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Approvals & Launches

Set Alert for Approvals & Launches

BeyondSpring's Next Move Uncertain After Plinabulin CRL

Chinese firm BeyondSpring dealt a setback after the US FDA refuses to approve plinabulin for chemotherapy-induced neutropenia.

Approvals Research & Development

Coronavirus Update: Lukewarm US Panel For Molnupiravir, Inovio, Bharat Look At Omicron

A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold. 

Coronavirus COVID-19 Approvals

VBI Poised To Take On GSK, Dynavax As Hep B Vaccination Market Takes Off

VBI Vaccines obtained FDA approval of its three-antigen hepatitis B vaccine PreHevbrio and will take on GSK’s Engerix-B and Dynavax’s Heplisav-B as CDC recommends universal HBV immunization.

Approvals Vaccines

ImmunoGen’s Mirvetuximab Confidence Justified With Ovarian Cancer Win

The response rate, with five complete responses, exceeds known responses to standard-of-care chemotherapy in heavily pre-treated folate receptor alpha-high patients. A US FDA filing is on track for early 2022.

Clinical Trials Personalized Medicine

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: the prospects and plans for J&J’s pharma and oncology business; China looks more inward under new policies; an important US approval for Takeda; and Moderna’s co-founder shares tips on innovation.

Business Strategies Commercial

Pipeline Watch: Six Phase III Trial Starts Plus 19 New 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

3D Med, Alphamab Get First SubQ Immuno-Oncology Approval, In China

A landmark approval and domestic tie-up in China mark the fast innovation that is shaping the country’s health sector.

Approvals ImmunoOncology

Takeda's Livtencity Approved For Refractory CMV Infection In Transplant Patients

Maribavir is the first antiviral agent targeting and inhibiting the pUL97 protein kinase, as well as Takeda's second new molecular entity approved by FDA this year.

Approvals Business Strategies

Amryt's Wings Clipped By Delay For Butterfly Skin Drug Decision

The Irish firm needs to give regulators in the US more information on its epidermolysis bullosa therapy but is confident of address those requests from its "existing data within the time periods required," according to CEO Joe Wiley.

Rare Diseases FDA

Aadi Starts Small With Fyarro, But Has Tumor-Agnostic Strategy In Mind

The approval of Fyarro marks the first for advanced malignant PEComa, a rare cancer that affects only 100-300 people in the US; it's also the first launch for Aadi Biosciences.

Approvals Cancer

BioMarin’s Voxzogo Predicted For Blockbuster Sales, But Market Must Be Built

Very early launch numbers look good in France and Germany, but US launch will be more challenging due to a fragmented patient base, the company said. Launch price is a flat $899 per vial.

Approvals Launches

Pipeline Watch: Phase III Trial Readouts In COVID-19 And Heart Failure

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
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