Drugs
An independent data safety monitoring board has recommended that the VIR-7831 arm of the National Institute of Health’s Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) Phase 3 trial be closed to enrollment due to questions about the magnitude of the drug’s potential benefit. Vir Biotechnology and
Drugs
FDA says it is aware that many patients, families, and others in the amyotrophic lateral sclerosis (ALS) community have had high hopes for BrainStorm Cell Therapeutics’ NurOwn therapy. An agency online notice says that with the recent completion of a Phase 3 trial comparing NurOwn to placebo, “it has become
Drugs
FDA has accepted for priority review an On Target Laboratories NDA for pafolacianine sodium injection as an adjunct for identifying ovarian cancer during surgery. The company says that many cancers, including over 95% of ovarian cancers, over-express folate receptors to enable the uptake of folic acid. Pafolacianine sodium injection
Drugs
An 8/4-8/13/20 FDA bioresearch monitoring program inspection at KDunn and Associates, doing business as HealthQuilt, Houston, TX, found objectionable conditions in the company’s work as the sponsor of a clinical investigation into a Covid-19 investigational drug. A 2/16 Warning Letter says specific objectionable
Drugs
FibroGen and partner AstraZeneca say FDA is requiring its Cardiovascular and Renal Drugs Advisory Committee to review their NDA for roxadustat for treating anemia caused by chronic kidney disease (CKD). FDA accepted the NDA 2/2020 and gave it a review action target date of 12/2020, which was extended
Drugs
Drug companies are pressing FDA to find ways to resolve the inspection backlog that has occurred due to Covid 19. Politico reports in an online post that between 3/2020 and 9/2020 FDA inspected just three overseas plants (well below the 600-plus visited in each of the prior
Drugs
Merck has withdrawn a Keytruda (pembrolizumab) indication for treating patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal is part of an FDA effort to clean up products/indications on the
Drugs
FDA has approved revisions to the labeling for ViiV’s Triumeq (abacavir/dolutegravir/lamivudine) and Dovato (dolutegravir/lamivudine) to include dosing in patients with creatinine clearance between 30 and 49 mL per min. An agency notice says that drug interaction information for Triumeq and riociguat also was included in the
Drugs
FDA has accepted an Oyster Point Pharma NDA for its OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease. The agency assigned a PDUFA target action date of 10/17, the company says. It also says FDA currently does not plan to schedule an
Drugs
FDA has accepted for review an Eyenovia NDA for MydCombi (tropicamide 1% and phenylephrine 2.5%) ophthalmic solution, a fixed combination mydriatic (pupil dilation) agent for use in routine eye exams. “MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation to improve the patient’s
Drugs
FDA 2/27 issued an emergency use authorization (EUA) to Janssen Biotech for its single intramuscular Covid-19 vaccine injection. The EUA follows an unanimous (22-0) advisory committee vote 2/26 (see earlier story). The company’s data “show that the vaccine’s known and potential benefits outweigh its
Drugs
In recognition of Rare Disease Day (2/28), FDA has announced new actions to advance development and approval of therapies to such diseases. For example, a new request for applications (RFA) has been posted within the agency’s Orphan Products Grants Program for “Efficient and Innovative Natural History Studies Addressing
Drugs
FDA has issued CorMedix a complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The agency letter cited concerns at a third-party manufacturing facility after a review of records requested by
Drugs
FDA has accepted for review a Merck NDA for gefapixant, an investigational selective P2X3 receptor antagonist for treating refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. An RCC is a cough that persists despite appropriate treatment of underlying conditions, and a UCC is a cough where the
Drugs
Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries have been ordered to pay $834 million to the state of Hawaii over marketing and promotion violations involving Plavix, a blood thinner used to reduce the risk of serious cardiovascular events such as heart attacks, strokes and blood clots. Hawaii
Drugs
FDA has issued Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer. The letter indicated concern about a safety risk due to an increase in neutropenia-related sequelae in patients on the oral paclitaxel arm compared with the intravenous paclitaxel arm
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system, a generic copy of now-discontinued contraceptive Ortho Evra (Janssen Pharmaceuticals). As part of the approval, Amneal was granted 180 days marketing exclusivity. The product will be marketed under the
Drugs
FDA has approved B. Braun Medical’s acetaminophen injection in IV bags in 1,000 mg in 100 mL and 500 mg in 50 mL doses. The products are being manufactured using dual-sourced active pharmaceutical ingredients to reduce potential supply risks, the company says. Acetaminophen is indicated for managing
Drugs
FDA has asked Merck for additional data beyond a recently completed Phase 3 study of investigational Covid-19 drug MK-7110, an immune modulator. Previously, the company and the U.S. government penned a $356 million deal to supply the U.S. with 60,000 to 100,000 doses of
Drugs
FDA has approved an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in pediatric patients five years of age and older. Approval was based on clinical trial (ENVISION I study) data showing that Humira induced clinical remission at week eight and maintained remission at
Drugs
A Consumer Reports (CR) investigation shows that FDA waited nine months in 2018 before warning the U.S. public about tianeptine, a dietary supplement that has opioid-like effects. The report says the magazine obtained FDA e-mails that “underscore concerns about FDA’s ability to police the $46 billion
Biologics
Former FDA chief of staff Lauren Silvis has been added to President Joe Biden’s Covid-19 response team. Silvis was agency chief of staff under former commissioner Scott Gottlieb. Before serving as chief of staff from 5/2017 to 6/2019, she was CDRH deputy director for policy. Silvis