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Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price negotiation purposes—even if approved by the FDA under a separate application—disincentivizing companies from investing time and money in gaining approval for new formulations and indications.

The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.

Pascal Soriot’s comments came during AstraZeneca’s Q2 earnings call in regard to President Donald Trump’s newly announced European pharma tariffs. The company also announced estimate-beating earnings, with its cancer portfolio driving earnings despite clinical roadblocks.

CEO Rob Davis referred to the cost reduction program as a ‘reallocation’ rather than a cut, with the savings to be reinvested to support up to 20 new product launches.

In a surprise double announcement Tuesday, Novo reduced sales guidance by 5%—attributing the change to slowed growth of its semaglutide franchise in the U.S.—and named current international operations head Maziar Mike Doustdar as its new president and CEO.

Six weeks after HHS Secretary RFK Jr. cited unexplained conflicts of interest in dismissing all 17 members of the CDC’s vaccine advisory committee, Democrats are asking for details.

While some analysts forecast the tariffs could mean billions in additional industry expenditure, others expect the overall impact to be “manageable.”

In a post on X, Health Secretary Robert F. Kennedy Jr. alleged that the Vaccine Injury Compensation Program has “devolved into a morass of inefficiency, favoritism, and outright corruption.”

BMS is spinning out a new company with five immunology assets, including oral drugs being developed for systemic lupus erythematosus and plaque psoriasis, and $300 million in funds from Bain Capital.

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.

In a Phase Ib/IIa trial, 91% of patients receiving the highest dose of trontinemab were amyloid negative after seven months of treatment, representing what B. Riley Securities called a “paradigm shift” to first-generation FDA-approved antibodies.

The German giant is looking to develop new drugs for undisclosed eye diseases using Re-Vana’s extended-release injectable platform to supply drugs to the eye for months at a time.

• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions

• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses

Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships

Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio