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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Novo Nordisk Seen Readying Steps To Offset US Pressures, Including Job Cuts

Novo Nordisk is rumored to be considering laying off up to 3,000 staff and dropping its long-term financial targets due to challenging US market conditions which the group flagged in its first-quarter update in May.

Business Strategies Companies

Real World Data Helping To Drive Rise Of Novartis' Entresto

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Cardiovascular Life Cycle Management

Esperion Posts Positive Phase III Bempedoic Acid Results, But Future Fixed-Dose Data Are Key

Esperion reported positive results from the third of five Phase III studies expected to read out this year, but data for a bempedoic acid/ezetimibe fixed-dose combo expected in August may be the key to the drug's commercial future.

Clinical Trials Cardiovascular

AstraZeneca’s Lokelma Approved In US With Label Benefits Over Veltassa

After delays caused by two complete response letters, AstraZeneca’s Lokelma has been approved in the US with label benefits over its major competitor, Vifor Pharma’s Veltessa.

Approvals Policy & Regulation

Portola Finally Gets FDA OK For Factor Xa Antidote AndexXa

It has taken a while and there were concerns that another trial may be needed before approval but AndexXa has got the green light in the US as a reversal agent for Eliquis and Xarelto. It comes with a warning and post-marketing commitments but Portola has very high hopes.

Blood & Coagulation Disorders Approvals

Deaths In Esperion's Long-Term Bempedoic Acid Trial Spur Fears Of Commercial Delay

On top of concerns about safety, which could present regulatory hurdles, bempedoic acid is likely to face a tougher competitive environment after the decline in PCSK9 inhibitor pricing.

Clinical Trials Drug Safety
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CNS

Set Alert for CNS

Latest From Neurology

Sarepta Outlines A Fast Path Forward For Its DMD Gene Therapy

Encouraging data testing the gene therapy in just three boys with Duchenne muscular dystrophy has investors jazzed. CEO Doug Ingram said the company will talk to FDA about how to advance the program. 
Clinical Trials Regenerative Medicine

Roche's Risdiplam Data Stir Up SMA Market

Positive results for the Swiss major's oral therapy suggests that Biogen and Ionis' monopoly of the lucrative spinal muscular atrophy market with Spinraza could soon be under considerable threat.

Rare Diseases Pediatrics

Teva's CGRP Inhibitor Fails In Chronic Cluster Headaches, Continues In Episodic

Unlike the migraine space, there is only one competitor for Teva's CGRP inhibitor in cluster headaches, but that opportunity narrowed with fremanezumab's failure in chronic cluster headaches, though a trial in episodic cluster headaches is ongoing.

Research and Development Strategies Neurology

Eisai Refocuses AiM As It Builds US Immuno-Dementia Research

Amid multiple industry drug failures in the sector, Eisai is opening a new US research facility to discover innovative therapies for dementia based on a long-standing immunology hypothesis.

Neurology Research and Development Strategies

Shionogi Deal Opens Asia To Sage’s Fast-Acting Antidepressant

Japan’s Shionogi has gained selected Asian rights to Sage’s promising fast-acting depression drug, in a deal worth up to $575m to the US company.

Japan Neurology

Lilly Stays Committed To Alzheimer's, Including Amyloid Hypothesis, Despite Many Failures

The failure of BACE inhibitor lanabecestat was the latest setback in Lilly's Alzheimer's pipeline, but the company has been working in this area with almost no success for decades, yet still feels a commitment to keep trying, Lilly Research Labs President Daniel Skovronsky tells Scrip.

Research and Development Strategies Neurology
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Incyte Will File Jakafi For Acute GVHD In US Based On Phase II Success

The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.

Research & Development Clinical Trials

Interview: EULAR Head Counting The Cost Of Rheumatic Disease

Hans Bijlsma, president of the European League Against Rheumatism, tells Scrip about the progress being made in rheumatic and muskuloskeletal diseases, the areas where more innovation is needed and the importance of early treatment, both clinically and financially.

Immune Disorders Biosimilars

Samsung, Celltrion Aim For Biosimilar Confidence, Convenience With New Studies

South Korean biosimilars companies Samsung Bioepis and Celltrion presented new study results, designed to increase overall switching rates away from the branded originator therapies and address prescriber concerns as well as improve administration convenience, at the European League Against Rheumatology (EULAR 2018) held June 13-16 in Amsterdam, Netherlands.

Biosimilars Research & Development

Interview: Novartis Counts On AS and PsA For Cosentyx Growth

Novartis immunology chief Eric Hughes tells Scrip a wealth of data is showing that early treatment with Cosentyx can prevent the structural changes that lead to lack of mobility in ankylosing spondylitis and psoriatic arthritis patients.

Immune Disorders Clinical Trials

Calliditas IPO To Support Phase III Berger's Disease Study

Calliditas is aiming to raise new funding in an IPO and listing on Nasdaq Sweden to support late-stage clinical development and commercialization of its Berger's disease candidate, and studies in additional indications.

 

Financing Renal

Lilly's Olumiant Makes Big Leap In Lupus Trial

A couple of weeks after the setback of getting a worse-than-expected label from the FDA for Olumiant in rheumatoid arthritis (RA), Lilly has some strong Phase II data banked for its JAK inhibitor in lupus.

Immune Disorders Research & Development
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

ViiV CEO: "We Aim To Be Top HIV Player By Mid-2020s"

ViiV CEO predicts strong pipeline and two-drug strategy will reinforces group's HIV market position and put it ahead of Gilead by the mid-2020s.

Analysis Business Strategies

Learning From Human Cell Hijacking Masters: ENYO Pharma Takes Virus Tricks Into Drug Discovery

Emerging Company Profile: ENYO Pharma has been around for barely four years, but it is already advancing its lead programs into Phase II trials in hepatitis B and NASH, and anticipates many more uses for its virology-based platform that will go way beyond treating virus infections.

StartUps and SMEs Platform Technologies

HVIVO Seeks Big Pharma Partner For ‘Phase III-Ready’ Universal Flu Vaccine

Presenting Phase IIb data on FLU-v, specialized CRO hVIVO now hopes to secure a big pharma partner for Phase III studies and commercialization of the universal flu vaccine candidate. The product has been developed in a joint venture with SEEK.

Vaccines Clinical Trials

ViiV Boosted By Early GEMINI Data, But More Details Wanted

ViiV Healthcare has positive early pivotal data for its second two-drug regimen for HIV, but more reassurance is needed on the relative rates of virologic suppression in patients with low and high viral loads, as well as on the long-term risk of virologic failure. The combination should help form ViiV's defense against rival Gilead and its new triple combination Biktarvy.

Clinical Trials Companies

Vical Faced With Failure of Another Vaccine Trial

Company will focus on getting oral anti-fungal candidate VL-2397 over the finish line, after another pipeline blow-up.

Research & Development Infectious Diseases

Historic Mapping Of Deadly Pathogens Allows PacBio To Showcase Its Platform

PacBio and Wellcome Sanger Institute tell Scrip why they've teamed up to decode genomes of more than 3,000 bacteria, including some of the world's most dangerous, and how it will help fight AMR and bioterrorism.

Platform Technologies Strategy
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

BI’s Business Development Focus Remains On Early Collaboration

Boehringer Ingelheim’s US business development head Ioannis Sapountzis outlines BI’s efforts to catch up with competitors in NASH and immuno-oncology via early-stage partnerships and licensing deals.

Business Strategies Research and Development Strategies

ADA Meeting's Around The Corner: Five Things To Watch For

Among other debates at the American Diabetes Association annual meeting, clinicians will discuss the future of cardiovascular outcomes studies for diabetes drugs – whether they should maintain course or are due for an overhaul.

Clinical Trials Research & Development

Galmed To Design Phase III NASH Trial With FDA After Strong Aramchol Data

The Israel-based biopharma company said a Phase IIb trial of its oral treatment of non-alcoholic steatohepatitis hit the necessary endpoints to support a Phase III trial and FDA marketing application.

Clinical Trials Companies

Novo Nordisk Seen Readying Steps To Offset US Pressures, Including Job Cuts

Novo Nordisk is rumored to be considering laying off up to 3,000 staff and dropping its long-term financial targets due to challenging US market conditions which the group flagged in its first-quarter update in May.

Business Strategies Companies

Menopausal Symptoms Cooled By KaNDy's Dual Neurokinin Antagonist

Faster relief of debilitating menopausal symptoms in early-stage clinical trial results suggest a potential new class of products being evaluated by UK biotech KaNDy Therapeutics may be useful against the condition.

Clinical Trials Metabolic Disorders

Madrigal May Shake Up NASH Race With Phase II Resolution Data

Madrigal reports data showing that MGL-3196 resolved non-alcoholic steatohepatitis and improved key secondary measures, data that suggest a better effect than other NASH candidates.

Research & Development Clinical Trials
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Oncology

Set Alert for Oncology

Latest From Cancer

BI’s Business Development Focus Remains On Early Collaboration

Boehringer Ingelheim’s US business development head Ioannis Sapountzis outlines BI’s efforts to catch up with competitors in NASH and immuno-oncology via early-stage partnerships and licensing deals.

Business Strategies Research and Development Strategies

iTeos Says Adios To IDO And Eyes US IPO

An oversubscribed financing round led by new US investor MPM Capital has brought in $75m for the Belgian company. Much of it will be used to advance its potential best-in-class adenosine A2A receptor now that its IDO1 drug has been shelved.

Financing ImmunoOncology

Roche Pushes Personalization With $2.4bn Foundation Buy-Out

By picking up the rest of Foundation Medicine, which is now valued at $5.3bn, the Swiss giant is expanding its leadership in cancer diagnostics, genomics and molecular information for personal medicine.

M & A Cancer

Opdivo Approval Opens China I-O Doors But Pricing Key

China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.

China Cancer

IGEM Therapeutics: Pursuing Novel IgE Antibodies For Solid Tumors

Emerging Company Profile: IGEM Therapeutics has been spun out of King's College London to evaluate the use of IgE-based monoclonal antibodies for the treatment of cancer, including difficult-to-reach solid tumors.

StartUps and SMEs Cancer

TMB Biomarker Is A Winding Path Rather Than Straight Road

The tumor mutational burden biomarker had a much higher profile at this year's ASCO meeting, promising to help target treatment to individuals, though practical barriers remain and testing still is not ready for prime time yet.

ASCO ImmunoOncology
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

HVIVO Seeks Big Pharma Partner For ‘Phase III-Ready’ Universal Flu Vaccine

Presenting Phase IIb data on FLU-v, specialized CRO hVIVO now hopes to secure a big pharma partner for Phase III studies and commercialization of the universal flu vaccine candidate. The product has been developed in a joint venture with SEEK.

Vaccines Clinical Trials

Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

Generic Drugs Respiratory

Verona CEO Outlines Plans For Respiratory Asset RPL554

With financing in place, Verona will next start a Phase II study of nebulized RPL554 added onto LABA/LAMA or triple therapy as a maintenance treatment for COPD patients - and then move to the crucial Phase III program.

Business Strategies Clinical Trials

All Over For AZ's Fasenra In COPD With Second Trial Fail

It is curtains for AstraZeneca's asthma therapy Fasenra as a COPD treatment after the failure of the TERRANOVA trial, which could be good news for GSK's fellow interleukin-5 drug Nucala, despite the latter's own mixed Phase III data.

Clinical Trials Respiratory

Early-Stage Idiopathic Pulmonary Fibrosis (IPF) Candidates Race to Phase III

Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.

Respiratory Research and Development Strategies

Severe Asthma Market Snapshot: A Competitive Therapy Area That Will Test Payers' Influence

Several biologic drugs are now available for the 10% of asthma patients with severe uncontrolled disease, and Dupixent could join them later this year, setting the therapy area up for a competitive showdown.

Respiratory Market Access
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