Thursday, July 11, 2024

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly' Listed Medical Device Patents

(7/10, Brian Bossetta, MedTech Insight) ...The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC's delisting push...While some companies have complied with the FTC's request to remove their patents from the Orange Book, others have refused, Koblitz noted. And of those, Koblitz said Teva has taken the firmest stance in resisting the commission...Regardless of how successful Teva is in standing up to the FTC or how things shake out in various challenges in court, Koblitz believes the commission is going to keep pushing... Sub. Req'd

Fresenius Announces EMA Acceptance for Review of Denosumab Biosimilar Candidates

(7/11, Fresenius Kabi) ...Fresenius, via its operating company Fresenius Kabi, announced that the European Medicines Agency has accepted for review the company's Marketing Authorization Applications for its biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab)... Full

Celltrion's Xolair Biosimilar Reaches UK, Following Key US Filing

(7/10, Dean Rudge, Generics Bulletin) ...Celltrion is continuing to spearhead global competition to Genentech/Novartis's Xolair (omalizumab), now picking up an approval from the UK's Medicines and Healthcare products Regulatory Agency for its Omlyclo biosimilar treatment for allergic asthma and chronic rhinosinusitis with nasal polyps...Other omalizumab biosimilar developers include Teva, which has been conducting a Phase III trial investigating its TEV-45779 candidate compared to Xolair also in adults with chronic idiopathic urticaria. According to the clinicaltrials.gov website, the study has completed... Global Sub. Full

Zydus Lifesciences Gains FDA Nod for MS and Heart Failure Treatments

(7/11, IIFL Securities) ...The first approval grants tentative FDA clearance for diroximel fumarate delayed-release capsules, specifically designed for treating relapsing forms of multiple sclerosis in adults. Manufactured at their Ahmedabad SEZ facility in India, these capsules have achieved substantial annual sales of $847.4 million in the United States as of May 2024 (IQVIA MAT). .. Full

Zydus Barred from Selling Cancer Biosimilar, For Now

(7/10, Viswanath Pilla, The Economic Times) ...The Delhi High Court has temporarily barred Zydus Lifesciences from selling its breast cancer drug Sigrima, a biosimilar of Roche's Perjeta (pertuzumab), due to a patent infringement lawsuit filed by Roche. The court granted an interim injunction against Zydus after Roche argued that Sigrima and another biosimilar, Womab from Dr Reddy's, violate its patents. Zydus had received conditional approval for its pertuzumab biosimilar but launched it amidst ongoing litigation, prompting the court to intervene to prevent potential market disruption... Full

Novo Nordisk's Weekly Insulin Rejected by FDA

(7/10, Elaine Chen, STAT Plus) ...The Food and Drug Administration rejected Novo Nordisk's weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant. The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year... Sub. Req'd

Pfizer Moves Forward with Once-Daily Weight Loss Drug

(7/11, Manas Mishra, Reuters) ...Pfizer plans to move a reworked, once-a-day version of its weight loss pill, danuglipron, into clinical trials later this year, the company said on Thursday, after it dropped development of an earlier daily-form of the drug last year. The new drug is part of the second-generation of weight-loss pills, under development by companies including Eli Lilly and Novo Nordisk, that will offer patients a more convenient dosing instead of injections. Some analysts expect the weight-loss drug market, currently dominated by Novo Nordisk's Wegovy and Eli Lilly's Zepbound, to be worth over $150 billion by the early 2030s... Full

Court Approves $50 Million Settlement in Pfizer EpiPen Price-Fixing Case

(7/10, CPI) ...Pfizer has received final approval for a $50 million settlement to resolve a long-standing multidistrict litigation accusing the pharmaceutical giant of conspiring to inflate the prices of life-saving EpiPen injections. The approval, granted by Judge Daniel D. Crabtree of the U.S. District Court for the District of Kansas, ensures immediate financial recovery for a class of direct EpiPen purchasers... Full

Missed Appeal Costs HEC $50 Million in Gilenya Drug Patent Case

(7/10, Christopher Yasiejko, Bloomberg Law) ...Failure to appeal the cancellation of a preliminary injunction bond cost HEC Pharm Co. its chance to recover $50 million in a patent dispute it ultimately won over HEC's copy of Novartis AG's blockbuster multiple sclerosis drug Gilenya, a federal judge ruled. Judge Kent A. Jordan's decision, issued Tuesday in the US District Court for the District of Delaware, denied HEC's motion for recovery of damages... Sub. Req'd

Move Over, Oncology: Obesity, Diabetes Meds Will Take Over 2030's Top Drug Rankings, Evaluate Forecasts

(7/11, Zoey Becker, Fierce Pharma) ...Reflecting a new shift, oncology drugs have taken a back seat to the rise of obesity and diabetes meds, specifically from Novo Nordisk and Eli Lilly. Lilly's tirzepatide products Mounjaro and Zepbound, plus Novo's semaglutide based Ozempic, Wegovy and its newest candidate CagriSema, are expected to be some of the top drugs by 2030 sales with a combined haul of more than $100 billion. Those five, plus Sanofi and Regeneron's Dupixent and AbbVie's Skyrizi, will help drive total worldwide prescription drug sales of some $1.7 trillion... Full

Rite Aid, Affiliates Settle Government Lawsuit On Opioid Dispensing

(7/10, Laurel Stone, WKBN) ...Rite Aid Corporation and 10 subsidiaries and affiliates have agreed to settle the government's allegations that the company allegedly filled hundreds of thousands of prescriptions for controlled substances that had "obvious red flags" amid the country's opioid epidemic. The Justice Department announced the settlement Wednesday... Full

FTC to Sue Drug Managers Over Insulin Prices

(7/10, Liz Essley Whyte and Anna Wilde Mathews, The Wall Street Journal) ...The agency plans to file lawsuits taking aim at business practices related to rebates brokered with drug manufacturers, people familiar with the matter said. The FTC is also investigating the role that insulin manufacturers play in the negotiations, one of the people said... Sub. Req'd

Feds Poised to Sue Pharmacy Gatekeepers Over High Drug Costs

(7/10, Josh Sisco, Politico) ...The pending case would target large pharmaceutical intermediaries owned by UnitedHealth Group, CVS and Cigna, claiming that they pushed patients to brand-name drugs, including insulin, according to the four people...The drug makers are also under scrutiny as part of the FTC probe of insulin prices but it couldn't be learned whether they would also be named in a lawsuit... Full

FTC Plans to Sue PBMs Over the High Cost of Insulin and Other Medicines

(7/10, Ed Silverman, STAT Plus) ...The focus on PBMs comes as the agency also takes a tougher stance toward the pharmaceutical industry over patents that are improperly or inaccurately filed with a registry maintained by the Food and Drug Administration. The FTC has warned several companies over their patent filings and last week opened an investigation into Teva Pharmaceuticals over concerns that the patent system is being abused in ways that unfairly extend monopolies held by brand-name drug companies that allow them to maintain higher prices for longer periods of time... Sub. Req'd

FTC's PBM Investigation Could Yield Litigation Over Insulin Contracting

(7/10, Cathy Kelly, Pink Sheet) ..."Three brand drugmakers control nearly the entire insulin market, and without competitive biosimilar alternatives, they raised their list prices by as much as 500% in lockstep with one another prior to 2012," CVS said. "That's when CVS Caremark fueled increased competition by creating new formulary options to fight back against these manufacturer price hikes," the company added. "We negotiated deep discounts on behalf of our clients … and embraced the launch of the first insulin biologic, helping bring insulin back to affordable levels for their members."... Sub. Req'd

US Senator Sanders Optimistic Novo Nordisk Can Be Pressured to Cut Wegovy, Ozempic Prices

(7/10, Ahmed Aboulenein, Reuters) ...Senator Bernie Sanders on Wednesday expressed confidence that Novo Nordisk can be convinced to cut the U.S. prices of its popular Ozempic and Wegovy drugs used for weight loss by publicly shaming the company over how much it charges compared with prices in other countries...Sanders wants to see Novo reduce the price of Ozempic in the United States to around $155, the drug's price in Canada... Full

Biden Health and Human Services Chief Rips Pharmacy Benefit Managers During Flint Visit

(7/11, Hannah MaCkay, The Detroit News) ...U.S. Health and Human Services Secretary Xavier Becerra called for funding and policies that support independent pharmacies by eliminating pharmacy benefit managers alongside representatives of the Michigan Pharmacists Association and the Michigan Independent Pharmacy Association during a visit to Flint on Wednesday..."The only winners in a world without PBMs are the big drug companies," CSV Caremark spokesman Phil Blando said in response to Becerra's comments.... Full

FTC Commissioners, Former U.S. Senator And Secretary Of State, Academics, And National Organizations Focused On Fostering Market Forces And Competition React To Flawed FTC Interim Report On PBMs

(7/10, PCMA) ...The interim report conspicuously lacks empirical data provided to the agency by PBMs. Instead, it relies on anecdotes and comments from anonymous sources and self-interested parties. Adding to the inaccuracy of the report, it is supported by merely a preliminary look at data for only two drugs, out of the tens of thousands of prescription drugs in the market... Full

7 Takeaways From the FTC Interim Report On PBMs

(7/10, Peter Wehrwein, Managed Healthcare Executive) ...One of the FTC commissioners, Melissa Holyoak, filed a dissenting statement that criticized the interim report for lacking economic rigor and "failure to offer empirical evidence to support claims about the market power of PBMs." So clearly the report is controversial and its findings, disputed. It is far more likely to stoke the ongoing battle between the PBM industry and its critics and opposing interests than to calm the waters and settle matters... Full

CMS To Codify How 340B, Drug Shortages Factor Into Medicare Inflation Rebate Policy

(7/10, Gabrielle Wanneh, InsideHealthPolicy) ...Nearly two years since Medicare first implemented a program requiring drug companies pay back the government when they raise the prices for drugs covered under Medicare Parts B and D faster than the rate of inflation, CMS is proposing to update its efforts and codify policies to adjust how 340B drugs and drugs currently in shortage are considered when calculating total inflation rebate amounts, the proposed rule for the calendar year 2025 physician fee schedule released Wednesday (July 10) says... Sub. Req'd

Agency and Industry Discuss Drug Supply Chain Policy Solutions

(7/10, Patrick Day, Lachman Consultants) ...The Duke-Margolis team introduced four panels to highlight current and planned actions to mitigate this decade-old problem. Several themes resonated with the in-person and virtual attendees; these messages included: Interagency cooperation is critical...There is no one agency or policy that can fix this complex problem in a silo...A strong public-private partnership is needed to mitigate a complex problem that affects a global supply chain... Full

A Perfect Storm for Drug Shortages in U.S.

(7/10, Nick Iacovella, The Washington Times) ...While the COVID-19 pandemic increased public awareness of drug shortages, they predate the pandemic. Two major factors are now exacerbating them: foreign government subsidies and massive regulatory oversight failures by the Food and Drug Administration... Full

Scoop: Senate Hotlines Drug Patent Bills

(7/10, Peter Sullivan, Axios) ...Senators are making preparations to try to pass a package of patent reform bills and other measures aimed at lowering drug prices by unanimous consent, Axios has learned...It is unclear whether any senators will object and whether the unanimous consent passage can go forward. Senate Judiciary Committee spokesman Josh Sorbe confirmed the hotline to Axios. Senate Majority Leader Chuck Schumer's office did not immediately respond to requests for comment... Sub. Req'd

Doctors ‘Overprescribing' Opioids isn't the Cause of the Overdose Epidemic — And it Never Was

(7/11, Richard A. "Red" Lawhern, STAT) ...A key part of the federal government's narrative about the epidemic of addiction and overdose deaths in the U.S. has been that it is driven by doctors and other clinicians overprescribing opioid painkillers. That story line is false — and was never true... Full

EFPIA: EU Must Up The Budget Of Next R&D Funding Framework

(7/10, Eliza Slawther, Pink Sheet) ...The European Commission's new research and innovation funding scheme should have a higher budget and be more "flexible and fit-for-purpose" than the existing "one-size-fits-all approach," pharma industry federation EFPIA says... Sub. Req'd

Novo Nordisk UK In Trouble Again, This Time For Failing To Disclose Payments

(7/10, Andrew McConaghie, Pink Sheet) ...Novo Nordisk has once again been found in serious breach of the UK pharma industry code of practice, after it failed to disclose millions of pounds of payments to healthcare organizations, physicians and patient groups in the UK...In its latest ruling, the PMCPA concluded: "It was apparent that Novo Nordisk had a lack of oversight and its processes were wholly inadequate." Moreover, it said its panel was concerned that matter only came to light via another complaint, rather than as a result of the company's "culture, policies and procedures."... Sub. Req'd

Hong Kong Enhances Expedited Drug Licensing Process; Adopts Refuse-To-File Tool

(7/10, Neena Brizmohun, Pink Sheet) ...Hong Kong has introduced more measures to incentivize companies to submit their drug marketing applications using the "1+" mechanism it launched last November to speed up the registration of products containing new chemical or biological entities for life-threatening or severely-debilitating diseases. In addition, the country has implemented a new refuse-to-file mechanism to "enhance its timeliness and efficiency" in managing the review of applications for the initial registration of pharmaceutical products/substances at the screening stage... Sub. Req'd

South Africa Drops J&J Bedaquiline Scrutiny After Generic Market Opens Up

(7/11, Dean Rudge, Generics Bulletin) ...South Africa's Competition Commission has drawn a line under its investigation into Johnson & Jonhson and its Janssen subsidiary over their Sirturo (bedaquiline) tuberculosis treatment, following uproar that the firms were unfairly restricting generic competition in a vital and underserved market... Global Sub. Full

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