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Regulatory Updates

Set Alert for Regulatory Updates

Pfizer/Lilly Discontinue Tanezumab, The Likely End For A Class Dogged By Safety

The nerve growth factor inhibitor for osteoarthritis pain is one of the last still in development after safety largely sidetracked the class of drugs.

Complete Response Letters Safety

Roche’s Port Delivery System Approved, Paving The Way For Ophthalmology Expansion

Susvimo, a PDS version of the blockbuster Lucentis, is a refillable eye implant that will extend Roche's commercial opportunity in wet-AMD but presents training challenges. Pricing is slightly below Lucentis.

Approvals Launches

Agenus PD-1 Down But Not Out With Cervical Cancer BLA Withdrawal

The company announced it would withdraw the BLA for balstilimab monotherapy in cervical cancer following Keytruda’s full approval, but it plans to keep developing the drug.

FDA ImmunoOncology

Pipeline Watch: Phase III Readouts In Breast And Liver Cancer Plus COVID-19

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

Coronavirus Update: Gates Foundation To Give $120m For Molnupiravir Access

The foundation is donating to help supply Merck/Ridgeback’s antiviral to low-income nations; also Pfizer got one step closer to full approval for booster shots of Comirnaty, while the FDA authorized Moderna and J&J boosters, and Daiichi Sankyo made progress on its own mRNA vaccine candidate. Shionogi's once-daily oral antiviral is also moving forward.

Coronavirus COVID-19 Vaccines

Sage/Biogen Delay Zuralone Filing, Commercial Path Remains Unclear

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

FDA Neurology

Oyster Point Prepares Major Push For New Dry Eye Drug

Execs told Scrip they hope to get Tyrvaya (varenicline) onto formularies and aim for pricing that would make its nasal spray competitive with Restasis and Xiidra.

Approvals Ophthalmic

Q3 Review: Editor’s Picks Of Scrip's Top Stories

From the latest COVID-19 advances to the emergence of a game changer for heart failure, Scrip’s editor in chief Eleanor Malone reviews the big stories of the past three months. Safety issues around JAK inhibitors and AAV vector-based gene therapy were also to the fore, while biopharma financing continued apace.

Commercial Companies

UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

Drug Review Immune Disorders

Gilead Sees Room For Trodelvy In European Markets

Gilead looks set to expand its lead position in the triple-negative breast cancer (TNBC) market in Europe with a positive opinion for Trodelvy from the CHMP.

Market Access Business Strategies

Pipeline Watch: Phase III Readouts in Fabry's Disease And COVID-19

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

Keytruda Cements Cervical Cancer Leadership With First-Line Nod

Although the label’s PD-L1 expression requirement could limit the addressable market, there is also potential for future combination with Seagen’s recently approved Tivdak.

Approvals ImmunoOncology
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