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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

BI/Lilly's Jardiance Takes On AstraZeneca's Farxiga With Heart Failure Approval

Cardiologists in Europe who have so far been unwilling to embrace the SGLT2 class now have two drugs approved for heart failure with reduced ejection fraction, with Jardiance soon to join Farxiga on the market, potentially attractive options especially for their diabetic patients.

Approvals Cardiovascular

Roxadustat CKD Doubts Fanned By FibroGen Data Blunder

AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.

Clinical Trials Companies

Boehringer Reflects On Resilience Of Older Therapies

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

Life Cycle Management Sales & Earnings

Regeneron/Sanofi, Amgen PCSK9 Rivalry Continues, But Not In US Courts

The battle for PCSK9 inhibitor market share continues with Amgen’s Repatha outselling Praluent, but a now-ended patent dispute no longer threatens Regeneron’s ability to sell its product in the US.

Intellectual Property Business Strategies

Regeneron's Evkeeza Approved For Ultra-Rare Genetic High Cholesterol – And Priced To Match

Evkeeza is the first ANGPTL3 approved by the FDA; Regeneron scientists discovered the angiopoetin gene family.

Approvals Cardiovascular

Scrip Asks…What Does 2021 Hold For Biopharma? Part 4: Technology And Disease

Around 100 executives highlight the hot areas to watch on the R&D front in 2021. From cancer to CNS and from regenerative medicine to real world data, expectations are high on many fronts.

Scrip Asks Artificial Intelligence
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CNS

Set Alert for CNS

Latest From Neurology

TG Therapeutics Plans Cut-Price Challenger To Ocrevus In MS

TG Therapeutics is confident its late-stage candidate can take a slice of the multiple sclerosis market away from Roche’s blockbuster.

Cancer Neurology

Biogen Gives Up On Gosuranemab After No Benefit Seen In Alzheimer's Study

Biogen’s investigational anti-tau antibody gosuranemab has missed its primary efficacy endpoint in a Phase II study in patients with Alzheimer's disease, prompting the end of the trial and termination of the compound’s further clinical development.

Clinical Trials Neurology

Biogen/Sage’s Zuranolone Data May Not Be Enough For Tough Commercial Landscape

The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption

Commercial Business Strategies

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.

Clinical Trials Approvals

Doctors Frustrated By Lack Of Guidance On Who Should Get Aduhelm

Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.

Neurology Launches

Aduhelm Approval Is Breakthrough For Neurimmune, Company Which Discovered It

The co-founder of the Swiss company which discovered aducanumab looks back over its 20 year wait for approval, and ahead to future growth plans.

Neurology Commercial
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

More Positive Data As Decision Day Looms For AstraZeneca Lupus Drug

Competition to GlaxoSmithKline’s Benlysta in the systemic lupus erythematosus space finally looks imminent with approval decisions on AstraZeneca's anifrolumab pending. The company has presented more data at EULAR to make its case for the first-in-class type I interferon inhibitor.

Innovation Immune Disorders

Novartis Looks To Extend Top-Selling Cosentyx Into Juvenile Arthritis

Top-line results from the Phase III JUNIPERA study of Novartis’s IL17A-targeting anti-inflammatory Cosentyx support its use in juvenile idiopathic arthritis, and the company intends to move quickly to enter the marketplace in pediatric patients with two subtypes of the condition.

Pediatrics Inflammation

Incyte Taps Wide-Open Vitiligo Market With Positive Ruxolitinib Results

Dermatologists have compared the current market for vitiligo to that of psoriasis 30 years ago, which grew from one with a dearth of therapies to one worth about $8bn.

Dermatology Immune Disorders

Sanofi Spotlights Nirsevimab In RSV, Further Dupixent Development

Sanofi executives are upbeat about the potential advantages of its monoclonal antibody-based approach to the prevention of RSV infections in infants, the future growth of the company’s Dupixent franchise, and the progress of its novel anticancers.

Immune Disorders Clinical Trials

Bristol Lays Groundwork For First Dermatology Launch, Ahead Of TYK2 Inhibitor

The company has not even filed the TYK2 inhibitor deucravacitinib for psoriasis, but Bristol will be a new player in a category dominated by entrenched rivals.

Immune Disorders Launches

Ventus Raises $100m To Take First Novel Compounds Into Clinic

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

Financing Innovation
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Start Designing Vaccines For The Next Pandemic, Urges NIH Chief

NIH director Francis Collins and former FDA commissioner Margaret Hamburg outline learnings from the COVID-19 pandemic and what needs to be done next amid concerns around the dangerous Delta and also Lambda variants. They also discuss the role of the WHO, which has “many masters to try and satisfy.”

Research & Development Coronavirus COVID-19

ViiV Aims To Extend HIV Drug Durations With Halozyme’s Technology

ViiV Healthcare’s head of R&D tells Scrip that extending the durations of its long acting HIV treatments is possible using drug delivery technology from Halozyme Therapeutics to expand the body’s capacity to absorb injected medicines.

Deals Infectious Diseases

Coronavirus Update: Veklury Shows Mortality Benefit In Real-World Data Analyses

Sotrovimab data could help with uptake, though the market remains challenging as infections fall. Plus RedHill presents encouraging Phase II data for oral drug to treat COVID-19 infection and inflammation after completing Phase II/III study enrollment and Japan taps its world-leading supercomputer.

Coronavirus COVID-19 Biologics

US Backs Oral COVID-19 Therapies And ‘Next Pandemic’ Drug Discovery With $3.2bn

Aiming to mimic public-private COVID-19 vaccine success, the US NIH will fund pandemic drug research, including taking candidates up to Phase II.

Companies Commercial

Blow For CureVac As COVID-19 Vaccine Hits 47% Efficacy

CureVac is not throwing in the towel just yet, but the odds are stacked against a successful end result.

Coronavirus COVID-19 Research & Development

BIO 2021 Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Horizon And Arrowhead To Develop RNAi Therapeutic For Gout

Arrowhead and Horizon Therapeutics have inked a deal to develop an investigational RNA interference therapy for uncontrolled gout, under which Arrowhead stands to get $40m upfront and up to $660m in milestones.

Inflammation Deals

Novo Nordisk Hopes To Gradually Build US Access To Obesity Therapy

With US FDA approval of Wegovy for obesity, Novo Nordisk prices the weekly injectable at par with its other obesity brand Saxenda. Ramping up sales will require patient, clinician and payer education, the company says.

Approvals Business Strategies

Novo Nordisk's Keenly Awaited Semaglutide Trial To ‘Redefine’ Alzheimer’s?

Novo Nordisk has initiated its Phase III trial assessing its oral GLP-1 semaglutide in early Alzheimer’s disease patients. The firm’s veteran GLP-1 agonist pioneer Lotte Bjerre Knudsen explains its promise to Scrip.

Clinical Trials Companies

Novo Nordisk To 'Double Obesity Drug Sales by 2025'

Novo Nordisk at its Q1 update lifted full-year guidance and voiced confidence it can double sales of innovative treatments for obesity by 2025.

Sales & Earnings Companies

More Growth Ahead For Farxiga From First-In-Class Kidney Disease Approval

AstraZeneca’s SGLT2 inhibitor produced 50% growth in Q1, and its new chronic kidney disease approval will give it an edge over Lilly and Boehringer’s Jardiance.

BioPharmaceutical Companies

Lilly Takes Another Leap Into Gene Therapy With Jaguar

Following last year's licensing deal with Precision Biosciences and the acquisition of Prevail Therapeutics, Eli Lilly is expanding its gene therapy efforts by backing Jaguar, a start-up staffed by former AveXis bosses.

Gene Therapy Financing
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Oncology

Set Alert for Oncology

Latest From Cancer

Merck's Keytruda Stakes Its Claim To First-Line Use In Advanced Cervical Cancer

Combining Merck & Co’s pembrolizumab with chemotherapy first-line improves survival and PFS in metastatic cervical cancer, reinforcing its position in a condition in the sights of a number of other companies, although usually in later lines of therapy.

Clinical Trials ImmunoOncology

Fosun Kite Bags First China CAR-T Green Light

Confounding earlier speculation, the first CAR-T cell therapy to gain approval in China is from the Fosun-Kite joint venture rather than Juno-WuXi AppTec. But pricing and market competition challenges are just beginning.

China Approvals

Intellia, Cellex Team Up On New CAR-T Firm, Backed By Blackstone

Blackstone is providing $250m to combine Intellia’s gene editing and Cellex’s cell manufacturing capabilities in a new CAR-T company using Cellex subsidiary GEMoaB’s technology and pipeline as a foundation.

Financing Regenerative Medicine

TG Therapeutics Plans Cut-Price Challenger To Ocrevus In MS

TG Therapeutics is confident its late-stage candidate can take a slice of the multiple sclerosis market away from Roche’s blockbuster.

Cancer Neurology

Fresh Win For AstraZeneca/Merck & Co Pact With Koselugo Approval

Koselugo (selumetinib) was largely forgotten after failing Phase III trials in thyroid and lung cancer, as well as uveal melanoma, but its approval in Europe for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1, which follows a US approval for the rare condition last year, has breathed new life into the once-lauded MEK 1/2 inhibitor.

Approvals Cancer

Kite CEO Christi Shaw On How Gilead Plans To Stay On Top In Cell Therapy

Shaw cites manufacturing speed and success as competitive edges. The Gilead subsidiary unveiled data at ASCO positioning Tecartus, its second CAR-T therapy, to add B-cell acute lymphoblastic leukemia to label.

Business Strategies Companies
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Lupin’s US Advair Generic Plans Turn Awry As Celon Pact Nears End

Lupin’s plans for a US generic to GSK’s Advair Diskus have turned awry as its contract with Celon Pharma is close to being terminated. The company has focused on other respiratory drugs like generic ProAir and Fostair even as the revenue potential for Advair has been shrinking post Mylan’s launch.

Commercial Strategy

Private Equity Eyes Pharma As Vectura Gets Snapped Up By Carlyle

Cash-rich private equity firms are eyeing opportunities in healthcare, especially among listed companies with sluggish share prices. The Carlyle Group could be getting a bargain if it seals a deal for the Chippenham-based inhalation specialist.

M & A Respiratory

Chiesi Keen To Nurture Disruptive Innovation

Chiesi may not be a big pharma giant but it is very good at spotting early-stage innovative projects and partnering with the likes of Moderna, Protalix and Bioasis to tackle respiratory and rare diseases, CEO Ugo Di Francesco tells Scrip.

Leadership Strategy

Canadian Biotech Pursues India Partnering Plans For COVID-19 Nasal Spray

SaNOtize is in partnering talks with large firms in India to manufacture and distribute its nitric oxide nasal spray for COVID-19. The Canadian company believes the product, which already has an interim approval in Israel, could potentially reduce viral load of SARS-CoV-2 variants, as well as influenza and other respiratory viruses.

India Commercial

Budesonide Shows COVID-19 Promise: Should It Be Evaluated In India?

UK studies indicate the potential of inhaled budesonide in improving COVID-19 recovery time in specific groups, with some leading Indian physicians suggesting that the widely available asthma/COPD therapy should be selectively evaluated in the Indian context as well.

Coronavirus COVID-19 Clinical Trials

Boehringer Reflects On Resilience Of Older Therapies

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

Life Cycle Management Sales & Earnings
See All
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