More than half a dozen generic rivaroxaban brands are now available in India, putting the heat on Bayer’s blockbuster anticoagulant Xarelto in the price-sensitive market. Many rival generics are priced over 50% lower than the innovator product.

Merck & Co.'s vericiguat, an sGC stimulator, was approved for heart failure but it enters a competitive space with a narrow indication.

CEO Amit Munshi told the J.P. Morgan meeting the company will double the size of its clinical-stage cardiovascular disease pipeline with the addition of temanogrel.

The Leverkusen-based firm has been touting the potential of its pharmaceutical pipeline which it hopes will be able to help soften the blow of patent expiries on the blockbusters Xarelto and Eylea in the next few years.

Putting aside the coronavirus pandemic for a while, and turning to industry’s more bread and butter R&D activities, Scrip takes a look at the industry’s biggest clinical trial hits and misses of the year.

The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.

The (virtual) doors closing on the J.P. Morgan Healthcare Conference is the sign for the biopharma industry that the new year has truly started, but before we get too far into 2021, Scrip has taken a look at five of the biggest non-COVID-19 story themes of 2020 in no particular order.

Biohaven’s investigational glutamate modulator troriluzole did not improve symptoms in patients with mild-to-moderate disease, adding to the list of failures in Alzheimer’s disease, as well as for the product itself.

Industry leaders share their expectations around COVID-19 for the coming year. Further product development and vaccine rollout will be key themes in 2021. Equitable supply and addressing the mental health challenges associated with lockdowns also loom large.

Join us for an audio catch-up on the latest key developments in the global biopharma industry, as reported by Scrip's global team, in this mini podcast version of Five Must-Know Things.

Lilly took a different path to positive results in Alzheimer’s with a smaller, biomarker-driven study to test the hypothesis that rapid, robust clearance of amyloid could slow disease progression, CEO David Ricks explains at J.P. Morgan.

Lilly reported positive results from a Phase II pivotal trial of donanemab, which targets a modified form of beta-amyloid called N3pG, and has a second pivotal Phase II study under way.

Great progress has been made in the treatment of RA with biologics and JAK inhibitors but there is a space for effective small-molecule therapies and Aclaris hopes to fill it with ATI-450.

GSK achieved a first-in-class market oncology launch in 2020, but will have to increase that hit rate in order to fulfil its blockbuster ambitions.

The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.

CEO Amit Munshi told the J.P. Morgan meeting the company will double the size of its clinical-stage cardiovascular disease pipeline with the addition of temanogrel.

Another UK biotech has been swallowed up by a big pharma with Sanofi acquiring the Cambridge-based firm in a deal that could be worth almost $1.5bn.

Having just filed efgartigimod in the US, the European biotech has signed up Zai Lab to help develop and sell the potential autoimmune blockbuster in China, where an estimated 200,000 people live with myasthenia gravis.

The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.

The SEEK spin-out ConserV Bioscience is developing a broad-spectrum coronavirus vaccine, aiming to get ahead of the arrival of new strains of the virus.

The company will seek emergency use authorization to prevent outbreaks in nursing homes. Regeneron is also positioning its antibody cocktail to prevent infections.

Valneva is scaling up manufacture of its coronavirus vaccine alongside the clinical development program, with a view to meeting its commitment to provide millions of doses for use in the UK and the EU.

Roche's Actemra is a major player in this space, but Humanigen is looking to take it on directly.

The company is developing a vaccine with both adenoviral and mRNA technology that could potentially overcome resistance mutations on the SARS-CoV-2 spike protein.

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Viatris debuts; Chi-Med charts its own path; Novo takes another go at obesity; Sangamo moves forward with CAR-Treg; Intercept readies for resubmission; and ImmunoGen is relying on a safety advantage for its ADC. 

Drug already approved for multiple rare genetic disorders of obesity shows significant weight-loss reduction in Bardet-Beidl syndrome, but not in the smaller indication of Alström syndrome.

Zealand has been hit by an unexpected Phase III failure for its glucagon analog product dasiglucagon in congenital hyperinsulinism, but all may not be lost for the indication.

Starting patients on a low dose yielded lower rates of GI adverse events for the GIP/GLP-1 agonist, but it remains uncertain how differentiated tirzepatide will be against entrenched GLP-1 rivals.

As Chinese returnees transform their startups to fully-fledged biopharma operations with a full product lineup and the global market in sight, the journey has been filled with challenges. Based on interviews and on-the-ground reporting, this new series takes a closer look at several companies' experiences.

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.

The ADC specialist could have a fourth cancer drug on the market this year and is preparing for its first commercial launch in Europe.

Key cancer asset is still looking for a Phase III validation after failing to outperform Keytruda in challenging frontline NSCLC setting.

Roche's Actemra is a major player in this space, but Humanigen is looking to take it on directly.

Ying Huang was named CEO as his predecessor came under investigation in China and as partner Janssen was getting closer to seeking US FDA approval for its lead CAR-T therapy.

The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.

GSK achieved a first-in-class market oncology launch in 2020, but will have to increase that hit rate in order to fulfil its blockbuster ambitions.

Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.

John Hood spent the past few years looking for a drug candidate worth forming a new company around before he zeroed in on Lilly’s taladegib as a treatment for idiopathic pulmonary fibrosis. 

The SOURCE failure is a reversal for the novel Amgen-partnered TSLP inhibitor after NAVIGATOR success last month, and comes just days after the US FDA requested more analyses of the pivotal data for the kidney disease anemia therapy roxadustat.

The UK’s Vectura plc is gaining value from its back catalog of novel compounds through licensing its pan-JAK inhibitor, VR588, to a US start-up, the venture capital-backed Kinaset Therapeutics.

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.

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.