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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Capricor's DMD Cell Therapy Has HOPE, But Market Is Unsure

Capricor will start a Phase II trial in the first quarter of 2018 for its regenerative cell therapy CAP-1002 in Duchenne muscular dystrophy following positive results in an early-stage trial – the stem cell product was dropped by Capricor's big pharma partner Johnson & Johnson earlier this year.

Clinical Trials Research & Development

Novartis Aims Canakinumab At Targeted CV Patients

New CANTOS analyses show that the "lower is better" mantra applies to inflammation as well as LDL-cholesterol. Novartis hopes they will lead canakinumab to becoming the first targeted anti-inflammatory therapy for heart attack patients, but hurdles lie ahead.

Clinical Trials Research & Development

Interview: Alnylam President On Patisiran Lift-Off Plans

Barry Greene, president of Alnylam, tells Scrip that the company is happy to consider risk-sharing with payers, as the firm is confident about the 'extreme value' that its RNAi therapeutic for hATTR amyloidosis will offer, if approved.

Companies Commercial

Life In The Old Dog Yet: Growth In Dyslipidemia Market Expected To 2025

Despite the further genericization of statins and ezetimibe, the arrival of expensive new therapies means the dyslipidemia market is still set for growth over the next eight years, say analysts from Datamonitor Healthcare.

Commercial Market Intelligence

Merck Calls It Quits On Anacetrapib

Despite the success in the REVEAL outcomes trial for the cholesteryl ester transfer protein (CETP) inhibitor, Merck will not submit the cholesterol therapy for regulatory approval.

Cardiovascular Clinical Trials

ESUS Fails But Hurt Minimal for Bayer/Janssen's Xarelto

Bayer and Janssen's bid for NOAC dominance through diversification has hit a buffer with the failure of a Phase III trial in stroke, but the indication is small and not expected to hit sales that much.

Clinical Trials Research & Development
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CNS

Set Alert for CNS

Latest From Neurology

Acorda Decides Tozadenant Isn’t Salvageable, Moves Primary Focus To Inbrija

Days after revealing seven cases of sepsis in trial participants receiving tozadenant – including five deaths – Acorda terminates development of the Phase III Parkinson’s candidate.

Research & Development Drug Safety

KemPharm Plans To License Out Commercial Rights For Pain, ADHD Candidates

KemPharm hopes a deep-pocketed company with neuroscience experience will want to market its prodrug of Ritalin for ADHD. For acute pain candidate Apadaz, the firm hopes to partner with a PBM that will price it to replace generics on formulary.

Business Strategies Pricing Strategies

Executive Interview: Building Merck KGaA's Specialty Business In EMEA

It’s an interesting challenge, commercializing in Europe the first novel pharmaceuticals to be developed and launched by Merck KGaA in a decade. The new head of its EMEA region explains his approach to the task.

Business Strategies ImmunoOncology

Acorda's Parkinson's Drug Tozadenant May Not Survive Safety Setback

The safety problems reported for tozadenant – including deaths – have not been reported for other A2a receptor inhibitors and the company sees them as "idiosyncratic," stirring doubts about a commercial future.

Drug Safety Neurology

FDA Approves First Digital Pill: Otsuka/Proteus' Abilify MyCite

Otsuka plans a slow, measured launch of Abilify MyCite, developed with Proteus Health. The product includes an ingested sensor that sends a signal to a wearable patch and an app that tracks ingestion, activity and mood to potentially improve management of psychiatric care.

Approvals Digital Health

Gates Injects UK-US Dementia Discovery Fund With $50m And Fresh Purpose

The Dementia Discovery Fund won a $50m private investment from Bill Gates – plus his ringing support to probe beyond the amyloid beta hypothesis in hopes of eventually defeating Alzheimer's.

Financing Innovation
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

BMS Q&A: Hunting For Biomarkers To Improve Treatment Of Autoimmune Diseases

Bristol-Myers R&D leaders Brian Gavin and Sean Connolly offered insight into the company's immunology focus for autoimmune diseases, which increasingly is driven by a search for biomarkers that point to the best use of the big pharma's drugs.

Personalized Medicine Immune Disorders

Novartis Has Blockbuster Targets For Cosentyx In New Autoimmune Indications

Next up for Cosentyx is psoriatic arthritis and ankylosing spondylitis. Novartis presented impressive long-term efficacy data at ACR in PsA and AS. Incoming CEO and Chief Medical Officer Vas Narasimhan said the company sees a blockbuster opportunity and is exploring the anti-TNF naïve market in AS.

Clinical Trials Immune Disorders

EU Confirms Sirukumab Filing Withdrawal, J&J Moves On

Janssen-Cilag has withdrawn the EU marketing application for the IL-6 inhibitor sirukumab, with the CHMP saying the long-term safety of sirukumab had not been well characterized and further clinical studies were required, a conclusion also drawn earlier by the US FDA.

Approvals Inflammation

ACR Roundup: JAK Safety Shown Across Multiple Trials

Low cardiovascular risk was shown in trials presented at the ACR/ARHP annual meeting for Pfizer's, Lilly's and AbbVie's JAK inhibitors in rheumatoid arthritis; AbbVie's Phase II risankizumab results in PsA, biosimilar doubts and more from ACR.

Immune Disorders Inflammation

ACR Notebook: Lilly's Baricitinib Differentiates On Pain, Ironwood's Duzallo Progress, Corbus Nears Phase III

The ACR/ARHP Annual Meeting in San Diego offered new details from studies of new and existing therapies across a range of rheumatic diseases, from rheumatoid arthritis to rare diseases. Scrip shares notes here from interviews with Lilly, Ironwood, Corbus and Samumed.

Business Strategies Clinical Trials

Celgene Plots Blockbuster Course For Ozanimod

Celgene, in need of good news, posted positive data on a potential blockbuster for multiple sclerosis at the joint ECTRIMS-ACTRIMS meeting. Ozanimod could have important safety and tolerability advantages over Gilenya, but investors already were expecting good news.

Clinical Trials Research & Development
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Heplisav-B Approval Has Dynavax Going It Alone On US Launch In Early 2018

Hepatitis B vaccine's favorable efficacy data relative to GSK's Engerix-B and neutral safety language mean that any partnership opportunity 'would need to be a highly attractive one to alter our current course,' Dynavax CEO Gray says.

Approvals Launches

Takeda's Dengue Vaccine Still Promising, But Could Be A Niche Market

Long-term Phase II data have backed Takeda's drive to study its dengue vaccine in Phase III, but to grow the market the company may have to reverse the reluctance of countries to fund public vaccination campaigns.

Vaccines Infectious Diseases

Influenza And Beyond: Sanofi Pasteur R&D Chief Talks Strategy

Sanofi Pasteur's R&D chief talks to Scrip about the integration process for Protein Sciences, a vaccine company the group acquired earlier this year in a $650m deal, and how Sanofi Pasteur is using new technologies to speed up vaccine development.

Vaccines Artificial Intelligence

Gilead Says 16 Cancer Centers Getting Ready To Administer Yescarta

Within weeks of its acquisition of Kite, Gilead is working to launch its first immuno-oncology drug, with a goal of training 70-90 US cancer centers. Q3 saw continued increase in HIV sales, decrease in HCV revenues.

Sales & Earnings Commercial

AMBER Data Support Green Light For Janssen's Symtuza

More Phase III data for Janssen's first once-daily single tablet containing four drugs for use against HIV Symtuza support its use in treatment-naïve patients; the product awaits US approval.

Clinical Trials Research & Development

GSK Spotlights Three Impending Drug Launches In 3Q Update

GlaxoSmithKline focused on three upcoming launches for its pharmaceutical business during its Q3 update, during which CEO Emma Walmsley also speculated briefly about acquiring Pfizer's consumer health business.

Sales & Earnings Launches
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Behind The NASH Leaders, Pursuers Already Anticipating Second-Wave Improvements

Privately held Cirius and NGM and big pharma Bristol-Myers Squibb are in Phase II for NASH with programs also working to validate non-invasive biomarkers for diagnosis, prognosis and treatment impact.

Clinical Trials Liver & Hepatic

USV Seeks To Progress Oral Insulin In India

USV Ltd expects to progress studies with Diabetology’s oral insulin in India, five years after the companies signed a licensing deal in 2012. The oral insulins space has seen mixed progress in the recent past, with a high profile pullback and funding support in another instance for an oral insulin candidate.

Research & Development Metabolic Disorders

Synlogic Moves Synthetic Biotics To The Clinic For Rare Metabolic Disease

Emerging Company Profile: Pioneering the development of a new class of living medicines that work in the microbiome, Synlogic completed a reverse merger earlier this year that took the company public.

StartUps and SMEs Metabolic Disorders

Novo's Semaglutide: Retinopathy Warning Unlikely To Dim Commercial Prospects

Sponsor's proposal for a label warning, but not a black box, on retinopathy risk with the once-weekly GLP-1 agonist finds support from a US FDA advisory committee, which overwhelming endorsed approval for treatment of type 2 diabetes on the basis of robust glycemic control efficacy data and a strong cardiovascular safety profile.

Advisory Committees Drug Review

If Orexigen Disappears, Who's Left In The Obesity Market?

Orexigen, one of just five biopharma companies with an obesity product on the market, has become concerned about its ability to stay in business. Even so, the misfortune of several firms hasn't dissuaded others, including Novo Nordisk, from investing in the potentially large weight-loss market.

Business Strategies Commercial

Smooth AdCom Passage Expected For Novo's Semaglutide Despite Retinopathy Queries

Novo Nordisk's Victoza follow-on semaglutide, forecast to become the third once-weekly GLP-1 product available on the highly competitive US diabetes market, is expected to secure a market-leading spot, by revenue, before 2025.

Metabolic Disorders Advisory Committees
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Oncology

Set Alert for Oncology

Latest From Cancer

Roche Causes Stir With Tecentriq/Avastin/Chemo Lung Cancer Win

There are no actual data yet but the news that the closely-watched IMpower 150 study met a goal of progression-free survival and showed 'encouraging' signs on the overall survival endpoint has made IO rivals sit up, especially Merck & Co.

ImmunoOncology Clinical Trials

GIST Market Comes Of Age

Patent expiries, novel pipeline treatments, and more patients are set to shake up the gastrointestinal stromal tumor market, finds Datamonitor Healthcare.

Market Intelligence Research & Development

Executive Interview: Building Merck KGaA's Specialty Business In EMEA

It’s an interesting challenge, commercializing in Europe the first novel pharmaceuticals to be developed and launched by Merck KGaA in a decade. The new head of its EMEA region explains his approach to the task.

Business Strategies ImmunoOncology

ImmuneOncia: A PD-L1 Latecomer Hoping To Break Into The Market

Emerging Company Profile: ImmuneOncia may be late entering the market for PD-L1 inhibitors, but the joint venture between Yuhan and Sorrento Therapeutics aims to develop best-in-class immuno-oncology drugs with differentiated products and strategy.

StartUps and SMEs Companies

PD-1 Earnings Roundup: Buckle Up For A Bumpy Ride

Results from a number of Phase III studies in non-small cell lung cancer for major immuno-oncology players are coming soon, with potential to change the market dynamics.

Market Intelligence ImmunoOncology

Wider Than AZ’s PACIFIC – Novartis Has Broad NSCLC Plans For Canakinumab

Novartis is taking its unexpected CANTOS cancer findings for canakinumab and running with them to Phase III in an adjuvant lung cancer setting that is broader that AstraZeneca's PACIFIC study.

Clinical Trials Research & Development
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

GSK's Triple Combo COPD Drug Gets Europe Okay

Europe's regulators have followed their US counterparts and given the green light to GSK's Trelegy. Now the company is hoping that having the first once-daily single inhaler triple therapy for COPD will boost its respiratory business.

Respiratory Approvals

AZ Looks To Lead Severe Asthma Market After US Fasenra OK

Following FDA approval, AstraZeneca believes that despite reaching the market after GlaxoSmithKline’s Nucala and Teva’s Cinqair, Fasenra's strong clinical package, convenient dosing and very competitive pricing will make it the leading biologic for severe asthma.

Respiratory Approvals

AstraZeneca’s Benralizumab Asthma Chase Gets Underway

Watch out GlaxoSmithKline and Teva: AstraZeneca's benralizumab has wind in its sails following a EU CHMP positive opinion for severe asthma. Approval in the US is also expected by year end.

Approvals Policy & Regulation

End Of The Line For AstraZeneca’s Tralokinumab In Asthma

Another Phase III failure looks likely to spell the end for AstraZeneca’s tralokinumab in severe uncontrolled asthma. The company’s eyes are now firmly fixed on benralizumab.

Clinical Trials Respiratory

AZ Licensing Deal Boosts Mereo Orphan Disease Model

UK group Mereo BioPharma is paying a very reasonable $5m to get its hands on AstraZeneca’s Phase II compound for the rare genetic disorder AATD.

Rare Diseases Respiratory

GSK Spotlights Three Impending Drug Launches In 3Q Update

GlaxoSmithKline focused on three upcoming launches for its pharmaceutical business during its Q3 update, during which CEO Emma Walmsley also speculated briefly about acquiring Pfizer's consumer health business.

Sales & Earnings Launches
See All
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