All News

Eli Lilly's Orforglipron may become the first drug fast-tracked under the FDA's new program, promising quicker access for weight loss treatment.

Updates to its policies have made FDA’s CRLs a key talking point.

In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s return-to-office mandate from its CEO, the evolving COVID-19 vaccine landscape in 2025, and Capsida’s decision to halt a gene therapy trial following a patient death.

AstraZeneca pauses its £271 million Cambridge investment, reflecting growing concerns over the U.K.'s life sciences sector and government support.

Novartis partners with Monte Rosa Therapeutics in a $5.7 billion deal to develop innovative treatments for immune-mediated diseases using AI technology.

The new administration has a different perspective of vaccines than the previous administration, causing confusion with the public.

In today’s Pharmaceutical Executive Daily, we cover the president’s call to lower drug costs for patients, the compliance and operational pressures facing pharmaceutical manufacturers, and a White House plan to restrict treatments discovered in China.

AbbVie’s stock surges 4.4% after securing 12 more years of exclusivity for Rinvoq, boosting sales projections and investor confidence.

The pause follows a patient death in the SYNRGY trial evaluating the novel therapy for STXBP1-related disorders, as the company prioritizes safety and transparency with the community.

Pharmaceutical Executive Daily highlights major industry shifts, including job cuts at Lundbeck and Novo Nordisk, and Trump's critique of drug advertising practices.

White House plans potential restrictions on Chinese-developed drugs, sparking lobbying from investors and pharmaceutical giants amid national security concerns.

The designation supports expedited development of SAR402663, Sanofi’s one-time gene therapy designed to reduce treatment burden and slow vision loss in patients with wet age-related macular degeneration.

Intercept Pharmaceuticals withdraws Ocaliva from the U.S. market following FDA concerns over safety and effectiveness for treating primary biliary cholangitis.

Merck withdraws from its London research facility, highlighting growing concerns over the UK's life sciences investment climate and industry competitiveness.

The draft assessment finds that the popular weight loss drugs are costly but worth the price tag, while also urging for broader coverage and policy solutions.

Approval was based on data from the Phase IIb SunRISe-1 trial (NCT04640623), in which Inlexzo demonstrated an 82% complete response rate in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

The company plans to switch to a partner-model for international markets.

Drugmaker aims to simplify operations, speed up decision-making, and reinvest savings into diabetes and obesity growth opportunities in latest round of pharma layoffs.

The President issued a memo directing HHS and FDA to enforce strict regulations against potentially misleading advertising.

The new funding is expected to fuel clinical progress for Alchemab’s muscle atrophy candidate and expand its AI-driven pipeline targeting immune and neurological diseases.

The agency noted ongoing safety violations at the location.

Novartis acquires Tourmaline Bio to enhance its cardiovascular pipeline with Pacibekitug, a promising anti-inflammatory therapy for ASCVD.

The company says addressing the issues raised in the CRL could take years.

The list prevents the import of ingredients from potentially dangerous facilities.

Regeneron’s Phase III trials show promising results for new antibody treatments, offering rapid and lasting relief from cat and birch allergies.

Servier's acquisition of KER-0193 marks a pivotal step in developing innovative treatments for Fragile X syndrome, enhancing its neurology pipeline.

Gilead Sciences partners with PEPFAR to enhance access to Lenacapavir for HIV prevention, aiming to support over 2 million people in resource-limited countries.

BioNTech's BNT323 shows promise in slowing breast cancer progression, boosting shares and paving the way for new treatment options.