Therapy Areas

Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.

The US major is investing over $360m in new money into the UK but the country has being losing its lustre as an appealing place to invest since Brexit and needs to offer more to multinationals.

The IL-23 antagonist Omvoh is under FDA/EMA review for Crohn’s disease; Lilly reported new Phase III data showing the drug is better than Stelara on multiple endpoints of histologic response.

The payout will bring GSK closer to resolving lawsuits which have occupied it for years – though investors are now likely to focus on new product growth concerns at the UK firm.

Arexvy has become the first RSV vaccine to show it can provide protection over three years – but that might mean lower market uptake than originally expected.

One of Enanta’s two antivirals in development for RSV showed efficacy in a healthy patient challenge trial. But analysts say field studies of infected patients are more telling.

Deal Snapshot: Merck likes the look of Evaxion's artificial intelligence-based technology platform to develop immunotherapies and signed a biobucks deal that will help ease the Copenhagen-headquartered biotech's financial situation.

The company said the CENTERSTONE study marked the first time a global Phase III trial showed reduced transmission of influenza.

Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.

The Swiss company is aiming to regain its innovator status and expand its offering across all breast cancer settings. Approval of Itovebi is just the start.

Recent major developments in the Korean biotech sector include Orum Therapeutics’ IPO plan and HLB’s US resubmission for the approval of rivoceranib in combination with camrelizumab for first-line liver cancer.

The TCR therapy showed strong efficacy and durability in patients with previously treated melanoma. A Phase III pivotal trial is due to start in December.

The Swiss major’s global health chief Lutz Hegemann tells Scrip on a trip to Rwanda that being a profitable enterprise while helping to improve access to new and older therapies for those who need it most is the real measure of a successful business.

Lotilaner, the active ingredient in Tarsus’s Demodex blepharitis drug Xdemvy, showed significant ability to kill ticks in a small Phase IIa study. Analysts call the Lyme program a likely out-licensing opportunity for Tarsus.

Gains from its COVID-19 vaccine made Serum Institute’s founder the world’s richest healthcare billionaire. But the demand for boosters hasn’t materialized as expected, leading to a deal with Biocon being tweaked. Meanwhile, gains from India’s first indigenously-developed HPV vaccine and Oxford-partnered malaria vaccine seem imminent.

Immix collaborates with Israeli research institutions on BCMA-targeted CAR-T therapy. NeoImmuneTech/NIAID alliance could pave way for “animal rule” approval in acute radiation syndrome.

The US FDA approved the drug for hemophilia A and B, and while it may struggle to compete in hemophilia A against Roche’s Hemlibra, it has a big convenience advantage in hemophilia B.

Once the deal with Sanofi closes, the rare disease drug will become one of Recordati’s fastest forecast sellers.  

The withdrawal amid concerns about the risk-benefit ratio reduces treatment options for sickle cell disease, but it is not expected to have much effect on the SCD market, including the gene therapies.

US FDA approval of Niktimvo for third-line chronic GVHD, a competitor to Sanofi’s Rezurock, came less than two months ahead of anticipated approval of Syndax’s leukemia drug revumenib.

The $100m upfront deal help AZ to fill out its cardiovascular, renal and metabolism portfolio, now joining Lilly in seeking to develop an oral Lp(a)-targeting therapy.

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

At an investor meeting in London, the Swiss company sets out plans for more disciplined decision-making to help it launch a new wave of blockbuster drugs.

An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.