Thursday, January 18, 2024

One Lot of Pediatrix Acetaminophen Oral Solution Recalled

(1/17, Carol Thomson, CJWW) ...One lot of pediatrix acetaminophen oral solution for children has been recalled due to the potential risk of an overdose. Teva Canada is recalling the affected lot where there may be 185 milligrams per 5 millilitres of acedtaminophen rather than the approved and labelled 160 milligrams per 5 millilitres. Health Canada is monitoring the company's recall. Return the product to your local pharmacy for proper disposal... Full

A Children's Medication Has Been Recalled In Canada Due To The Potential Risk Of Overdose

(1/17, Sarah Rohoman, Narcity) ...On January 17, the government agency advised that consumers should stop using the affected product as it contains a higher amount of acetaminophen than it describes on the label. "Teva Canada Ltd. is recalling one lot of Pediatrix Acetaminophen Oral Solution after routine product testing found a higher than acceptable amount of acetaminophen in the affected lot (approximately 185mg/5mL rather than the approved and labelled 160mg/5mL)," says the advisory. "This could lead to children receiving too much acetaminophen."... Full

Global Increase in Demand Affecting Availability of ADHD Medication

(1/18, RNZ) ...In November, Pharmac switched 4000 patients to the Concerta brand of the drug methylphenidate, because the Teva brand faced supply issues. An update on Pharmac's website said the country was now also running low on the Concerta brand...It was now asking health professionals to switch people from Concerta back to Teva, when Teva is back in pharmacies. "We have received clinical advice that it is safe to switch between the two brands."... Full

Catalyst Pharmaceuticals: Until The TEVA ANDA Is Resolved, There Is A Risk

(1/17, Seeking Alpha) ...The patent issue began after Teva Pharmaceutical (TEVA) filed an ANDA and questioned the validity of 6 Orange Book listed patents held on Firdapse. The earlier of these patents expire in 2032, so, with any luck, CPRX had 9 more years left to get revenue from Firdapse, which means, given the ~$400mn they made last year from the drug, and assuming a 10% growth for 9-10 years, that the drug is worth at least $8bn to CPRX, in simplistic terms. This is what they stand to lose over the ANDA issue... Full

Formycon Believes Itself Among Frontrunners For Mammoth Keytruda Opportunity

(1/17, Dean Rudge, Generics Bulletin) ...Germany-based pure-play biosimilars developer Formycon believes it will see "eight to ten competitors max" in the race to develop a biosimilar to Merck & Co's €10bn ($10.9bn) PD-1 inhibitor Keytruda (pembrolizumab), in contrast to the more saturated development pool for Humira (adalimumab), ahead of plans to kick off clinical trials for its FYB206 pembrolizumab biosimilar candidate at the end of this year or early in 2025...With FYB206 one of six biosimilars in Formycon's disclosed pipeline, the firm says it will "continue focusing on closing" a commercialization deal for the biosimilar, following development and regulatory success with its existing partners on other biosimilars including Polpharma and Teva... Global Sub. Full

Formycon Ranibizumab Biosimilar FYB201/Cimerli® Achieved a Market Share of 38% in the United States in December 2023

(1/18, Formycon AG) ...Formycon AG today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI® (Ranibizumab-eqrn) in the US...[Dr. Stefan Glombitza, CEO of Formycon AG] "We are extremely pleased with the successful uptake of our Lucentis® biosimilar in the US, which has continued to gain momentum from quarter to quarter. The figures are similarly positive in the UK, where FYB201 (trade name: Ongavia®) achieved a market share of 69% in November 2023.6 This is confirmation of the outstanding quality of our biosimilar and the strong performance of our commercialization partners.”... Full

Bio-Thera And Macter Partner On Bevacizumab

(1/17, David Wallace, Generics Bulletin) ...China's Bio-Thera Solutions has agreed a licensing deal with Macter International Ltd. that will give Macter marketing and distribution rights to Bio-Thera's BAT1706 biosimilar rival to Avastin (bevacizumab) in Pakistan and Afghanistan. "This partnership will leverage Macter's strong local presence, and sales and marketing capabilities in Pakistan and Afghanistan," Bio-Thera stated... Global Sub. Full

Celltrion to Export Three Anticancer Drugs to Europe

(1/17, Dae-Kyu Ahn, The Korea Economic Daily) ...South Korea's Celltrion Inc. announced on Thursday that it has secured supply contracts for three anticancer biosimilars in European countries including France, Italy, Belgium, and the Netherlands. The company reported successful contracts for the anticancer biosimilars Herzuma (trastuzumab) for breast and stomach cancer treatment and Vegzelma (bevacizumab) for non-small cell lung cancer and metastatic colorectal cancer therapy from public hospital unions GRAPS and GAULoYS in France... Full

Bayer and Sun Pharma Sign Marketing and Distribution Agreement for Second Brand of Cardiac Drug in India

(1/18, Financial Express) ...Sun Pharmaceutical Industries Limited and Bayer on Thursday announced that both companies have signed an agreement to market and distribute a second brand of Finerenone in India...Under the terms of the agreement, Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa. Finerenone was first launched by Bayer under the brand name Kerendia TM in 2022... Full

Sun Pharma and Taro Announce Merger Agreement

(1/18, PT Jyothi Datta, The Hindu) ...In what could end years of cross-country parleys between the two companies, Sun Pharmaceutical Industries Limited and Taro Pharmaceutical Industries Ltd said that they have entered into a definitive merger agreement in which "Sun Pharma, Taro's controlling shareholder, has agreed to acquire all of the outstanding ordinary shares of Taro other than the shares already held by Sun Pharma or its affiliates for $43 per share in cash without interest.". Upon completion of the merger which is expected to close in the first half of 2024, Taro will become a privately held company and its shares will no longer be listed on the NYSE, the companies said... Full

Bora Plants its Flag in the US with $210M Acquisition of Generics Manufacturer Upsher-Smith

(1/17, Kevin Dunleavy, Fierce Pharma) ...Upsher-Smith, which was established in 1919, brings two manufacturing facilities that are five miles apart in the suburbs of Minneapolis. These become Bora's first facilities in the U.S..."This is a significant milestone for Bora Group, marking the most critical expansion of Bora's presence in the U.S. market and significantly enhancing Bora's position as a global competitor," Bora CEO Bobby Sheng said in a release... Full

Humira Biosimilar Market Remains Stagnant, With AbbVie Losing Only 2% of Market Share, Samsung Report Shows

(1/17, Zachary Brennan, Endpoints News) ...AbbVie is showing off to the world how it's maintaining most of the sales volume for the Humira (adalimumab) franchise in the US, losing just 2% of market share since several biosimilars launched in July, according to a new Samsung Bioepis biosimilars report. The biosimilar market for Humira has remained stagnant, even with new entrants and lower prices. Three of the nine Humira biosimilars currently marketed are priced about 85% less than Humira's wholesale acquisition cost... Full

Biocon Joins Pending Validity Review of Regeneron Eylea Patent

(1/17, Christopher Yasiejko, Bloomberg Law) ...Biocon Biologics Inc. can act as a "silent understudy" to fellow biosimilars maker Samsung Bioepis Co. in a pending validity review of a Regeneron Pharmaceuticals Inc. patent for Eylea, an administrative tribunal said... Sub. Req'd

Amid a National Shortage, The US Adderall Black Market is Booming

(1/17, John Semley, The Guardian) ...The Centers for Disease Control and Prevention has found that adult prescriptions for ADHD medication increased by 7.9% between 2020 and 2021, compared with a 1.4% average annual increase between 2016 and 2020. In 2021, doctors authorized in excess of 30m prescriptions for Adderall, serving nearly 4 million patients. But over the past two years, many of patients have been unable to procure their prescription, due to manufacturing shortfalls. With the delta between demand and supply widening, some adults with diagnosed ADHD are forced to forsake CVS, Rite Aid, Walgreens and other drug retailers, and turn elsewhere... Full

Cancer Death Rate Continues to Decline But New Cases Expected to Top 2 Million This Year, Study Finds

(1/17, Heather Landi, Fierce Healthcare) ...The mortality rate has dropped as a result of less smoking, earlier detection for some cancers and improved treatment, according to Rebecca Siegel, senior scientific director, surveillance research at the American Cancer Society and lead author of ACS's new annual report. But, this progress is jeopardized by increasing incidence for 6 of the top 10 cancers as the projected number of new diagnoses now tops 2 million for the first time, according to new data. In 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the United States... Full

Copay Coupons for Some Drugs Must Count Toward Deductibles, After Biden Court Move

(1/17, John Wilkerson, STAT Plus) ...Insurers will have to count drug copay coupons toward deductibles and patient spending caps in most cases, after a Biden move in federal court on Tuesday...The development is a win for patients and drugmakers. The HIV+Hepatitis Policy Institute and the Diabetes Leadership Council are both plaintiffs in the lawsuit. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said it's cruel for insurers to collect coinsurance assistance from drug companies and not count it toward patients' cost sharing... Sub. Req'd

Six Reasons Drug Prices Are So High in the U.S.

(1/17, Rebecca Robbins and Christina Jewett, The New York Times) ...Research has consistently found that drug prices in America are significantly higher than those in other wealthy countries. In 2018, they were nearly double those in France and Britain, even when accounting for the discounts that can substantially reduce how much American health plans and employers pay. "The U.S. market is the bank for pharmaceutical companies," said Ameet Sarpatwari, an expert in pharmaceutical policy at Harvard Medical School. "There's a keen sense that the best place to try to extract profits is the U.S. because of its existing system and its dysfunction."... Sub. Req'd

ICER's New President On What She Wants From Industry – And From Medicare Price Negotiations

(1/17, Jessica Merrill, Pink Sheet) ...In an interview, Sarah Emond talks about why she is ‘worried' about cell and gene therapy, when ICER might revise its assessment of obesity drugs, and how CMS could build a reliable and transparent Medicare price negotiation program...There are no big changes under way at ICER, Emond said, as the organization continues to emphasize improved access and affordability for drugs, even as the sector moves into new and increasingly complex areas. "We have to shift to what is next," Emond said. "We need to be able to meet the moment. Right now, I think that is cell and gene therapy."... Sub. Req'd

BIO Seeks To Push Bipartisan R&D Tax Credit Plan Over Finish Line

(1/17, Gabrielle Wanneh, InsideHealthPolicy) ...The Biotechnology Innovation Organization is asking its members to weigh in with their lawmakers to help push over the finish line a new bipartisan, bicameral proposal to restore the ability of U.S. businesses to fully deduct research and development expenses immediately rather than over a five-year period. The lobby group says restoration of the R&D tax credit could help spur development of new medical treatments... Sub. Req'd

Global Medicine Spending to Reach $2.3 Trillion by 2028 as More Patients Get Access to Better Therapies, Says IQVIA Institute Report

(1/17, IQVIA) ...Global spending and demand for medicines will increase over the next five years to approximately $2.3 trillion by 2028 as more patients get access to new and better medicines, according to a new report from the IQVIA Institute for Human Data Science titled, "The Global Use of Medicines 2024 – Outlook through 2028."... Full

Trends in Retail Prices of Prescription Drugs Widely Used by Older Americans, 2006 to 2020

(1/17, Leigh Purvis, and Dr. Stephen Schondelmeyer, AARP) ...Average price increases for prescription drugs widely used by older Americans, including Medicare beneficiaries, outstripped the price increases for other consumer goods and services between 2006 and 2020...The average annual cost of therapy for widely used generic drug products was $679...The continued increases in overall prescription drug price growth despite substantial price decreases among widely used generic drugs could be an indication that public and private health care payers can no longer rely on lower-priced generic drugs to counterbalance the price growth trends seen in the brand name and specialty prescription drug markets... Full

10 Prescription Drugs With Excessive Price Increases

(1/17, Dena Bunis, AARP) ...A new AARP report reveals that the prices of brand-name and specialty drugs that millions of Americans rely on for their health have continued to increase faster than inflation — in many cases, far faster. The latest findings underscore the importance of a provision in the new AARP-backed Rx law that penalizes big drugmakers for such outsize hikes...AARP's analysis includes 260 brand-name drugs, 503 generic medications and 180 specialty prescriptions. Specialty drugs typically are among the most complex and expensive medications used to treat very serious illnesses... Full

Drug Companies Abuse The Patent System

(1/17, Patricia Kelmar, The Gazette) ...The new year could mean a new era of more affordable medications in Iowa and across the United States — if Congress passes legislation preventing drug companies from gaming our patent system. More than 80% of voters across party lines want federal agencies to encourage prescription drug competition. Sen. Chuck Grassley has worked across the aisle for years to mend this broken system. This January, we need Sen. Grassley and other Iowans in Congress to pass decisive patent reforms through the U.S. Senate and House... Full

Pharmacy Organizations Raise Concerns About Florida's Drug Importation Program

(1/17, American Pharmacists Association) ...Our pharmacy organizations are deeply concerned about FDA's recent authorization of a state drug importation program, which could open the door for harmful and counterfeit drugs to enter our nation's drug supply, with no evidence that this will result in cost savings for our patients...While our organizations share concerns regarding the high cost of medicines in the United States, patient safety should not be compromised under any circumstance... Full

New Minnesota Prescription Drug Board Gets Up And Running But Expects Industry Resistance

(1/17, Mark Zdechlik, MPR News) ...Debate in Washington over prescription drug pricing has gone on for a long time. But state leaders, including those in Minnesota, have grown impatient with the pace of activity in Congress, so they're trying to tackle cost matters themselves. That's one of the drivers behind a new Prescription Drug Affordability Board, which was established in law last year and will soon begin its work..."The board is going to look for the drugs that have the biggest impact on Minnesotans," said DFL state Rep. Zack Stephenson, the lead author of the legislation that created the board... Full

Prescription Drug Affordability Act Aims to Set Limits On High Medication Prices

(1/17, Jeramie Bizzle, CBS News) ...On Wednesday, they announced the Prescription Drug Affordability Act. The legislation would create an independent Prescription Drug Affordability Board. "Drugs don't work if people can't afford them. Today, 28% of Illinoisans have reported not filling their prescriptions or rationing their medication to save money," said State Rep. and co-sponsor Nabeela Syed (D) Palatine... Full

Illinois Lawmakers Floating the Idea of Attempting to Cut the Cost of Prescription Drugs

(1/17, Dave Dahl, WJBC) ...Illinois lawmakers are floating another attempt to curb the costs of prescription drugs, announcing a bill to set up a "prescription drug affordability board," which would evaluate drug costs and set what advocates say are reasonable rates. "Health care – specifically, prescription drugs – are just too expensive to afford, said the House sponsor, State Rep. Nabeela Syed (D-Inverness)... Full

Maryland Prescription Drug Affordability Board Working To Bring Down High Costs

(1/17, FOX 45 News) ...The Biden administration recently announced it would exercise the right to cease control of prescription patents funded with federal dollars, and the effect is leading to states pushing for more local authority. President of the Maryland Healthcare For All Coalition, Vinny DeMarco, joined FOX45 News to share more on why there needs to be a push at the state level to bring the price of prescription drugs down... Full

European Commission Launches New Alliance to Address Critical Drug Shortages

(1/17, Anna Brown, Endpoints News) ...The European Commission on Tuesday laid out the road map for its new advisory committee, the Critical Medicines Alliance initiative, which aims to mitigate drug shortages in Europe over the next five years...The alliance will "unlock manufacturing, contractual or financing solutions to allow better strategic autonomy for critical medicines," the EC said... Full

UK To Combat Clinical Trial Issues With Upstream Support For Sponsors & International Collaboration

(1/17, Eliza Slawther, Pink Sheet) ...The UK medicines regulator is mulling the possibility of drawing on its existing international regulatory partnerships, such as the ACCESS Consortium, to tackle challenges in its clinical trials sector, and says sponsors can expect greater support early in the trial process..."We know that clinical trials have been through a difficult period. But I'm very pleased to say that we are meeting or exceeding all statutory limits on initials and amendments," said Marc Bailey, chief scientific officer at the MHRA, during the agency's most recent board meeting on January 16... Sub. Req'd

Brazil Updates GMP Rules For Advanced Therapies

(1/17, Francesca Bruce, Pink Sheet) ...Anvisa, Brazil's medicines regulator, has updated the country's good manufacturing practices for advanced therapies based on standards issued by PIC/S, the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme. Regulation IN 270/2023 will complement the regulatory framework for advanced therapies and guidelines on GMP and good practices for human cells. It also applies provisions of the guidelines on good practices in blood and good practices in tissues to advanced therapies... Sub. Req'd

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