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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Billions At Stake As Generic Approvals Open Up Japan Big Sellers

Japan has approved a new batch of first-time and other generic drugs that will be reimbursed and launched in June, putting at risk several billion dollars’ worth of combined sales of some major branded products.

Generic Drugs Japan

COMPASS Success Reinforces J&J/Bayer's Broad Labeling Strategy For Xarelto

J&J will be talking to FDA regarding expanded approval for peripheral arterial disease and coronary artery disease following early stop of COMPASS outcomes study; strong data will be needed if asymptomatic patients are targeted.

Clinical Trials Research and Development Strategies

Prevention, Cure And Interception Vital ForJanssen Cardiometabolic R&D

With readouts in trials of key drugs Invokana and Xarelto coming, Dr. James F. List of Janssen is also looking for assets designed to prevent, cure or even intercept the progression of key diseases such as obesity and NASH.

Companies Research and Development Strategies

Amgen’s Repatha Passes CVOT Test, But Contribution To 2017 Sales Growth Unclear

Amgen’s PCSK9 inhibitor Repatha succeeded in the FOURIER cardiovascular outcomes study, but the data may not impact the company’s revenue until 2018 – after a potential revenue decline in 2017.

Commercial Business Strategies

Can Slow Selling Heart Drug Entresto Perk Up In 2017? Novartis Hopes So

Sales of Novartis' Entresto have been painfully slow and missed their 2016 target of $200m – but the big pharma hopes the heart failure drug's sales momentum will take off next year and it remains confident the first-in-class therapy will eventually reach peak annual sales of around $5bn.

Business Strategies Companies

J&J's Actelion Courtship Seen Unaffected By Macitentan MAESTRO Failure

Johnson & Johnson is expected to keep pursuing Actelion despite news the target's pulmonary arterial hypertension drug macitentan missed a primary endpoint in a Phase III study of patients with PAH due to Eisenmenger Syndrome.

Business Strategies Clinical Trials
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CNS

Set Alert for CNS

Latest From Neurology

UCB Predicts Briviact Sales Of €450m by 2026; Plans New Partnerships

UCB says its early to mid-stage pipeline contains 10 promising breakthrough molecules, some of which it aims to partner with other pharma players as part of its open innovation strategy.

Companies Sales & Earnings

After APOLLO: Trevena Weighs Commercial Viability Of Opioid Oliceridine

A mixed bag of safety results for the new opioid Olinvo (oliceridine) in the Phase III APOLLO pain trials disappoints the market, but analysts are encouraged by the totality of the data and optimistic about approval.

Clinical Trials Neurology

Behind The Blockbuster: Investors Sound Off On Biogen's Future With Spinraza

Entering 2017 with freshly approved Spinraza and new CEO Michel Vounatsos, Biogen still faces challenges and uncertainty. A poll of investors highlights expectations for the company.

Business Strategies Commercial

Safety Is Key As Celgene's Ozanimod Succeeds In First Pivotal MS Test

Celgene's ozanimod successfully cleared its first Phase III hurdle in multiple sclerosis, but safety will be the S1P receptor modulator's differentiating factor in results presented later this year, with additional value coming from ulcerative colitis and Crohn's disease in the coming years.

Research & Development Clinical Trials

Another Nail In Amyloid Hypothesis Coffin? Merck Ends Pivotal BACE Inhibitor Study

In another blow for the amyloid hypothesis in Alzheimer's disease, Merck ended its pivotal EPOCH study for the BACE inhibitor verubecestat based on an interim assessment that there was "virtually no chance of finding a positive clinical effect" in the nearly completed Phase II/III clinical trial.

Clinical Trials Research & Development

Axovant Plans Nelotanserin PhIII But Trial Endpoint Has Eyebrows Raised

Axovant will move its 5HT2A receptor, nelotanserin, into Phase III studies later this year for Lewy body dementia patients, but the company is switching gears to focus on motor function over its previously stated target of visual hallucinations in patients.

Clinical Trials Research & Development
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Akari Hopes Tick-Based Drug Will Be Safer, Cheaper Than Alexion's Soliris

Akari Therapeutics is looking to ticks to provide a new therapy that it hopes will offer a safer and cheaper alternative to Alexion Pharmaceuticals' Soliris for some rare orphan diseases.

Clinical Trials Companies

10 Approvals To Watch For In Early 2017

Dupixent, Austedo, brigatinib and Olumiant are among a raft of new drug approvals expected in the first four months of the year. Here, with help from Informa Pharma's Biomedtracker, we take a look at 10 of the more interesting products looking close to reaching the market, some for the second time of asking.

Approvals Commercial

Canada First To OK Sanofi/Regeneron’s Sarilumab, But Struggle To Differentiate Looms

Sanofi/Regeneron’s Kevzara (sarilumab) has won its first worldwide approval for treating moderately to severely active rheumatoid arthritis from Health Canada. But as more regulators follow, the companies will face a battle to differentiate the drug from chief rival, Roche/Chugai’s Actemra (tocilizumab).

Approvals Market Access

J.P. Morgan Notebook Day 3: Novartis' Cancer Reorg, AbbVie's Price Pledge, Genentech’s Partnering And More

Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco: Comments from President-elect Donald Trump hovered over the crowd, but companies aimed to stay focused on moving forward regardless of what policy changes are coming.

Therapy Areas Strategy

OSE Immunotherapeutics And Servier Join Forces In Auto-Immune Field

French groups OSE Immunotherapeutics and Servier have inked a pact to develop and commercialize the newly formed biotech's interleukin-7 antagonist in ulcerative colitis.

Commercial Companies

GSK's Nucala Shows Promise In A Rare Systemic Vasculitis

GlaxoSmithKline is cementing its leadership position in eosinophilic conditions with promising pivotal results with Nucala as an add-on therapy for the rare disorder eosinophilic granulomatosis with polyangiitis. The development is expected to lead to an extension of its indications.

Clinical Trials Immune Disorders
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Merck's Write-Down Of Phase II Nuc Illustrates Current Reality In HCV

While a dwindling patient base and pricing pressures are depleting the market opportunity in hepatitis C, Merck's decision also may result from regulatory dialogue potentially delaying the start of a Phase III study.

Business Strategies Commercial

Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Business Strategies Research and Development Strategies

Novel Antibody Products Ring The Treatment Changes In HIV

Two Canadian companies – Theratechnologies and CytoDyn – exploring the use of monoclonal antibodies in the fight against HIV presented data for their novel late-stage candidates at the recent CROI meeting in Seattle. They are aimed at patients experiencing multi-drug resistance and represent a change in this mature therapy area dominated by small-molecule oral products.

Clinical Trials Companies

Janssen Strives For Simplicity In HIV R&D, While Hunting For A Cure

HIV may be effectively treated and managed with available therapies, but there is still great unmet need for a functional cure and better prevention to stop the epidemic.

Clinical Trials Infectious Diseases

AmpliPhi Advances Phage In Clinic To Address Microbial Infections

Emerging Company Profile: Using cocktails of bacteriophages to attack bacterial infections, San Diego-based AmpliPhi has made progress in Phase I studies for its lead program. CEO Scott Salka explains to Mike Ward how he is looking to secure sufficient capital to support the Phase II development of AmpliPhi's lead program against chronic rhinosinusitis while advancing other product candidates.

Commercial Companies

Gilead's Bictegravir Data Could Mean Continued HIV Sector Dominance

Phase II data presented at CROI aren't sufficient to demonstrate statistical superiority over ViiV's Tivicay, but one analyst predicts that a repeat performance in larger Phase III trials could support a superiority claim.

Life Cycle Management Research & Development
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Melior, Bukwang Seek Diabetes Edge With Novel Insulin Sensitizer

MLR-1023, a repositioned oral compound being developed for type 2 diabetes by Melior and Bukwang, is set to move into Phase IIb in the US and South Korea, and the firms are looking to its novel mechanism of action, improved tolerability and efficacy to carve a niche in a highly competitive sector.

Research & Development Diabetic Care

Second Genome CEO Predicts Paradigm Shift With Microbiome Discovery

California biotech, which has backing from major pharmas, explains the application of its microbiome discovery platform to multiple disease types.

Companies Research & Development

Prevention, Cure And Interception Vital ForJanssen Cardiometabolic R&D

With readouts in trials of key drugs Invokana and Xarelto coming, Dr. James F. List of Janssen is also looking for assets designed to prevent, cure or even intercept the progression of key diseases such as obesity and NASH.

Companies Research and Development Strategies

Novo Still Seeking Superior Tresiba Follow-On, Says CSO

Despite dropping its Phase II oral insulin program in the second half of 2016, Novo Nordisk's chief scientific officer says the company is quietly continuing to explore options for an oral therapy better than its leading insulin option, Tresiba.

Business Strategies Metabolic Disorders

PhaseRx Makes More Noise Than Silence With mRNA Delivery

Having ditched silence RNA in 2012, PhaseRx president and CEO Dr Robert Overell explains to Mike Ward, global director of content at Informa Pharma Intelligence’s insights portfolio, how delivering messenger RNA inside diseased cells may revolutionize and grow the current $4bn enzyme replacement market.

Research & Development Research and Development Strategies

Novo Uses UK Academia To Feed Diabetes Pipeline Despite Brexit Doubts

Novo Nordisk, which says it still has faith in the UK's life science expertise even in the face of Brexit disruption, plans to establish a new research center at the University of Oxford – but will this be enough to help plump up its lackluster pipeline?

Deals Metabolic Disorders
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Oncology

Set Alert for Oncology

Latest From Cancer

OncoSec Pushes IL-12 Approach Forward In PD-1 Melanoma Failures

Company plans to pursue accelerated approval based on a single-arm registrational study of PD-1 failures, after reporting positive results from a Phase II study at the ASCO-SITC meeting.

Clinical Trials ImmunoOncology

Novartis Combo On Track To Be First Targeted BRAF NSCLC Therapy

The EU's CHMP has granted a positive opinion for Novartis' combo of MEK inhibitor Mekinist and BRAF inhibitor Tafinlar for BRAF-positive non-small cell lung cancer patients.

Approvals Commercial

New EU Nod For J&J/Genmab's Darzalex Brings It Closer To Rivals

The EU's CHMP has given the go ahead to extend the EU licence for Janssen/Genmab's Darzalex to include its use earlier in the treatment paradigm, bringing into line with the US label and its rivals.

Europe Drug Review

UCB Predicts Briviact Sales Of €450m by 2026; Plans New Partnerships

UCB says its early to mid-stage pipeline contains 10 promising breakthrough molecules, some of which it aims to partner with other pharma players as part of its open innovation strategy.

Companies Sales & Earnings

New FDA Revlimid Approval Extends Celgene's Myeloma Empire

Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.

Approvals Policy & Regulation

Argos And Agenus Trials Pile On Fresh Cancer Vaccine Disappointments

Argos mum on details surrounding Phase III failure of rocapuldencel-T in kidney cancer, while Agenus distances itself from failed Phase II glioblastoma study of Prophage G-200 as an investigator-sponsored trial with a challenging design.

Research & Development Clinical Trials
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

GSK’s Vallance On Efficiency In R&D And Entering “The Cure” Era

Dr Patrick Vallance, President R&D at GlaxoSmithKline, tells Scrip that R&D efficiency is a priority for the company and specifies increased transparency on R&D decision-making and its returns. In a wide-ranging interview, Vallance also discusses the attention GSK’s Nucala is garnering within the severe asthma space.

Research & Development Innovation

GSK Braces For Impact: Advair Generic Could Reduce US Brand To £1Bn

Although it’s not yet clear if an interchangeable version of the respiratory blockbuster will be approved by FDA, CEO Andrew Witty prepared investors to expect a hit, forecasting that a mid-year launch could significantly reduce revenues.

Sales & Earnings Business Strategies

Mylan's Cold-Eeze OTC Acquisition Aims To Leverage Respiratory Expertise

Mylan could tap respiratory product experience to develop line extensions to the homeopathic product, now seen as the centerpiece of its US consumer business.

United States Deals

GSK Spin-Out NeRRe Raises £23m For NK Antagonists

New cash will fund further clinical testing of NeRRe's two neurokinin receptor antagonists for cough and hot flashes.

Companies Financing

Advair: A Big Generic Opportunity And A Big Question Mark In 2017

Takeda’s Velcade, Pfizer’s Viagra and Gilead’s Viread are among the brand drugs expected to face generic competition in the US for the first time in 2017. One unknown is if FDA will approve Mylan’s or Hikma’s ANDAs for a generic version of GSK’s Advair.

Respiratory Generic Drugs

Sunovion To Commercialize Novartis’s COPD Products In US

Sunovion has secured US rights to Novartis's respiratory inhalers, and will cash in on Novartis's FLAME data in COPD patients which recently helped change treatment guidelines.

Commercial Deals
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