Strategy

Ozempic debuts in India, priced in the ‘affordable zone’ for the country's population, with Novo Nordisk hoping the blockbuster drug can hold its own post impending loss of exclusivity in the country next year.

The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.

Arcus is ending development of its TIGIT-targeted antibody domvanalimab after it was determined a Phase III study would not show a survival benefit in gastrointestinal cancers.

The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.

Triple agonist retatrutide yielded 28.7% weight loss at 68 weeks, besting Zepbound’s Phase III data, while also showing benefit in knee osteoarthritis pain.

Subsidiary Pulmovant plans to report Phase II data in pulmonary hypertension associated with interstitial lung disease in 2026, one of several programs highlighted during an investor event.

FOPO Edition: Capitalizing on positive data, eight drug developers priced follow-on public offerings that brought in $3.2bn, including $650m each for Terns and Structure plus $602m for Kymera.

With its M&A war chest diminished and still seeking to add to its weight-management pipeline, Pfizer obtains an oral GLP-1 analog from Fosun subsidiary YaoPharma.

Early atopic dermatitis data on the oral STAT6 degrader helps the US firm’s hopes of matching the Sanofi and Regeneron injectable blockbuster on efficacy.

Dyne’s data from a larger Phase I/II trial cohort showed much greater dystrophin production with z-rostudirsen (DYNE-251) than seen with Sarepta’s Exondys 51 and some functional gains.

With three approved drugs and volixibat in pivotal studies for two cholestatic liver diseases, Mirum is betting $570m in cash and equity to pick up Bluejay’s Phase III hepatitis D candidate.

The Polish biotech says that data presented at the Orlando meeting also strengthens its confidence in the CDK8/19 inhibitor's potential across hematologic cancers with limited treatment options.

The consolidation of Biocon-BBL is expected to unlock value, deliver operational synergies and provides BBL’s minority shareholders an 'earlier liquidity event'. Investor Viatris also signals accelerated expiration of biosimilars non-compete restrictions.

Hanmi Pharm Group announces new mid-term strategy including expansion of its obesity focus to aging with goal of more than doubling revenue by 2030 and becoming a true global player.

Public Company Edition: Uncertainty about the US FDA’s direction earlier in the year caused biotech stocks to sag, but recent leadership upheaval has not sunk the XBI. Also, Belite raised $350m, Capricor grossed $150m and Immatics brought in $125m in follow-on offerings.

A submission to the FDA in the coming months for essential tremor drug ulixacaltamide could be swiftly followed by a filing of relutrigine for two rare forms of epilepsy.

Roughly four months after raising its 2025 revenue forecast, UCB has done it again, helped by strong performance of its IL-17A and IL-17F inhibitor.

Plus deals involving Simcere/Vigonvita, Formosa/Rxilient, Shionogi/Japan Tobacco, Taiho/NEC/JFCR, Toray/Sanodyne, SK Biopharmaceuticals/WARF, BioCorteX/CD Biopharma, ToolGen/GenEditBio and Actimed/Mankind.

Vertex, Bristol Myers and Regeneron updated investors on launches underway, while Sanofi CEO Paul Hudson assured investors on the late-stage pipeline.

The company says that clascoterone presents the first potential innovation in over 30 years in male hair loss.