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Business Strategies

Reddy’s To Keep Producing Semaglutide In India As Novo Denied Interim Relief

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

Bristol To Add Patients To Cobenfy Trial To Make Up For Site Irregularities

The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.

FDA Approval Sets Stage For Accord’s 2026 Denosumab Biosimilars Rollout

FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.

Amneal Scores Dual FDA Wins In High-Value Complex Generics

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

Parexel Exec On AI: RoI, US FDA’s ‘Open Table Discussions’

After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue.

Finance Watch: Protego Raises $130m, Will Initiate AL Amyloidosis Pivotal Trial

Private Company Edition: Protego’s series B round comes four years after its $51m series A. Also, Aspen Neuroscience reveals a $115m series C round, Profluent raises $106m to fund AI-enabled protein design and Phrontline brings in $60m in pre-series A+ financing.

Some CAR-Ts Are Thriving While Others Are Falling Behind. Why?

With Gilead reporting that both of its approved CAR-Ts saw sales declines as other products saw growth, a mixture of different competitive headwinds seems to be behind the disparities.

Finance Watch: Lilly Toes The $1 Trillion Valuation Line

Public Company Edition: Lilly’s obesity franchise makes it the highest-valued health care company in the US. Also, Genmab accesses $4.5bn to fund its $8bn Merus buy, Moderna locks in a $1.5bn credit facility and Ionis sells $700m worth of notes.

Biological E Joins Pfizer, Others On WHO PCV Podium; Watches India Pricing Outcome

Biological E joins the ranks of Pfizer, GSK and Serum with WHO prequalification for its pneumococcal vaccine. As WHO's purchase data for Serum’s PSV10 indicate significant opportunity, Scrip spoke to Biological E on supply readiness and its application for exemption from price control in India

AstraZeneca Scores FDA Win For Imfinzi In Perioperative Stomach Cancer

The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.

Manufacturing Hurdles Push Xbrane’s Ranibizumab Timeline To Late 2026

Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.

Formycon Expands European Aflibercept Footprint With NTC Deal In Italy

Deal gives NTC exclusive rights to commercialize Formycon and Klinge’s Baiama aflibercept biosimilar in Italy, expanding Formycon’s growing network of European ophthalmology partners.