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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Diabetes-CV Disease Link Boosts EASD Buzz

Linkage between cardiovascular disease and type 2 diabetes was a top theme of discussion and data presented at this year's EASD meeting in Portugal's capital.

Metabolic Disorders Cardiovascular

Manufacturing Snag May Stall Portola's Bevyxxa Launch

Company has priced its Factor Xa anticoagulant at $15 per capsule, on par with competitors, and is gearing up for a launch, but it first must resolve manufacturing issues with FDA as it scales up to commercial capacity.

Approvals Regulation

Medicines Company Gets Aggressive With Inclisiran Phase III Plans

Updated ORION-1 data presented at the European Society of Cardiology have encouraged The Medicines Company to take an "aggressive" approach to its Phase III plans for the novel PCSK9 synthesis inhibitor.

Clinical Trials Companies

REVEAL: Limited Benefit Leaves Merck & Co Still Undecided On Anacetrapib's Future

The commercial future of Merck & Co's CETP inhibitor anacetrapib is still in limbo as the 9% reduction in the risk of CV events seen in REVEAL underwhelms. Filings look unlikely.

Clinical Trials Companies

COMPASS Sets Course For J&J/Bayer's Xarelto In Unexplored Indications

A large new market in coronary artery and peripheral arterial disease beckons after Xarelto showed a 24% reduction in the risk of major cardiac events, a benefit that may outweigh the increase in major bleeding.

Clinical Trials Cardiovascular

CANTOS: Modest CV And Intriguing Lung Cancer Benefit With Canakinumab

With CANTOS, Novartis's canakinumab has become the first investigational treatment to show that selectively targeting inflammation significantly reduces cardiovascular risk, albeit modestly, but with the added bonus of reducing lung cancer.

Clinical Trials Companies
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CNS

Set Alert for CNS

Latest From Neurology

Snapshot Of The Opioid Crisis, An Infographic

The opioid market is expected to total $18.4bn by 2020 – but the growing crisis of opioid abuse plagues manufacturers, policy makers and public health. Scrip takes a look at the pipeline of abuse-deterrent formulations and physician opinions about what impact those will have.

Neurology Drug Safety

Allergan Urgently Seeks FDA Guidance To Unblock Vraylar sNDA Review

In its initial assessment of Allergan's sNDA for Vraylar, the FDA has found the application - for treating negative symptoms associated with schizophrenia – wanting, and thus says it doesn't merit a full review.

Approvals Companies

Nuvelution Puts Business Model Into Action With Teva/Austedo Deal

Focused on drug development risk-sharing partnerships, Nuvelution signs its first partnership, with Teva, to conduct Phase III development of recently approved Austedo for pediatric Tourette syndrome.

Deals Research and Development Strategies

Ocrevus Delay As CHMP Continues Assessment?

The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.

Companies Approvals

Precision Medicine In Psychiatry: Astellas Joins Search For Biomarkers, Drug Targets

Biomarkers for psychiatric disorders are lacking, but Astellas is investing in its own and external efforts to identify drug targets as well as patients who'll respond to new therapies.

Research and Development Strategies Clinical Trials

Sage Says Brexanolone's SRSE Result Doesn't Mean PPD Studies Will Fail

The Phase III study for brexanolone in super-refractory status epilepticus did not meet its primary endpoint, but Sage is optimistic about the drug's prospects in postpartum depression and its earlier-stage SAGE-217.

Clinical Trials Business Strategies
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Roche Racks Up Another RoActemra Green Light To Boost Revenues

The Swiss giant's blockbuster is the first non-steroid therapy approved in Europe for giant cell arteritis and the first major advance in treatment for over 50 years.

Immune Disorders Policy & Regulation

Keen Kevzara Pricing Will Be Sanofi’s Best Hope After Speedy NICE Nod

A three-month turnaround from approval in Europe for Sanofi’s rheumatoid arthritis drug to recommendation in England is pretty quick. The firm will need to maintain keen pricing in a competitive field.

Immune Disorders Reimbursement

Provention Builds On J&J Disease Interception Model

Founded earlier in 2017 with a plan of making quick "go/no-go" development decisions based on objective data, Provention taps into Johnson & Johnson for a pair of IBD candidates.

Deals Business Strategies

Parvus Seeks Autoimmune Answers Through Restoring Immune Tolerance

Emerging Company Profile: Partnered with Novartis on a nanoparticle candidate for type 1 diabetes, Parvus develops its proprietary Navacims to help the body’s immune system differ between a pathogen and itself.

StartUps and SMEs Business Strategies

JAK Inhibitors Have Dupixent In Their Sights For Atopic Dermatitis

Analysts predict that Sanofi and Regeneron's Dupixent is going to dominate the severe eczema market but the oral options of Lilly/Incyte's baricitinib and AbbVie's upadacitinib are progressing through the pipeline to make a challenge.

Immune Disorders Dermatology

Lupus Nephritis May Be As Straightforward As Lupus R&D Gets

Some drug makers are tackling lupus R&D by focusing on a specific subset of the disease, lupus nephritis, where diagnosis is more clear cut and the clinical endpoints are more straightforward.

Clinical Trials Market Intelligence
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Sanofi And NIH To Test 3-In-1 Antibody In HIV After Monkey Trial Success

Sanofi's focus on developing multi-specific therapies is being turned to HIV.

Clinical Trials Companies

Nabriva's Antibiotic Lefamulin Does Well In First Of Two Pivotal Trials

Results from the first Phase III study – LEAP 1 – of the antibiotic lefamulin are positive, and Nabriva still has one trial to go. But the firm believes that regardless of that result, the totality of data could be used to support regulatory filings.

Infectious Diseases Drug Approval Standards

Gates Foundation’s $40m Incentivizes Cancer Specialist Immunocore To Develop TB, HIV Drugs

Oxford, UK-based Immunocore, which is developing immunotherapies against cancer, has secured $40m in funding from the Bill & Melinda Gates Foundation to boost its research activities in infectious diseases. The company hopes to develop novel therapeutics to reduce treatment timelines and improve outcomes for patients with HIV and TB.

Deals Infectious Diseases

2017 Filing For Shionogi's Novel Flu Drug In Japan On Back Of Strong Phase III Data

Shionogi is on track to file its novel flu treatment S-033188 with regulators in Japan by the end of the year on the back of positive Phase III data.

Clinical Trials Research and Development Strategies

With J&J’s Departure From HCV, Gilead Stands Alone In ‘Nuc’ Field

J&J is the latest firm to back away from the hepatitis C field, reflecting the dominant position Gilead has built with its sofosbuvir franchise. In February, Merck lowered sales expectations for its investigational "nuc" MK-3682.

Business Strategies Deals

ALIS In Wonderland: Insmed Reaches Fairy Tale Heights On Lung Disease Results

Insmed will commercialize ALIS, its inhaled amikaycin formerly known as Arikayce, on its own for a rare, bacteria-driven lung disease if the company can win accelerated approval based on new Phase III results.

Clinical Trials Respiratory
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

VELOCITY Failure For Versartis's Lead Drug Sends Shares Into Tailspin

Versartis's long-acting growth hormone product missed Phase III non-inferiority endpoint, wiping more than 83% of the company's value.

Clinical Trials Companies

Genexine Edges Ahead In Pediatric GHD After Versartis Trial Failure

Versartis's failure in a Phase III study of somavaratan places Genexine's GX-H9 in a favorable position to become the best-in-class long-acting growth hormone for pediatric growth hormone deficiency.

Clinical Trials South Korea

APOLLO Success Clears Alnylam For Lift-Off

Phase III APOLLO results finally give the beleagured firm the first late-stage success for an RNAi thereapeutic and potentially a strong lead in the rare hereditary disease. 

Clinical Trials Drug Safety

Refocused Novo Nordisk Says On 'Road To Recovery' After Traumatic 2016

Novo Nordisk's head of international operations says the company has learned from the past, taken corrective steps, and is now on the road to recovery.

Business Strategies Leadership

Clustering Of Diabetes Subgroups May Aid Outcome Predicting

This year's EASD meeting in Lisbon heard calls to re-categorize type 2 diabetes into novel subsets, as data suggest the approach could lead to better targeted treatments.

Companies Innovation

Diabetes-CV Disease Link Boosts EASD Buzz

Linkage between cardiovascular disease and type 2 diabetes was a top theme of discussion and data presented at this year's EASD meeting in Portugal's capital.

Metabolic Disorders Cardiovascular
See All

Oncology

Set Alert for Oncology

Latest From Cancer

Tyme Ticks On With Mid-Stage Development Of A Broad Cancer Therapy

The small biotech presented positive interim data from a Phase II trial testing its lead candidate SM-88 in prostate cancer at ESMO and is gearing up to initiate a trial in pancreatice cancer.

Cancer Companies

Merck KGaA/Pfizer Get Europe OK For Bavencio In Rare Skin Cancer

The Merkel cell carcinoma area is very niche but getting approval means that Merck and Pfizer can now prepare to compete with the likes of Opdivo and Keytruda in the European PD-1/PD-L1 space.

Approvals ImmunoOncology

EU Moves To RATIFY Novartis' Rydapt for AML

Rydapt represents the first major development in targeted acute myeloid leukaemia treatment in more than 25 years as Novartis plots its commercial launch in Europe.

Cancer Approvals

MURANO To Drive AbbVie/Roche's Venetoclax In CLL

Top-line MURANO data support Venclexta's current conditional approvals and expand its use into a broader population that should radically boost sales.

Clinical Trials Companies

No Clear Winner in BMS, Exelixis/Ipsen First-line Renal Cancer Race

While the CheckMate-214 data on the Opdivo/Yervoy combo made the headlines at ESMO, a closer look at the results show there is plenty of room for Cabometyx to have sizeable market share.

ImmunoOncology Cancer

Samsung Bioepis’s Biosimilar Trastuzumab First To Take On Roche’s Herceptin In EU

Samsung Bioepis’s Ontruzant is likely to be the first biosimilar to take on Roche’s Herceptin in the EU market after it was recommended for marketing authorization by the EMA’s CHMP on Sept 15.

Biosimilars Approvals
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Expanded IMPACT For GSK Respiratory Business From New Trelegy Data

Headline data from GlaxoSmithKline's IMPACT study comparing its new triple therapy Trelegy Ellipta with the company's dual therapies Breo/Relvar Ellipta and Anoro Ellipta support the product's ability to reduce exacerbations in more severe COPD. However, the benefit of IMPACT in expanding GSK's respiratory sales may be limited given pricing pressures and the make-up of GSK's current portfolio.

Clinical Trials Respiratory

Trelegy Approval Boosts GSK's US Respiratory Business But Pressure Remains

With the FDA approval of Trelegy Ellipta, GlaxoSmithKline will enjoy first-to-market status with a LABA/LAMA/ICS triple combination therapy to treat COPD in the US. However, it faces the challenge of convincing payers.

Approvals Respiratory

GSK's COPD Triple Combo Wins EU Nod

Ahead of a regulatory verdict in the US, GSK's triple combination therapy for COPD, Trelegy Ellipta, has won a positive recommendation in Europe.

Approvals Respiratory

GSK's COPD Triple Combo To Challenge Chiesi's Trimbow In EU

GSK's closed triple combination for COPD, Trelegy, is expected to get a green light for approval in Europe on Friday – but the product will be fighting for market share against Chiesi's triple combination Trimbow, which has a head start.

Approvals Regulation

Sanofi and Regeneron Hit Asthma Phase III Endpoints With Dupixent

Dupixent has upped the ante on Nucala and Cinqair, showing broad activity in Phase III in asthma. But will it be bested by AstraZeneca and Amgen's tezepelumab?

Clinical Trials Research & Development

AstraZeneca Respiratory Head: Tezepelumab Could Be 'Game Changer'

AstraZeneca's first in class biologic tezepelumab, which targets TSLP, has revolutionary potential in treating severe asthma, the UK drug maker's respiratory head tells Scrip.

Clinical Trials Inflammation
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