Regulatory

New nominee may need a charm at the CDC

Fri, 17 Apr 2026 12:00:00 -0400

As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office.

Daiichi to divest consumer health unit to Suntory for $1.5B

Fri, 17 Apr 2026 12:00:00 -0400

Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology.

Delta-Fly eyes NDA path despite AML phase III miss

Fri, 17 Apr 2026 12:00:00 -0400

Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.

Roche plots route to EMA approval for DMD gene therapy

Fri, 17 Apr 2026 12:00:00 -0400

Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.

HHS budget hearing not so much about budget

Thu, 16 Apr 2026 12:00:00 -0400

U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.

FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC

Thu, 16 Apr 2026 12:00:00 -0400

The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.

Maryland 340B law likely pre-empted, appeals court rules

Thu, 16 Apr 2026 12:00:00 -0400

Given its recent decision in a challenge to a West Virginia law, it’s no surprise that the U.S. Court of Appeals for the Fourth Circuit issued a 2-1 unpublished opinion April 14 overturning a lower court that had refused a preliminary injunction to stall a similar Maryland law that would require drug manufacturers to offer 340B prescription drug discounts to unlimited contract pharmacies.

FDA clears IND for Naturecell’s Astrostem-AU for autism

Thu, 16 Apr 2026 09:00:00 -0400

Naturecell Co. Ltd.’s U.S. subsidiary, Naturecell America, has received IND clearance from the FDA for Astrostem-AU, an autologous adipose-derived mesenchymal stem cell therapy for adults with autism spectrum disorder (ASD).

CSPC’s SYS-6051 cleared for clinic in China for solid tumors

Thu, 16 Apr 2026 09:00:00 -0400

CSPC Pharmaceutical Group Ltd.’s SYS-6051 has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for advanced solid tumors. SYS-6051 is a human tissue factor-targeted antibody-drug conjugate that binds to tissue factor expressed on the surface of tumor cells.

China’s NMPA accepts Mabwell’s IND application for 6MW5311

Thu, 16 Apr 2026 09:00:00 -0400

Mabwell (Shanghai) Bioscience Co. Ltd.’s has announced IND acceptance by China’s National Medical Products Administration (NMPA) for the company’s LILRB4/CD3 T-cell engager bispecific antibody 6MW5311. The drug candidate is being developed for hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia and multiple myeloma.

Flow of Trump EOs slowing way down

Wed, 15 Apr 2026 12:00:00 -0400

Despite key vacancies, ongoing staffing challenges and policy issues at the U.S. CDC, FDA and NIH, some of the regulatory churn that roiled those agencies in the first year of the second Trump administration is settling a bit, at least in terms of the number of executive orders (EOs) coming out of the Oval Office.

Pricing standoff leaves Australian patients in limbo

Wed, 15 Apr 2026 12:00:00 -0400

A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.

Alivecor receives CE mark for AI-powered, portable ECG system

Wed, 15 Apr 2026 12:00:00 -0400

Alivecor Inc. has secured CE marking for its Kardia 12L electrocardiogram (ECG) system, which is powered by its KAI 12L AI technology and can detect life-threatening cardiac conditions. Kardia 12L is a portable, AI-guided, 12-lead ECG solution that delivers measurements and interpretations similar to standard 12-lead ECG solutions, right at the point of care. The company said the simplified design will enable faster acquisition of complete ECG data while leading to better patient outcomes.

New guidance advises on assessing safety of gene editing

Wed, 15 Apr 2026 09:00:00 -0400

The U.S. FDA’s latest draft guidance on gene therapies focuses on nonclinical studies using next-generation sequencing-based methods and bioinformatics to evaluate safety risks associated with off-target editing and loss of genome integrity in human gene-edited products.

Mabwell announces Chinese clinical trial clearance for SST-001

Wed, 15 Apr 2026 09:00:00 -0400

Mabwell (Shanghai) Bioscience Co. Ltd. has announced that SST-001 (18F-FD4), an α-synuclein-targeted PET tracer developed by Mabwell’s incubated company Synusight Biotech, has received clinical trial clearance from China’s National Medical Products Administration (NMPA). The planned phase I trial will enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease.

Glyconex’s GNX-1021 cleared for clinic in Japan for GI cancers

Wed, 15 Apr 2026 09:00:00 -0400

Glyconex Inc. has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the initiation of a first-in-human phase I trial of GNX-1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal (GI) cancers.

New guidance advises on assessing safety of gene editing

Tue, 14 Apr 2026 12:00:00 -0400

Everest to acquire Singapore unit of Hasten Bio in $250M deal

Tue, 14 Apr 2026 12:00:00 -0400

Everest Medicines Ltd. has agreed to acquire a Singapore-based commercial unit of Hasten Biopharmaceuticals (Asia) Ltd. for $150 million up front, gaining market authorization holder rights to 14 marketed products originally developed by Takeda Pharmaceutical Co. Ltd.

US FDA cites first dispenser for violating Rx supply chain act

Tue, 14 Apr 2026 12:00:00 -0400

If a recent warning letter is anything to go by, the U.S. FDA could be using the 2013 Drug Supply Chain Security Act as another enforcement tool to shut down unauthorized suppliers by clamping down on the dispensers that purchase their unapproved drug products.

Nearly 30% of trials not up to date on results disclosures

Tue, 14 Apr 2026 12:00:00 -0400

The U.S. FDA sent out a friendly reminder to more than 2,200 sponsors and researchers, associated with more than 3,000 clinical trials, who may be delinquent in disclosing the results of those studies on clinicaltrials.gov.

Travere’s Filspari approved for rare kidney disease FSGS

Tue, 14 Apr 2026 08:00:00 -0400

Becoming the first and only fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), Travere Therapeutics Inc.’s Filspari (sparsentan) has gained access to a second lucrative market with a regulatory package that validates proteinuria as a surrogate endpoint.

CMS looks to bring Rx prior authorization into digital age

Mon, 13 Apr 2026 12:00:00 -0400

In a move that could give patients quick access to drugs their doctors prescribe, the U.S. CMS is proposing a rule giving insurers no more than 24 hours to respond to urgent prior authorization requests and 72 hours for standard requests. The rule also would require full disclosure of claims denials and appeals outcomes.

FDA accepts Telix’s resubmitted NDA for brain imaging agent

Fri, 10 Apr 2026 12:00:00 -0400

The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.

Kennedy expands ACIP function, membership criteria

Fri, 10 Apr 2026 12:00:00 -0400

Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>

FDA accepts Telix’s resubmitted NDA for brain imaging agent

Fri, 10 Apr 2026 12:00:00 -0400

Endospan’s FDA nod for Nexus brings acquisition by Artivion closer