@FierceBiotech: Who should make this year's Fierce 15? Nominate the most promising private biotechs. Nomination form | Follow @FierceBiotech
@JohnCFierce: Female libido drug lobbying sparks a backlash as FDA decision looms. Story | Follow @JohnCFierce
@DamianFierce: Patrick Soon-Shiong tacitly creates another company every time he does anything. NantKwest?! Press release | Follow @DamianFierce
> AstraZeneca is selling ex-U.S. rights to its IBD drug Entocort (budesonide) from AstraZeneca for $215 million in cash. Release
> Seattle Genetics has launched a Phase II clinical trial evaluating Adcetris (brentuximab vedotin) in systemic lupus erythematosus. Release
> Australia's Benitec has acquired full rights to a pre-clinical hepatitis B program from China's Biomics Biotechnologies, which had been working with Benitec in a joint venture. Release
Medical Device News
@FierceMedDev: ICYMI yesterday: Study: Brain scan can be used to distinguish between traumatic brain injury and PTSD. Article | Follow @FierceMedDev
@EmilyWFierce: Sunshine Act payment data leaves out newly influential prescribers. More from FiercePharma | Follow @EmilyWFierce
> One year after IPO, Intersect ENT still going strong--starts pivotal testing, raises $103M. Story
> Not quite profitable, IPO star K2M cashes out investors with $177M in 2015. Report
Pharma News
@FiercePharma: U.S. government orders additional $133M of Bavarian Nordic's smallpox vaccine. FierceVaccines story | Follow @FiercePharma
@CarlyHFierce: Here's the latest episode of @FierceBiotech radio--and it even comes endorsed by @brentlsaunders! (He's real.) Listen | Follow @CarlyHFierce
> Payers think they can squeeze prices on cancer immunotherapies? Not so fast, analyst says. Story
> BMJ: Pfizer, Allergan antidepressants show no links to birth defects. Report
Vaccines News
> Shantha's cholera jab prevents 37% of cholera cases in Bangladeshi study. More
> Poll: parents view vaccines as safer, more beneficial. Item
> J&J's HIV vaccine shows promise in monkeys; PhI/IIa to start soon. Article
> NIAID launches PhI trial of investigational West Nile virus vaccine. Story
> U.S. government orders additional $133M of Bavarian Nordic's smallpox vaccine. Report
CRO News
> Recipharm takes a 25% stake in its drug-developing partner. Item
> Parexel uses virtual clinical trials to improve real-life R&D. Report
> Charles River spends $212M to beef up its microbial testing. Story
> BioClinica buys a patient recruitment firm to bolster study startup. Article
Pharma Manufacturing News
> Twitter chat redux: In case you missed the chat, we don't want you to miss the info. More
> India may use FDA as model for bolstering its oversight. Item
> Lupin antibiotic products banned by Brazil. Story
> Chinese staffer key to negotiating deal to bolster FDA staff in China. Report
> FDA sends drugmakers warning letters reminding them to pay up. Article
Pharma Asia News
> India's Lupin hit by Brazil regulator suspension of antibiotic API. News
> Drug firms in Australia to report gifts to doctors starting Oct. 1, ABC says. Item
> India aims at U.S. FDA standards on drugs with name change afoot. Report
> Watch out AbbVie, Samsung Bioepis does fine with Humira biosimilar in PhIII. Story
> Israel's Oramed says $50M oral insulin deal with Sinopharm Capital-Hefei, not Guangxi Wuzhou. Article