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Approvals & Launches

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Pipeline Watch: Japan Dominates 25 New Approvals, Plus Six Phase III Updates

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

Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate

The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.

Approvals Market Access

Global First Approval For Daiichi’s EZH1/2 Inhibitor Valemetostat In Japan

Japan has granted to the first approval worldwide to Daiichi Sankyo’s dual EZH1/2 inhibitor valemetostat, for the treatment of adult T-cell leukemia/lymphoma. Taisho’s trivalent anti-TNFα nanobody ozoralizumab also received its global first approval, as part a large new batch of regulatory nods in the country.

Japan Approvals

Pharming’s Leniolisib On Track To Become First Disease-Modifying APDS Drug

The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.

Drug Review Companies

Chinese-Language Podcast: ESMO上的中国数据

Special guest, Citeline's Annie Siu, discusses the recent ESMO meeting and Jiangsu Hengrui and BeiGene's PD-1 data for hepatocellular carcinoma in this latest episode of the Chinese-language China Biotech podcast.

China Clinical Trials

Pipeline Watch: 22 Approvals And 15 Trial Updates

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

Biogen Prepares More Doubtful Phase III Results For FDA Scrutiny, This Time In ALS

After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?

Clinical Trials Commercial

Leqvio Launch Will Be Fundamental To Success Of New Novartis

Discussion of the launch trajectory for the twice-yearly cholesterol therapy dominated the marketing portion of Novartis’s investor event and the firm is confident the foundations have been laid to push strong sales growth by the second half of next year.

Cardiovascular Launches

Fennec Prepared For Market As Pedmark Finally Gets FDA Nod

After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.

Approvals Cancer

Tezspire All Set To Tackle Big Biologic Rivals In Severe Asthma

With a European approval in the bag for Tezspire, AstraZeneca is looking for quick and successful launches of the severe asthma drug so it can mount a challenge to the other biologics in the space, notably Sanofi and Regeneron’s Dupixent.

Approvals Respiratory

Bluebird Confident In Financial Runway For Skysona Launch

The $3m gene therapy for the rare disease cerebral adrenoleukodystrophy marks bluebird’s second approval in just under a month.

Approvals Gene Therapy

Seven Potential Blockbuster Approvals To Look Out For In 2023

After highlighting oncology drugs pegged to make a splash next year with the help of Biomedtracker, Scrip takes a look at seven potential blockbusters across a range of therapeutic areas including neurology, dermatology and blood disorders slated for approval next year.

Approvals Companies
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