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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Phase III Data For La Jolla's Angiotensin II Drug Leave Questions About Clinical Benefit

La Jolla's LJPC-501 meets primary blood pressure endpoint in the Phase III ATHOS-3 vasodilatory shock trial, but data suggest benefits may not translate into clinically meaningful improvements.

Clinical Trials Cardiovascular

Cardior Exploring MicroRNAs As Heart Failure Target

Emerging Company Profile: The German company Cardior has been set up to evaluate inhibitors of a microRNA in the treatment of heart failure, a condition that is poorly treated by current therapies.

Financing Research and Development Strategies

More Pressure On Pradaxa? US Payers May Narrow Coverage Of NOACs

US payers may increasingly look to leverage the competition among the novel oral anticoagulants by contracting for preferred coverage with two of the leading drugs in the field, rather than all three.

Research & Development Reimbursement

Novartis's Entresto Voyage: Hindsight Is 20/20

What caused Novartis's innovative heart failure drug to falter, missing sales targets by $30m in 2016, and how is it expected to bounce back in 2017? Scrip explores Entresto's journey and what this experience shows about the changing face of pharma's customers.

Cardiovascular Market Access

Entresto Facing Pressure From Diabetes Drugs

With diabetes therapeutics adding cardiovascular risk reduction claims, Novartis's heart failure drug Entresto could face pressure from new fronts – just as sales start to take off.

Cardiovascular Metabolic Disorders

PCSK9 Sponsors Still Face Challenges In Turning Around Dismal Launches

After reporting yet another quarter of disappointing sales, Amgen and Sanofi/Regeneron look forward to better performance now that outcomes data are out, but payers may not be up for easing hurdles enough.

Cardiovascular Market Access
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CNS

Set Alert for CNS

Latest From Neurology

GW's Epidolex Epilepsy Data Paves Way For Cannabinoids

Safety and efficacy in study published in New England Journal of Medicine bode well for cannabinoid therapy Epidiolex, which is headed to FDA mid-year.

Neurology Clinical Trials

PML Case With Roche's Ocrevus, Link Unlikely

A German case of PML in a patient treated with Ocrevus, but who was also previously treated with Tysabri, threatens to take the gloss off Roche’s new multiple sclerosis therapy.

Drug Safety Neurology

Neurocrine Blames Sub-Par Dosing For Ingrezza Study Failure

Neurocrine's stock fell 9% on May 24 after the company said a closely-watched Phase II study for Ingrezza in pediatric Tourette's syndrome failed, but blamed a sub-therapeutic dose for the disappointing results. Most analysts gave the prospects for a higher dose study the benefit of the doubt.

Clinical Trials Neurology

NeuroVive To Take Traumatic Brain Injury Drug Into Mid-Stage Studies

Protecting the function of mitochondria may be key to developing medicines to reduce the nerve damage caused by traumatic brain injuries. NeuroVive Pharmaceutical is moving its cyclosporine candidate into Phase IIb studies.

Clinical Trials Research & Development

Celgene's Positive Ozanimod Data Puts Focus On MS Commercialization

A second Phase III multiple sclerosis trial testing the S1P1 modulator was positive, turning attention to whether or not Celgene will market the drug independently for the indication and how the drug might be positioned against an eventual generic Gilenya.

Research & Development Neurology

Ipsen's New CEO Targets At Least One New Drug Annually 'Forever'

The French pharma under its American CEO plans to transform itself through R&D and M&A, and promises to launch at least one new drug or new valuable indication every year - "forever".

Business Strategies Commercial
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

TxCell Plans First In Man Trial Of Regulatory T-Cells

Stéphane Boissel, CEO of TxCell, discusses the company's plans to advance its lead next-generation regulatory T-cell candidate into human studies, after having switched to a new platform, in a video interview with Scrip.

Research and Development Strategies Platform Technologies

Sanofi/Regeneron's Kevzara Priced To Break Into A Crowded Market

The partners are looking to create a compelling value proposition for the interleukin-6 inhibitor, approved by FDA to treat moderate to severe RA, by pricing it below the market-leading anti-TNFs.

Immune Disorders Pricing Strategies

J&J Forges Ahead In Immunology Despite Competitive Dynamics

The diversified pharma has two NMEs and three sNDAs pending at FDA in immunology, as well as six more anticipated sNDA filings. Immunology Therapeutic Head Susan Dillon told investors why there is still plenty of opportunity for growth in key autoimmune diseases.

Business Strategies Launches

Quest To Use AI In Drug Discovery Joins Sanofi and Exscientia

Sanofi hopes to use Exscientia's artificial intelligence (AI) platform to develop bispecific-small-molecule drugs for diabetes and associated metabolic conditions.

Business Strategies Companies

Mite Trial Failure 'The Final Straw' As Circassia Ends Anti-Allergy Investing

Circassia has thrown in the towel on investing in anti-allergy vaccines and will focus now on respiratory activities, after its house dust mite allergy study missed its primary endpoints.

Business Strategies Clinical Trials

Baricitinib Complete Response May Put Lilly/Incyte Behind IL-6 Blockers In RA

FDA complete response letter seeks additional data on dosing and other safety concerns, delaying potential approval for an NDA that already had been pushed back three months. Interleukin-6 inhibitors sarilumab and sirukumab, now under review at FDA, both could obtain approval before baricitinib.

Complete Response Letters Pricing Strategies
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Tetraphase Bets On I.V. Eravacycline Rerun As Antibiotic Market Influx Looms

Tetraphase has been keeping its head down since a 2015 Phase III trial failure for its lead antibiotic drug eravacycline sliced around $1.3bn from the company's market cap – but 2017 will be a turnaround year, says CEO Guy Macdonald.

Infectious Diseases Clinical Trials

Infant Bacterial Therapeutics Harnesses Microbiome To Treat Preterm Babies

By harvesting Lactobacillus reuteri from lactating mothers, Infant Bacterial Therapeutics has developed an approach to treat necrotizing enterocolitis, a major killer of premature babies.

StartUps and SMEs Business Strategies

‘World First’ CCHF Vaccine To Invigorate Turkey’s Vaccine Ambitions?

Turkey’s health ministry has disclosed that a local university is close to successfully developing what it believes is the world’s first vaccine against Crimean-Congo hemorrhagic fever, under a 2015 collaboration with the Cuban government. But other efforts to build domestic vaccine production capacity are largely stalled over tender concerns.

Vaccines Turkey

Encouraging HIV 'Cure' Data Strengthen Abivax

Hepatitis C is effectively cured. Could this success be replicated in another serious chronic viral condition ‒ HIV? Abivax, which last year abandoned its hepatitis B lead program, has bounced back with data suggesting a 'functional cure' for HIV is more than just a pipe dream.

Research & Development Infectious Diseases

Theratechnologies' Novel AIDS Drug Filed In US

Theratechnologies' partner TaiMed Biologics is seeking US approval of its novel antibody treatment for multidrug resistant HIV, ibalizumab, which offers a new therapy avenue for the increasing number of HIV patients who have worked through existing treatment options.

Policy & Regulation Drug Review

Ferring Looks For Early Microbiome Wins, But Willing To Do Heavy Lifting

Switzerland’s Ferring is diving deep into the microbiome, looking at a range of potential therapy platforms including bacteriophage and probiotics. Its CSO believes a microbiome-based therapeutic approach could benefit dermatological and women’s health conditions, as well as gastro-intestinal disorders.

Research and Development Strategies Infectious Diseases
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Disappointing Bydureon EXSCEL Outcomes Data May Raise Stakes For Victoza

AstraZeneca's EXSCEL study could have created confidence in a GLP-1 class-wide outcomes benefit, but instead it has raised questions about whether differences in trial results boil down to trial design.

Research & Development Metabolic Disorders

Novo Nordisk CEO Puts Pricing On The Line

Lars Fruergaard Jørgensen, Novo Nordisk's CEO, says the group's pledge on price transparency, goals for improved outcomes and experimental use of digital health are commercially linked.

Commercial Companies

Entresto Facing Pressure From Diabetes Drugs

With diabetes therapeutics adding cardiovascular risk reduction claims, Novartis's heart failure drug Entresto could face pressure from new fronts – just as sales start to take off.

Cardiovascular Metabolic Disorders

'Think Global, Act Local' - Novo Nordisk CEO To Empower Regions, Cut Red Tape

Novo Nordisk's new CEO says bureaucracy and centralized control hinder sales growth, so one of his three top priorities is to give regional centers more commercial autonomy.

Business Strategies Commercial

What Artificial Intelligence Brings To Drug Discovery – Sanofi Interview

By adding another AI deal to Sanofi's innovation quiver, the French group says it's widening its hunt to find single molecules that offer dual or multi-specific targeting to fight disease.

Commercial Companies

Corporate VCs Wade In With Funds To Pursue Gene Therapy For Wilson Disease

Rare copper-overload disorder Wilson disease is seeing a surge of interest: one new copper chelator recently garnered a CHMP recommendation, a novel copper modulator has had promising Phase II data, and French biotech Vivet has secured significant funds to pursue a gene therapy approach to the disease.

Commercial Financing
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Oncology

Set Alert for Oncology

Latest From Cancer

Bayer's Weinand On Broadening Value-Based Pricing Views

Bayer's pharma head Dieter Weinand talks about his biggest issues with current value-based pricing assessments for new drugs and how companion diagnostics will pave the way to easier pricing of oncology therapies.

Pricing Strategies Reimbursement

Three CHMP Negative Opinions ‒ But Who Got A Boon?

The European Medicines Agency's advisory committee, the CHMP, unusually issued three negative opinions at its recent monthly meeting. Which companies received an unexpected boon at the news?

Commercial Therapy Areas

Korean Pharma Spawns US Cancer Biotech Startup

Dr. Benjamin R Cowen, COO of ImmunoMet Therapeutics, reveals how the Houston-based startup is developing OXPHOS inhibitors to treat drug resistant and relapse cancers.

Companies StartUps and SMEs

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards

Merck Expands Aduro Collaboration In Keytruda Tie-Up

Aduro Biotech's scientists have a long association with Merck & Co's Keytruda, and things have come full circle as the small biotech's lead anticancer shows promise in combination with the high-profile checkpoint inhibitor.

Research & Development ImmunoOncology

IDO Updates At ASCO: Incyte's Combos With Merck And Bristol Take Center Stage

The immuno-oncology highlight of the upcoming American Society of Clinical Oncology annual meeting will be clinical data for Incyte's epacadostat with Merck's Keytruda as well as data with Bristol's Opdivo.

Clinical Trials ImmunoOncology
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Respiratory

Set Alert for Respiratory

Latest From 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

Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic

FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.

Generic Drugs Respiratory

Asthma Pipeline Pressure For AstraZeneca As STRATOS 1 Fails

The failure of AstraZeneca's novel asthma therapy in its first pivotal trial is of little surprise but increases the pressure on its other late-stage asthma product in this key therapy area for the company.

Clinical Trials Respiratory

Relvar/Breo “Real World” Asthma Benefits Help GSK – But Can't Remove Generic Threat

Top-line data from a second patient group, asthmatics, in the Salford Lung Study indicate that switching from usual therapy to GSK’s’s Relvar Ellipta improves symptoms, but the results may not be enough to encourage switching before generic Seretide/Advair takes hold.

Clinical Trials Comparative Effectiveness

AstraZeneca Taps Pieris For Inhaled Asthma Anticalins

AstraZeneca is to pay $57.5m to get its hands on biotech Pieris Pharmaceuticals' Anticalin technology to bolster its early stage respiratory portfolio, with a lead product candidate already being prepared for Phase I.

Companies Deals
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