Drugs
Sanofi and GlaxoSmithKline have announced a delay in their Covid-19 vaccine program to improve immune response in older adults. “Phase 1/2 study interim results showed an immune response comparable to patients who recovered from Covid-19 in adults aged 18 to 49 years, but a low immune response
Biologics
FDA late Friday (12/11) granted an emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. The agency action comes after the White House reportedly ordered FDA commissioner Stephen Hahn to grant the EUA or submit his resignation by the end of the day. “Today’s action follows
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delayed-release tablets, 400 mg. The withdrawal decision is based on FDA concerns about certain phthalate esters, including dibutyl phthalate (DBP), being developmental and reproductive toxicants in laboratory animals. Asacol (mesalamine) contains DBP
FDA Policy/General
Federal Register notice: FDA has announced the names of the members who will serve on its fiscal year 2020 Performance Review Board. The board is intended to provide fair and impartial review of staff’s Senior Executive Service, Senior Professional, 21st Century Cures Act, and Title 42(f) performance appraisals,
Drugs
The International Council on Harmonization (ICH) says the electronic Common Technical Document (eCTD) v4.0 question-and-answer and specification change request document v1.4 reached Step 4 of the ICH process this month. An ICH statement says the document is a summary of questions received by the eCTD implementation
Devices
FDA has authorized LabCorp’s Pixel Covid-19 Test Home Collection Kit for direct-to-consumer use without a prescription by an individual age 18 and older. An agency statement says the kit allows individuals to self-collect a nasal swab at home and send the sample to LabCorp for
Drugs
At the 10/13 meeting of the PDUFA 7 FDA and the industry negotiation regulatory decision tools subgroup, FDA discussed the Complex Innovative Trial Design (CID) program and its PDUFA 6 pilot. A meeting summary says FDA discussed a need to build upon the current pilot to provide time, expertise,
Drugs
AvKare (Pulaski, TN) has withdrawn one lot of sildenafil 100 mg tablets and one lot of trazodone 100mg tablets due to a product mix-up that led them to be inadvertently packaged together during bottling at a third-party facility. Unintentional consumption of sildenafil may pose serious health risks because
Drugs
Torrent Pharmaceuticals has recalled one lot of anagrelide capsules due to a dissolution test failure detected during routine quality testing. “Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body,” a recall notice says. “For seriously ill patients with
Drugs
Oblato says that in discussions with FDA officials on the company’s plan for a Phase 1/2 clinical trial to start developing a new treatment for diffuse intrinsic pontine clioma (DIPG), a rare pediatric disease, using the company’s OKN-007, the agency gave consent for matters such as
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a healthcare professional e-mail for Azurity Pharmaceuticals’ Xatmep makes false or misleading claims and/or representations about the drug’s risks and efficacy. An 11/24 Notice of Violation says the violations are especially concerning from a public health perspective
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. Panel members voted 17 to 4 that: based on the totality of scientific evidence available, the benefits of the vaccine outweigh its risks for use
Drugs
FDA has granted X4 Pharmaceuticals a rare pediatric disease designation for mavorixafor for treating WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company says the drug is currently being investigated in a global pivotal Phase
Drugs
FDA has accepted for filing an Atox Bio NDA for reltecimod to treat suspected organ dysfunction or failure in patients age 12 and older with necrotizing soft tissue infections, in conjunction with surgical debridement, antibiotic therapy, and supportive care. The agency assigned a PDUFA action date of 9/30/21,
Devices
Swedish researchers say that an interim analysis of data from a clinical trial in which patients with peripheral artery disease received treatment with either paclitaxel-coated or uncoated endovascular devices found no difference in all-cause mortality between the groups in the incidence of death during one to four years
Drugs
The American College of Obstetricians and Gynecologists (ACOG) says it strongly supports the recommendation stated in an FDA draft guidance to consider including premenopausal women in breast cancer drug development programs. However, the ACOG comment letter says, it recommends expanding the guidance scope to include survivorship issues, such as fertility
Biologics
FDA plans to warn patients who’ve had previous severe reactions after being vaccinated about such risks with Pfizer-BioNTech’s Covid-19 vaccine if granted an Emergency Use Authorization, according to CBER director Peter Marks. The vaccine is headed to an advisory committee review and vote 12/10. Addressing
Biologics
FDA has accepted for priority review a Pfizer BLA for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate and its use for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults ages 18 years and older. The submission is based on data from Pfizer’s clinical program
Devices
FDA has granted SoniVie a breakthrough device designation for the Tivus System for renal artery denervation and its use in treating resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one
FDA Policy/General
HHS published 12/7 a rulemaking formally adopting good guidance practices (GGP) that are to be followed by all component HHS agencies, including FDA. Attorney T. Daniel Logan (Kleinfeld Kaplan Becker) outlines the impact on FDA, which has had its own different good guidance practices that were adopted 20 years
Biologics
A panel of three former FDA commissioners told the Milken Institute 2020 Future of Health Summit that FDA has been acting properly to oversee the development of Covid-19 vaccines. Former commissioners Robert Califf, Mark McClellan, and Margaret Hamburg appeared in a 12/8 online discussion that centered on the
Devices
Services firm CyberMDX says that GE medical imaging devices have a cybersecurity vulnerability that potentially puts the operation of the systems and the health data contained on them at risk. MedTech Dive reports in an online post that the vulnerability also can affect certain workstations and imaging devices used in