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May 23, 2018

Today's Rundown

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Featured Story

Gilead R&D chief Bischofberger to go back to his roots at startup Kronos

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.

Top Stories

AstraZeneca opens South San Francisco facility housing 400 R&D staff

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.

House passes 'right-to-try' bill, sending it to President Trump's desk

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.

[Sponsored] Growing Requirements for Medicines for Children

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.

Takeda divests Chinese JV for $280M after reaching Shire deal

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.

Cara signs $540M deal with Fresenius and Vifor Pharma to commercialize Korsuva

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.

Lava bags cash from Gilde and Versant and hires Genmab veteran to advance bispecific T-cell engagers

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.

Verrica seeks $86M IPO to take on compounded dermatology drug

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.

Esperion's LDL drug aces a third pivotal trial

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.

Merck rains on Roche's parade with double Keytruda win in squamous lung cancer

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.

Resources

[Whitepaper] Compliance Certificate and Training for Life Sciences Professionals

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.

[Whitepaper] Choosing the Best Steriles Dosage Form for Your Phase I Clinical Supply Needs

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.

[Whitepaper] Risk-based Approach to Change Management of GxP 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.

[Whitepaper] Regulatory Transformation at UCB

UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off.

[Whitepaper] Five Tracking Spreadsheets it’s Time for Regulatory to Retire

Find out how to eliminate regulatory’s tracking spreadsheets for good.

[Whitepaper] A Simpler Approach to RBM in Clinical Trial Management

Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

Events

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