Mar 9, 2023

Tyler Patchen News Reporter Gener­ics man­u­fac­tur­er Apo­tex is vol­un­tar­i­ly pulling six lots of its bri­moni­dine tar­trate oph­thalmic so­lu­tion off the shelves af­ter cracks were re­port­ed on some bot­tle caps. Bro­ken caps can im­pact the steril­i­ty of the prod­uct, and even lead to a po­ten­tial ad­verse event, the com­pa­ny said. The drug is used to re­duce in­traoc­u­lar pres­sure for pa­tients with open-an­gle glau­co­ma or oc­u­lar hy­per­ten­sion, and af­fect­ed batch­es were dis­trib­uted across the US be­tween April 5 of last year and Feb. 22, 2023. Apo­tex has been no­ti­fy­ing whole­salers, ware­hous­es and phar­ma­cies of the re­call and is ar­rang­ing for the re­turn of any re­called prod­uct. The FDA’s re­call re­port states that pa­tients who have re­ceived the drug or have ques­tions should con­tact their phar­ma­cy and no­ti­fy their health­care provider for med­ical ad­vice. Jor­dan Berman In an email to End­points News, Jor­dan Berman, VP of cor­po­rate glob­al af­fairs, busi­ness trans­for­ma­tion and strat­e­gy at Apo­tex, said that there have been “no drug safe­ty re­ports re­lat­ed to neg­a­tive health out­comes due to this prod­uct.” Apo­tex has is­sued a few re­calls in the past. In 2021 , the man­u­fac­tur­er re­called three lots of the AD­HD treat­ment guan­facine due to trace amounts of que­ti­ap­ine fu­marate in one of the lots, the con­sump­tion of which could lead to a drop in blood pres­sure, sleepi­ness and dizzi­ness. The man­u­fac­tur­er al­so launched a vol­un­tary re­call of two batch­es of the blood thin­ner in­jec­tion enoxa­parin sodi­um in 2021 af­ter dis­cov­er­ing that some sy­ringes were mis­la­beled and could pos­si­bly lead to pa­tients get­ting more of the drug than need­ed. AUTHOR Paul Schloesser Associate Editor On the heels of Merck reporting a Phase III win with Keytruda before and after surgery in non-small cell lung cancer (NSCLC), AstraZeneca is announcing its own win in the space — following a win from last summer. The UK pharma said Thursday that its anti-PD-1 drug Imfinzi, showed a statistically significant improvement in event-free survival when combined with neoadjuvant chemotherapy before surgery and after surgery by itself in an adjuvant setting. The data came from a planned interim analysis, AstraZeneca said, but no hard figures were released. Keep reading Endpoints with a free subscription Unlock this story instantly and join 162,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Tyler Patchen News Reporter Experts who track drug supply and care for cancer patients say they are watching with concern about shortages of several generic drugs that are widely used in treating cancer patients. Three drugs used in various cancer treatments are currently on the shortage list kept by the American Society of Health-System Pharmacists (ASHP). Those include methotrexate, which treats cancer by slowing the growth of cancer cells; cisplatin, a backbone of chemotherapy for advanced cancers in the ovaries, bladder and other locations; and fluorouracil, another widely used chemotherapy drug. Keep reading Endpoints with a free subscription Unlock this story instantly and join 162,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Drew Armstrong Executive Editor A trial of Eli Lilly’s Alzheimer’s drug solanezumab that began in 2013 didn’t show any benefit in patients, who were followed for a decade to try and answer whether the amyloid-targeting drug might slow the disease. Lilly’s study enrolled about 1,100 patients ages 65 to 85 who had yet to show signs of clinical impairment but who had brain imaging scans showing amyloid plaque accumulation, an early diagnostic signal of Alzheimer’s. Patients got the drug for four and a half years and were followed for the rest of the study — far longer than the year or two that’s more common for such trials. Read More March 8, 2023 03:40 PM EST Kyle LaHucik Associate Editor More layoffs have hit the biotech industry this week, with Coherus BioSciences saying it let go about 60 employees and an antimicrobial drug developer parting ways with 30% of its staff. The layoffs at Coherus, an immuno-oncology biotech and maker of biosimilars, equates to roughly 20% of the 359 full-time and part-time employees it had at the end of 2022, all based in the US. The Redwood City, CA biotech disclosed the news in its quarterly update. In an SEC filing , Coherus said most of the layoffs would go into effect on Friday. Keep reading Endpoints with a free subscription Unlock this story instantly and join 162,400+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Zachary Brennan Senior Editor Take a look at the 53 inhalers approved by the FDA to treat asthma and COPD from 1986 to 2020, and you will find generic versions for just four of those brand-name products, and a widening gap where manufacturers may be hesitant to jump in, researchers from Georgetown, the University of Calgary, University of West Virginia and Harvard wrote in a Health Affairs article published yesterday. That dearth of competition has meant decades of monopolies for blockbuster inhalers dispensing common asthma, COPD and other treatments like albuterol, budesonide formoterol, and fluticasone-salmeterol. But there has been a slight uptick in progress recently as they note: Read More