This week's sponsor is Premier Research. | | Can You Boost Your Odds in Early-Phase Oncology Trials? Find Out! Despite advances in molecular targeting, developing new cancer drugs remains a long shot. Download our white paper for insights on maximizing early-phase trial success. Premier Research. It's what we do. Best. | Today's Rundown Gilead’s longtime R&D lead Bischofberger steps down Biogen buys Pfizer’s unwanted neuro med for $75M as sell-off starts Sanofi walks away from Alnylam rare disease drug Time’s a-ticking for bankrupt Orexigen to sell off Contrave Realm scraps eye drug after midphase flop, sinking stock Anthera’s Sollpura canned after phase 3 flop, shares plunge Savara abandons drug behind last year’s reverse merger with Mast TAE bags $40M to take targeted radiotherapy mainstream No leniency for Shkreli: Bad-boy pharma executive gets 7 years in prison for fraud Featured Story | Monday, March 12, 2018 Gilead’s long-serving Norbert Bischofberger, Ph.D., is stepping down as EVP of R&D and chief scientific officer this April, as the company promotes John McHutchison, M.D., to the top job. |
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| Top Stories Monday, March 12, 2018 As Pfizer clears house of its unwanted neuro assets, Biogen has become a buyer for one, namely a phase 2-ready schizophrenia drug. Monday, March 12, 2018 Sanofi has turned down the chance to opt into Alnylam’s primary hyperoxaluria type 1 drug lumasiran. The French pharma’s decision gives Alnylam control of a phase 3-ready rare disease drug with an FDA breakthrough therapy designation. Monday, March 12, 2018 Orexigen Therapeutics is filing for bankruptcy and plans to auction off its obesity med, Contrave, to pay down its debt. Monday, March 12, 2018 Realm Therapeutics has scrapped development of PR013 after the opthalmic drops failed to improve outcomes in patients with allergic conjunctivitis. The setback wiped almost 30% off Realm’s stock as investors digested the loss of the program and assessed its implications for the rest of the pipeline. Monday, March 12, 2018 Anthera has seen its fair share of setbacks over the years, and today that tally only got longer as it cut loose a failed late-stage Lilly castoff, Sollpura (liprotamase), and now seeks those dreaded “strategic alternatives.” Monday, March 12, 2018 Inhaled sodium nitrite missed both primary and secondary objectives in heart failure patients with preserved ejection fraction. Monday, March 12, 2018 TAE Life Sciences has raised $40 million to eliminate the main bottleneck to widespread use of boron neutron capture therapy (BNCT). The startup, a spinoff from a nuclear fusion company, is working on a neutron source designed to take BNCT out of nuclear research reactors and into hospitals. Friday, March 9, 2018 The sentence is in. Despite pleas for sentencing mercy, “Pharma Bro” Martin Shkreli will spend up to seven years in prison on federal securities fraud charges. This week's sponsor is Eurofins Advinus. | | | Resources Sponsored by: Reprints Desk The competitive landscape in medical device R&D is tough. And simply investing in R&D is no guarantee for profitability. So how do you accelerate time-to-market? Sponsored by: MK&A There’s no magic bullet to successful access but insights from patient advocates and industry experts can help shape future strategies. Learn how in this webinar. Sign up now! Presented by: Box and USDM Life Sciences Learn how biopharma and medical device companies can now collaborate on, manage and distribute regulated clinical, lab and manufacturing content in Box. That means all of your content is standardized on a single content repository that meets regulatory and compliance standards, so you can eliminate inefficient silos, enable seamless collaboration and accelerate the validation process. Sponsored by: RBC Wealth Management Employee stock option trading & administration, Restricted stock transactions (Rule 144), Affiliated trading plans (10b5-1), Directed share plans, Equity comp plan administration — private to public Sponsored by: WCG Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals. Presented by: Covance Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives. Presented by: Charles River Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols. Presented by: Catalent Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility. Presented by: Catalent Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology. Presented by: Catalent Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing. Sponsored by: RTI Health Solutions In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods. Drug Approval, Manufacturing Quality & Regulation 2018 | Online BioBasics: Biotech for the Non-Scientist March 29-30, 2018 | Boston, MA MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! |