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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Heartache For Novartis As Serelaxin Failure Ups Pressure On Entresto

Novartis's latest Phase III study of serelaxin has failed, deleting a significant chunk of forecasted revenue that analysts had attributed to the heart failure drug candidate.

Research & Development Clinical Trials

Is Amgen's FOURIER Enough For Physicians, Payers To Expand Repatha Use?

Detailed results presented at ACC show a reduction in risk of major adverse cardiovascular events, but perhaps not at the level hoped for by payers.

Clinical Trials Market Access

What To Look Out For At ACC

Amgen has already reported the positive topline result of its FOURIER cardiovascular outcomes trial for its PCSK9 inhibitor Repatha, but analysts from Datamonitor Healthcare and Biomedtracker lay out the reasons to check out the full results and other highlights at the upcoming American College of Cardiology meeting.

Cardiovascular Clinical Trials

Billions At Stake As Generic Approvals Open Up Japan Big Sellers

Japan has approved a new batch of first-time and other generic drugs that will be reimbursed and launched in June, putting at risk several billion dollars’ worth of combined sales of some major branded products.

Generic Drugs Japan

COMPASS Success Reinforces J&J/Bayer's Broad Labeling Strategy For Xarelto

J&J will be talking to FDA regarding expanded approval for peripheral arterial disease and coronary artery disease following early stop of COMPASS outcomes study; strong data will be needed if asymptomatic patients are targeted.

Clinical Trials Research and Development Strategies

Prevention, Cure And Interception Vital ForJanssen Cardiometabolic R&D

With readouts in trials of key drugs Invokana and Xarelto coming, Dr. James F. List of Janssen is also looking for assets designed to prevent, cure or even intercept the progression of key diseases such as obesity and NASH.

Companies Research and Development Strategies
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CNS

Set Alert for CNS

Latest From Neurology

Newron Needs To Up Ante In Large-Scale Schizophrenia Studies

Newron has reported positive Phase IIa data for schizophrenia drug evenamide but Phase III will be critical for the add-on therapy to demonstrate a more robust treatment effect to justify its use on top current treatments.

Clinical Trials Neurology

Newron's Parkinson's Disease Drug Xadago Priced At $600-700/Month

First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.

Approvals Regulation

Parkinson’s Niche To Expand With New Drugs, More Patients

Newron’s new Parkinson’s disease therapy, Xadago, approved in the US after a regulatory delay, is expected to be the first of several new products to be introduced in this long-neglected therapeutic sector.

Approvals Commercial

As MS Space Awaits Ocrevus, MedDay Sees 'Synergistic' Positioning Opportunity

With Roche's Ocrevus expected to be given the green light at any moment for the underserved progressive multiple sclerosis market, a tiny French biotech with a "synergistic" product for the same indication also believes it could soon have a commercial success on its hands.

Commercial Neurology

FDA Moves On Endo’s Opana ER Unlikely To Sweep Up Other Opioids

Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.

Drug Safety Advisory Committees

Roche In New Phase III Bet On MorphoSys' Anti-Amyloid Agent

Roche is taking a punt on a new Phase III trial with gantenerumab in patients with mild Alzheimer's despite ending one called SCarlet RoAD in similar patients just over two years ago.

Clinical Trials Companies
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

PureTech Health: Applying Deep Thinking And Business Acumen

Targeting the age-dependent decline in immune function is the aim of a new PureTech Health subsidiary, resTORbio, that has licensed two clinical-stage mTORC1 inhibitors from Novartis.

Business Strategies Deals

The Microbiome, An Infographic

Changing the composition of the microbiome, the multitude of bacteria, fungi, protozoa and viruses that reside in or on our bodies, or the way the microbiome interacts with its human host, could lead to novel therapeutic approaches to disease. Inflammatory bowel disorders, Clostridia-associated diarrhea and obesity are all potential targets for microbiome altering medicines.

Research and Development Strategies Research & Development

Vacant Post-Lung Transplant Market Is Big Opportunity For Breath Therapeutics

Where else would you find a 50% five-year mortality rate and no approved drugs? Investors are confident of the significant commercial potential for Breath Therapeutics' drug/device combo that tackles the main cause of poor mortality after lung transplantation. A €43.5m series A to finance Phase III testing has been secured.

StartUps and SMEs Immune Disorders

Akari Hopes Tick-Based Drug Will Be Safer, Cheaper Than Alexion's Soliris

Akari Therapeutics is looking to ticks to provide a new therapy that it hopes will offer a safer and cheaper alternative to Alexion Pharmaceuticals' Soliris for some rare orphan diseases.

Clinical Trials Companies

10 Approvals To Watch For In Early 2017

Dupixent, Austedo, brigatinib and Olumiant are among a raft of new drug approvals expected in the first four months of the year. Here, with help from Informa Pharma's Biomedtracker, we take a look at 10 of the more interesting products looking close to reaching the market, some for the second time of asking.

Approvals Commercial

Canada First To OK Sanofi/Regeneron’s Sarilumab, But Struggle To Differentiate Looms

Sanofi/Regeneron’s Kevzara (sarilumab) has won its first worldwide approval for treating moderately to severely active rheumatoid arthritis from Health Canada. But as more regulators follow, the companies will face a battle to differentiate the drug from chief rival, Roche/Chugai’s Actemra (tocilizumab).

Approvals Market Access
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Sumagen’s World First Killed Whole HIV Vaccine Set For Phase II

After a positive outcome from a US Phase I study, South Korea's Sumagen is stepping closer to the launch of the world's first killed-whole HIV vaccine with potential to both prevent and treat AIDS.

Research & Development Clinical Trials

Inhaled Anti-Infectives With Extended Lung Retention: Pulmocide Secures Cash To Fund Trials

When tackling pulmonary infections, getting therapeutics into the lungs that stay there long enough to be effective is the key challenge. Pulmocide has just persuaded investors it is up to the task, raising $30m to fund two clinical programs.

Commercial Companies

Access To HCV Therapies Decreasing Despite Pricing Reductions

Data presented by Trio Health covering about 15,000 US hepatitis C patients from 2014 to 2016 show that failure to start treatment increased from 8% to 29%. Denials of coverage by private insurers, Medicare and Medicaid are the main reason driving this trend, the data analysis firm contends.

Market Access Government Payers

New Anti-CMV Therapies Post-Transplant: Merck & Co Leads The Pack

Merck & Co’s investigational anti-CMV therapy letermovir is expected to be filed for approval later this year and could be the first of a new generation of anti-CMV therapies, following top-line Phase III data showing it reduced all-cause mortality in bone marrow transplant patients.

Clinical Trials Market Intelligence

WHO Publishes List Of Pathogen Threats To Rouse Drug Developers

The World Health Organisation has released a list of 12 bacteria it says pose the greatest threat to human health as a way of urging governments and the drug development industry to incentivize and launch an R&D response against the increasing global issue of antibiotic resistance.

Research and Development Strategies Infectious Diseases

Cempra Goes Back To The Future With New Product/Old Antibiotic Taksta

Cempra's plans to get an old antibiotic product approved at last in the US have received a boost with positive Phase III data, but it still needs to see if the FDA wants another pivotal trial, and analysts are wondering where sales will come from.

Clinical Trials Companies
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Ultragenyx Seizure Miss Is Not A Catastrophe, Claim Analysts And Management

Analysts claim Ultragenyx's Phase II failure of triheptanoin for seizures in patients with the rare GLUT1-deficiency syndrome (GLUT1-DS) doesn't mean the end of the road for the product, and still see plenty of potential commercial success down the road for the company. However, the company's share price slipped up to 15% on the news.

Research & Development Metabolic Disorders

Cardiovascular Benefits of SGLT2 Inhibitors: A Class Effect?

The first large real-world evidence study has found SGLT2 inhibitors cut the rate of hospitalizations for heart failure and all-cause mortality in patients at low risk of cardiovascular events, but the results of CV outcomes studies are awaited to confirm the findings.

Clinical Trials Comparative Effectiveness

Melior, Bukwang Seek Diabetes Edge With Novel Insulin Sensitizer

MLR-1023, a repositioned oral compound being developed for type 2 diabetes by Melior and Bukwang, is set to move into Phase IIb in the US and South Korea, and the firms are looking to its novel mechanism of action, improved tolerability and efficacy to carve a niche in a highly competitive sector.

Research & Development Diabetic Care

Second Genome CEO Predicts Paradigm Shift With Microbiome Discovery

California biotech, which has backing from major pharmas, explains the application of its microbiome discovery platform to multiple disease types.

Companies Research & Development

Prevention, Cure And Interception Vital ForJanssen Cardiometabolic R&D

With readouts in trials of key drugs Invokana and Xarelto coming, Dr. James F. List of Janssen is also looking for assets designed to prevent, cure or even intercept the progression of key diseases such as obesity and NASH.

Companies Research and Development Strategies

Novo Still Seeking Superior Tresiba Follow-On, Says CSO

Despite dropping its Phase II oral insulin program in the second half of 2016, Novo Nordisk's chief scientific officer says the company is quietly continuing to explore options for an oral therapy better than its leading insulin option, Tresiba.

Business Strategies Metabolic Disorders
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Oncology

Set Alert for Oncology

Latest From Cancer

Bristol Teams Up With Billionaire-Backed Parker Institute On IO Research

A key goal of Bristol's second major academic research collaboration is to get trials up-and-running more quickly.

Clinical Trials Research & Development

Deal Watch: BioLineRx, Ono, Vedantra Ink Separate Cancer Immunotherapy Pacts

BioLineRx buys Agalimmune and its alpha Gal candidate for melanoma and possibly other oncology indications. Japan's Ono signs an R&D agreement with Switzerland's Numab, while Boston biotechs Vedantra and Neon will collaborate on potential cancer vaccines.

Commercial Deals

Erytech Could Launch Several New Studies Following Pancreatic Cancer PhII Success

Erytech's lead therapy has shown strong anti-cancer activity in pancreatic cancer, on top of the hematological indications it is already targeting in late-stage trials, spelling good news for the French firm to pursue more studies in other oncology indications such as ovarian cancer.

Clinical Trials Cancer

Broad Label Gives Tesaro's Niraparib A Head Start In Ovarian Cancer

Tesaro takes opportunity of broad approval for Zejula (niraparib) in recurrent ovarian cancer to highlight franchise expansion opportunities in other tumor types, including PD-1 inhibitor combination studies.

Approvals Clinical Trials

CHMP Opinions: Opdivo Sees Keytruda's Hodgkin's And Raises It Head & Neck

Merck & Co and Bristol Myers Squibb's rival anti-PD1 products continue their game of one-upmanship with each gaining a new indication in the latest round of EU CHMP opinions.

Approvals Drug Review

Science Matters: A Druggable Target For PTEN-Deficient Prostate Cancer

By taking a different slant on synthetic lethality – the therapeutic process behind AstraZeneca's Lynparza –scientists have identified a potential new drug target for use in prostate cancer, the chromatin helicase DNA-binding factor CHD1.

Research and Development Strategies Cancer
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Phase III Data Boost Prospects For Jazz's Sleep Apnea Drug

Data from two studies in obstructive sleep apnea suggest drug may hold its own against approved generics, analysts say.

Clinical Trials Research & Development

Inhaled Anti-Infectives With Extended Lung Retention: Pulmocide Secures Cash To Fund Trials

When tackling pulmonary infections, getting therapeutics into the lungs that stay there long enough to be effective is the key challenge. Pulmocide has just persuaded investors it is up to the task, raising $30m to fund two clinical programs.

Commercial Companies

Circassia Builds US Respiratory Presence with AstraZeneca Deal

Circassia has put memories of last year's Cat-SPIRE disappointment firmly behind it with a new deal with AstraZeneca for Tudorza and Duaklir in COPD that will allow it to concentrate on boosting its respiratory franchise.

Deals Companies

Sanofi Pasteur, AstraZeneca Link To Develop MEDI8897 Infant RSV Vaccine

Sanofi Pasteur and AstraZeneca will collaborate over the UK pharma's monoclonal antibody MEDI8897 to develop and commercialize a pediatric vaccine against respiratory syncytial virus.

Commercial Companies

PTC Tumbles On Ataluren Failure In Cystic Fibrosis

With a second Phase III failure in nonsense mutation CF, the New Jersey biotech ends development of ataluren for CF, but continues with the drug in three smaller indications.

Clinical Trials Rare Diseases

Mylan Plans Summer Launch For Advair Generic, Now Called Wixela Inhub

Wixela Inhub could be the first interchangeable generic version of the blockbuster asthma drug on the US market if it is approved by FDA.

Respiratory Generic Drugs
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