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Zulresso Is Sage’s First Step In Postpartum Depression Treatment

I.V. Zulresso is the first US FDA-approved drug for postpartum depression (PPD) and Sage's first commercial product – with a list price of $34,000. It will help the company build a presence in PPD as it completes late-stage development for oral candidate SAGE-217.

Approvals Launches Market Access

Urovant’s Vibegron Faces Tough Commercial Climb Despite Phase III Success

Roivant subsidiary thinks EMPOWUR data would position the drug as best-in-class in overactive bladder, but investors responded to the data with a clear thumbs-down.

Gynecology & Urology Clinical Trials Research & Development

Price ‘Anchoring’? Zolgensma And The Art Of Managing Gene Therapy Sticker Shock

Public statements by Novartis and Avexis suggest Zolgensma could be cost effective at a price up to $5m. Analysts expect $2m. The lower estimate is still stunning, but could it be considered reasonable by comparison?

Pricing Strategies Pricing Debate Rare Diseases
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GETTING IT RIGHT – Drawing Together Key Stakeholders To Shape The Real-World Data Revolution

This special report reveals the challenges and solutions for early payer involvement in real-world data clinical trials, as discussed by industry leaders at a recent roundtable.

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Commercial Explore this Topic

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Merck KGaA Interview: China E-Health Push A ‘Long-Term Strategy’

Merck KGaA's alliances with Chinese internet giant Tencent and Alibaba Health is part of the German group's long-term strategy for China and reflects the high speed with which digital healthcare is evolving there, global operations head Chris Round tells Scrip.

 

China Business Strategies Companies

PureTech’s Karuna Gets Another $68m For Re-engineered Lilly CNS Candidate

Karuna Therapeutics plans to expand its development program for lead candidate KarXT beyond its current Phase II trial in schizophrenia. The series B financing follows a $42m series A in 2018.

Financing StartUps and SMEs Commercial

Abbott Builds Its Digital Reach In India

Abbott’s new digital initiative in India, which already has 2,000 physicians and 1,000 patients on board, aims to provide services and information to improve health outcomes. Gamification concepts and an offline component such as a learning program for physicians are also part of the new offering.

India Commercial

Finance Watch: Panic Over FDA Commissioner's Resignation Was Short-Lived, Though IPOs Still Languish

Public Company Edition: Biotech stocks sank when US FDA Commissioner Scott Gottlieb announced his departure, but have nearly recovered to pre-resignation levels, except for newly public firms. Also, Biohaven's raises cash for PRV purchase and Endo issues $1.5bn in new debt.

Deals Financing

Dermira’s Lebrikizumab Data Set Up Atopic Dermatitis Showdown With Dupixent

Dermira hopes to move into Phase III quickly with IL-13 inhibitor lebrikizumab, looking at monthly dosing in the maintenance setting. Efficacy in Phase IIb appears similar to Sanofi/Regeneron’s Dupixent.

Clinical Trials Dermatology

Imara Broadens Hematology Horizons With $63m Fundraising

Imara has raised $63m to pursue its PDE9 inhibitor for sickle cell disease, and hopes to broaden the Phase II drug candidate into related blood disorders such as beta thalassemia.

Commercial Financing

AbCellera Finds Antibody Candidates Other Technologies Might Not

Emerging Company Profile: A platform research company, AbCellera is not developing any drugs, but has seen triple-digit revenue growth each year since 2015 via a model of discovering next-generation therapeutic antibody candidates for partners.

Platform Technologies Business Strategies

Going Generic: Big Brands Poised To Lose Marketing Exclusivity In The US In 2019

With the first generic versions of blockbuster brands like Advair, Lyrica, Restasis and Sensipar and the first biosimilars of Herceptin, Avastin and Rituxan expected to launch in the US, 2019 could be a notable year for generics and biosimilars.
Generic Drugs Market Intelligence

Policy & Regulation Explore this Topic

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India’s Top Court Tells Singhs To Come Up With Plan To Pay Daiichi, Uphold Nation’s ‘Honor’

India’s Supreme Court has told Malvinder Singh and Shivinder Singh, once corporate billionaires, to work out a strategy within two weeks to pay Japanese drug giant Daiichi Sankyo a $500m arbitration award and "uphold the nation’s honor."

India Commercial Companies

Finance Watch: Panic Over FDA Commissioner's Resignation Was Short-Lived, Though IPOs Still Languish

Public Company Edition: Biotech stocks sank when US FDA Commissioner Scott Gottlieb announced his departure, but have nearly recovered to pre-resignation levels, except for newly public firms. Also, Biohaven's raises cash for PRV purchase and Endo issues $1.5bn in new debt.

Deals Financing

Cancer, Rare Disease Drugs To Be Covered As China Expands Reimbursement

China's national reimbursement drug list will undergo a much anticipated expansion in 2019, and therapies for cancer, pediatric and rare conditions from international firms including Roche and Actellion are likely to receive long-awaited coverage.

China Market Access

Celgene/Bristol's Revlimid Patent Risk Incrementally Lower After PTAB Denies Alvogen IPR

Bristol-Myers Squibb pitches Celgene's pipeline as its most valuable asset, but investors remain fixated on the coming Revlimid patent cliff. A recent PTAB decision to deny an inter partes review incrementally decreased that risk.

Intellectual Property Business Strategies

Research & Development Explore this Topic

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TIME-2b Disappointed: Aerpio’s Lead Product Fails In Diabetic Retinopathy

As its lead product fails at Phase IIb in diabetic retinopathy, Aerpio’s attentions turn to its other potential indications, but investors will need more convincing that this strategy will pay dividends.

Clinical Trials Companies Research & Development

Latest REDUCE-IT Results Bolster Case For Amarin's Vascepa Fish Oil Pill

Data may pave way for inclusion in heart disease treatment guidelines, ACC spokesperson says.

Clinical Trials Research & Development

Allergy Therapeutics Stumped As Birch Product Fails At Phase III

A strong immunological response to the PQ Birch vaccine did not translate into any appreciable reduction in symptoms in the Phase III trial, leaving the UK firm perplexed, and its share price southwards.

Clinical Trials Companies

Pipeline Watch: Phase III Starts In PTSD, Ulcerative Colitis And Prader-Willi Syndrome

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Approvals Pipeline Watch
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