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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

AZ's Dapagliflozin Impresses In Topline Phase III Heart Failure Study

AstraZeneca’s SGLT2 inhibitor has grabbed attention for its potential role in chronic heart failure patients, with or without type 2 diabetes, following initial results from the DAPA-HF study.

 

Clinical Trials Market Intelligence

Regeneron’s Cholesterol Drug Aces Phase III, Teeing Up US FIling

The trial linked ANGPTL3 antibody evinacumab to a steep decline in LDL cholesterol in patients with homozygous familial hypercholesterolemia, setting Regeneron up to file for US FDA approval next year.

Clinical Trials Companies

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Advisory Committees Cardiovascular

Finance Watch: Amarin Raises Cash To Boost Vascepa Marketing Under Soon-To-Be Expanded Label

Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.

Financing Business Strategies

Bayer CV Pact Gives AI-Focused Sensyne Health Its First Big Deal Since 2018 IPO

The UK-based group will help Bayer accelerate clinical development of new treatments for cardiovascular disease using Sensyne Health’s clinical AI technology platform and NHS data.

Deals Cardiovascular

Novartis’s Entresto PARAGON-HF Miss Puts Large Commercial Opportunity At Risk

Entresto has narrowly failed to hit the primary endpoint in a Phase III trial in heart failure with preserved ejection fraction, a potentially lucrative indication with no approved treatments.

Clinical Trials Research & Development
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CNS

Set Alert for CNS

Latest From Neurology

Retrophin's Focus Shifts After Phase III PKAN Drug's Failure

Fosmetpantotenate missed all endpoints in a Phase III trial, so Retrophin will shelve the candidate for the rare disease PKAN. Now, the biotech turns focus to Phase III sparsentan in a pair of indications.

Clinical Trials Business Strategies

Sarepta Surprised By CRL For Exon 53-Skipping DMD Drug Golodirsen

The US FDA issued a complete response letter rejecting golodirsen based on risk of infection at intravenous infusion ports and preclinical renal toxicity.

Complete Response Letters Drug Safety

Lundbeck Looks To Pipeline As Generic Competition Hits

Lundbeck highlighted R&D and the strong growth of four strategic products in the first half, as revenues were hit by generic competitors to top-selling products.

 

Sales & Earnings Neurology

Jazz Pharma Zeros In On Essential Tremor With Cavion Buy

Jazz’s $312.5m acquisition will add to the company’s pipeline of products in neurological conditions, but only at the Phase-II stage.

 

M & A Neurology

UK's AstronauTx Gets Cash For Alzheimer's Programs

The Dementia Discovery Fund is backing the UCL spin-off's efforts to develop therapies that modulate astrocyte function.

Financing Neurology

Nektar Pins Falling Cancer Response Rate On Manufacturing Problem

A post-hoc analysis linked “physical differences” in two lots of Nektar’s drug to lower efficacy when given in combination with Bristol-Myers Squibb’s Opdivo. Nektar’s share price tumbled following the update.

Clinical Trials Manufacturing
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies

Taltz Tops Tremfya In Head-To-Head Psoriasis Study On Complete Skin Clearance

Lilly's IL-17A inhibitor ixekizumab outperformed J&J's IL-23 inhibitor guselkumab on achieving complete skin clearance in moderate-to-severe psoriasis patients at 12 weeks in a head-to-head trial. 

Comparative Effectiveness Immune Disorders

Pharming Adds CDZ173 To Its Rare Disease Pipeline, Foresees Launch by 2022

The Dutch rare disease group says licensing CDZ173 from Novartis is Pharming’s first step towards building off the commercial success of its sole product, Ruconest, in HAE.

Commercial Companies

Amgen’s Future Looks Brighter After Ruling Lifts Threat Of Enbrel Copycat

Markets are re-assessing Amgen’s long-term value after a US judge upheld two patents relating to Amgen's blockbuster rheumatoid arthritis drug Enbrel, denying a challenge by Novartis and allowing investors to focus now on the pharma’s promising pipeline.

Commercial Companies

UCB Spotlights Bimekizumab And Other Later-Stage R&D Projects

Belgium-headquartered UCB has a group of antibody-based products in mid to late-stage clinical studies which will be competing in the dermatology/immune disorders marketplace in the next few years. 
Immune Disorders Clinical Trials

Breath Therapeutics Snapped Up Post Series A By Specialty Company Zambon

Italy’s privately held Zambon could pay up to 500m to bulk up its respiratory products pipeline, producing a nice return for Breath Therapeutics’ syndicate of European investors.

 

M & A Respiratory
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Longer Intervals OK With ViiV's Injectable Anti-HIV Regimen

Topline results from the Phase III ATLAS-2M study indicate that injections every two months of ViiV/Janssen’s two-drug anti-HIV regimen are non-inferior to a once-monthly injectable regimen.

 

Infectious Diseases Clinical Trials

Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Infectious Diseases Approvals

Osivax CEO Hopes Vaccines Maker Can Develop Universal Flu ‘Silver Bullet’

Emerging Company Profile: Osivax is using its oligoDOM technology platform to developer a vaccine pipeline. The French biotech aims to establish proof-of-concept in influenza A then expand the pipeline to provide a universal flu vaccine.

StartUps and SMEs Business Strategies

Ebola Success For Regeneron’s Triple Antibody Cocktail

PALM study stopped early after two agents being tested proved better than ZMapp, the current standard of care, in the ongoing Ebola outbreak in the Democratic Republic of Congo. One is being developed by Regeneron.

Clinical Trials Companies

Gilead’s Marketing Of Descovy For HIV Prevention Should Not Suggest Superiority To Truvada

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

Advisory Committees Advertising, Marketing & Sales

Basilea's Ceftobiprole On TARGET, Needs Positive Second Study For US

The first pivotal Phase III study required for US approval of Basilea’s ceftobiprole has reported positive topline results; a second study is expected to read out in 2021.

 

Clinical Trials Infectious Diseases
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Novo Nordisk's Ultra-Fast Acting Insulin Cleared For Pediatric Use In EU

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

 

Metabolic Disorders Approvals

US Is Land Of Opportunity For Zealand

The Danish group is beefing up its operations across the Atlantic as it prepares filings for dasiglucagon and glepaglutide.

Metabolic Disorders Strategy

Novo's Ozempic Soars As Focus Shifts To Oral Semaglutide

Sales of injectable semaglutide shored up Novo's second quarter, but all eyes are on the expected launch of an oral version in the third quarter.

Sales & Earnings Metabolic Disorders

Rhythm Preparing NDA Submission In Rare Genetic Obesity Disorders

Setmelanotide reduced feelings of hunger in patients with POMC and LEPR deficiency obesities and helped many lose weight, with some caveats across certain endpoints.

Clinical Trials Rare Diseases

Alizé Pharma 3 Raises €67m To Build ‘Fully Fledged’ Biotech

The Series A financing positions Alizé to take a rival to Shire’s Natpara through to clinical proof of concept over the next few years.

Financing StartUps and SMEs

Sanofi And Lexicon Fall Out Over Zynquista, As French Group Exits Diabetes Pact

Lexicon labelled Sanofi’s unilateral decision to exit their alliance ‘invalid’ and said the French drugmaker was thus ‘in breach of contract’. Sanofi said its move was triggered by Phase III trial data studying the dual SGLT1 and SGLT2 inhibitor in type-2 diabetes. 
Commercial Companies
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Oncology

Set Alert for Oncology

Latest From Cancer

Oncorus Raises $79.5m To Take Its First Oncolytic Virus Into The Clinic

The company has two oncolytic virus platforms – a herpes simplex-based intratumoral injection and a synthetic virus-based intravenous technology for repeat systemic administration.

Financing StartUps and SMEs

AstraZeneca’s Imfinzi-Treme Checkpoint Inhibitor Combination Fails Again In NSCLC

The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.

Clinical Trials Companies

Amgen's US Biosimilar Launches Are Off To A Steady Start, With A Big Coverage Decision

United HealthCare agreed to cover Mvasi and Kanjinti in a preferred position. Amgen VP-oncology sales & marketing Susan Logan talked to Scrip about the company's first US biosimilar launches.

Biosimilars Launches

Roche's New Chief Medical Officer Levi Garraway Brings Deep Cancer Genomics Expertise

CMO Sandra Horning will retire at the end of the year, to be succeeded by Lilly's former senior VP of oncology R&D on 1 October.

Leadership Research and Development Strategies

Inrebic Approval Is A Boost For Myelofibrosis And Celgene's Buyer Bristol

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

Approvals Cancer

Roche/Genentech Set Lower Rozlytrek Price To Catch Up With Bayer’s Vitrakvi

Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.

Approvals Personalized Medicine
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Korea Races For IPF Drug Development Amid Keen Global Interest

Following major global licensing out deals in the sector this year by South Korean bioventures Bridge Biotherapeutics and TiumBio, Scrip takes a look at why firms in the country are competitively pursuing development of drugs for IPF.

South Korea Respiratory

AZ Heads Talk Pipeline And Partnerships

The drugs major believes it has assembled a pipeline that is looking well stocked for several years to come.

Strategy Clinical Trials

Breath Therapeutics Snapped Up Post Series A By Specialty Company Zambon

Italy’s privately held Zambon could pay up to 500m to bulk up its respiratory products pipeline, producing a nice return for Breath Therapeutics’ syndicate of European investors.

 

M & A Respiratory

Boehringer Further Buoys IPF Portfolio With Bridge's Autotaxin Inhibitor

Pre-IPO Bridge Biotherapeutics inks major idiopathic pulmonary fibrosis license agreement with Boehringer Ingelheim, marking the biggest single product licensing out deal by a South Korean biotech. The move is poised to further bolster the German firm's leading position in the field and reflects global pharma's increasing interest in IPF.

South Korea Deals

Dupixent Gets Room To Grow With New Indication In Chronic Rhinosinusitis

The new indication represents the third one for Sanofi/Regeneron's IL-4/IL-13 inhibitor, after atopic dermatitis and moderate to severe asthma.

Approvals Inflammation

Glenmark Boosts Respiratory Thrust In Brazil With Novartis Deal

Glenmark will market three COPD therapies from Novartis in Brazil and expects a significant uptick in its Latin America business on the back of such alliances.

Brazil Deals
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