Tue.May 31, 2022

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FDA grants speedy review to Dupixent rare skin disease

pharmaphorum

Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients hope of a first-approved therapy for the highly-debilitating disease.

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Lilly invests $2.1bn in new Indiana manufacturing sites

Outsourcing Pharma

Eli Lilly and Company plans to expand its manufacturing footprint in Indiana by investing $2.1bn in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

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SEC accuses former AstraZeneca exec of insider trading

pharmaphorum

The US Securities and Exchange Commission has sued a former AstraZeneca executive over alleged insider trading in connection with its 2019 deal to acquire rights to Daiichi Sankyo’s breast cancer therapy Enhertu. The complaint was filed against Hugues Pierre Joublin (54) – formerly global head of corporate affairs for oncology at AZ until his role was terminated on 15 December 2019 – in New York Southern District Court last week.

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Jumping Through Time Zones: How to Stay on Top of Time Changes

Aureus Medical Group

Traveling is an exciting part of your job as a travel nurse; you get to see new parts of the country, experience new things, and make new connections! But there is a side-effect of constant travel– long-distance flights and changing time zones can impact your internal body clock, induce jet lag, or create confusion around time commitments. And after a long day of jumping through time zones, it can take up to one day for our body clocks to adjust for every hour the time shifts.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Representation in UK pharma: A progress report

pharmaphorum

Pharma understands that building equitable health services starts with building equitable institutions. But how is the UK’s industry progressing on its equality, diversity, and inclusion pathway? And what more needs to be done? Equity, diversity, and inclusion (ED&I) strategies in the UK’s pharma sector are beginning to take shape, but there is still much work to be done.

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Withings system aims to simplify remote patient monitoring

Outsourcing Pharma

Withings Health Solutions' new remote patient monitoring (RPM) system seeks to tackle complexities identified after the launch of its first offering in the space.

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Sandoz launches new global health inequalities initiative

Pharma Times

‘Act4Biosimilars’ will improve patient access and increase adoption in over 30 countries by 2030

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Roche puts pressure on SMA rivals with new FDA approval

pharmaphorum

Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its use to include infants less than two months of age. The new label means that Evrysdi (risdiplam) can now be used across all ages – from newborns to adults – allowing it to target the same groups as rival therapies Spinraza (nusinersen) from Biogen and Novartis’ one-shot gene therapy Zolgensma (onasemnogene abeparvovec).

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Memo Therapeutics initiates pioneering BK virus therapy trial

Pharma Times

Antibody addresses high unmet medical need in rapidly growing kidney transplant market

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GSK bolsters vaccines division with $3.3bn swoop on Affinivax

pharmaphorum

GlaxoSmithKline has agreed a $3.3 billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. GSK said it is paying $2.1 billion upfront for Cambridge, Massachusetts-based Affinivax, with another $1.2 billion in potential development milestones, to get its hands on the ASP3772 shot, which recently claimed a breakthrough designation from the FDA for the treatment of p

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.