Drugs
Just-posted FDA review documents show how CDER management reconciled using the accelerated approval pathway for Biogen’s Alzheimer’s drug Aduhelm (aducanumab) and dismissed reviewers’ recommendations for traditional approval or outright denial of the BLA submission. A memo from CDER Office of New Drugs director Peter Stein noted that
Drugs
A column posted online at The Conversation by a physician and a pharmacist at the University of Connecticut says the likelihood of drug manufacturing errors that slip through the cracks has increased as a result of decreased FDA facility inspections. “Over the past few years, tens of millions of doses
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Janssen Pharmaceutical has submitted an NDA for Xarelto (rivaroxaban) and its use in pediatric patients. The company says the NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients less than 18 years of age after at least five days
Drugs
Attorney Josephine Torrente (Hyman, Phelps & McNamara) says FDA has drug sponsors at a disadvantage by refusing to hear appeals from an end-of-phase 2 (EOP2) disagreement over Phase 3 study parameters. Writing in her firm’s FDA Law Blog, Torrente says in 2015 the agency revised its 15-
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FDA says its review of a Web site maintained by Molecular BioLife, Sheldon, IA, determined that the firm takes orders for Shark 2 Collagen and Balanced Kollagen. A just-released 4/15 Warning Letter says the claims on the firm’s Web site establish that the products are drugs because
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Agios Pharmaceuticals has submitted an NDA for mitapivat for treating adults with pyruvate kinase (PK) deficiency. The company says there are no approved therapies for PK deficiency, and current treatments include blood transfusions and splenectomy, which are associated with both short- and long-term risks, including iron overload, blood clots
Drugs
Researchers in pharmaceutical and academic settings say FDA regulatory guidance should be updated to acknowledge the utility of external controls in drug trials, particularly retrospective natural history data. Writing in an open-access article in Therapeutic Innovation and Regulatory Science, the authors discuss their review of 45 FDA approvals between
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Merck has reported favorable data from a study investigating its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, for first-line treatment of patients with persistent, recurrent or metastatic cervical cancer. The company says the
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FDA has issued a guidance, Providing Regulatory Submissions in Electronic Format—Standardized Study Data, with the requirements for electronic submission of standardized clinical and non-clinical study data under Section 745 (a) of the Federal Food, Drug, and Cosmetic Act. The document implements the electronic submission requirements for study data
Drugs
FDA has accepted for filing Fennec Pharmaceuticals’ resubmission of an NDA for Pedmark, described as a unique formulation of sodium thiosulfate for preventing ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic solid tumors. The company says the PDUFA
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Real-world data involving Gilead Sciences’ Veklury (remdesivir) show that the therapy offered a lower mortality risk in hospitalized Covid-19 patients. Data from three retrospective real-world data studies show a reduction in mortality was “observed across a spectrum of baseline oxygen requirements,” the company says. For example, one
Drugs
James Chadwick Brooks (Norcross, GA) and his company CCB Nutrition have pleaded guilty to introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead FDA. The government contends that from 2016 to 2019, Brooks marketed supplements containing anabolic steroids such as androsterone, trestolone, epiandrosterone and
Drugs
Tarsus Pharmaceuticals says it is planning an NDA submission next year after just reporting positive data from a Phase 2b/3 trial (Saturn-1) that evaluated the company’s novel investigational therapeutic, TP-03 (lotilaner ophthalmic solution, 0.25%), in patients with demodex blepharitis. The company says the highly prevalent
Drugs
FDA says it proposed FY 2022 budget requests an increase of $38 million above the current year’s enacted level to support CDER and CDRH activities involving the opioid crisis. In an online post, FDA acting commissioner Janet Woodcock says the agency’s work going forward will address four priority
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FDA has approved Boehringer Ingelheim Pharmaceuticals’ Pradaxa (dabigatran etexilate) oral pellets to treat children aged three months to less than 12 years with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days. It also approved the drug for preventing
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FDA has granted Roche an emergency use authorization for its cobas SARS-CoV-2 nucleic acid test for use on the cobas Liat System. The company says the singleplex test is the first real-time reverse transcriptase polymerase chain reaction test that can identify SARS-CoV-2 infection within 20
Drugs
FDA has issued Orphazyme a complete response letter on an NDA for arimoclomol, a heat shock protein amplifier intended for treating Niemann-Pick disease Type C (NPC). In the letter, the agency requested “additional qualitative and quantitative evidence to further substantiate the validity and interpretation of the 5-domain NPC
Drugs
FDA has approved Bayer Healthcare’s Astepro (azelastine hydrochloride nasal spray, 0.15%), a nasal antihistamine for nonprescription use under an Rx-to-OTC switch. Astepro is indicated for treating seasonal and perennial allergic rhinitis for adults and children six years of age and older. The approval is a first-
Drugs
Bausch Health is petitioning FDA not to approve any ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act that cites Duobrii as the reference-listed drug unless the application meets all the specifications sought by the company. The 5/28 petition asks that the agency
Drugs
FDA has issued an immediately-in-effect guidance, Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, to assist sponsors in the clinical development of drugs for treating or preventing Covid-19. The document does not apply to preventive vaccines and convalescent plasma. The guidance describes the agency’
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FDA has accepted for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The company says it expects a review decision in October. The submission includes data from the BREEZE clinical study that demonstrated
Drugs
Public Citizen says FDA acting commissioner Janet Woodcock, CDER director Patrizia Cavazzoni, and CDER Office of Neuroscience director Billy Dunn should resign or be dismissed over what the advocacy group calls the “reckless approval of aducanumab for Alzheimer’s.” Public Citizen calls for the three to leave the agency in