Drugs
A former employee at Eli Lilly has filed a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired in retaliation for allegedly raising issues about GMP problems and data falsification involving top-selling Type 2 diabetes drug Trulicity. The plaintiff, Amrit Mula, was terminated in 2019 after bringing
Drugs
CDER Office of Drug Security, Integrity, and Response director Leigh Verbois says the agency will continue to revise and update the APEC (Asia Pacific Economic Cooperation) toolkit to assist in drug supply chain integrity. Interviewed on an Rx 360 podcast, Verbois said that as the toolkit was developed, it became
Drugs
A California federal judge has approved a $10.8 million settlement between Bristol-Myers Squibb and direct buyers of HIV medication who claimed the company engaged in anti-competitive conduct to block generic competition and artificially inflate medication prices. The case involves KPH, a retail and online pharmacy operator, that
Drugs
A 10/5-10/19/21 FDA inspection at the Aire-Master of America drug manufacturing facility in Nixa, MO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 5/23 Warning Letter says specific violations were: * failing to establish laboratory controls
Drugs
The Washington State Supreme Court ruled 6/2 that the state does not have any drug direct-to-consumer advertising exception requiring pharmaceutical marketers to specifically warn patients about potential adverse events when drug products are advertised directly to consumers. When a drug marketer advertises its products directly to consumers,
Drugs
Drug companies that receive complete response letters on their submissions cannot circumvent the agency’s hearing process to petition courts for redress. So says the Washington, DC Court of Appeals in a 6/3 decision that rejected a Nostrum Pharmaceuticals request for the court to hear arguments on the company’
Drugs
India-based Lupin Pharmaceuticals has hired recently retired FDA New Jersey District director Diana Amador-Toro as the company’s senior vice president of global compliance. Based in Somerset, NJ, Amador-Toro presumably will be charged with helping to correct ongoing violations at Lupin’s New Jersey manufacturing facility. The
Drugs
FDA has extended the review of an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. The new user fee review action target date is 9/29. The agency review extension will allow more time to review
Drugs
FDA has released the FDA-483 issued following a multi-day inspection between 11/10/21 and 1/8/22 at CFP Acquisitions, a Tulsa, OK, producer of sterile drug products. The inspection observations were: * releasing drug product in which the strength differs from that it purports or is represented
Drugs
Centessa Pharmaceuticals has decided to discontinue developing lixivaptan for autosomal dominant polycystic kidney disease (ADPKD). The company says its “strategic decision” to stop the Phase 3 ACTION study and the open-label ALERT study was based on a “thorough reassessment of the commercial potential of lixivaptan as a potential best-
Drugs
FDA has accepted for review an sNDA submitted by Pfizer and Myovant Sciences for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). A Pfizer statement says the sNDA proposes updates to the Myfembree labeling based on safety and efficacy data from the Phase 3 LIBERTY
Drugs
Three doctors have filed suit in a Texas federal court protesting FDA’s attempts to block the use of ivermectin to treat Covid-19. According to The Texan, the complaint says the agency has approved ivermectin for human use since 1996 for several diseases. But after the Covid-19 pandemic
Drugs
Sens. Maggie Hassan (D-NH) and Rand Paul (R-KY) have introduced legislation (S. 4338) they say will streamline the process for approving generic drugs. A statement says companion legislation was introduced in the House by Rep. Annie Kuster (D-NH) earlier this year. Hassan says the bill would require
Drugs
FDA has granted Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Kymriah was the first CAR-T cell therapy to receive regulatory approval 8/2017, for treating patients up to 25 years of age
Drugs
Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH) say FDA and the Patent and Trademark Office (PTO) should close oversight gaps that they say delay generic drugs from coming to market and thus keep drug costs high. In a statement, the senators say a lack of coordination between
Drugs
FDA has withdrawn its approval of TG Therapeutics’ Ukoniq (umbralisib), indicated to treat two specific types of lymphoma, for safety reasons. An agency drug safety communication says updated findings from the UNITY-CLL clinical trial continue to show a possible increased risk of death in patients receiving Ukoniq. “As a
Drugs
FDA has launched a Web page on FDA-recognized susceptibility test interpretive criteria (STIC). The page includes information on both antibacterial and antifungal susceptibility test interpretive criteria. According to the page, the 21st Century Cures Act requires FDA to post online information about the agency’s recognition or withdrawal from
Drugs
FDA has granted breakthrough therapy designation to Sanofi’s efanesoctocog alfa to treat people with hemophilia A. A company statement says efanesoctocog alfa is the first factor VIII therapy to receive the designation. Sanofi says the designation was based on the XTEND-1 Phase 3 study that demonstrated a clinically
Drugs
University and Veterans Affairs researchers say their study of Centers for Medicare and Medicaid Services (CMS) spending for drugs that received FDA accelerated approval often found that the approval was not associated with added value relative to existing therapeutic options. The study was published in JAMA Health Forum. The researchers
Drugs
FDA has lifted a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for treating adults with relapsed or refractory T-cell lymphoma. The hold was placed in February after one
Drugs
FDA has approved two drug combinations for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma. Approval was given to Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy and Opdivo in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab)
Drugs
FDA has placed a clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lilly. The agency said the hold is related to issues surrounding the trial’s protocol design, according to the company. Sanofi’s