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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Novartis CEO Sees Recovery Ahead, Fueled By Pipeline And Alcon Growth

Novartis' half-year results show eye business Alcon and heart drug Entresto - which have been the two main sources of concern - are finally turning around, and its pipeline is firing on all cylinders towards a post-Gleevec recovery.

Sales & Earnings Companies

Without J&J, Capricor Plans To Advance Progenitor Cell Therapy In DMD

California biotech says it will move forward with knowledge and expertise gained through the failed partnership. Capricor hopes to re-partner CAP-1002 for cardiovascular indications, while continuing the candidate’s DMD development itself.

BioPharmaceutical Commercial

Arena Rises, But Raises Questions With Phase II Ralinepag Data In PAH

Arena reported statistically and "clinically" significant results from its Phase II study for ralinepag in pulmonary arterial hypertension (PAH), driving its share price up by more than 40%, but details expected later this year or in 2018 are needed to shed more light on the data.

Clinical Trials Cardiovascular

Big REVEAL: Merck's Anacetrapib Surprises With Success, But What Next?

Merck & Co has triumphed against the odds announcing positive top-line results from the cardiovascular outcomes trial of its CETP inhibitor anacetrapib. But questions remain about the level of benefit and the regulatory prospects.

Clinical Trials Cardiovascular

Portola's Bevyxxa Poised To Capture Niche Novel Anticoagulant Market

Portola prepares to launch new anticoagulant betrixaban in niche patient population of patients with acute medical illness at risk of VTE, following FDA approval, despite mixed Phase III data.

Approvals Launches

CANTOS Trial Brings Unexpected CVD Promise For Novartis & Regeneron

Few expected the positive top-line results from CANTOS showing the Phase III cardiovascular disease study using canakinumab met the primary endpoint. Most want to see the full details being unveiled later in 2017.

Clinical Trials Commercial
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CNS

Set Alert for CNS

Latest From Neurology

Will Mitsubishi's High Offer Price For CNS Target NeuroDerm Deter Others?

Japan's Mitsubishi Tanabe Pharma is offering to buy Israeli CNS specialist NeuroDerm for $1.1bn and the 79% pre-rumor stock price premium may put off other potential suitors.

M & A Companies

Uphill Climb For Gedeon Richter's Cariprazine After Delayed EU OK

Gedeon Richter has finally had its antipsychotic cariprazine approved in the EU for treating schizophrenia - but its delay to market could dampen demand for the drug unless it can differentiate itself from rivals.

Approvals Business Strategies

A $63m VC Round Takes E-Scape Into Clinic With Alzheimer's, Parkinson's Drugs

E-Scape's Series A cash will fund the development of small molecules targeting genetic drivers of neurodegenerative diseases, such as ApoE4 in Alzheimer's disease. The venture capital financing with big pharma backing will be used to take two programs into the clinic.

Financing StartUps and SMEs

Infographic: A Look At Korea’s Alzheimer's Disease Landscape

While rising dementia populations are a worldwide problem, South Korea has to pay particularly close attention to tackling the issue as it has one of the fastest-rising incidences globally. Scrip takes a graphical look at the country’s Alzheimer's disease landscape, including drug pipelines and comparing it with the international situation.

Commercial Neurology

Opana ER Withdrawal Adds Weight To Endo's Ongoing Revenue Decline

With Endo's announcement July 6 that it will conform with FDA's request to remove Opana ER from the market, the specialty firm's prospects seem tied even more tightly to its generics business.

Drug Safety Business Strategies

Alkermes ENLIGHTEN Hints At Efficacy Benefit But Weight Profile Still In Balance

The first Phase III trial results for Alkermes' combination product for schizophrenia ALKS 3831 show hints of added benefit over olanzapine alone but no benefit yet on weight gain, the product's raison d'être. Analysts are hoping upcoming longer-term data will produce the goods.

Clinical Trials Companies
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

UCB's Bimekizumab Could Struggle With Saturated Psoriasis Market

UCB's has reported strong Phase IIb data for its novel psoriasis therapy bimekizumab, but the drug is unlikely to launch before 2022 and is at risk of being redundant on a crowded market.

Clinical Trials Immune Disorders

Ablynx Adds Sanofi To Its List Of Big Pharma Partners

Sanofi is the latest big pharma, following on from Merck & Co., AbbVie and others, to team up with Belgian Nanobody drug developer Ablynx.

Deals Immune Disorders

Remicade: Biosimilars And Pricing Pressure Wear On J&J's Blockbuster Brand

US sales were down 14%, but much of the hit was due to a 2016 price adjustment that was felt across the pharma portfolio, and execs insisted the impact of biosimilars is more moderate than expected.

Sales & Earnings Biosimilars

J&J's First-In-Class Tremfya Poised To Join A Crowded Psoriasis Market

FDA approved Johnson & Johnson's IL-23 blocker guselkumab July 13; the drug will be priced at an annual wholesale acquisition cost of $58,100, roughly in line with the currently marketed IL-17 blocker Cosentyx.

Launches Dermatology

Flagship Pioneering Nurtures Unique Start-Ups Until They Can Take Wing

Flagship Pioneering founder and CEO Noubar Afeyan says "watch this space" for another new start-up financing after Evelo Biosciences' successful $50m raising.

Financing Business Strategies

Critical Clinical Trial Updates Expected in 3Q

Ten clinical trial data readouts to watch for in the third quarter of 2017 that are expected to shift stocks and potentially change standard of care options in some disease areas.

Clinical Trials Research and Development Strategies
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

J&J's Symtuza Will Debut In Europe On Cramped HIV Market

Johnson & Johnson's combination HIV therapy Symtuza has secured a greenlight in Europe, marking its first approval worldwide – but will the big pharma be able to catch up with successful HIV opponents from AbbVie and Gilead?

Infectious Diseases Approvals

J&J's Quad HIV Combo Likely To Pass CHMP; EU Market Uptake Is Trickier

Johnson & Johnson's quadruple HIV combination is likely to win a positive recommendation for approval in Europe this week – but clever positioning will be required to secure strong uptake for the combination considering its late entry onto a competitive market place.

Approvals Regulation

Gilead Completes HCV Clinical Development With Vosevi Approval

Bringing three-drug, single-tablet regimen to market means Gilead has an answer for every hepatitis C patient, company says. It still lacks an answer, however, for its future business direction as HCV revenue wanes.

Approvals Companies

AMR Roundtable Part 2: The Need For Patient Perspectives To Reinforce Urgency Of Antimicrobial Drug Development

Scrip spoke with the CEOs of Zavante and Amplyx as well as a BARDA official during a roundtable discussion at BIO about the challenges of antimicrobial drug development. This second part of the roundtable centers on the lack of patient advocates in the area of antimicrobial-resistant infections.

Market Access Infectious Diseases

AMR Roundtable Part 1: Incentives Spur Antimicrobial Investments, But More Needed

Scrip spoke with the CEOs of antibiotic firm Zavante and antifungal specialist Amplyx as well as a BARDA official who oversees antibiotic funding programs during a roundtable discussion at BIO about what's needed to boost antimicrobial drug development. Topics addressed in this part 1 of the discussion include company funding strategies, impact of the CARB-X program, and unique opportunities and challenges for antifungals.

Business Strategies Infectious Diseases

Early Stage Science Watch

Scrip scans for early stage research – from bench to clinic – that could lead to novel treatments or changes in therapy recently published in major science journals.

Research & Development Cancer
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Merck's Lantus Copy Lusduna Poised For US Market Pending Litigation

The Merck and Samsung Bioepis formulation of Sanofi's insulin glargine was tentatively approved by FDA, a designation that permits the drug to enter the market pending the resolution of ongoing patent litigation.

Biosimilars Approvals

Novo Nordisk Warns About Insulin Pen Cartridge-Holder Problems

New insulin-cartridge holders are being sent to users worldwide after the use of cleaning chemicals was linked to cracked holders in specific batches of NovoPen Echo and NovoPen 5, and increased ADR risks.

Drug Safety Metabolic Disorders

Novo Nordisk Will Eat Itself In Obesity

The Danish diabetes specialist is forging ahead with pivotal trials for its latest GLP-1 offering semaglutide in obesity after highly impressive Phase II efficacy data, but is likely to take the biggest market share from its own product, Saxenda.

Companies Analysis

Alnylam's Overshadowed Givosiran Comes Into The Phase III Light

While attention has been focused on other products, Alnylam is set to take another RNAi product candidate – givosiran – into pivotal testing following positive early data in acute hepatic porphyria.

Clinical Trials Companies

Novo Nordisk's Great Hope Semaglutide Shines In Ph II Obesity Study

Highly positive top-line weight loss results for Novo Nordisk's new GLP-1 agonist semaglutide are propelling it into Phase III trials next year for the notoriously tricky indication. The product is currently under review for type 2 diabetes.

Clinical Trials Companies

Novo Readies For Victoza CV Benefit Claim With US FDA Panel Nod

HeartofType2 unbranded campaign is aimed at increasing awareness of CV disease in type 2 diabetics. FDA advisory committee strongly endorses new claim for the GLP-1 agonist but recommends limiting it to diabetics with established CV or chronic kidney disease.

Advisory Committees Advertising, Marketing & Sales
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Oncology

Set Alert for Oncology

Latest From Cancer

Soriot's Future And MYSTIC Data To Dominate AstraZeneca's 2Q

Impending critical data for AstraZeneca's PD-1 inhibitor Imfinzi, which is expected to be the backbone of the company's growing cancer immunotherapy portfolio, and speculation around CEO Pascal Soriot's recent trip to Israel, where it is rumored he met with a rival pharma company about its vacant chief exec role, will be hot topics during the company's second-quarter earnings call this week.

Business Strategies Leadership

Bayer And Morphosys Brush Off ADC Mesothelioma Failure

A mid-stage trial of a Bayer/Morphosys antibody-drug conjugate for mesothelioma has failed, crossing one indication off the list of its potential uses, but development in other indications continues.

Clinical Trials Companies

Immuno-Oncology Outlook: Getting To The Root Of Head And Neck Cancer

As PD-1 inhibitors march toward earlier-stage head and neck cancers, researchers consider ways to improve the precision of immunotherapy through better patient selection and combinations for this accessible tumor type.

ImmunoOncology Cancer

Merck KGaA/Pfizer's Bavencio Set To Enter Europe's Crowded I-O Market

The highly-competitive PD-1 field in Europe is very likely to have a new player as Bavencio gets a CHMP recommendation for Merkel cell carcinoma, but the success of Merck KGaA and Pfizer's checkpoint inhibitor will be gauged on how it competes with the competition already on the market in wider, more valuable indications.

Cancer ImmunoOncology

Roche's Tecentriq Gets The Double At The EU CHMP

Roche's checkpoint inhibitor Tecentriq clears the EU approval hurdle in locally advanced or metastatic urothelial carcinoma and locally advanced or metastatic non-small cell lung cancer.

Approvals Policy & Regulation

Spanish Biotech Star Oryzon Slumps After Roche Rejection

Barcelona-based Oryzon Genomics remains upbeat about the prospects for 'a first-in-class, best-in-class LSD1 inhibitor' for cancer even though Roche has walked away from what was a potentially lucrative partnership.

Deals Companies
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Are Theravance And Mylan's US COPD Chances Bigger Than First Thought?

With Theravance Biopharma's promising once-daily nebulized LAMA bronchodilator, partnered with Mylan, set for FDA filing later this year, analysts say the product might have a bigger market than initially presumed, and are now looking beyond to the firm's other pipeline activities.

Clinical Trials Respiratory

Early Stage Science Watch

Scrip scans for early stage research – from bench to clinic – that could lead to novel treatments or changes in therapy recently published in major science journals.

Research & Development Cancer

Pulmotect Seeks Quick-To-Market Path For Rapid-Acting Respiratory Drug

Selected by NIH and NSF for the Innovation Zone at BIO 2017, the Houston biotech's synthetic broad-spectrum drug has shown activity in animal models against every pathogen tested. Pulmotect hopes PUL-042 can prevent exacerbations in COPD patients who develop upper respiratory infections.

Respiratory Infectious Diseases

Kamada's Plans For Emphysema Drug Delayed By Years After MAA Withdrawal

Kamada has withdrawn its European approval application for an inhaled version of its emphysema drug Glassia – a move that shocked investors because of the company's continued insistence data from a failed pivotal study would be enough to convince regulators.

Market Intelligence Respiratory

Chiesi Wins EU Nod For COPD Triple Combo, But Partner Is Predicted For Launch

Chiesi's triple combination therapy for COPD, Trimbow, has secured its first approval globally after winning a positive recommendation from the CHMP for its use in Europe – but analysts expect a respiratory partner will be required to launch the product.

Approvals Respiratory

Hikma's CRL Proves GSK's Witty Was Right: Generic Advair Is Hard

FDA issued a complete response letter for Hikma's ANDA to market a generic version of GSK's Advair, the second application to be rejected by FDA.

Complete Response Letters Generic Drugs
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