Market Access
The US-India dance on pharma goes on as they announce a trade deal framework that continues to exempt generics from the reduced 18% tariffs till a “negotiated outcome” is reached post a Sec. 232 investigation. However, oil imports from US could increase costs for Indian pharma firms
The Novartis CEO believes the west has much to learn, especially in terms of clinical trial regulations and enrolment.
The Trump administration has launched TrumpRx, a website the White House says could help save Americans billions in pharmaceutical spending, although it does not itself sell or dispense drugs.
The Danish drugmaker is getting ready to celebrate a first-in-class approval from the European Commission for semaglutide for metabolic dysfunction-associated steatohepatitis.
A complete response letter will delay Joenja’s US growth, which Pharming needs as its flagship product, Ruconest, faces growing competition.
Strides Pharma aims for higher revenues from Canada and other ex-US markets while waiting for controlled substances to ramp up gradually under the leadership of ex-Apotex CEO Peter Hardwick. However, a cut in US funding for the Global Fund is hurting the company and its competitors.
CEO Thomas Schinecker is signalling that historic investment in Switzerland cannot be sustained unless the country makes its investment and pricing environment more pharma-friendly.
The process will pit breast cancer treatment competitors Kisqali and Verzenio against each other as CMS develops pricing offers.
Conclusion of India-EU talks sets ground for a free trade agreement to cut pharma tariffs, in turn lowering the cost for novel drugs like Novo’s obesity treatment Wegovy, though an investment protection agreement – likely influencing data exclusivity – will be concluded later.
Industry leaders predict pricing uncertainty will force companies to abandon blanket global launches. However, AI platforms will reshape commercial execution and new access models will break down barriers limiting patient reach.
BMS tells Scrip it will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company
Zydus is to gain from a world-first nod for a Menkes disease drug in the US amid speculation on a deal to acquire Ardelyx. Scrip examines how Zycubo approval, Agenus’s oncology BOT/BAL combination progress and a Formycon partnership help the Indian major
The Swiss pharma co-authored a “call for bold life sciences investment” with the Eurasia Group, critiquing global trade policy and advocating “innovation-friendly” reforms, including moving away from reference pricing.
The plan does not include many details but is intended to help Congress draft legislation ensuring Most Favored Nation drug pricing agreements can be made, as well as implement measures intended to lower insurance premiums.
While the regulatory environment for vaccines sours in the US, Valneva tells Scrip it is mulling an Asia hub and finalizing a strategy - that includes partnerships - for its marketed and pipeline products. Could it consider India or China as a new regional center?
What is the strategic intent behind Aurobindo’s moves to settle a Galafold patent dispute with Amicus Therapeutics, acquire the non-oncology business of compatriot Khandelwal Labs and get full control of a Chinese JV with Shandong Luoxin?
A deal for the Duchenne muscular dystrophy treatment with Nxera is valued at up to $205m.
A year after Valneva entered a tech transfer agreement for its chikungunya vaccine with Serum Institute, the deal has been called off. Regulatory approvals for the vaccine in Asia are yet to be obtained and the biologics license for Ixchiq remains suspended in the US. What happens hereon?
There has not been a dull moment in the biopharma sector this year. With just a day left, and in no particular order, Scrip takes a look at five of the biggest stories of 2025.
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.