Drugs
Teva is urging the U.S. Supreme Court to dismiss a GlaxoSmithKline (GSK) argument that the high court should not hear Teva’s appeal of a “skinny label” case involving GSK’s heart drug Coreg (carvedilol). In its appeal, Teva framed the question for the high court as: If a
Devices
FDA has cleared a Boston Imaging 510(k) for its V7, an ultrasound system designed for use with the company’s Crystal Architecture to enhance image clarity. The V7 is also equipped with “Intelligent Assist” features to be used in both general imaging and women’s health ultrasound cases. Boston
Drugs
FDA has approved a Spectrum Pharmaceuticals BLA for Rolvedon (eflapegrastim-xnst) injection for decreasing the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The approval of the long-acting granulocyte
Biologics
Non-profit PATH’s chief scientific officer David Kaslow has been selected as CBER Office of Vaccines Research and Review (OVRR) director, replacing Marion Gruber, who retired last year in protest over how the agency and Biden Administration were handling Covid-19 vaccine reviews and approvals. Last year, Gruber and
Drugs
FDA has accepted for review a Pfizer NDA for baldness drug ritlecitinib for treating adults and adolescents 12 years of age and older with alopecia areata. The agency is expected to make a decision in the second-quarter next year. Pfizer says the submission was based on previously announced topline
Drugs
FDA has published a final guidance, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products, encouraging sponsors and applicants to identify in their submission cover letters certain uses of real-world data (RWD) and real-world evidence (RWE). The document says that
Devices
FDA has denied a 2014 petition asking that the agency (1) require a Boxed Warning on LASIK devices concerning a high incidence of induced visual symptoms and dry eyes; and (2) send letters to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology to advise
Devices
Sklip Inc. says it has received IRB approval to clinically test its Sklip artificial intelligence (AI) skin cancer triage system with patients in home settings. The device, which has gained a breakthrough designation from FDA, is considered a “software as a medical device” tool that uses “proprietary artificial intelligence technology
FDA Policy/General
The Union of Concerned Scientists (UCS) is preparing to distribute an online survey to tens of thousands of federal scientists in seven agencies to assess the state of science in their agencies under the Biden administration. “Surveying federal scientists to hear directly from them about their experiences is one of
Devices
FDA says it is aware of reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. An agency safety alert says the lymphomas reported are not the same as the lymphomas described in an earlier communication as breast implant-
Devices
FDA has published an immediately effective guidance, Policy for Monkeypox Tests to Address the Public Health Emergency, describing the agency’s review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests. The document also covers the FDA enforcement policies for certain diagnostic tests that are developed by and
Drugs
In a filing with the National Stock Exchange of India, Panacea Biotec says it has been informed by FDA that the classification of the agency’s 5/30-6/8 inspection at the Panacea facility in Baddi, Himachal Pradesh, India, is “Official Action Indicated.” The filing says the classification means
Devices
An FDA safety alert is warning about potential clip lock malfunctions with Abbott’s MitraClip Delivery Systems. The company has issued an Urgent Medical Device Correction to inform health care providers about an increase in complaints regarding clip locking malfunctions, which have been observed before and after clip deployment. “These
Biologics
FDA has approved a Revance Therapeutics BLA for Daxxify (daxibotulinumtoxinA-lanm) for injection for temporarily improving moderate-to-severe frown lines (glabellar lines) in adults. The product, which will compete against Allergan’s Botox, is being touted as the first long-acting neuromodulator that “demonstrates a median duration of six
Drugs
FDA has published a draft guidance, Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products, with labeling recommendations intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products. The document says labeling for
FDA Policy/General
For the second time in six months, an FDA advisory committee convened to discuss data on Amylyx’s amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol), but unlike the 3/30 near mixed vote that recommended against approving the therapy,
Drugs
FDA has released the form FDA-483 issued following an 8/12-8/20/21 inspection at the Hugel drug substance and drug product manufacturing facility in Chuncheon, Gangwon, Korea. The seven inspection observations were: * Clostridium botulinum spore containment in the drug manufacturing areas is inadequate to mitigate spore cross-
Drugs
FDA has published a draft guidance, General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products, to assist sponsors of INDs, Section 505 NDAs, BLAs, and supplements to those applications who are planning to conduct clinical studies in pediatric populations. The document also is intended to assist clinical
Devices
Philips Respironics has recalled 17 million masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern related to magnets that connect components to hold the device in place. “The magnets can
Drugs
CDER and CBER have accepted the first submission for the Innovative Science and Technology Approaches for New Drugs pilot program for developing drug development tools (DDTs). An FDA post says the first accepted letter of intent submission is for a tool that proposes to evaluate off-target protein binding for
Drugs
Ionis Pharmaceuticals and AstraZeneca plan to submit an NDA for eplontersen later this year for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) based on new study results announced 9/7. ATTRv is a severe, progressive, and life-threatening disease caused by the abnormal formation of the transthyretin
Drugs
While praising FDA efforts to develop guidances and standards to implement the Drug Supply Chain Security Act, four industry stakeholders are seeking changes to a draft guidance on the interoperable exchange of information for tracing of certain human, finished prescription drugs. The American Pharmacists Association (APhA) says the information guidance