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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Bayer Still Confident Of Future Prospects Post-Xarelto

The German group has been talking up its pharmaceuticals division but analysts are not convinced it has addressed the elephant in the room that is the loss of patent protection for its blockbuster anticoagulant Xarelto in 2024.

Cancer Business Strategies

Adrenomed Treads A New Path In Septic Shock

German firm Adrenomed has received new funding to push its innovative antibody for septic shock further into development. The company talks to Scrip about how it works, and why it won’t allow the asset to be a victim of strategic decision making.

Cardiovascular Financing

Novo Nordisk May Use Priority Review Voucher To Speed Oral Semaglutide To Market

Novo Nordisk’s chief science officer tells Scrip the readout of its PIONEER 6 trial on oral semaglutide came earlier than originally thought, allowing for an FDA filing in first-half 2019, and that use of a priority review voucher is a clear option that could speed up the process.  

Clinical Trials Comparative Effectiveness

What The New US Cholesterol Treatment Guidelines Mean For Esperion

Guidelines place high emphasis on low cost, but also outcomes data. Esperion plans to file bempedioc acid next year, but outcomes data won’t be available until 2022.

Cardiovascular Cost Effectiveness

Pharma Products Face Uncertain Future In Boston Scientific's 'Logical' £3.3bn Bid For UK's BTG

Boston Scientific CEO says US group has been tracking UK-based BTG "for more than two years" and that interventional medicine is a key attraction.

M & A Blood & Coagulation Disorders

New US Cholesterol Guidelines Hit PCSK9s Hard On Pricing, Value

Already outdated? The latest ACC/AHA guidelines say at mid-2018 list prices, PCSK9 injectables are of low value, but the costs have plummeted since then.

Cost Effectiveness Cardiovascular
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CNS

Set Alert for CNS

Latest From Neurology

Valbenazine's Consistent But Weak Effect In Tourette Dismays Neurocrine

In "very top-line" Phase IIb data, the magnitude of the treatment effect for valbenazine in children with Tourette syndrome was weaker than expected, and its loss from active development means there will be only a handful of candidates under evaluation for the disorder.

Clinical Trials Neurology

Novartis Pruned Pipeline Producing Attractive Respiratory And Neurology Fruits

Novartis executives highlighted their stars from its refined pipeline during the company’s first R&D day since Vas Narasimhan took the helm and after a cull that reduced the firm’s development portfolio by 20%.

Companies Research & Development

Lilly And AC Immune Partner On A Small Molecule With Potential In Alzheimer's Combinations

Eli Lilly signed a licensing deal to develop a tau aggregation inhibitor small molecule for Alzheimer's disease – a drug that works differently from existing antibodies and could offer potential in combination regimens. AC Immune CEO Andrea Pfeifer talked to Scrip about the deal.

Neurology Deals

Japan Pharma Climbing Aboard Digital Health Train, But Not Up To Speed?

The still somewhat loosely defined concept of 'digital health' continues to take concrete forms through recent deals in Japan, where major pharma firms are building initiatives related mainly to patient well-being.

Japan Commercial

Eisai Adds To Alzheimer's Arsenal With Anti-Tau Drug

It is a field littered with failures but Eisai remains hopeful that its pipeline of candidates for Alzheimer's disease, which has just been added to, gives the firm a number of shots at getting a disease-modifying agent to market.

Neurology Pricing Debate

Axovant Closes Chapter On Failed, Second-Rate Small Molecule Strategy

Termination of nelotanserin, a small molecule licensed from Arena, in Lewy body dementias comes after a dramatic shift toward gene therapy.

Research & Development Neurology
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

ECLIPSE: J&J's Tremfya Beats Novartis' Cosentyx For Long-Term Psoriasis Clearance

Novartis stresses long-term safety database for Cosentyx – with five years' worth of data in three indications – psoriasis, psoriatic arthritis and ankylosing spondylitis.

Clinical Trials Research & Development

Profitable Pharming Expands Ruconest Potential And Resurrects Pompe Pipeline

Dutch rare disease company Pharming talked to Scrip about turning a profit for the first time in the company’s history, finally restocking the pipeline in potentially blockbuster indications, and turning its attention back to Pompe disease after 20 years in the cold.

Rare Diseases Companies

Gilead Lures Roche Pharma CEO O'Day As CEO; Genentech's CEO Will Replace Him

O'Day brings Gilead experience in oncology and M&A from a large, diversified organization.

Appointments Leadership

Novartis Targets Chronic Urticaria As Ligelizumab Enters Late-Stage Trials

Two Phase III studies, PEARL 1 and PEARL 2, will compare Novartis's candidate anti-IgE antibody with the previous generation anti-IgE MAb, Xolair, for the treatment of chronic spontaneous urticaria.

 

Dermatology Clinical Trials

Boehringer Bails On Biosimilars Outside US

In a strategic shift confirmed by the German company, BI's Humira biosimilar Cyltezo will only be launched in the US while its version of Avastin has been abandoned altogether.

Biosimilars Business Strategies

Stallergenes' Mite Allergy Results An Early Leaving Present For Retiring CEO

Positive Phase III data with its sublingual house dust allergy tablet heralds a likely increase in competition in the US allergy sector in the years to come and also provide an early leaving present for the company's retiring CEO.

 

Clinical Trials Immune Disorders
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Gilead Lures Roche Pharma CEO O'Day As CEO; Genentech's CEO Will Replace Him

O'Day brings Gilead experience in oncology and M&A from a large, diversified organization.

Appointments Leadership

Brii Builds China Ops With Hep B Assets, New Partnerships

China-focused Brii Biosciences, formed earlier this year, unveils plans to take its first projects into the clinic by way of deals with VBI and Vir for hepatitis B, and builds other alliances and operations in the country.

China Commercial

More Vaccines Restructuring As Daiichi's Oncology Pivot Gains Momentum

Daiichi Sankyo makes further vaccine business restructuring moves as it emphasizes oncology amid global generic challenges to its former big seller olmesartan.

Japan Vaccines

Medical Research Council Hopes To Build On UK / China AMR R&D Collaborations

Financial grants are bringing UK and Chinese researchers together in bilateral collaborations to fight the growing global threat from antimicrobial resistance.

Infectious Diseases Emerging Markets

BioNTech CBO Outlines Infectious Disease Ambitions

German mRNA-focused biotech BioNTech is branching out from its immuno-oncology focus to explore the potential of its platforms in infectious diseases. Speaking at the sidelines of BIO-Europe 2018, Sean Marett, BioNTech’s CBO and CCO, reveals how deals signed in the second half of 2018, with Pfizer to create a new type of flu vaccine and Penn University to deliver up to 10 IND-ready infectious disease-targeted assets, will underpin the development of a second major pillar for the company.

 

Companies Research & Development

Breast Cancer, HIV Drugs May Face Tougher Part D Climate Under Protected Class Proposal

Medicare proposed rule exposes Part D protected class drugs to threat of formulary exclusion if price increases exceed a certain threshold. Here's how it might play out for cancer and HIV drugs.

Pricing Debate Medicare
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders

Novo Nordisk CSO Outlines Obesity R&D Strategy, Calls Condition "Ticking Time Bomb"

Novo Nordisk' obesity pipeline consists of projects addressing both appetite reduction and energy expenditure, with GLP-1 semaglutide topping the list, its CSO says in an interview with Scrip.

Business Strategies Commercial

Novo Nordisk May Use Priority Review Voucher To Speed Oral Semaglutide To Market

Novo Nordisk’s chief science officer tells Scrip the readout of its PIONEER 6 trial on oral semaglutide came earlier than originally thought, allowing for an FDA filing in first-half 2019, and that use of a priority review voucher is a clear option that could speed up the process.  

Clinical Trials Comparative Effectiveness

Lilly’s CVOT Success With Trulicity Causes Bullish Outlook For Diabetes Franchise

Lilly reported strong sales growth for many of its recently launched products, but news of the potentially differentiating REWIND cardiovascular outcomes trial data dominated the pharma’s third quarter earnings call.

Sales & Earnings Metabolic Disorders

Novo Nordisk, Embark Seek Obesity Drugs That Boost Body's Energy Use

Danish duo enter pact to discover novel therapeutics for obesity and related metabolic diseases using mechanisms that increase the body's expenditure of energy.

Commercial Companies

Sanofi's Vaccines Performance Helps Offset Diabetes Decline

Performance of Dupixent, which just picked up a new indication, was a third quarter highlight and bodes well for future growth, but sales of the blockbuster insulin glargine Lantus are crumbling.

Sales & Earnings Research & Development
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Oncology

Set Alert for Oncology

Latest From Cancer

Advaxis Stumbles Further As Amgen Exits Early-Stage Cancer Immunotherapy Pact

Troubled by a clinical hold for another program, Advaxis now regains all rights to ADXS-NEO, a personalized immunotherapy in Phase I for cervical and head-and-neck cancers.

ImmunoOncology Deals

AZ Goes Into The MYSTIC And Finds Positives For Imfinzi

Against all the odds, AstraZeneca still has hopes for Imfinzi in first-line NSCLC with data from the failed MYSTIC trial suggesting strong survival in patients with a high tumour mutation burden.

ImmunoOncology Clinical Trials

Astellas Exercises Option To Acquire Potenza, For Up To $405m

Astellas has exercised an option to acquire Potenza, paying up to $404.7m in cash for the private US venture in a deal that will boost its presence in immuno-oncology.

M & A Cancer

After Imbruvica Passes Chemo-Free Tests, Shorter Duration Regimens Could Be Next Value-Adds

AbbVie/Pharmacyclics executives Danelle James and Mohamed Zaki, in an interview at ASH, discussed Imbruvica's worth in chemo-free settings and noted additional value that could be created with shorter durations of treatment in combination regimens.

Research and Development Strategies Cancer

Novartis Pruned Pipeline Producing Attractive Respiratory And Neurology Fruits

Novartis executives highlighted their stars from its refined pipeline during the company’s first R&D day since Vas Narasimhan took the helm and after a cull that reduced the firm’s development portfolio by 20%.

Companies Research & Development

City Of Hope's Joseph Alvarnas On CAR-T Real-World Use, Reimbursement

City of Hope hematologist/oncologist Joseph Alvarnas shares his perspectives on how CAR-T therapies are requiring new models of health care delivery and engagement with more kinds of stakeholders, during an interview at the recent ASH annual meeting.

ImmunoOncology Market Access
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Glenmark’s Lonhala Version Hits ‘Intriguing’ Indian Nebulizer Market

Glenmark’s nebulized, long-acting muscarinic antagonist for COPD has hit the Indian market. Delivered via a novel mesh nebulizer, it is seen as likely catering to a relatively small patient group.
Commercial Strategy

Novartis Pruned Pipeline Producing Attractive Respiratory And Neurology Fruits

Novartis executives highlighted their stars from its refined pipeline during the company’s first R&D day since Vas Narasimhan took the helm and after a cull that reduced the firm’s development portfolio by 20%.

Companies Research & Development

Can Fresh INTEREST Breathe New Life Into Faron's Traumakine?

Faron's ARDS drug looked doomed after the INTEREST study earlier this year but the Finnish group claims that a DNA analysis has identified some patients for whom Traumakine treatment could potentially be effective.

Respiratory Clinical Trials

Vertex's CF Three-Drug Combo Excels In Phase III, But Filing Depends On Second Regimen's Results

Vertex duplicated promising efficacy observed in Phase II for its cystic fibrosis triple combo that includes VX-659, but wants to see data expected in early 2019 for a triplet containing VX-445 before filing for approvals.

Clinical Trials Research & Development

Severe Asthma Proves Too Much Of A Challenge For Vectura

An ambitious trial of a budesonide-based drug/device combo for uncontrolled asthma has failed, but Vectura is upbeat as it switches resources to a potential pediatric asthma treatment.

Respiratory Clinical Trials

Galecto Funnels Funding Into Phase II For Inhaled IPF Therapy

Galecto Biotech recently raised €79m in a Series C funding round. Chief medical officer Richard Marshall spoke to Scrip about how it plans to invest the capital in its pipeline treatment for idiopathic pulmonary fibrosis.

Financing Respiratory
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