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Featured Stories


AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies Immune Disorders

Europe's Biotechs Gathering Steam With Filgotinib Filing

Galapagos is another step closer to commercializing its products with its lead candidate, filgotinib, now under the gaze of EU regulators.

Approvals Inflammation Regulation

Inrebic Approval Is A Boost For Myelofibrosis And Celgene's Buyer Bristol

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

Approvals Cancer Deals
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PRECISION MEDICINE RESEARCH: How Advanced Data Analytics Support The Journey From Clinic to Bedside

Precision medicine offers huge promise to patients and health systems. It can also substantially increase the efficiency of drug development by enabling more focused, data-rich clinical trials.

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Commercial Explore this Topic

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Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation

Glenmark appears close to sewing up a deal for its biosimilar version of Novartis/Genentech's Xolair amid the firm's ongoing focus on partnering out some key assets. It also expects to kick off plans to raise capital in the US for its innovation business in Q4 of fiscal 2019-20.

Commercial Strategy Sales & Earnings

Interview: Mereo All Set For Key Setrusumab Data

Although far from a one-product company, data in Q4 will be key to whether the brittle bone drug could become a blockbuster for the UK NASDAQ-listed biotech.

Strategy Orthopedics Rare Diseases

Deal Watch: Aevi Options AstraZeneca Antibody For Rare Disease

Aevi needs to raise funds first, but hopes to develop MEDI2338 for adult-onset Still’s disease. Also, Alnylam plans to leverage Ironwood’s GI expertise for givosiran in acute hepatic porphyria and Ultragenyx snags option to buy GeneTx.
Deals M & A

Start-Up Quarterly Statistics: Financings Fell 17% To $2.84bn In Q2

A review of second quarter biopharma start-up deal-making and financing activity from Strategic Transactions showed a quarter-over-quarter drop in dollars raised despite multiple mega-rounds, including $100m-plus VC deals for SpringWorks and Fusion.

Deals Financing

Janssen's Imbruvica Leads CLL Market Expansion In Europe

Imbruvica is keeping ahead of potential competitors in Europe by expanding its use in patients with chronic lymphocytic leukemia and Waldenström’s macroglobulinemia.

 

Market Intelligence Cancer

Asia Trial Setbacks, Asset Returns Symptomatic Of Industry Challenges?

While deal-making in the Asian pharma space shows no signs of slowing down, the past few months have been marked by a series of high-profile cases involving the return of rights by licensees or setbacks in clinical trials. Scrip's regional team looks at some of the factors at work.

Asia Pacific Commercial

Sun’s Ilumya Ramps Up In Skyrizi’s Shadow

Patient numbers and prescriptions in the US for Sun’s psoriasis therapy Ilumya are steadily on the rise, and the Indian firm said that the arrival of AbbVie’s rival Skyrizi hasn’t adversely impacted its formulary position.

Commercial Strategy

Novartis Swaps Two AveXis Executives For One Following Zolgensma Data Manipulation

The big pharma could not confirm whether AveXis co-founder and CSO Brian Kaspar and his brother, SVP of R&D Allan Kaspar, were fired. Instead, Novartis noted that the withholding of preclinical safety data for Zolgensma was limited to the action of a few employees. NIBR preclinical safety chief takes key role at AveXis

Leadership Gene Therapy

Policy & Regulation Explore this Topic

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Kala Needs Big STRIDE To Get Dry Eye Drug OK

The US FDA has issued a complete response letter for KPI-121 but Kala hopes to resubmit the drug during the first half of next year backed by data from the ongoing STRIDE 3 study.

Ophthalmic Strategy FDA

Roche/Genentech Set Lower Rozlytrek Price To Catch Up With Bayer’s Vitrakvi

Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.

Approvals Personalized Medicine

Gilead’s Marketing Of Descovy For HIV Prevention Should Not Suggest Superiority To Truvada

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

Advisory Committees Advertising, Marketing & Sales

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Advisory Committees Cardiovascular

Research & Development Explore this Topic

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Mallinckrodt’s Phase III Kidney Failure Trial Hits Primary Endpoint

The data position Mallinckrodt to file for US FDA approval of terlipressin early next year. Mallinckrodt thinks the drug could generate sales of $300m a year, helping it to mitigate its challenges.

Clinical Trials Companies Renal

Regeneron’s Cholesterol Drug Aces Phase III, Teeing Up US FIling

The trial linked ANGPTL3 antibody evinacumab to a steep decline in LDL cholesterol in patients with homozygous familial hypercholesterolemia, setting Regeneron up to file for US FDA approval next year.

Clinical Trials Companies

Lundbeck Looks To Pipeline As Generic Competition Hits

Lundbeck highlighted R&D and the strong growth of four strategic products in the first half, as revenues were hit by generic competitors to top-selling products.

 

Sales & Earnings Neurology

AZ Pushes Further Ahead In PARP Race With Lynparza/Avastin Combo

The PAOLA-1 study has shown the benefit of Lynparza for ovarian cancer patients regardless of tumor mutation status which should firm up the drug's dominance in the PARP inhibitor space.

Cancer Clinical Trials
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