The Swiss major’s CDK4/6 inhibitor has met the primary endpoint in a Phase II trial in first-line aggressive advanced breast cancer, supporting off-label use as the firm goes head to head with Pfizer’s rival drug Ibrance.

Nkarta has updated its early results for its natural killer cell therapy, where it has shown promising efficacy and potentially superior safety to existing CAR-Ts.

Janssen has dropped out of the running to acquire Irish biotech Horizon, leaving Sanofi and Amgen to vie over the potential megadeal, with some observers identifying the former as the better fit.

The FDA and Sarepta have had a controversial history with the accelerated approvals of the firm’s earlier drugs for Duchenne muscular dystrophy – but the company’s investigational gene therapy, SRP-9001, now under a priority review, could be a genuine breakthrough.

When Mads Øvlisen was persuaded by his father-in-law to join the family business, Novo Industri, in 1974 for a short stint in the legal department, little did he know it would the beginning of a lifetime of service to the company that he helped to shape into the diabetes powerhouse it is today.

The evolution of new drugs to treat diabetes has enabled some diabetes franchises to shrug off biosimilar competition to insulins. But is some of the growth of therapies for diabetes and obesity a result of the pandemic?

The German biotech announced in March that it was terminating the early-stage oncology R&D projects that came with its purchase of Constellation last year and Novartis has snapped up one of them.

Deal Snapshot: Akeso has already sought to secure FDA approval for its PD-1 inhibitor, but the agency has shown reluctance to approve drugs based on China-only data.

Janssen has dropped out of the running to acquire Irish biotech Horizon, leaving Sanofi and Amgen to vie over the potential megadeal, with some observers identifying the former as the better fit.

After failure to close of a potential $177m buyout by EW Pharma, TherapeuticsMD will resolve its debt by selling its three-product women’s health portfolio to Mayne.

Roivant will form a new "vant" company to develop and commercialize Pfizer's TL1A inhibitor for ulcerative colitis.

Transactions involving Biocon/Zentiva, CrystalGenomics/PanGen, Umoja/IASO, Marinus/Tenacia, Ono/Captor and Daewoong/HitGen plus deals in brief.

The German biotech announced in March that it was terminating the early-stage oncology R&D projects that came with its purchase of Constellation last year and Novartis has snapped up one of them.

When Mads Øvlisen was persuaded by his father-in-law to join the family business, Novo Industri, in 1974 for a short stint in the legal department, little did he know it would the beginning of a lifetime of service to the company that he helped to shape into the diabetes powerhouse it is today.

More foreign pharma firms, this time Sanofi and GSK, are reorganizing sales and marketing efforts accompanied by layoffs in India. Scrip talks to experts about what’s driving the right-sizing and the wider trend.

The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab. 

The positive Phase II/III results for acoziborole have led researchers to claim that the goal of eliminating sleeping sickness by 2030 is now very much a reality.

Some entrepreneurs combine talent and experience to produce multiple profitable exits for investors. But there are many who do not, and past success is indeed no guarantee of future performance.

The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab. 

United Health's pharmacy benefit manager outlined plans for early inclusion of up to three biosimilar versions of adalimumab on its formularies in 2023, at parity to the brand.

Multi-product players may be able to use bundled rebates for preferred formulary status and biosimilars offer a new competitive dynamic, but there is hope for novel therapies.

Multi-product players may be able to use bundled rebates for preferred formulary status and biosimilars offer a new competitive dynamic, but there is hope for novel therapies.

Remission rates with existing therapies leave much room for improvement, so a variety of treatments are needed – leaving major players attempting to carve unique paths in a crowded market.

The ulcerative colitis and Crohn’s disease landscapes may shift soon but new drugs will compete with entrenched blockbusters, including Humira, Stelara and Entyvio, with biosimilars on the way.