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Approvals & Launches

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A Duchenne Breakthrough Awaits In 2023 - But Risks Remain For Sarepta And US FDA

The FDA and Sarepta have had a controversial history with the accelerated approvals of the firm’s earlier drugs for Duchenne muscular dystrophy – but the company’s investigational gene therapy, SRP-9001, now under a priority review, could be a genuine breakthrough.

Approvals Neurology

Pipeline Watch: Eight Approvals As CTAD Dominates 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

Rigel Ready To Hit The Ground Running After Early AML Drug Approval

Rezlidhia, which was only recently licensed by Rigal from Novo Nordisk-owned Forma Therapeutics, should challenge the market dominance of Servier's Tibsovo in the IDH-1 inhibitor subset of acute myeloid leukemia patients. 

Approvals Business Strategies

Ferring Makes Important Milestone For Microbiome With Rebyota Approval

The microbiome therapy won approval for preventing recurrence of Clostridioides difficile infections, but an analyst said the future could be in more targeted approaches.

Approvals Infectious Diseases

Pipeline Watch: Nine Approvals And Phase III 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

Third Time Lucky As Japan Finally Approves Shionogi’s Oral COVID Antiviral

Shionogi’s once-daily oral COVID-19 antiviral finally gets Japan approval after being considered for the third time by an expert panel, paving the way for public availability of the country’s first such home-grown option in early December.

Japan Commercial

AbbVie's Skyrizi Adds Crohn's Disease Indication In Europe

Skyrizi is the first specific IL-23 inhibitor for the treatment of Crohn's disease in Europe, though the drug was approved with a broader label in the US.

Immune Disorders Approvals

UniQure/CSL Set To Launch First Hemophilia B Gene Therapy Next Year At Record Price

The firms’ gene therapy Hemgenix has won a US thumbs up for the treatment of hemophilia B and plans are underway for a US launch with a big price tag that experts agree should pay off in the long-term.

Approvals Gene Therapy

UCB Makes Another Push To Get Bimzelx Over Finishing Line In US

The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.

Dermatology Complete Response Letters

Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes

Blenrep’s withdrawal will add to GSK’s blockbuster drought, and hopes of separate trial success for the BCMA-targeting drug in earlier stage myeloma may now be harder to achieve.

Approvals Companies

Provention Plans Two-Phase Launch Of Tzield, Pricing Drug Higher Than Expected

At nearly $194,000, the wholesale acquisition cost for Tzield came in above analysts’ $100,000-$115,000 estimates, but payer pushback is not expected as the drug faces no competition.

Approvals Metabolic Disorders

Pipeline Watch: 13 Approvals And 33 Phase III 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 Clinical Trials
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