nasdaq.com. But now Fouse, who’s had to contend with some setbacks along the way, has a whole new future in mind. Al­though we know the CRL will slow down Brae­burn, it’s tough to gauge the im­pact. Agios made its name as a cancer drug developer under the legendary founder David Schenkein, who took the company from a famously blank sheet of paper to commercialization before he stepped aside a couple of years ago and handed the reins to Celgene vet Jackie Fouse. If you're already an Endpoints subscriber, enter your email below for a magic link that lets you sign in quickly without using a password. A com­pa­ny spokesper­son said the com­pa­ny had no fur­ther com­ment be­yond the press re­lease. When asked what “ad­di­tion­al in­for­ma­tion” the FDA is re­quest­ing, Brae­burn de­murred. Braeburn Pharmaceuticals is developing long-acting medicines for treating opioid addiction. 26 Apr 2017 Braeburn Pharmaceuticals announces intention to submit NDA to the US-FDA for Schizophrenia in December 2017 ; 26 Apr 2017 Adverse events, efficacy, pharmacokinetics data from a phase II trial in Schizophrenia released by Braeburn Pharmaceuticals ; Restricted Access If your organization has a subscription then there are several options available to help you access AdisInsight … Brae­burn was hop­ing to be the first to mar­ket with a month­ly in­jectable buprenor­phine, but the FDA said it needs more in­for­ma­tion be­fore it moves the ap­pli­ca­tion for­ward. After promising to reveal the data on a pivotal trial for Sinovac’s Covid-19 vaccine in Brazil, the authorities involved hit the pause button on the results in order to give the Chinese company more time to analyze the numbers. Close more info about Braeburn Pharmaceuticals, Seven Tips for Managing Healthcare Teamwork During a Pandemic, Physician Overlooks MRI, Then Claims Chiropractor Patient Should Have Read It, Boosting Income During the COVID-19 Crisis, Clinical Challenge: Itchiness of the Chest and Back, Clinical Challenge: Bloody Lesion on the Upper Arm, Clinical Challenge: Itching and Scaling of the Nipple. We are com­mit­ted to in­tro­duc­ing this in­no­v­a­tive treat­ment to bet­ter meet the over­whelm­ing needs of pa­tients.”, Lucy Abreu, Employee Engagement and Change Management, Syneos Health “Brae­burn will con­tin­ue to work close­ly with the FDA with the goal of bring­ing CAM2038 to mar­ket as quick­ly as pos­si­ble,” said Mike Derkacz, pres­i­dent and CEO of Brae­burn, in the re­lease. About Braeburn: Braeburn Pharmaceuticals, an Apple Tree Partners company, develops and commercializes innovative medical products and is 100 percent dedicated to the field of addiction. 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