Drugs
FDA says the Arizona federal court has entered a consent decree of permanent injunction ordering Smart Women’s Choice and its CEO, Jennifer Richard, to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic Act and meets other requirements in the decree. According to a
Drugs
Ascendis Pharma has resubmitted an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism. In May, FDA issued a complete response letter on the original NDA, citing manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according to the company.
Drugs
A 2/20-3/2 FDA inspection at Global Pharma Healthcare in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/19 Warning Letter says the firm’s drug products are adulterated because they were “prepared, packed, or held
Drugs
Bayer is withdrawing its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The decision follows discussions with FDA about a failed confirmatory study that was required to confirm the therapy’s clinical benefit, according to the company. Aliqopa
Drugs
FDA is asking the Oncologic Drugs Advisory Committee (ODAC) to consider at its 11/16 meeting the lengthy delays Acrotech Biopharma is experiencing in completing confirmatory post-marketing requirement trials for its Folotyn (pralatrexate) and Beleodaq (belinostat). An agency briefing document circulated before the meeting says the drugs were granted
Drugs
AstraZeneca says the Phase 3 PACIFIC-2 trial of its Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival versus chemoradiotherapy alone to treat patients with unresectable, Stage 3 non-small cell lung cancer. A company statement says that
Drugs
Manhattan Institute senior fellow Randall Lutter, a former FDA senior scientific and regulatory advisor, says there are many steps Congress should be taking to have a fuller understanding of drug shortages and to hold FDA accountable for its actions. In an Issue Brief, Lutter says congressional Democrats and Republicans have
Drugs
A new Reagan-Udall Foundation report, “Enhancing Post-Market Evidence Generation for Medical Products,” addresses barriers, proposes solutions, and makes recommendations to FDA and other stakeholders that aim to facilitate evidence generation in the postmarket setting. The report defines pragmatic evidence generation as conducting prospective clinical studies of medical products
Drugs
House Energy and Commerce Committee Republicans are threatening FDA with a subpoena if it continues to delay submitting documents on what they consider “risky” research conducted at agency facilities. The committee has called for increased scrutiny of federal laboratory biosafety protocols following the Biden administration’s lack of transparency in
Drugs
BridgeBio Pharma says it will submit by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM). The study of the next-generation, small molecule stabilizer of transthyretin (TTR) demonstrated that it “improved clinical outcomes for
Drugs
Novo Nordisk says data from its Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly semaglutide 2.4 mg (Wegovy) in adults with established cardiovascular disease and overweight or obesity without diabetes showed that the drug was associated with a 20% risk reduction in MACE [major adverse
Drugs
FDA has approved a Pacira BioSciences supplemental NDA to expand Exparel’s (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa. The drug was previously approved to produce postsurgical local analgesia via infiltration in patients
Drugs
Neurocrine Biosciences says it is stopping the development of two drugs being evaluated for treating focal onset seizures and anhedonia after reporting what it called were “disappointing results” from Phase 2 studies. The investigational selective NaV 1.6 inhibitor, NBI-921352, licensed from Xenon Pharmaceuticals, did not demonstrate a meaningful
Drugs
The Puerto Rico federal court has entered a consent decree requiring Droguería Betances LLC (Betances), one of the territory’s largest pharmaceutical distributors, to pay $12 million and make extensive improvements to its compliance program. According to the Justice Department, the consent decree resolves an 11/3 complaint alleging that
Drugs
FDA has accepted for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Abbvie’s Humira. The submission was based on data from a Phase 4 clinical study (NCT05510063) that assessed the pharmacokinetic similarity
Drugs
CDER director Patrizia Cavazzoni says the Office of Pharmaceutical Quality will reorganize effective 1/14/2024. She says the reorganization “streamlines the office’s core functions to bring added flexibility without compromising accountability.” Under the change, the Office of New Drug Products, Office of Lifecycle Drug Products, and Office of
Drugs
FDA has approved a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in adult patients suffering from metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if medically appropriate and RAS wild-type, an anti-EGFR therapy. Approval is based
Drugs
FDA revised 11/7 the existing indication of Merck’s Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinomas. An agency post says the updated indication, which remains approved under
Drugs
The CDER Office of Therapeutic Biologics and Biosimilars (OTBB) has recommended a determination that the first interchangeable exclusivity (FIE) expired on 4/15 for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), 40mg/0.8mL and 20mg/0.4 mL for subcutaneous use, and on 9/18 for Cyltezo injection 10mg/0,
Drugs
FDA has approved an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in adults with obesity who are on a reduced calorie diet and an exercise regimen. Tirzepatide, which is already approved under the trade name Mounjaro for treating Type 2 diabetes, is intended for use
Drugs
Organon says it agrees with a proposal in an FDA 9/18 draft guidance on biosimilar labeling that both biosimilars and interchangeables include a biosimilar statement. In a comment letter, the company says it agrees with the agency’s rationale that the interchangeability standard is not likely to be useful
Drugs
Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) have introduced the Protecting Consumer Access to Generic Drugs Act of 2023, which would support access to lower-priced generic prescription drugs. The bill would “end harmful pay-for-delay practices and provide the FTC