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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Amgen Hands Omecamtiv Back To Cytokinetics

While Amgen said the Phase III GALACTIC-HF results for omecamtiv mecarbil did not meet its high expectations for the heart failure candidate, Cytokinetics sees a path to treating certain patients.

Deals Cardiovascular

Pharvaris Oral HAE Candidate Heading Into Phase II In 2021

European biotech Pharvaris has received series C funding to support its novel potential therapy for hereditary angioedema, in a competitive sector of drug development.

Cardiovascular Financing

Cytokinetics Sees Omecamtiv Potential In Certain Heart Failure Patients

Detailed data for omecamtiv mecarbil at AHA show a slim overall benefit, but Cytokinetics highlighted its effects in sicker patients and investigators emphasized the drug’s impact on reduced hospitalizations.

Clinical Trials Cardiovascular

Ionis, AstraZeneca To Use Real-World Data To Accelerate RNA-Targeting Cholesterol Drug

Early data presented at the American Heart Association showed strong PCSK9 and LDL cholesterol lowering for ION449; AstraZeneca plans rapid development under an RWE-based FDA pilot program.

Research & Development Analysis

Troubled Bayer Boosted By Big Two Pharma Earners

While the legal woes over the seeds giant Monsanto continue, the German group's pharmaceuticals business posts unspectacular third quarter results.

Sales & Earnings Strategy

Novo Nordisk Eyes Residual CV Risk In Atherosclerosis With Ziltivekimab

With GLP-1 sales increasing by 31% in the third quarter, Novo Nordisk has raised its sales and operating profit outlooks for 2020 to 5-8% at CER, and has outlined promising R&D progress against atherosclerosis and obesity.

Cardiovascular Inflammation
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CNS

Set Alert for CNS

Latest From Neurology

GemVax Aims For Alzheimer’s 'Game Changer' As Phase III Approaches

After announcing positive topline Phase II results for its Alzheimer’s candidate late last year, Korea's GemVax releases additional data showing significant improvement in secondary outcomes, further raising expectations for the novel peptide drug.

South Korea Clinical Trials

D&D Pharmatech Confident As It Takes On Parkinson’s, Alzheimer’s

After completing a major financing last year, expectations are rising at D&D Pharmatech as it progresses large-scale, Phase II global trials with its neuroinflammation pipeline for Parkinson’s and Alzheimer’s disease. Its CEO talks to Scrip about what's in store for the South Korean biotech.

Neurology Research & Development

BrainStorm's Cell Therapy Disappoints In Phase III ALS Study

Top-line results from BrainStorm’s NurOwn Phase III ALS study show the cell therapy missed the primary efficacy endpoint, but clinically meaningful responses were seen in a pre-specified subgroup which investigators considered potentially a significant step forward in therapy.

Neurology Clinical Trials

Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections

Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.

Drug Approval Standards Manufacturing

ADDF’s Fillit On FDA’s Tough Aducanumab Decision, Advances In Alzheimer’s

The pending US FDA decision on Biogen’s drug overshadows progress in Alzheimer’s diagnosis, symptomatic treatments and the need to keep studying anti-tau therapies after Roche’s setback.

Neurology Research and Development Strategies

UCB Acquires Belgian Gene Therapy Firm Handl

The Brussels-based company has leant on its local knowledge to snap up Leuven-headquartered biotech Handl and its proprietary AAV capsid technology platform.

M & A Gene Therapy
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Janssen's Tremfya Gains Psoriatic Arthritis Indication In EU

The European Commission has extended the indications for Janssen’s Tremfya to include psoriatic arthritis, and those for BMS’s Opdivo to include gastroesophageal cancer.

Cancer Approvals

Hotter Than Oncology? China Immunology Players Raise $650m

The China bioventure sector is poised to set a record for initial public offerings and fundraising, but one therapeutic area is taking a surprise lead - immunology.

China Financing

Arena Sees Phase III Path For Etrasimod After Atopic Dermatitis Miss

Arena said its S1P receptor modulator missed the primary endpoint in a Phase IIb trial but data from patients with uninterrupted treatment justify moving etrasimod into a pivotal program.

Clinical Trials Gastrointestinal

Positive Atopic Dermatitis Data On Lilly's Newly-Approved Olumiant

It has gone under the radar that Eli Lilly and Incyte's Olumiant has recently become the first JAK inhibitor to be approved anywhere for atopic dermatitis and the companies have been touting promising long-term data on the therapy as it expands beyond rheumatoid arthritis.  

Approvals Immune Disorders

Novartis's Cosentyx Climbs Despite Competitors And COVID-19

CEO Vas Narasimhan told Scrip how impressed he was by the resilience of the brand and while Cosentyx is holding its market share in dermatology, its rheumatology sales are continuing to fly high.

Sales & Earnings Strategy

Aimmune's Peanut Immunotherapy Palforzia Gets CHMP Backing

Palforzia will almost certainly be the first treatment to get the green light for peanut allergy in Europe and its new owner will be hoping for a more successful launch than has been seen in the US.

Drug Review Europe
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

A Stroke Of Luck Boosts Oxford/AZ’s “Vaccine For The World”

AstraZeneca's research head admits that the half dose approach was a lucky mistake – but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.

Coronavirus COVID-19 Companies

Regeneron COVID-19 Cocktail’s Flame To Burn Brightly But Unclear For How Long

Lilly has launched a similar antibody product, but demand is expected to outpace supply for the foreseeable future.

BioPharmaceutical Infectious Diseases

Oxford/AZ Vaccine Hits 70% Efficacy In Phase III Trials

Topline results have produced a lower efficacy rate than seen in the Pfizer and Moderna trials, but a subgroup receiving a half-dose in their first injection showed a 90% efficacy result.

Coronavirus COVID-19 Companies

Regeneron Leaders On Getting A Call From Trump And Building A Bioreactor Farm

Regeneron CEO Len Schleifer and President George Yancopoulos talked at the Stat Summit about launching their COVID-19 antibody cocktail and planning for the next pandemic.

Coronavirus COVID-19 Manufacturing

Gilead’s Lenacapvir May Offer Twice-Yearly HIV Salvage Therapy

A first-in-class capsid inhibitor for HIV, lenacapavir has produced strong efficacy data for viral load reduction in treatment-experienced patients. The data measure up well against Viiv’s Rukobia, analyst says.

Clinical Trials Business Strategies

Coronavirus Update: CureVac's EU Vaccine Deal, J&J's New Vaccine Study, BioNTech/Fosun Get China Go-Ahead

CureVac seals EU Deal for 405 million doses of CVnCoV, a second Phase III trial for J&J’s COVID-19 vaccine starts, and BioNTech, Fosun get OK for China vaccine trial.

Clinical Trials Companies
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Stockwatch: The Lexicon Of Biotech Survival

Lexicon’s announcement of two positive cardiovascular outcome studies was tempered by the realization that its drug is not approved in the US, nor in Europe in the diabetic populations studied.

Sales & Earnings Research and Development Strategies

Novo Nordisk Pays $1.80bn To Buy Emisphere

The Danish major will develop the US firm's technology and use it on current and future pipeline assets with the aim of making more biologics orally available.

M & A Metabolic Disorders

Approval Beckons For Orchard’s Gene Therapy Libmeldy

Orchard Therapeutics is on the cusp of the first approval for its ex vivo gene therapy, Libmeldy, for metachromatic leukodystrophy.

Companies Gene Therapy

$1bn Deal Boosts Takeda, Arrowhead’s Liver Disease And RNAi Ambitions

Takeda's global deal for one of US RNAi specialist's lead assets follows recent promising clinical results in serious disorder with no current therapeutic options.

Commercial Deals

Daewoong Readies Diabetes Contender Enavogliflozin, Aiming For '23 Launch

With multiple South Korean INDs to begin Phase III trials with its SGLT-2 inhibitor enavogliflozin, Daewoong is aiming to speed domestic and global development of the potentially best-in-class drug for type 2 diabetes.

South Korea Clinical Trials

Indo-German Collaboration Delivers Novel Diabetic Foot Ulcer Treatment

Centaur-CytoTools introduces novel topical treatment for diabetic foot ulcers in India, for which they see limited direct competition and hope to change the way the difficult-to-treat diabetes complication is managed. Phase III studies are ongoing in Europe.

Commercial India
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Oncology

Set Alert for Oncology

Latest From Cancer

Janssen's Tremfya Gains Psoriatic Arthritis Indication In EU

The European Commission has extended the indications for Janssen’s Tremfya to include psoriatic arthritis, and those for BMS’s Opdivo to include gastroesophageal cancer.

Cancer Approvals

BioNTech Looks To AI Partnership To Accelerate Drug Discovery

The German biotech has developed its COVID-19 vaccine in record-breaking time, but artificial intelligence could help accelerate drug discovery over the longer term.

Artificial Intelligence Cancer

Genmab Accelerates Priority Candidates, Ends Enapotamab Vedotin Development

Denmark’s biotech Genmab has dropped the AXL targeted antibody-drug conjugate, enapotamab vedotin from early clinical development, and is focusing its resources on other therapeutic programs.

Cancer Research and Development Strategies

SynOx Seeks Solution For TGCT With Roche Antibody

The UK's Celleron has attracted a "blue chip suite of investors" to an Irish-domiciled spin-off based on the potential of Roche-developed emactuzumab for TGCT, a debilitating orphan disease that causes joint damage and has limited clinical options.

Financing Rare Diseases

Keytruda Combination Gives Celyad’s Off-The-Shelf CAR-T A Shot In The Arm

Celyad has been in the CAR-T field for many years, but hopes that a new focus on allogeneic platforms and new targets will put it ahead of competitors. 

Companies Cancer

BeiGene’s PD-1 Remains Solid In First Global Pivotal Study

Tislelizumab meets overall survival endpoint in later-line NSCLC at planned interim analysis, but faces exploding competition in the Chinese immuno-oncology sector.

Cancer Clinical Trials
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Novartis Puts Down $50m For Mesoblast COVID-19 Cell Therapy

The Australian company's off-the-shelf cell therapy fell foul of the US FDA for graft-versus-host disease recently but Novartis is backing remestemcel-L as a potential treatment for acute respiratory distress syndrome.

Coronavirus COVID-19 Deals

Boehringer, Bridge IPF Deal Collapses On Toxicity Concerns

The termination of a major idiopathic pulmonary fibrosis collaboration between Bridge Biotherapeutics and Boehringer Ingelheim is a blow to both companies in an increasingly competitive indication, but the Korean biotech says it's still committed to further development of the autotaxin inhibitor and will work out a future development plan.

Commercial Respiratory

NAVIGATOR: Tezepelumab Could Transform Severe Uncontrolled Asthma Care

In top-line results from the Phase III NAVIGATOR study, AstraZeneca/Amgen’s human monoclonal antibody tezepelumab has significantly reduced disease exacerbations in patients with severe asthma regardless of their type of inflammation, including those with low eosinophil counts.

Respiratory Clinical Trials

The Curious Case Of The Pandemic And AstraZeneca’s Pulmicort In China

China’s adherence to face masks to protect against COVID-19 has also helped children avoid other respiratory infections.

China Respiratory

AZ's Fasenra Gets Boost From Steroid-Sparing Data

The POTENTE trial demonstrated Fasenra’s impact in eliminating or reducing oral corticosteroid use for severe asthma patients, which should help AstraZeneca as it takes on GlaxoSmithKline’s rival IL-5 inhibitor, Nucala.

Respiratory Strategy

Cut-Price Generics Set To Challenge Boehringer’s Nintedanib In India

Glenmark and Sun Pharma introduce nintedanib generics in India at a fraction of the innovator product’s price, vying for a share of the IPF market where pirfenidone currently holds sway.

India Generic Drugs
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