The failure of the SGLT2 inhibitor is not unexpected, but allays any concerns that it could have worsened outcomes for patients with hypertension or heart disease.

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Pfizer is looking to address breast cancer resistant to Ibrance and other CDK4/6 inhibitors, but sees potential paths to earlier lines of treatment and additional tumors.

Interview: CEO Jean-Paul Kress talked to Scrip about the US launch of Monjuvi, commercial expansion and the aspiration to build a European biotech that can compete in the big leagues.

Entries for the Scrip Awards are now open. Now in their 17th year, the Awards seek to reward the outstanding achievements of the pharmaceutical, biotech and allied industries in improving human health and will take place in London on 2 December.

The EMA and MHRA issue parallel safety updates on the vaccine, with the UK offering an alternative of the Pfizer/BioNTech or Moderna vaccines to the under 30s.

Oncology partnership with Swiss major follows late 2020 pact with Merck KGaA. Pfizer divests Phase Ib breast cancer candidate to Celcuity.

Kyorin, Eisai build on earlier OAB deal to team on vibegron. Plus deals involving Piramal/Hemmo, ImmuneOncia/3D Medicines, Kyowa Kirin/Cerecor, Simcere/Kazia, Nippon Shinyaku/Menarini, Tarsus/LianBio

In an unprecedented move, eight of India’s top pharma companies, including Sun Pharma, Cipla, Torrent and Lupin, have set up a common vehicle for digitization initiatives. Having acquired local market research firm AIOCD AWACS and B2B platform Pharmarack, could the mandate extend to other services?

Q2 promises to be ‘transformational’ for AbiVax, propelled by key readouts for investigational anti-inflammatory, ABX464, and cancer agent, ABX196, but more funds will be needed by year end.

Cidara partners its antiviral conjugate platform for seasonal and pandemic influenza with Janssen, which also gets option rights to an AVC candidate for respiratory syncytial virus.

South Korean conglomerate SK Group continues its cross-border acquisitions of contract manufacturers, this time of French biologics specialist Yposkesi, marking a new push into the gene and cell therapy sector as it looks to become a global leader in the production of both innovative chemical drugs and biologics.

The Danish biotech's stock sank after arimoclomol failed in a Phase II/III trial for inclusion body myositis. Orphazyme is hoping for much better news in the coming weeks as the US FDA makes its decision on the drug as a treatment for Niemann-Pick disease Type C.

The rise of the biosimilars has been predicted for many years, but the commercial dynamics after complex biologic drugs’ loss of exclusivity suggests that it may not be so straightforward.

Destiny Pharma's XF-73 achieved an "exceptionally high" 99.5% reduction in Staphylococcus aureus bacterial nasal carriage in a mid-stage trial, a result that should attract a number of potential partners for the UK firm.

Boehringer Ingelheim’s incoming India managing director outlines intent to scale up in areas including diabetes and stroke, as the private German multinational seeks to move up the rankings in the competitive Indian market. Enabling the global pipeline in field including immunology, CNS and oncology also part of the effort.

After a fresh cash injection, Step is ready to take STP938 for the treatment of T-cell blood cancers into Phase I trials in February.

Jardiance and Ofev are growing strongly but the German drugmaker is also confident its pipeline will bear fruit, boosted by a rising research budget that represents almost 23% of sales.

A new pilot program by the insurer is offering a $500 debit card to patients who switch from the blockbuster Novartis psoriasis drug to Lilly's rival Taltz or other preferred drugs.

Lilly Bio-Medicines president Ilya Yuffa oversees newer products in competitive therapeutic areas and drug classes, but additional indications and new therapies within the group’s immunology, pain and neuroscience focus areas will capitalize on the group’s existing commercial expertise. 

The head of Novartis Gene Therapies in Europe tells Scrip that innovative payment models and involving all stakeholders have helped payers see beyond a simple price tag and see the benefits of a one-time gene therapy for spinal muscular atrophy.

The impact of the coronavirus pandemic on the size of the pharma R&D pipeline in 2020 could be felt in a number of ways.

Around 100 executives highlight the hot areas to watch on the R&D front in 2021. From cancer to CNS and from regenerative medicine to real world data, expectations are high on many fronts.

Executives expect the changes wrought by necessity in the face of a global pandemic to have lasting effects, both positive and negative, on the biopharma sector. Here they share their predictions for the coming year.