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Regulatory Updates

Set Alert for Regulatory Updates

Stock Watch: When Governments Step In

Typically, state intervention in pharmaceuticals is aimed at drug cost control which, if taken to extremes, can border on nationalism.

Stock Watch Advisory Committees

Coronavirus Update: Korea Approval For Nuvaxovid, Japan Filing For Paxlovid

More progress for vaccines and oral antivirals in Asia as South Korea issues an approval for Novavax's vaccine, Pfizer files for Japanese approval of Paxlovid, and SK bio progresses late-stage trials of its recombinant vaccine. 

South Korea Japan

Pfizer And AbbVie JAKs Finally Join Dupixent In US Atopic Dermatitis Space

The arrival on the US eczema market of a couple of oral JAK inhibitors with stellar data on itching could provide a challenge to Sanofi and Regeneron's blockbuster Dupixent. However, Pfizer and AbbVie will have to overcome dermatologists' fears about the class-effect safety warnings their drugs come with.

Approvals Dermatology

A Deep Dive Into The Game-Changing Drugs For Skin Diseases

Scrip's Kevin Grogan joins Datamonitor's Pamela Spicer and Davinderpreet Mangat to discuss the skin disease landscape and whether atopic dermatitis is now where psoriasis was a decade ago as another wave of innovative products start to reach the market.

Approvals Dermatology

Pipeline Watch: 10 Approvals And Four Phase III Trial Starts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Idorsia Adds Hollywood Sparkle To Sleep Drug Quviviq

The Swiss biotech needs to wait for a scheduling review before it can officially launch the insomnia drug Quviviq but this delay gives Idorsia a few months to prime the US market with educational campaigns.

Launches Business Strategies

Idorsia In Dreamland With Insomnia Drug Approval

The Swiss biotech has got the thumbs up in the US for its insomnia drug which will be sold as Quviviq and is expected to be provide serious competition for Merck & Co's rival dual orexin receptor antagonist Belsomra.

Approvals Neurology

Eight COVID-19 Vaccines Approved In India In 2021, mRNA Addition Awaited

While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.

Coronavirus COVID-19 Regulation

Pipeline Watch: Four Phase III Trial Starts And Four Approvals

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Novartis MS Franchise Boosted After Fending Off Last Gilenya Challenge

The Swiss firm expects no generic versions of Gilenya in the US market "for at least the next two years" after a court again ruled against HEC Pharma, the only remaining company challenging its patent.

Generic Drugs Neurology

Applied Therapeutics’ Pivotal Galactosemia Product Stalls, Confirming Analyst Concerns

Analysts’ fears have been confirmed as a US FDA demand for clinical outcomes data has forced Applied Therapeutics to delay a planned filing for its lead product candidate, AT-007, in the rare disease galactosemia based on biomarker data alone.

Companies Clinical Trials

Lots To Celebrate Among 2021 Drug Launches, But Underlying Trends Underwhelm

The number of new drugs that launched in 2021 was on par with recent high trends, but launch trajectories generally underwhelmed commercially – except for COVID-19 vaccines.

Launches Scrip Perspectives
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