Drugs
AstraZeneca and Handa Pharmaceuticals have agreed to pay $51.4 million to resolve allegations they participated in a pay-for-delay scheme to block generic competition to AstraZeneca’s antipsychotic drug Seroquel XR. The lawsuit was brought in 2019 by direct purchaser plaintiffs who requested preliminary approval of the proposed
Drugs
Restoring FDA’s and other health agencies’ credibility always starts at the top. So when HHS secretary Robert F. Kennedy Jr. is called out for citing nonexistent science as the partial basis for his recent Make America Healthy Again (MAHA) report (see story), how seriously will stakeholders and the public
Drugs
Merck/Daiichi Sankyo have withdrawn their BLA for patritumab deruxtecan to treat patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer. A Merck statement says the decision to pull the BLA was based on topline results from the confirmatory HERTHENA-Lung02 Phase 3 trial
Drugs
FDA has published a draft guidance, Replacing Color Additives in Approved or Marketed Drug Products, describing considerations for replacing a color additive. The document says if a color additive is used in a drug product, the additive must conform to the agency’s color additive regulations. “If FDA deems the
Drugs
FDA has granted the Experimental Drug Development Center a fast-track designation for EBC-129 and its use for treating pancreatic ductal adenocarcinoma. EBC-129 is described as a first-in-class antibody drug conjugate (ADC) targeting a novel, tumor-specific N256-glycosylated epitope on the CEACAM5 and CEACAM6 proteins.
Drugs
FDA has granted Beam Therapeutics an orphan drug designation for BEAM-302, a liver-targeting lipid-nanoparticle formulation of a guide RNA and an mRNA encoding a base editor designed to correct the disease-causing mutation in patients with alpha-1 antitrypsin deficiency (AATD). The inherited genetic disorder affects the
Drugs
After extending its review and missing a 4/29 user fee review target date, FDA has now issued Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek accelerated approval for treating Barth syndrome. The review was extended in January to allow FDA to
Drugs
FDA has approved an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disease (DED). Tryptyr is described as a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. Approval is based
Drugs
Former McKinsey & Company senior partner Martin Elling has been sentenced to six months in federal prison for obstructing justice related to his work on Purdue Pharma matters. A Department of Justice statement says a 1/2025 information charged Elling with knowingly destroying records with the intent to impede, obstruct,
Drugs
Veru is announcing positive topline results from its Phase 2b QUALITY clinical trial that is evaluating the safety and efficacy of enobosarm in older patients using semaglutide (Novo Nordisk’s Wegovy) for chronic weight management. The company says the drug combination aims to enhance fat loss while preventing muscle loss
Drugs
FDA has accepted for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for treating motor fluctuations in people living with Parkinson's disease (PD). The agency set a user fee review action target date for the
Drugs
FDA has released the form FDA-483 with seven observations from a 1/16-1/24 inspection at Zhejiang Huahai Pharmaceutical Co. in Linhai, Zhejiang, China. The inspection observations were: * failure to clean equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality,
Drugs
The CDER Accelerating Rare Disease Cures (ARC) program online newsletter says ARC closed out a strong 2024 for rare disease therapeutic development with 26 novel orphan drug approvals. “Having built a strong foundation, CDER’s ARC program renews our commitment in 2025 to strengthen collaboration, including our commitment to the
Drugs
An 11/12-11/22/2024 FDA inspection at the AACE Pharmaceuticals drug manufacturing facility in Fairfield, NJ, was conducted after a 1/15-1/19/2024 agency inspection found violative conditions at Brassica Pharma Private Limited, a Mumbai, India, contract manufacturer used by AACE to produce ophthalmic drugs. A
Drugs
FDA has placed a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Danon disease, following the death of a participant who experienced serious complications during the study. The patient developed a serious adverse event (SAE)related to capillary leak syndrome,
Drugs
FDA has issued a Refusal-to-File (RTF) letter for a Savara BLA for Molbreevi (molgramostim) inhalation solution for treating autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The agency concluded that the submission was not sufficiently complete to permit a full review, citing the need for additional chemistry, manufacturing, and controls
Drugs
FDA has approved Liquidia’s Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Yutrepia is designed to “enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort,” the company says. Approval was
Drugs
FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. “It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with
Drugs
Gilead Sciences is announcing promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for immunotherapy. The data show that Trodelvy significantly improved progression-free survival compared to standard chemotherapy, marking
Drugs
“The health of American children is in crisis.” That’s the premise of a report, “Make Our Children Healthy Again: Assessment” issued by the President’s Make America Healthy Again Commission. The report says it “presents the stark reality of American children’s declining health, backed by compelling data and
Drugs
FDA commissioner Marty Makary was pressed by lawmakers during a Senate appropriations hearing over the Trump administration’s secrecy about the agency’s fiscal year 2026 budget proposal, which calls for a $400 million (11.5%) cut in budget authority, and the instability at the agency caused by an over
Drugs
A HuffPost analysis says that if President Donald J. Trump follows through with planned tariffs on pharmaceuticals, “these largely foreign-made drugs would be targeted with tariffs, potentially causing unexpected shortages and making your doctor’s visit look much different in the future.” The online post quotes University of Utah