The Phase III FIDELIO trial of finerenone has been a success but analysts want to see some actual data before declaring it an unqualified one.

Over 150 medical charities including the British Heart Foundation and Cancer Research UK are forecasting a 41% decrease in their research budgets over the next year and are demanding £310m in 2020/21 from the UK government as part of a matched funding program.

Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.

The Phase III EXPLORER-HCM trial evaluating mavacamten in obstructive hypertrophic cardiomyopathy (oHCM) succeeded on all primary and secondary endpoints.

AstraZeneca's biopharmaceuticals president Ruud Dobber tells Scrip that the price for Farxiga in the heart failure indication should reflect its potential to improve survival and reduce the need for hospitalization.

AstraZeneca, during a strong first-quarter update, underscored its determination to test existing portfolio assets for use in fighting the COVID-19 pandemic.

EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.

More progress for partners’ amyloid-targeting antibody portfolio as they look to demonstrate benefit of early intervention in pre-symptomatic disease in new collaborative Phase III trial.

Biogen/Eisai’s US filing of aducanumab for Alzheimer’s has a ripple effect in China, where a leading biomedical researcher has publicly questioned data for the country’s first approved drug for the disease, GV971.

Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.

The Swiss biotech will be hoping that the improved daytime functioning seen with daridorexant in trials will allow the drug to complete in the DORA class led by Merck & Co's Belsomra and Eisai's Dayvigo.

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

After talking with the FDA, Atox will file an NDA for its necrotizing soft tissue infections therapy despite missing primary endpoints in a pivotal trial, the biotech’s CEO tells Scrip.

An ultra-fast-acting allergy immunotherapy to induce tolerance to house dust mites is being sought in a collaboration between two Swiss biotechs, Anergis and Virometix.

Kymera will receive $150m upfront from Sanofi in a deal the big pharma views as an opportunity to develop a breakthrough oral drug for atopic dermatitis and other conditions.

Gesynta’s SEK190m ($20m) private placement allows its lead asset to enter Phase IIa studies for treating chronic inflammatory conditions in certain systemic sclerosis patients.

AbbVie Japan has seen strong growth for its commercial and R&D portfolios over the past few years, but with flagship product Humira facing its first local biosimilar competition, the company is looking to brand strength and an increased oncology presence to address the challenge.

Sanofi's R&D operation has shaken the dust of diabetes off its feet with an update on its ambitious pipeline plans at an R&D day event.

A round-up of developments in the COVID-19 vaccine field from Moderna, Fosun, Merck & Co and Medicago and more.

Neutralizing antibodies were seen in all 45 people injected across three dose levels in the first-in-human study. The middle dose of 100mcg will be tested in the company’s Phase III trial starting 27 July.

The granting of fast-track status is a clear signal that the US FDA wants to maintain its high standards of drug and vaccine appraisal.

EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.

Leader of London university's vaccine contender hopeful of breakthrough in early 2021, but thinks Oxford's forecast of September overly optimistic.

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

The Phase III FIDELIO trial of finerenone has been a success but analysts want to see some actual data before declaring it an unqualified one.

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.

Sanofi's R&D operation has shaken the dust of diabetes off its feet with an update on its ambitious pipeline plans at an R&D day event.

Novo Nordisk is paying $725m to acquire the VC-backed US biotech, Corvidia Therapeutics and its promising Phase II candidate, ziltivekimab, for chronic kidney disease, but further payments could total more than $2bn.

Eighty-eight insurers who offer Medicare Part D plans are interested in the demonstration project, which would limit insulin copays to $35.

Sanofi’s decision to return to originator Hanmi all rights to the novel diabetes candidate efpeglenatide, which is in global Phase III trials, has placed the South Korean pharma in a difficult spot. Unless there are some surprisingly positive data, finding a major global partner for commercialization may be tough.

Licensed from PharmaMar for the US market at the start of the year, Jazz Pharmaceuticals is hoping its new small-cell lung cancer therapy, Zepzelca (lurbinectedin), may have potential for other cancer types and in different combinations.

The antibody-drug conjugate now looks set for US approval, but its limitations leave plenty of scope for CAR-T and bispecific rivals.

The collaboration between the Swiss major and Blueprint Medicines, which could be worth up to $1.7bn, should help pralsetinib provide stiff competition to Eli Lilly's RET mutation drug Retevmo.

EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.

Lead immuno-oncology asset NC318 targeting Siglec-15 showed encouraging early activity in patients refractory to PD-1/L1 inhibitors, but now Phase II plans are scuttled in lung and ovarian cancers.

Company told more measures needed to limit damage to patients' eyes caused by antibody drug conjugate.

The Swiss company's asthma triplet is now approved in Europe and Japan but Enerzair is well behind GSK's rival LABA/LAMA/ICS in the US where Novartis's product has not even been submitted yet.

The UK firm has tapped into EU funds through an Irish subsidiary to advance its treatment for acute respiratory distress syndrome based on a reformulation of Novartis's Gleevec.

Verona Pharma’s candidate COPD therapy ensifentrine has a first-in-class dual mechanism of action and is to be explored as an add-on to LAMA and LABA therapy in two Phase III clinical studies.

Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.

Abivax will test its anti-inflammatory ABX464 in early COVID-19 patients after the small molecule showed it could reduce SARS-CoV-2 viral replication in human lung tissue in addition to its anti-inflammatory and tissue-healing effects.    

Glenmark rolls out three-in-one inhaler therapy for COPD in India and hopes to address challenges faced by patients suffering from the severe form of the disease. Some early physician outlook appears mixed for the new combination in a segment where leading respiratory player Cipla has an established product.