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Featured Stories


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 Legal Issues

New CV Outcomes Study May Mean Big Boost For Amgen's Repatha Market

The addressable patient population in the US could increase by 4.5m if new trial is successful.

Clinical Trials Research & Development Cardiovascular

Oxford Biomedica, Microsoft Pact Aims At Better, Cheaper Lentiviral Vectors

Oxford Biomedica and Microsoft have joined forces to improve the yield and quality of next-generation gene therapy vectors using the cloud and machine learning, the UK gene and cell therapy company's chief business officer tells Scrip.

Artificial Intelligence Business Strategies Commercial
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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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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 Commercial

Asia Deal Watch: Athenex Changes Mind, Gets Back Chinese Rights To Actinic Keratosis Candidate

Following a positive Phase III data readout for KX2-391, Athenex requests dissolution of its recent deal conferring rights to the drug in China to Chongqing Jingdong Junzhuo. TaiwanJ licenses Asian rights outside its home market for JK-122 to Newsoara.
Asia Pacific Deals 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.

Commercial Clinical Trials

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

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

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

Ortho Derm Turns To Cash-Pay Model To Address Prior Authorization Hurdles

With dermatologists reporting issues with prior authorization requirements, Ortho Derm is offering several reduced-price products under a new cash-pay format.

Pricing Strategies Dermatology

Policy & Regulation Explore this Topic

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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 Reimbursement

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

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

Advicenne Prepares For Launch As Rare Kidney Disease Drug Is Filed In The EU

Having had a bid for accelerated assessment rejected by the EMA last year, the French biotech is getting a standard review for ADV7103 in dRTA patients and hopes to launch late 2020.

Rare Diseases Renal

Research & Development Explore this Topic

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Shorter Treatment Time For Chagas Could Blunt Kissing Bug Disease

Chagas is in the spotlight with Novartis, Bayer and DNDi running different trials designed to tackle the neglected tropical parasitic disease.

Clinical Trials South America Cardiovascular

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

Vifor Pharma: Targets Acquisitions As Pure-Play Strategy Delivers

Switzerland’s leader in iron deficiency therapies wants to add new products in this and adjacent therapeutic areas, as strong revenue growth in 2018 backs its strategy of concentrating its efforts on the pharmaceuticals business.

 

Sales & Earnings Companies
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