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FDA Clears High-Dose Spinraza to Enhance SMA Clinical OutcomesLatest Content

FDA Clears High-Dose Spinraza to Enhance SMA Clinical Outcomes

Pharmaceutical Executive Daily: Eli Lilly Presses U.K. Government to Raise NHS Drug Pricing

Eli Lilly Seeks Agreement with U.K. Government to Raise Prices for Medicines: Report

Eli Lilly and Insilico Enter $2.75 Billion Research and Licensing Agreement to Advance AI Drug Discovery

What Was Unique About Soley Therapeutics' Approach to Developing its Core Technology?

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In today's Pharmaceutical Executive Daily, Novartis agrees to acquire Excellergy for up to $2 billion to advance a next-generation anti-IgE therapy while Otsuka moves to acquire Transcend Therapeutics in a deal valued at up to $1.225 billion, the FDA approves two first-of-their-kind therapies in Novo Nordisk's once-weekly basal insulin Awiqli and Rocket Pharmaceuticals' gene therapy Kresladi for a rare pediatric immune disease, and a new commentary argues that orphan drug manufacturers should be proactively evaluating risk contracting as a hedge against an emerging downward pricing environment.

While they may be linked, the administration’s DTC drug coupon site is not necessarily the entirety of its MFN efforts.

Kresladi becomes the first FDA-approved gene therapy for children with severe LAD-I due to biallelic variants in ITGB2, and Awiqli the first and only once-weekly basal insulin treatment for adults with type 2 diabetes.

Novartis and Otsuka Pharmaceutical are advancing deals to expand pipelines in allergy and psychiatry, with Novartis targeting next-generation anti-IgE therapy and Otsuka betting on a rapid-acting PTSD treatment.

Yerem Yeghiazarians, MD, discusses the importance of understanding why certain cells (like cancer cells) can survive in situations that would kill other healthy cells.

In today's Pharmaceutical Executive Daily, the Trump administration misses a statutory deadline to nominate a permanent CDC director, leaving the agency in continued leadership limbo, the FDA grants accelerated approval to Denali Therapeutics' Avlayah as the first therapy designed to cross the blood-brain barrier and treat the neurological manifestations of Hunter syndrome, and a new commentary breaks down what CMS's updated ASP reporting requirements mean for Part B drug manufacturers ahead of a key April deadline.

The White House postponed naming a permanent CDC director as the Trump administration navigates competing political pressures ahead of midterm elections.

FDA has granted accelerated approval to Avlayah, the first therapy engineered to cross the blood-brain barrier and treat the neurological manifestations of Hunter syndrome.

For pharma products, ensuring proper delivery requires the majority of work to occur before the product hits the road.

In today's Pharmaceutical Executive Daily, the FDA issues a warning letter to ImmunityBio over misleading promotional claims about its bladder cancer therapy Anktiva, Merck agrees to acquire Terns Pharmaceuticals in a $6.7 billion deal while Shionogi moves to take full ownership of the Shionogi-Apnimed Sleep Science joint venture, and a new commentary examines the structural pricing problem sitting at the center of the GLP-1 access debate.

eHealth’s vice president of consumer enablement discusses pricing and cost issues with GLP-1s.

The warning letter is directed at promotional claims about Anktiva’s efficacy and use.

Merck is acquiring Terns Pharmaceuticals for $6.7 billion to bolster its oncology pipeline, while Shionogi is set to purchase 50% of Apnimed's ownership of SASS.

While the space has traditionally been dominated by smaller biotechs, that may be changing.

In today's Pharmaceutical Executive Daily, Bayer shares briefly dip after activist investor Inclusive Capital offloads its remaining stake at a loss, Quotient Therapeutics enters a multi-year research collaboration with Merck to discover novel drug targets in inflammatory bowel disease, and Gilead Sciences agrees to acquire privately held Ouro Medicines in a deal valued at up to $2.18 billion.
























