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Claims Stream In Under COVAX No-Fault Compensation Program

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The WHO indicates that several claim applications have been made under the COVAX no-fault lump-sum compensation program for COVID-19 vaccines. It remains to be seen how the scheme may apply to countries like India, which is also expected to take a call on indemnity to vaccine makers.

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10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

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Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: vaccine efficacy and the Delta and Delta Plus variants; breakthroughs in CRISPR gene editing and microbiome therapies; and the pandemic’s possible effect on regulatory pathways.

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Canadian Biotech Progresses COVID-19 Nasal Spray, Claims Promise Against Variants

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SaNOtize is to start Phase III trials for its nitric oxide nasal spray for COVID-19 and hopes to enlist volunteers from several countries, including India. The Canadian firm claims initial studies have demonstrated effectiveness across SARS-CoV-2 mutations, with plans afoot to validate it against the spreading Delta variant.

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Intellia Achieves Gene-Editing Breakthrough With First In Vivo CRISPR Therapy

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The first use of CRISPR/Cas9 in humans shows promising safety and efficacy against rare disease ATTR, and opens up the possibility of treating many genetic diseases.

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Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a look at pharma CEO pay; Pfizer’s CEO gives the inside track on COVID vaccine development; GSK elaborates on its restructuring and strategic plans; and Kite talks about its cell therapy plans under Gilead.

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Fresh Win For AstraZeneca/Merck & Co Pact With Koselugo Approval

Koselugo (selumetinib) was largely forgotten after failing Phase III trials in thyroid and lung cancer, as well as uveal melanoma, but its approval in Europe for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1, which follows a US approval for the rare condition last year, has breathed new life into the once-lauded MEK 1/2 inhibitor.

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Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Scrip's Five Must-Know Things: new developments in the TIGIT field; doctor frustration over Aduhelm guidance; are pediatric COVID vaccines necessary: the battle of the SERDs; and one Indian firm’s plans for lung disease leadership.

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US Backs Oral COVID-19 Therapies And ‘Next Pandemic’ Drug Discovery With $3.2bn

Aiming to mimic public-private COVID-19 vaccine success, the US NIH will fund pandemic drug research, including taking candidates up to Phase II.

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Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.

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Novavax’s Latecomer COVID-19 Vaccine Impresses With 90% Efficacy Result

Arriving two to three months later than planned, Novavax’s nanoparticle-based vaccine is still a welcome addition to the field, for both rich and poor countries.

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Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.

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IQVIA Biotech’s Sockalingam On Clinical Research Virtualization In APAC

In this audio interview, the head of IQVIA Biotech (Japan-Asia Pacific) talks to Scrip on a range of aspects around digitalization and virtualization of clinical research in the region, including sharply reduced site contracting timelines. He also touches on the digital product launch efforts that are currently a reality in several markets.

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Drug Pricing eBook

Tap into expert coverage of the complex world of drug pricing with insights from analysts at Scrip and Pink Sheet. This eBook includes vital information about issues affecting drug pricing for the US, EU, and other global markets, including patient access, regulatory issues, commercial challenges, value-based pricing, and more.