IntellaTurn, LLC

• Roche’s cancer treatment Avastin (bevacizumab) has long been employed as an off-label option for wet age-related macular degeneration (AMD) patients. And now the FDA has approved a new formulation of the VEGF inhibitor for regulated use in the US.

• Bringing it to the market is New Jersey-based Outlook Therapeutics, which labored through three FDA rejections to finally secure a nod.

• With the approval, Outlook said it expects to gain 12 years of reference product market exclusivity as specified by the Biologics Price Competition and Innovation Act (BPCIA).

• Outlook enters a massive US market—estimated at $8.5 billion by the company—with only a few drugmakers splitting the pie. They include Roche with Vabysmo, Regeneron with Eylea and companies producing biosimilar versions of Novartis and Roche’s Lucentis. (Fierce Pharma)

• The FDA approved Simtriyo (centanafadine) as the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for attention-deficit/hyperactivity disorder (ADHD).

• By blocking the reuptake of the three neurotransmitters, Simtriyo — a central nervous system stimulant — is designed to increase their availability in pathways tied to attention and behavioral regulation.

• The once-daily, extended-release capsule was specifically greenlit for adults and pediatric patients aged 6 years and older weighing at least 20 kg.

• Following scheduling by the US Drug Enforcement Administration, Simtriyo is expected to be available to patients later this year. (FirstWord)

• Flush with GLP-1 cash and pipeline success, Eli Lilly rose from 16th to first over five years in Norstella’s inaugural Pipeline-to-Patient Productivity Index (P3i), which evaluated 25 large, global biopharma companies on R&D productivity, market access and commercial performance.

• Norstella designed the index to give biopharma funders more information about how companies are performing and help guide their portfolio decisions.

• Norstella CEO Mike Gallup said an industry requiring the time and capital investment of biopharma needs a clearer scoreboard to track success.

• “It is the first benchmark to follow a molecule across the entire journey: from disclosure through clinical risk, into market access and on to commercial return,” he said. (Fierce Biotech)

• Capricor Therapeutics failed to win the backing of an FDA advisory panel for deramiocel, a therapy intended to slow the rate of decline in cardiac function in patients with Duchenne muscular dystrophy.

• The agency’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 9-3 against the drug on Wednesday, with some panelists offering moderate support.

• Ultimately, the committee’s vote sided with FDA reviewers who had maintained deramiocel had failed to show significant efficacy. That analysis triggered a slide of more than 60% in Capricor’s stock price on Monday. (Endpoints)

• GSK is turning to a multibillion-dollar cost-cutting program to help the company grow profits while absorbing the impact of a sizable patent cliff.

• In its latest quarterly earnings report on Tuesday, the British pharma company revealed a three-year restructuring plan designed to save a total of about £1.9 billion, or $2.5 billion, per year.

• GSK didn’t disclose specific details about the plan, but said that it should “simplify the organization” and help “reallocate capital and resources” towards specialty medicines. (BioPharma Dive)

• This has created a dynamic environment among these upstart companies, with plenty of eyes watching to see if they succeed.

• After reporting the failure of a phase 2 study for tebapivat in sickle cell disease, Agios’ management will have to show confidence in the biotech’s remaining pipeline when reporting second quarter earnings.

• Arrowhead has already begun its fiscal fourth quarter of 2026 on strong footing, with the announcement last week that two phase 3 studies of plozasiran in severe hypertriglyceridemia (sHTG) were successful.

• BridgeBio is on track to deliver a strong second quarter report, as Attruby continues to steal market share in the crowded transthyretin amyloid cardiomyopathy (ATTR-CM) space, according to Jefferies.

• Ionis is well ahead in the marketplace with Tryngolza, which now has two approved indications in familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG) but is still facing immense pressure from Arrowhead.

• Ultragenyx has been through the wringer this year, with a high profile failure for a bone disease drug and an FDA rejection for a rare disease gene therapy. Heading into the third quarter, analysts are keenly watching for any details on a phase 3 readout for apazunersen in Angelman syndrome, which could help turn the ship around.

• Ezplaz is intended for patients who need plasma -- such as those who are bleeding, need massive transfusion, or are bleeding while on warfarin -- when conventional frozen plasma is not available.

• Unlike conventional plasma products, Ezplaz can be stored at room temperature, is stable after exposure to temperature fluctuations, and is rapidly reconstituted.

• The FDA also noted Ezplaz is packaged in a plastic bag rather than a glass bottle, which reduces breaking risks during handling and transport.

"This milestone action addresses an important unmet medical need -- particularly for our military personnel and others who may be far from traditional hospital infrastructure."