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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

InCarda Gets $30m Closer To Inhalable AF Drug/Device Therapy

The first close of a series C financing should enable InRhythm to enter Phase III as an inhalable anti-arrhythmic for paroxysmal atrial fibrillation in a medically supervised setting.

Financing Research and Development Strategies

Stockwatch: Some Failed Drugs Never Die, They Just Find New Investors

Drugs that have failed in clinical studies often come back for another go, making the same mistakes for a new cohort of investors who missed the first failure. The global pandemic is also enabling this for once- or twice-failed drugs.

Research and Development Strategies Research & Development

Amgen/Cytokinetics Phase III Heart Failure Data Are Below Expectations

Analysts considered the Phase III GALACTIC-HF study of omecamtiv mecarbil a failure but some anticipated that detailed data to be presented next month could at least partially redeem the drug.

Cardiovascular Clinical Trials

BMS Buys MyoKardia, Plans To Use Eliquis Experience To Grow Mavacamten

Paying $13.1bn for MyoKardia and its potential first-in-class HCM drug, BMS sees a blockbuster sales opportunity that it will grow gradually. MyoKardia team will be absorbed into BMS, Caforio says.

M & A Business Strategies

Stockwatch: Esperion – Bonfire Of The Surrogates

For a biotech launching its first product the pandemic has compounded the usual pressures of a competitive indication against deeper-pocketed competition.

Stockwatch Companies

Silence Therapeutics Continues Transformation, Improves US Visibility

The UK's Silence Therapeutics is moving its candidate products into early clinical studies in cardiovascular diseases and improving its visibility with a NASDAQ listing.


Financing Gene Therapy
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CNS

Set Alert for CNS

Latest From Neurology

Novartis Takes Huntington's Path With SMA Therapy Branaplam

With Roche's oral spinal muscular atrophy therapy Evrysdi off to a strong start after its recent US launch, Novartis is switching its priorities for rival RNA-splicing drug branaplam and putting it into a Phase IIb trial for Huntington's disease.

Neurology Clinical Trials

Kyowa Kirin’s Parkinson’s Successor Shows Phase IIb Promise

Positive clinical results pave path forward for Japanese firm’s potential istradefylline successor.

Clinical Trials Research & Development

Tecfidera Headwinds Could Mean Cuts At Biogen, Unless Aducanumab Succeeds

Biogen lowered revenue guidance for the year by $600m due to Tecfidera generics and said it could consider broader cost cuts in 2021 depending on the outcome of aducanumab at the US FDA.

Business Strategies Sales & Earnings

Is Biogen’s Aducanumab Approvable? Opinions Divided Ahead Of Review

Many clinicians doubt that aducanumab can really help slow the decline in Alzheimer’s patients – but  US FDA could offer it the benefit of the doubt.

Commercial Companies

Aptinyx To Forge Ahead With Pivotal PTSD Study

Positive Phase II data for Aptinyx’s novel NMDA receptor modulator are strong enough to take the product into a pivotal study in this difficult-to-treat area.

Clinical Trials Companies

Lilly Tries New Neuro Approach With Disarm Buyout

Deal Snapshot: Lilly bets $135m on biotech’s preclinical SARM1 inhibitor program, seeing potential in peripheral neuropathy and possibly some bigger targets in neurology like MS and ALS.

M & A Deals
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

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

Belgium's Argenx Advances On More Positive Efgartigimod Data

Argenx's efgartigimod, an antibody fragment that blocks FcRn, looks most likely to be the first drug to challenge Alexion's Soliris in the myasthenia gravis market after the company presented more positive data from the ADAPT trial.

Rare Diseases Clinical Trials

Shaking Off US Rebuff, Gilead And Galapagos Get Filgotinib Green Lights In EU And Japan

Galapagos and Gilead's JAK inhibitor has been approved for rheumatoid arthritis in the second and third biggest pharma markets, softening the blow somewhat of rejection from the US FDA in the biggest market last month.

Approvals Immune Disorders

Sun’s Ilumya To Claw Into Japanese Psoriasis Market

Tildrakizumab debuts in Japan, marking a key milestone for Sun Pharma, though heavyweight competitors including same class rival Skyrizi are already available on the market there.

Immune Disorders Launches

Merck KGaA Rebounds After COVID-19 Lockdowns

The coronavirus pandemic hurt the German group's healthcare division but helped the contract development and manufacturing activities of Merck's life sciences business.

Sales & Earnings Business Strategies

Ziritaxestat Phase II Success Gives Galapagos Something To Cheer

It has been a tough couple of months for the Belgian biotech since the FDA surprisingly rebuffed its JAK inhibitor filgotinib but promising data on the oral autotaxin inhibitor ziritaxestat helped soften the blow and drive up Galapagos stock.

Clinical Trials Companies
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Coronavirus COVID-19 Vaccines

US COVID-19 Vaccine Adcomm: First Take-Aways

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.

Coronavirus COVID-19 Vaccines

Pfizer/BioNTech COVID-19 Vaccine Will Miss US Election, Bourla Clarifies

Pfizer CEO says that an EUA request for its COVID-19 vaccine is unlikely before late November. Analyst calls Pfizer’s development pace an encouraging sign it could be a more nimble company.

Coronavirus COVID-19 Drug Approval Standards

Coronavirus Update: No Mortality Gains From Remdesivir In WHO Trial, Gilead Questions Results

Plus Sanofi and Translate Bio release preclinical data from their COVID-19 vaccine candidate, another entrant to the now crowded mRNA vaccine field.

Companies Clinical Trials

Regeneron's Inmazeb Approval For Ebola Paves The Way In COVID-19

The US FDA approved the first antibody cocktail for ebolavirus infection, supporting a supply contract with BARDA. The development experience informed Regeneron's work in COVID-19.

Infectious Diseases Approvals

Synairgen Supercharges R&D With $100m Financing

With a candidate COVID-19 therapy in clinical development, the UK’s Synairgen has raised $101m on the UK’s AIM to support clinical studies and manufacturing plans.

Financing Coronavirus COVID-19
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Metabolic

Set Alert for Metabolic

Latest From 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

Quick Listen: Scrip’s Five Must-Know Things

Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of developments in the global biopharmaceutical industry.

Clinical Trials Coronavirus COVID-19

Korea Gains Speed In Race For NASH Therapies

NASH has become a major therapeutic focus for pharma firms in South Korea, where companies are speeding up development and expanding their pipelines after Yuhan’s sizable global license deals last year.

South Korea Research and Development Strategies
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Oncology

Set Alert for Oncology

Latest From Cancer

With $850m, Nuvation Aims To Speed Novel Cancer Drugs To Patients

Nuvation started in 2018 and raised a $275m series A round in 2019. Now it is merging with the EcoR1 Capital-sponsored SPAC Panacea Acquisition Corp. and raising $500m in equity capital.

Financing Deals

Voronoi’s Brain-Permeable NSCLC Candidate Attracts ORIC To Major Deal

Through a licensing-out deal with ORIC for its EGFR/HER2 exon-20 inhibitor, South Korea's Voronoi hopes to gain from its new partner's commercialization experience in NSCLC. The alliance aims to build a potentially best-in-class presence in a competitive landscape.

Cancer South Korea

Quick Listen: Scrip’s Five Must-Know Things

Join us for a brief audio roundup of the major developments in the international biopharma industry over the past week, as covered by Scrip's global team.

Coronavirus COVID-19 Deals

Kite’s Tecartus PRIMEd For EU Market With CHMP Nod

Gilead/Kite’s second CAR-T product is given the go-ahead for approval by the CHMP for mantle cell lymphoma.

Approvals Companies

From Undruggable To Druggable: Activating Protein Phosphatase 2A, Rappta's New Approach To Cancer

The development of first-in-class anticancers that activate protein phosphatase 2A is the aim of the Helsinki-headquartered Rappta Therapeutics. It has just raised €9m in a series A involving top-tier biotech VCs to move promising candidates towards the clinic.

Financing Cancer

New Data Set Up Padcev For Potential Expanded Use

Positive top-line data from a second pivotal trial cohort are set to support regulatory filings for the ADC in patients whose cancer has progressed after immunotherapy but are ineligible for cisplatin.

Clinical Trials Research & Development
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

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

Ionis Inhaled Antisense Drug Shows Potential In CF

The Phase I trial of IONIS-ENAC-2.5Rx for cystic fibrosis represents the first time an antisense medicine delivered directly to the lung has shown a significant reduction in ENaC messenger RNA levels.

Respiratory Clinical Trials

Sanofi Touts Positive Dupixent Data For Severe Childhood Asthma

Dupixent is already is a big seller in severe asthma in adults and adolescents but Sanofi is looking to expand the label after presenting data showing that it is the only biologic in Phase III trial to have demonstrated improved lung function in children.

Respiratory Clinical Trials

Roche Returns To Cystic Fibrosis Fray With Enterprise Deal

While Vertex appears to have the cystic fibrosis market covered with its CFTR modulators, Enterprise has been exploring another channel, TMEM16A, in the hope of developing compounds that could possibly be used by everybody with the lethal genetic disease.

Respiratory Deals

Sanofi Files New Pompe Hope Avalglucosidase Alfa In EU

The French drugmaker is looking to consolidate its dominance of the Pompe disease area by filing its successor to Myozyme in Europe, but Amicus Therapeutics' potential rival AT-GAA is on the horizon.

Rare Diseases Clinical Trials

Ziritaxestat Phase II Success Gives Galapagos Something To Cheer

It has been a tough couple of months for the Belgian biotech since the FDA surprisingly rebuffed its JAK inhibitor filgotinib but promising data on the oral autotaxin inhibitor ziritaxestat helped soften the blow and drive up Galapagos stock.

Clinical Trials Companies
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