Friday, January 19, 2024

Klobuchar Urges Drugmakers to Remove Patents FTC Calls Improper and Inaccurate

(1/18, Ed Silverman, STAT Plus) ...In a series of letters sent on Thursday, Sen. Amy Klobuchar (D-Minn.) demanded the companies explain why they have, so far, not responded to warnings issued two months ago by the Federal Trade Commission to remove more than 100 patents from the registry...So far, though, very few companies have responded to the FTC — Impax Labs, Kaléo, and two GSK subsidiaries. And a total of 18 patents have been removed from the Orange Book. As a result, Klobuchar sent letters to AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Mylan and Teva, urging the companies to remove all of the patents identified by the FTC by the end of January... Sub. Req'd

Klobuchar Calls on Pharmaceutical Companies To Remove Improperly Listed Patents from FDA Orange Book To Allow for More Competition

(1/18, United States Senator for Minnesota Amy Klobuchar) ...U.S. Senator Amy Klobuchar (D-MN) sent letters to six pharmaceutical companies, Abbvie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan-Viatris, and Teva, requesting the removal of all patents identified by the Federal Trade Commission as improperly or inaccurately listed in the FDA Orange Book by the end of the month... Full

EPO Rules in Favor of Exelixis On Patent Covering Cabometyx

(1/18, The Fly) ...Exelixis announced it has successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd., and Generics (U.K.) Ltd. in a hearing before the Opposition Division of the European Patent Office... Full

Exelixis Says European Patent Office Ruled in Favor of Cancer-Treatment Patent

(1/18, Sabela Ojea, Dow Jones) ...The oncology company on Thursday said the three-member Opposition Division rejected all grounds of opposition from Stada Arzneimittel, Teva Pharmaceutical Industries and Generics (U.K.) Ltd. The patent expires on July 18, 2031, Exelixis said, adding that the decision is specific to the European patent at issue and is subject to appeal to the European Patent Office technical boards of appeal... Full

Children's Pain and Fever Medicine Recalled Due to Acetaminophen Overdose Risk

(1/18, Megan DeLaire, CTV News) ...Drugmaker Teva Canada Ltd. is recalling one lot of its Pediatrix Acetaminophen Oral Solution after product testing found the children's liquid pain medicine contains too much acetaminophen, posing an overdose risk... Full

Kids Pain Product Recalled in Canada Due to Potential Overdose Risk

(1/18, Saba Aziz, Global News) ...The agency issued a recall alert Wednesday for one lot of Pediatrix Acetaminophen Oral Solution sold by Teva Canada Ltd. The medicine is sold over the counter without a prescription and it's for children aged two to 11 years. The recall was prompted after the company found in routine testing a higher than acceptable amount of acetaminophen in the affected lot... Full

Children's Pain and Fever Relief Medicine Recalled Due to Risk of Overdose

(1/18, The Canadian Press) ...Drug manufacturer Teva Canada Ltd. is recalling one lot of a children's pain and fever relief medicine because it contains too much acetaminophen and poses a risk of overdose...Health Canada says this could lead to children receiving too much acetaminophen, with signs of an overdose including nausea, vomiting, lethargy, sweating, loss of appetite and pain in the upper part of the abdomen or stomach... Full

A Kid's Medication Sold Across Canada Has Been Recalled Due To Potential Overdose

(1/18, Mike Chaar, MTL Blog) ...The recall was triggered by Teva Canada Ltd. after a routine product testing found "higher than acceptable amounts of acetaminophen in the affected lot." The federal health agency is urging Canadians to verify if they have the recalled Pediatrix product and to stop using it, especially if their child begins to "show signs/symptoms of acetaminophen overdose."... Full

Drugmakers Raise Prices of Ozempic, Mounjaro and Hundreds of Other Drugs

(1/18, Jennifer Calfas, The Wall Street Journal) ...Drugmakers kicked off 2024 by raising the list prices for Ozempic, Mounjaro and dozens of other widely used medicines. Companies including Novo Nordisk, the maker of Ozempic, and Eli Lilly, which sells Mounjaro, raised list prices on 775 brand-name drugs during the first half of January, according to an analysis for The Wall Street Journal by 46brooklyn Research, a nonprofit drug-pricing analytics group. The drugmakers raised prices of their medicines by a median 4.5%, though the prices of some drugs rose by around 10% or higher, according to the research group... Sub. Req'd

Drugmakers Hiking Prices for More Than 700 Medications, Including Ozempic and Mounjaro

(1/18, Aimee Picchi, CBS News) ...In a statement to CBS MoneyWatch, Novo Nordisk said that it "increases the list price of some of our medicines each year in response to changes in the health care system, market conditions and the impact of inflation."... Full

Shortage of ADHD Drugs Continues as Patients Scramble to Find Medication

(1/18, Susan Kreimer, UPI) ...The shortage of ADHD medications "has caused some strain on patients and families," Dr. Lisa Spector, division chief of developmental and behavioral pediatrics at Nemours Children's Health Florida in Orlando, told UPI in a telephone interview...The shortage of ADHD medications is "pretty severe and it has been for the last 18 months or so," Manali Patel, a pharmacist who is the manager of retail/specialty purchasing and inventory at Vanderbilt University Medical Center in Nashville, told UPI in a telephone interview. "Some of the strengths of the shortage medications don't have any available substitute options on the market," Patel said... Full

Sun Set To Get Taro Deal Over The Line, 17 Years After First Trying

(1/18, Dean Rudge, Generics Bulletin) ...More than a decade after a renewed bid to take control of Taro failed, Sun Pharma is set to take full control of the Israeli-based derma specialist, which has seen material growth and much controversy in the US under Sun's ownership. Sun Pharma praised its Israel-based Taro Pharmaceutical subsidiary for "remaining a key player in the generic dermatology market in a challenging environment" as the Indian firm announced that it was paying $43 per share to acquire Taro's remaining shares, in a bid to shore up the company and ensure it can continue to run profitably... Global Sub. Full

Sanofi CEO Paul Hudson: We've Got Perhaps the World's Best Immunology Pipeline

(1/18, CNBC) ...Sanofi CEO Paul Hudson joins ‘Squawk Box' to discuss the company's plan to become an immunology powerhouse, drug pipeline outlook, using AI for future drug discoveries, and more... Full

Glenmark Life Sciences Signs MSA with Japanese Pharma Company

(1/19, Express Pharma) ...Glenmark Life Sciences has signed a Master Supply Agreement with a Japanese innovator pharma company. Under the aegis of the Master Supply Agreement, Glenmark Life Sciences will manufacture API in the therapeutic area of urinary anti-spasmodic, to supply to the Japanese firm. As part of this collaboration, product portfolios of various affiliates of the Japanese company may also be added in the future... Full

Zydus, Synthon Sign Licensing and Supply Pact for Palbociclib Tablets for US Market

(1/19, Express Pharma) ...Zydus Lifesciences' wholly owned subsidiary, Zydus Worldwide DMCC, has entered into an exclusive licensing and supply agreement with Synthon BV for Palbociclib Tablets (a generic version of IBRANCE) for the US market... Full

Lupin Gets USFDA Nod to Market Generic Hyperuricemia Treatment Drug

(1/18, Press Trust Of India) ...Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing... Full

Samsung Bioepis Biosimilars Report Slams ‘Stagnant' US Adalimumab Uptake

(1/18, David Wallace, Generics Bulletin) ...Six months after the launch of multiple Humira (adalimumab) biosimilars in the US, and nearly a year after Amgen introduced the first biosimilar rival to the top-selling brand, biosimilar adoption "remains stagnant," thereby "delaying an opportunity for major financial relief to the US healthcare system," according to the latest figures and commentary from Samsung Bioepis...Samsung Bioepis includes a host of information about uptake and wholesale acquisition cost pricing for individual biosimilar molecules in the US, but this time around focuses its attention particularly on adalimumab and its penetration of the US market as of Q4 2023... Global Sub. Full

Eagle Sues for Patent Damages From Rival Branded Cancer Drugs

(1/18, Christopher Yasiejko, Bloomberg Law) ...Eagle Pharmaceuticals Inc. filed three new federal lawsuits seeking lost profits for its Belrapzo leukemia drug and alleging branded copies made by Apotex Inc., Slayback Pharma LLC, and Baxter Healthcare Corp. infringe two patents issued in the past month...Eagle alleges that Slayback's Vivimusta and branded copies sold by Baxter and Apotex infringe US Patent Nos. 11,844,783 and 11,872,214, which cover liquid formulations of bendamustine, the active ingredient in Belrapzo and Bendeka, a cancer drug sold by Teva Pharmaceutical Industries Ltd. under a license from Eagle... Sub. Req'd

Public Transit Agencies Fight Opioid Deaths With Naloxone

(1/18, Teresa Xie, Bloomberg Law) ...Over the last few years, several US cities and states have started installing Narcan containers near public transit and equipping transit officers with the overdose antidote. As the US opioid crisis continues, trains, buses and transit stations have become the sites of many overdoses. More than 150 people died from opioid-related overdoses on Chicago Transit Authority property between 2018 and 2022... Sub. Req'd

Bernie Sanders Proposes Subpoenas of CEOs of J&J, Merck On Drug Prices

(1/18, Rachel Cohrs, STAT) ...Senate health committee chair Bernie Sanders has taken a step toward subpoenaing the CEOs of Johnson & Johnson and Merck related to an investigation into high drug prices in the United States, he announced Thursday. The step is highly unusual, as the health committee hasn't issued a subpoena in more than 40 years... Full

Senate Health Committee to Vote On Rare Subpoenas for J&J and Merck CEOs Over Drug Pricing Testimony

(1/18, Zachary Brennan, Endpoints News) ..."It is absolutely unacceptable that the CEOs of Johnson & Johnson and Merck have refused an invitation by a majority of members on the HELP Committee to appear before Congress about the outrageously high price of prescription drugs," Sanders said ahead of the vote next Wednesday, Jan. 31. J&J said in an emailed statement to Endpoints News that it "expressed our concerns with the hearing as it is currently planned."...Senate Democrats on the health committee are also now pressing inhaler manufacturers over their high US prices and how they've used the patent system to maintain exclusivity, according to letters sent earlier this month to AstraZeneca, Boehringer Ingelheim, GSK and Teva... Full

Sanders Accused of Targeting Pharma CEOs for Drug Price Lawsuits

(1/18, Ian Lopez, Bloomberg Law) ...Johnson & Johnson is accusing Sen. Bernie Sanders (I-Vt.) of retaliating against the company and others that sued the Biden administration to stop a program to negotiate how much Medicare pays for high-cost drugs...Merck expressed a similar sentiment in its own letter to Sanders. “We appreciate that many Committee members have expressed their disagreement with our lawsuit, and we respect their good-faith views," Jennifer Zachary, Merck's executive vice president and general counsel, wrote... Full

Bernie vs. CEOs: Are J&J, Merck, And Bristol On Hot Seat, Or Is Medicare Price Negotiation?

(1/18, Cathy Kelly, Pink Sheet) ...In its description of the hearing, the committee challenges the prices of Imbruvica, which Johnson & Johnson co-markets with AbbVie Inc., Merck & Co., Inc.'s Januvia, and Eliquis, which Bristol Myers Squibb Company co-markets with Pfizer Inc., relative to prices for the drugs in other markets. But J&J and Merck believe it's no coincidence that all three companies invited to testify are engaged in litigation aimed at shutting the negotiation program down. Eight of the companies that market the drugs on the negotiation list have filed lawsuits against the Health and Human Services Department challenging the program... Sub. Req'd

Generic Drugs In The US Are Too Cheap To Be Sustainable, Experts Say

(1/18, Jessica Glenza, The Guardian) ...Generic drugs are the singularity of American healthcare – they are too cheap. And it's driving some manufacturers out of business altogether. Drug prices regularly spark recrimination and outrage on Capitol Hill, such as a recently announced investigation by Senate Democrats and Bernie Sanders into the price of albuterol inhalers..."It's great to keep costs down and keep [insurance] premiums down," said Inmaculata Hernandez, a professor at the University of California San Diego Skaggs School of Pharmacology, an expert on pharmacy policy. "But we've seen it's just too low for manufacturers to have sufficient incentives to manufacture drugs."... Full

CSRXP: Big Pharma's January Price Hikes Climb to 775 As Pharmaceutical Industry Doubles Down On Business-As-Usual Approach to Price-Gouging

(1/18, The Campaign For Sustainable Rx Pricing) ...The Campaign for Sustainable Rx Pricing released a statement Thursday on a new report that found Big Pharma hiked prices on 775 brand name prescription drugs in the first two weeks of the year, with the median price increase outpacing the current rate of inflation...[CSRxP executive director Lauren Aronson] "The rapidly rising tally of Big Pharma's January price hikes demonstrates the pharmaceutical industry will continue to double-down on a business-as-usual approach to price-gouging while hiding behind a bogus blame game and debunked rhetoric on innovation to avoid accountability."... Full

Humira Biosimilar Adoption Starts Slow In Medicare

(1/18, Michael McCaughan, Pink Sheet) ...US Medicare Payment Advisory Commission will be tracking adoption of Humira biosimilars – both because of the direct impact on costs in the Part D program, but also to test whether changes to the benefit design will work to encourage price competition. Only about 60% of enrollees in the US Medicare outpatient prescription drug program will be in plans that offer at least one biosimilar version of AbbVie Inc.'s Humira (adalimumab) in 2024, the Medicare Payment Advisory Commission staff reports... Sub. Req'd

Drug Patent Push Provides Bipartisan Meeting Point

(1/18, Peter Sullivan, Axios) ...House Budget Committee Chair Jodey Arrington's sponsorship of a plan to keep drugmakers from gaming the patent system highlights the increased scrutiny some influential Republicans are giving an industry the GOP has long allied itself with..."Attacking innovation and myopically focusing on the number of patents a medicine has won't help lower costs for patients," Megan Van Etten, a spokesperson for the drug industry trade group PhRMA, told Axios when asked about the bill... Sub. Req'd

US Congress Passes Bill to Avert Government Shutdown, Sends it to Biden

(1/19. Richard Cowan and Makini Brice, Reuters) ...The U.S. House of Representatives on Thursday approved a stopgap bill to fund the federal government through early March and avert a partial government shutdown, sending it to President Joe Biden for final approval... Full

340B Investigation: US Sen. Cassidy Expands Probe To Contract Pharmacies, Targeting CVS, Walgreens

(1/18, Cathy Kelly, Pink Sheet) ...Ranking Republican on Senate HELP Committee seeks detailed information on companies' 340B operations, revenue sources and whether discounts are shared with patients. Senate Health, Education, Labor and Pensions Committee ranking Republican Bill Cassidy, LA, is targeting heavyweights CVS Health Corp. and Walgreens in the latest step in his ongoing investigation into potential provider abuses of the 340B drug discount program... Sub. Req'd

Hobbs Continues to Press for Affordable Prescription Prices

(1/18, Howard Fisher, Arizona Daily Sun) ...Gov. Katie Hobbs is defending her call for lawmakers to impose caps on prescription drug price hikes despite a lack of specifics. "Arizonans deserve access to more affordable medication," she said Thursday. But the plan she first trotted out in her budget proposal last week still lacks many details, including what drugs would be subject to state regulation. That, said press aide Christian Slater, would be determined by a yet-to-be named board... Full

IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Competition

(1/18, Skylar Jeremias, The Center For Biosimilars) ...Projected spending growth in the US is expected to be 2% to 5%, primarily influenced by rising originator spending on an invoice basis. This growth is accentuated by increased off-invoice discounts and rebates under the IRA. Off-invoice discounts and rebates, which are anticipated to be 37% lower than invoice levels in 2023, are projected to further decrease to 47% lower in 2028... Full

Court Decision On Supplementary Protection Certificate (SPC) Manufacturing Waiver Risks Undermining Its Use

(1/18, Medicines for Europe) ...Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate manufacturing waiver issued by the Munich District Court, Germany in October 2023...In this judgement, the Munich District Court adopted an inordinately restrictive interpretation of the SPC manufacturing waiver, which cannot be derived from the letter of the law, and which contradicts the purpose and spirit behind the amendments that were introduced during its prosecution until its final approval. This utterly frustrates the aims of the legislation and disincentivises investments in Europe... Full

‘Extensive Alignment' Needed For Ukraine To Integrate With EU

(1/18, David Wallace, Generics Bulletin) ...Seven "priority steps" to support Ukraine's EU accession ambitions have been recommended to the European Commission in an open letter from Medicines for Europe, in conjunction with Ukraine's European Business Association...Signed by Medicines for Europe director general Adrian van den Hoven and EBA executive director Anna Derevyanko, the open letter proposes "priority steps to continue the EU integration of the Ukrain's pharmaceutical industry."... Global Sub. Full

Swissmedic Announces Stricter Criteria For Fast-Track Approvals

(1/18, Ian Schofield, Pink Sheet) ...Switzerland's medicines regulator has updated its requirements for the accelerated assessment of drug approval applications, including stricter criteria on the clinical evidence needed to show a "high therapeutic benefit." Swissmedic also said that from now on it will issue a preliminary decision to reject an application for a fast-track authorization procedure if its assessment of the dossier shows the criteria for an FTP are not met... Sub. Req'd

China Regulatory Overreach Prompts Concerns For FDA Inspections, Innovation

(1/18, Brian Yang, Pink Sheet) ...As the implementation of Chinese legislation aimed at tightening information-gathering and the overseas transfer of data rolls out, concerns are growing around whether that could pose challenges to unannounced FDA field inspections. However, Yaning Wang, a former director of the US FDA's Division of Pharmacometrics in the Office of Pharmacology and now CEO of the Chinese small molecule cardiovascular drug venture CreateRNA Science & Technology, told the Pink Sheet that impact is not imminent, at least not on FDA inspections relating to pending new drug approvals from China... Sub. Req'd

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