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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Acesion Tackles Atrial Fibrillation Through SK Channel Inhibition

Acesion Pharma is focusing on SK channel inhibition to develop safer and more effective drugs to treat and prevent atrial fibrillation. During BIO-Europe Spring 2018, Acesion CEO Frans Wuite described to Scrip his partnering and financing ambitions for the lead program which is entering Phase I testing.

Commercial StartUps and SMEs

PCSK9 Add-On Study Helps Esperion Cover All The Bases With Bempedoic Acid

Phase II data on use with PCSK9 injectable support bempedoic acid's safety and efficacy profile as an add-on therapy in high cholesterol.

Clinical Trials Research & Development

Repatha Inroads Build Gradually As EU Extension Nears

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Approvals Cardiovascular

Hyperkalemia Market Hots Up In EU with Okay for AZ's Lokelma

Rival Vifor Pharma has predicted blockbuster status for Veltassa and AstraZeneca expects the same for its just-approved oral potassium-removing agent, hoping that Lokelma's faster onset of action will help it win the fight for market share in hyperkalemia.

Approvals Europe

PCSK9 Turning Point? Sanofi/Regeneron Dangle Lower Price Carrot For Praluent

ODYSSEY outcomes study homes in on value of PCSK9 inhibition for the subgroup of patients with LDL of at least 100 mg/dL, a potentially large market, but how much will payers ease restrictions in exchange for a lower price?

Pricing Strategies Reimbursement

Bristol/Pfizer's Eliquis Better For Preventing Strokes And Bleeding In Large Real-World Trial

In Bristol/Pfizer's ARISTOPHANES real-world study, the rate of major bleeding with Eliquis was 46% lower than J&J/Bayer's Xarelto and 33% lower than Boehringer's Pradaxa.

Clinical Trials Cardiovascular
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CNS

Set Alert for CNS

Latest From Neurology

FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval

Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.

Drug Review Neurology

Genentech Bets On Kineta's Early-Stage, Disease-Modifying Pain Therapy

Genentech partners with the Seattle biotech on a non-opioid approach to chronic pain. Kineta says there's disease-modifying potential.
Deals Neurology

UCB Spinout Syndesi Brings New Approach To Dementia

Emerging Company Profile: Syndesi Therapeutics, a new biotech built upon research from UCB, aims to develop novel drugs for neurodegenerative conditions like Alzheimer's disease; the company has a stream of big name investors such as J&J Innovation and Novo Holdings.

StartUps and SMEs Neurology

Pfizer Advances Duchenne Drug As It Prioritizes Gene Therapy

High value deal with Bamboo Therapeutics starts to come to fruition with start of small study in Duchenne muscular dystrophy, which aims at underlying cause as opposed to symptoms of disease.
Regenerative Medicine Rare Diseases

Alexion's Pipeline Rebuild Plan Targets Wilson's Liver Drug, More M&A Likely

Swedish target's sole product WTX101 is in Phase III trials for treating Wilson Disease. Alexion says expect more deals. 

Analysis Business Strategies

Pacira Sees Big Opportunity In Exparel's Narrow Nerve Block Indication

Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.

Approvals Advertising, Marketing & Sales
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Rigel Readies Tavalisse For Late-May Launch After FDA Approval

Rigel has its first US FDA approval for Tavalisse (fostamatinib) and plans to launch the drug for adults with immune thrombocytopenia (ITP) in late May, after working on the drug's development for more than a decade across multiple indications.

Approvals Immune Disorders

At J&J, Oncology Closes In On Immunology As The Leading Pharma Franchise

Global oncology sales grew 45% to $2.31bn in the first quarter, powered by strong growth of Darzalex, Imbruvica and Zytiga, narrowing the gap with J&J's top-selling immunology franchise.

Sales & Earnings Commercial

ImmuPharma Puts On Very Brave Face After Lupus Drug Flop

Shares in the UK biotech have fallen through the floor following a failed Phase III trial of Lupuzor but ImmuPharma remains surprisingly upbeat about the lupus drug's prospects.

Immune Disorders Clinical Trials

Orchard To Use Divested GSK Rare Disease Gene Therapies To Grow Globally

Orchard Therapeutics will acquire GSK’s portfolio of approved and investigational rare disease gene therapies, including EU-approved Strimvelis and additional late-stage gene therapies.

Analysis Business Strategies

Celgene's Terrie Curran On Building, Broadening The I&I Franchise

Celgene has hit multiple roadblocks in building its inflammation and immunology (I&I) portfolio, but it has a lot of potential shots on goal to eventually help the company diversify its revenue beyond the cancer blockbuster Revlimid, starting with flagship product Otezla.

Business Strategies Immune Disorders

Ablynx's AbbVie-Partnered Lupus Candidate Hits End Of Road

Ablynx's IL-6 inhibitor has reached the end of the road in lupus; failure of the Phase II STEADY trial is unlikely to affect the biotech's acquisition deal with Sanofi but its development partner AbbVie is expected to dump the drug.  

Immune Disorders Clinical Trials
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

TVM Raises White Flag On Biovertis & Morphochem

Denoive acquires from TVM Capital both Biovertis and Morphochem, plus a Phase II ready antibiotic asset, for an initial 4% stake worth €900,000. Since their formation, Biovertis and Morphochem have had more than $96m invested in them.

Commercial M & A

HIV Market Snapshot: Gilead's Biktarvy Set To Soar, But ViiV May Win In The End

Gilead's Biktarvy (B/F/TAF) single tablet is poised to become a huge success, surpassing competitors in the HIV market by far, but the GlaxoSmithKline-backed ViiV Healthcare looks better positioned in the long run.

Market Intelligence Infectious Diseases

How Will Novel Agents Impact The HIV Market?

ViiV and Merck are looking to novel mechanisms of action as an opportunity to make up ground on HIV leader Gilead, which has de-emphasized early virology research. 

Research & Development Business Strategies

India Leads Global 65% Surge In Antibiotics Use

Human antibiotic consumption globally jumped dramatically between 2000 and 2015, with India posting the biggest rise, reports a new US study, which calls for a radical policy rethink to prevent antimicrobial drug resistance soaring.

India Policy & Regulation

Sanofi Underpins Vaccine Strategy With New Manufacturing Facilities

Sanofi's major investments in vaccine manufacturing are continuing with the expansion of its Toronto, Canada facility, to be completed in 2021.

Manufacturing Vaccines

Precision Medicine For Pseudomonas Spurs Polyphor's Swiss IPO Plans

The Swiss developer of a Phase III potential first-in-class antibiotic for Pseudomonas infections plans to list on the Swiss Stock Exchange, SIX, underlining the unmet need for better drugs for nosocomial pneumonia, and also the upturn in the bourse's popularity for European IPOs.

 

Financing Infectious Diseases
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Alexion's Pipeline Rebuild Plan Targets Wilson's Liver Drug, More M&A Likely

Swedish target's sole product WTX101 is in Phase III trials for treating Wilson Disease. Alexion says expect more deals. 

Analysis Business Strategies

Chiesi Committed To Becoming A Major Player In Rare Diseases

The Italian group has got the green light in Europe for Lamzede, the first disease-modifying therapy for alpha mannosidosis and believes the drug, along with Procysbi and an investigational Fabry disease being developed with Protalix, constitute a strong portfolio in the rare metabolic disease area.

Rare Diseases Metabolic Disorders

Encapsulated Living Cells For Diabetes: The Final Push?

Lilly has linked up with US biotech Sigilon Therapeutics to develop encapsulated cell therapies for diabetes, a second "living therapeutics" approach to the condition to attract funding in the past six months.

 

Deals Metabolic Disorders

Zealand Rushes Out Good Safety News On Phase III Dasiglucagon Rescue Pen

Early results confirm dasiglucagon's safety profile with no treatment-induced or treatment-boosted anti-drug antibodies.

Clinical Trials Commercial

Diurnal's £11m Placing To Promote First Product Launch And Pipeline

Diurnal's CEO Martin Whitaker says 2018 promises to be transformational for the late-stage endocrinology company.

Financing Business Strategies

Orexigen Follows Through On Warning It May Have To Liquidate

Orexigen hoped its go-it-alone strategy would boost obesity drug Contrave's sales enough to keep the company afloat, but now it has initiated bankruptcy proceedings, following through on a warning in October that it might not meet debt holders' requirements.

Business Strategies Metabolic Disorders
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Oncology

Set Alert for Oncology

Latest From Cancer

China Vs Cancer: An Infographic Snapshot

Cancer cases are rising in China, with larger increases for certain types including thyroid and pancreatic. To combat the rising tide, the government will implement zero tariffs on imported anticancer drugs  from May.

Cancer China

IOnctura CEO On Pipeline Strategy And Funding Goals

IOnctura’s CEO Catherine Pickering outlines the company’s business model and its approach to cancer R&D targeting the tumor microenvironment.

StartUps and SMEs Companies

In The Hot Seat: Bristol Defends IO Position Amid Sliding Stock And Forecasts

Bristol's stock price dipped after the AACR meeting, where pivotal lung cancer data for Opdivo/Yervoy disappointed relative to Merck's Keytruda/chemo combo, but Bristol still has many immuno-oncology irons in the fire in other indications and expressed confidence in its strategy.

Clinical Trials ImmunoOncology

At J&J, Oncology Closes In On Immunology As The Leading Pharma Franchise

Global oncology sales grew 45% to $2.31bn in the first quarter, powered by strong growth of Darzalex, Imbruvica and Zytiga, narrowing the gap with J&J's top-selling immunology franchise.

Sales & Earnings Commercial

Roche's IMpower150 Gets AACR Applause But Merck's KEYNOTE-189 Big Winner

Roche’s Tecentriq IMpower150 trial showed Tecentriq plus Avastin plus paclitaxel and carboplatin significantly improved progression free survival compared to Avastin and chemo alone; overall survival data will be coming later this year.

Clinical Trials Cancer

Servier's Shire Oncology Buy Gives Base For US Expansion

With the $2.4bn acquisition of Shire's oncology assets, including Oncaspar and Onivyde, the French drug maker has laid down a marker to become a key player in cancer and sees the US in particular as the land of opportunity.

M & A Cancer
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Experts Challenge GSK Triple Inhaled COPD Therapy Claims

While GSK and collaborators publish findings from the IMPACT trial comparing once-daily single-inhaler triple versus dual therapy in patients with COPD in NEJM, two clinicians in an accompanying editorial argue that the trial falls short of providing robust evidence for switching strategy.

Clinical Trials Research & Development

Enterprise Therapeutics Raises £29M To Advance Respiratory Assets

UK biopharma Enterprise Therapeutics raises £29M in a series B round co-led by Versant Ventures and Novartis Venture Fund to advance pipeline of novel respiratory disease treatments into clinical development.

 

 

Commercial Financing

Executive Interview: Vectura's Ward-Lilley On Re-Focusing On The Respiratory Sector

Respiratory delivery specialist Vectura is to concentrate on developing enhanced inhaled products, as well as substitutable inhaled generics for the US market, and is pulling back from NME work. CEO James Ward-Lilley explains why.

 

Respiratory Generic Drugs

Dupixent Stopped at UK Gate For AD As EMA Agrees To Review It In Asthma

Dupixent has been initially rejected by NICE to treat eczema on cost grounds, but Sanofi remains hopeful of UK entry - and the biologic's overall promise.

Reimbursement Cost Effectiveness

Roche Gains With Tecentriq IMpower131 NSCLC Data, But For How Long?

Roche is "first to market" with Phase III Tecentriq data in first-line squamous NSCLC setting, but analysts note Merck and Bristol are not far behind.

Analysis Clinical Trials

New Hikma CEO Eyes M&A, Upbeat Despite Generic Advair Woes

 Sigurdur Olafsson is impressed with the balance sheet he has inherited at Hikma and said he is looking forward to both organic and inorganic growth.

M & A Generic Drugs
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