FDA Policy/General
A recent notice of violation that was issued by the CDER Office of Prescription Drug Promotion (OPDP) to Mayne Pharma about a Nextstellis professional promotion is a reminder that OPDP puts as much energy into reviewing promotions targeting healthcare professionals as it does with direct-to-consumer promotions. That’s
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Merck/Daiichi Sankyo have withdrawn their BLA for patritumab deruxtecan to treat patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer.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
Biologics
Eight congressional Democrats who were members of the Select Subcommittee on the Coronavirus Pandemic say they are deeply concerned about the FDA decision to limit the approval of updated Covid-19 vaccines. “We find it perplexing that this new guidance undermines the foundational principles of Operation Warp Speed, a program
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FDA has published a draft guidance, Replacing Color Additives in Approved or Marketed Drug Products, describing considerations for replacing a color additive.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,
Devices
An 11/4-11/7/2024 FDA inspection at DRG Instruments GmbH in Marburg, Germany, found multiple violations in the firm’s manufacturing of several in vitro diagnostic devices. A just-released 3/31 Warning Letter says two of the firm’s diagnostic devices are adulterated because DRG does not
FDA Policy/General
Democrats on the House Energy and Commerce Committee say HHS secretary Robert F. Kennedy, Jr.’s “silence on the widespread impacts of public health cuts is deafening.” In a 12-page 5/28 letter to Kennedy, the ranking members on the full committee and its Health and Oversight and Investigations
Devices
FDA has published one final and one draft guidance on aspects of its medical device Q-Submission program. The final guidance Request for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program gives an overview of the mechanisms available to submitters through which they can request interactions with
FDA Policy/General
GSK says it will submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical trial early following interim results that showed their oral antibiotic tebipenem HBr is effective in treating complicated urinary tract infections
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
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. is continuing his verbal assault against the pharmaceutical industry, claiming that they control the nightly news content because of direct-to-consumer (DTC) advertising, which he says will be limited soon under his watch. During a 5/27-aired The Ultimate Human podcast, Kennedy
FDA Policy/General
Senator Dick Durbin (D-IL) has written FDA commissioner Marty Makary over concerns about how CDER’s Office of Prescription Drug Promotion (OPDP) can adequately regulate prescription drug advertising after the group was gutted by HHS reduction-in-force efforts and the recent departures of senior leaders (see story). “These
FDA Policy/General
[Commentary by James G. Dickinson] Like each of the past 15 FDA commissioners I have known since 1975, the current incumbent is both eminently qualified and dedicated to the agency’s mission. But unlike any of them, Martin Makary serves under the most science-defiant HHS secretary ever to hold
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
Devices
A 1/20-1/24 FDA inspection at Sedecal S.A. in Madrid, Spain, found Quality System Regulation violations in the firm’s manufacturing of mobile digital radiography systems. A 5/5 Warning Letter says the specific violations were: * failure to adequately establish and maintain procedures for implementing corrective and