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Approvals & Launches

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Daiichi Sankyo/AstraZeneca Get Two Lucky Breaks For Enhertu

The FDA granted accelerated approval for the small but significant HER2-mutated NSCLC indication, while the arbitrator in Seagen’s arbitration case ruled in Daiichi Sankyo’s favor.

Approvals Legal Issues

Lupin Counts On Generic Spiriva Launch In Q4 To Turn US Tide

Even as it prepares for competition from an authorized generic, Lupin expects a launch of its generic to Boehringer’s blockbuster Spiriva in the fourth quarter of FY23. It hopes the launch will help its position in the US, where it has exited low margin products amid heightened competition, leading in turn to manufacturing job losses in India

Commercial Business Strategies

Strides’ Stelis Moves Closer To EU Nod For Forteo Biosimilar In FY23

Strides’ biopharma arm Stelis Biopharma has moved closer to approval in the EU and likely the US too for a biosimilar to Eli Lilly’s Forteo in FY23, following GMP certification for its manufacturing units. Meanwhile, merchant bankers have been appointed to evaluate strategic options to raise cash for Stelis.

Commercial Approvals

Myovant Expects Gradual Growth For Myfembree With Endometriosis Approval

Myovant and partner Pfizer have expected a slow ramp for Myfembree in uterine fibroids and new indication endometriosis as they build awareness and grow the market for the GnRH antagonist class.

Approvals Business Strategies

Enhertu Goes Into High Gear With HER2-Low Breast Cancer Approval

AstraZeneca and partner Daiichi Sankyo obtain the first approval for targeted therapy in HER2-low metastatic breast cancer for Enhertu, about four months ahead of the FDA action date.

Approvals Personalized Medicine

Pipeline Watch: Six New Approvals And 20 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

Arcutis Launches Zoryve For Psoriasis As A New Topical In A Growing Category

Zoryve joins Dermavant's Vtama as a new topical drug with a broad label for plaque psoriasis and offers some points of differentiation, including price.

Launches Approvals

Pipeline Watch: Nine Approvals And Seven 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

Bristol’s New Products Meet Early Launch Expectations

Sales rose significantly for Reblozyl and for Abecma and Breyanzi, despite manufacturing challenges for the two cell therapies. Newly approved Opdualag and Camzyos are off to encouraging starts.

Growth Launches

AstraZeneca’s Triple Regulatory Wins For Enhertu, Tezspire And Ultomiris Herald Sales Boost

The major has won US priority review for a commercially crucial label expansion of its breast cancer drug Enhertu while Tezspire and Ultomiris attracted positive CHMP opinions across the Atlantic.

Companies Approvals

Idorsia’s Quviviq Needs To Rise And Shine After Slow Launch

The company’s Quviviq launch has fallen short of early expectations, but Idorsia believes a patient approach will pay off for the blockbuster-tipped insomnia treatment.

Commercial Companies

Pipeline Watch: 11 Approvals And 10 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
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