| This week's sponsor is Premier Research. | | | Rare Cancer Drug Research: What to Know Going In
Rare cancer drug research requires oncology and rare disease expertise and careful attention to trial design and regulatory demands. Get started with our white paper. Premier Research. It's what we do. Best. |
Today's Rundown | Publisher’s Note: In preparation for the new GDPR taking effect this month, we would like to reconfirm your subscription to our newsletter(s). Please click this link to reconfirm your subscription. For more information about GDPR, please visit this page. | |
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Gilead R&D chief Bischofberger to go back to his roots at startup Kronos AstraZeneca opens South San Francisco facility housing 400 R&D staff House passes 'right-to-try' bill, sending it to President Trump's desk [Sponsored] Growing Requirements for Medicines for Children Takeda divests Chinese JV for $280M after reaching Shire deal Cara signs $540M deal with Fresenius and Vifor Pharma to commercialize Korsuva Lava bags cash from Gilde and Versant and hires Genmab veteran to advance bispecific T-cell engagers Verrica seeks $86M IPO to take on compounded dermatology drug Esperion's LDL drug aces a third pivotal trial Merck rains on Roche's parade with double Keytruda win in squamous lung cancer Featured Story | | | Wednesday, May 23, 2018 Longtime Gilead research vet Norbert Bischofberger has landed at the cancer drug discovery startup Kronos Bio as its new president and CEO. He stepped down in April as executive VP for R&D and chief scientific officer at Gilead, following nearly three decades at the company. |
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Top Stories Wednesday, May 23, 2018 AstraZeneca has officially opened its new research facility in South San Francisco, bundling five of its Bay Area sites into a single unit at the heart of California’s biotech cluster. Tuesday, May 22, 2018 The House voted 250-169 to pass a "right-to-try" bill that would allow terminally ill patients access to experimental drugs. The bill, approved by the Senate last August, is headed to the desk of President Donald Trump, who is expected to sign it into law. Monday, May 21, 2018 Progress has been made in developing medicines for children with the passing of pediatric regulation, but gaps still exist. Here’s what you need to know about recent updates from an expert at Synteract. Tuesday, May 22, 2018 Takeda's $62 billion acquisition of Shire added $31 billion to its debt load. Now, the Japanese drugmaker is looking to trim the fat where it can—starting by selling off its stake in the Chinese biopharma company Techpool. Wednesday, May 23, 2018 A joint venture of Vifor Pharma Group and Fresenius Medical Care acquired an international license to Cara Therapeutics’ investigational Korsuva injection, an alternative opioid analgesic with a somewhat-rocky development history, for treating the severe itching associated with chronic kidney disease in hemodialysis patients. Wednesday, May 23, 2018 Gilde Healthcare and Versant Ventures have driven Lava Therapeutics to a €16 million ($18.8 million) financing. The round equips Lava to advance bispecific engagers of gamma-delta (γδ) T cells, a small subgroup of lymphocytes involved in natural and induced immunity to cancer. Wednesday, May 23, 2018 Verrica Pharmaceuticals has filed to raise $86 million from public investors. The planned IPO will give Verrica the money it needs to take a treatment for viral skin infection molluscum through phase 3 and onto the market. Wednesday, May 23, 2018 Esperion's bempedoic acid is continuing its roll, lowering LDL cholesterol in patients with atherosclerosis who cannot use statins and for whom background lipid-modifying medications do not work. Wednesday, May 23, 2018 Merck already controls a big piece of the first-line non-small cell lung cancer market, and it likely just secured most of the rest. Its immunotherapy Keytruda nailed a study in previously untreated patients with the squamous form of the disease, who represent up to 30% of newly diagnosed NSCLC cases. | This week's sponsor is IQVIA. | | | |
Resources Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. Presented by: Patheon There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development. Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Veeva Systems UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off. Sponsored by: Veeva Systems Find out how to eliminate regulatory’s tracking spreadsheets for good. Sponsored by: Veeva Systems Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation. Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Building your Program for Immunomodulating Therapeutics Wednesday, 6 June, 2018 | Paris, France BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | Toronto, Canada The Liquid Biopsy Summit June 20–22, 2018 | San Francisco, CA Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 