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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

New CEO Brett Monia Takes The Lead As Ionis Prioritizes Non-Partnered Programs

Monia told Scrip at the J.P. Morgan Healthcare Conference that the company will be more selective about partnerships going forward and build commercial capabilities to market Ionis-owned drugs.

Leadership Business Strategies

Amgen To Buy Out Japan JV With Astellas

Full, planned acquisition of Tokyo-based operation will give US biotech giant a firmer foothold in key market and new platform for Otezla growth.

Japan Deals

AstraZeneca's Dobber On Ramping In Renal, Expanding In CV And Business Development

Biopharmaceuticals President Ruud Dobber talked to Scrip about the launches of Lokelma and roxadustat in kidney disease, building with a high bar in cardiovascular disease and expanding in cell and gene therapy.

Business Strategies Leadership

AZ Halts Epanova Study As High Placebo Effect Kills Acasti’s Omega-3 TRILOGY-1 Trial

Acasti’s omega-3 candidate drug CaPre missed the primary endpoint in TRILOGY-1 due to an unexplained high placebo effect, as AstraZeneca said its STRENGTH study was unlikely to show a treatment benefit.

Companies Clinical Trials

Novartis Inks World-First Pact With NHS England For Inclisiran

The innovative collaboration should accelerate access to the first-in-class cholesterol lowering drug acquired with The Medicines Company buy.

United Kingdom Deals

AZ’s Farxiga Gets FDA Priority Review For Heart Failure

AstraZeneca has got off to a strong start in 2020, with the FDA granting a fast review for its diabetes drug Farxiga in heart failure and China approving Lokelma for hyperkalemia.

Cardiovascular Drug Review
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CNS

Set Alert for CNS

Latest From Neurology

New CEO Brett Monia Takes The Lead As Ionis Prioritizes Non-Partnered Programs

Monia told Scrip at the J.P. Morgan Healthcare Conference that the company will be more selective about partnerships going forward and build commercial capabilities to market Ionis-owned drugs.

Leadership Business Strategies

Kissei Discussing Rovatirelin Path After Mixed Phase III Results

Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.

Japan Clinical Trials

Market Snapshot: Migraine Prevention Therapies’ Slow Road To Blockbuster Status

Aimovig, Emgality and Ajovy have been on the market for more than a year, but are still far from blockbusters even though millions of patients are eligible for treatment – and at least one new competitor is coming.

Market Intelligence Launches

Novartis Q4 Preview: Launches Likely To Deliver

Having had a very fruitful year in terms of regulatory approvals, the Swiss major will reveal how successful its new products have been commercially. Of particular interest will be the performance of eye drug Beovu as it takes on Bayer's rival Eylea.

Sales & Earnings Strategy

Novartis MS Drug Mayzent Gets Europe OK

Mayzent is the first oral treatment specifically indicated for patients with secondary-progressive multiple sclerosis and while it is expected to be a blockbuster, the company tells Scrip that educational programs for physicians are a priority.

Neurology Approvals

Roche Gears Up For Potential Neuroscience Breakthroughs

Neuroscience could be this decade’s big growth story, but clinical and market access challenges differ to oncology.

Commercial Gene Therapy
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

J&J's Stelara Gets Europe OK For Pediatric Psoriasis

The European Commission has backed J&J's blockbuster to treat children with psoriasis but the drug has fallen foul of NICE for ulcerative colitis.

Immune Disorders EU

J&J’s Gorsky Hails Strong Performance By Immunology Therapies Tremfya, Stelara

A strong fourth quarter and full-year 2019 performance by J&J was driven by significant sales growth for Tremfya and Stelara. CFO Wolk said a $4bn opioids settlement remains on track.

Sales & Earnings Business Strategies

Fewer US Market Access Restrictions For Branded I&I Drugs Will Drive Growth

Access to branded drugs has remained steady, but there has been less management across brands by commercial payers, according to an analysis of the I&I market access environment by Bernstein.

Market Access Inflammation

J&J To Power Ahead With 10 Launches In Four Years

 Johnson & Johnson has achieved exceptional growth in recent years, and a raft of new products is set to sustain it further. 

Legislation Medicare

Microbiome’s Moment Approaches: Finch Joins Rival C Diff Companies

After a trial failure in 2016, four rival companies could produce pivotal data this year

Research & Development Gastrointestinal

Apellis Comes Closer To Taking On Alexion In PNH

Besting Alexion’s Soliris in a head-to-head Phase III trial portends a place in the market for Apellis’ competitor in paroxysmal nocturnal hemoglobinuria. But challenges dog both companies.

 

Research & Development Clinical Trials
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Health Sector On High Alert As Wuhan Coronavirus Spreads

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

China Policy & Regulation

India’s Hilleman Plans ‘Affordable’ Vaccine Against Group B Strep

India’s Hilleman Laboratories says it’s aiming to develop an affordable vaccine that will target pregnant women in low- and middle-income countries to prevent Group B Streptococcus, a potentially fatal infection passed to babies during childbirth.

Vaccines Infectious Diseases

Novo Executive Calls For ‘Real AMR Action’ In Davos

The Novo Nordisk Foundation is sponsoring a panel at Davos this week on finding solutions to the global crisis on antimicrobial resistance – and hopes world leaders will listen.

Companies Research & Development

O’Day Lays Out Plan For Gilead’s Continued HIV Dominance

Biktarvy’s powerful sales growth and the potential of a first-in-class capsid inhibitor in both prevention and heavily treatment-experienced patients are key to Gilead’s plan for staying on top in HIV.

Business Strategies Life Cycle Management

Summit Therapeutics CEO Applauds UK Antibiotics Market Pilot

The world hopes a UK pilot can offer guidance on making novel antibiotics commercially viable, Summit Therapeutics CEO tells Scrip, but adds his lead asset won’t take part this time. 
Companies Research & Development

AMR Crisis Experts See Hopeful Signs For 2020

2020 could be a watershed year in tackling AMR, but success needs market reforms that ensure new antibiotics get to market and prevent innovators going bust, experts tell Scrip. 

Policy Research & Development
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Scrip Asks… What Does 2020 Hold For Biopharma? Part 4: The Patient

From the general to the particular: drug developers are increasingly tailoring therapies to individuals. Driven by important advances in understanding biology as well as new tools to harness big data, industry participants expect significant progress in biopharma’s approach to the patient.

Personalized Medicine Artificial Intelligence

Interview: KaNDy Menopause Therapy Hits Sweet Spot

Prospective partners will be impressed by data which shows that the UK company's once-daily oral treatment reduces hot flashes and night sweats and has also shown very rapid improvements in mood and sleep.

Clinical Trials Metabolic Disorders

Novo Nordisk’s New India Chief Steps Into Bustling Diabetes Arena

Novo Nordisk’s new India managing director takes charge amid heightened competition in the diabetes space. The Danish firm stays committed to bringing new products to this market at a faster clip and all eyes will be on the launch trajectory of therapies like semaglutide.

India Commercial

Dicerna Ready To Challenge Alnylam’s RNAi Dominance In 2020

Alnylam set for further expansion in ‘gene silencing’ but Dicerna could have best-in-class rival.

Research & Development Metabolic Disorders

Hanmi Says Sanofi Made 'Optimal' Efpeglenatide Decision, Still Eyes 2021 Approval

Hanmi Pharm is remaining upbeat after Sanofi’s decision to find another commercialization partner for efpeglenatide, saying it was the best strategy for the long-acting GLP-1 agonist given the strategic change in the big pharma’s diabetes strategy.

Deals South Korea

Novo Nordisk Targets Smart Insulin, Stem Cell-Therapies

Novo Nordisk’s CEO talks to Scrip about the promise of glucose-responsive insulin, stem cell therapy, and a diabetes landscape without Sanofi.

Companies Strategy
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Oncology

Set Alert for Oncology

Latest From Cancer

Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

Approvals Business Strategies

After Real-World Data Row, AZ Looks To NHS England For Tagrisso Deal

Tagrisso has become AstraZeneca’s oncology flagship product, but cannot secure frontline use in England.
Commercial United Kingdom

Tecentriq Disappoints In Post-Surgery Bladder Cancer

Failure is a knock-back for the blockbuster product, but Tecentriq has many more opportunities for trial success in 2020.
Commercial ImmunoOncology

European Clinical-Stage Cancer Vaccine Gains South Korean Support

A group of Belgian and South Korean investors are providing series B funding to support an early-stage clinical study of an off-the-shelf cancer immunotherapy candidate based on an allogeneic plasmacytoid dendritic cell line.

 

Financing ImmunoOncology

Novartis Q4 Preview: Launches Likely To Deliver

Having had a very fruitful year in terms of regulatory approvals, the Swiss major will reveal how successful its new products have been commercially. Of particular interest will be the performance of eye drug Beovu as it takes on Bayer's rival Eylea.

Sales & Earnings Strategy

UK Biotech Financing Holds Up Despite Woodford and Brexit

Neil Woodford’s fall from grace and Brexit dragged on an otherwise buoyant sector.

Biologics Commercial
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Novartis Culls Fevipiprant After LackLUSTER Data

Any lingering hopes Novartis had that fevipiprant could become a blockbuster have disappeared and the Swiss major has ended development of the asthma drug after two more trials failed, this time for severe disease.

Respiratory Clinical Trials

Chiesi Tackles Carbon Footprint Of Inhalers

The Italian firm has laid out its ambitious plan to introduce the first carbon minimal pressurized metered dose inhaler for asthma and COPD by 2025 and secured supply of a new environmentally friendly propellant.

Innovation Respiratory

Verona Foresees FDA End-Of-Phase II COPD Meeting

Verona CEO tells Scrip Phase III COPD studies for its lead asset will start next year, take up to two years to complete, leading to commercial launch “probably in 2024.”

Companies Strategy

Roche Paying $390m Up Front For Fibrosis-Fighting Promedior

The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.

Deals M & A

HES Flare: GSK's Nucala Edges Forward

GlaxoSmithKline’s interleukin-5 inhibitor, Nucala (mepolizumab), is the first treatment shown to reduce the hypereosinophilic syndrome flare-ups in a 100-patient pivotal study.

 

 

 

Immune Disorders Clinical Trials

Ambitious AB Science Gets Masitinib Win For Severe Asthma

Plagued by concerns on the integrity of data and compliance issues with its clinical practices, the French firm still believes masitinib could be effective for ALS, multiple sclerosis, cancers, asthma and even Alzheimer's.
Strategy Clinical Trials
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