Wednesday, January 10, 2024

Teva Hit With Immediate Appeal After Overcoming US Korlym IP

(1/9, Dean Rudge, Generics Bulletin) ...Teva has gone one better than earlier ANDA settlers Hikma and Sun after winning its long-running legal battle against Corcept Therapeutics over Korlym IP...Teva may have to face up to a promised appeal from Corcept Therapeutics after the Israeli firm convinced a US district court that its Korlym (mifepristone) generic did not infringe two patents shielding the originator's branded Cushing's syndrome treatment, including on the basis that Corcept "failed to introduce credible record evidence that anyone has ever previously infringed" an asserted claim... Global Sub. Full

Teva Pharmaceuticals Scores Win In Patent Infringement Suit

(1/9, Kimberly Redmond, NJBIZ) ...A U.S. District Court judge in New Jersey ruled in favor of Teva Pharmaceuticals USA...Shortly thereafter, Corcept filed a Hatch-Waxman lawsuit, alleging patent infringement and seeking a permanent injunction to restrict Teva from launching...In response, Teva asked the United States Patent and Trademark Office's Patent Trial Board and Appeal Board to cancel patent helds by Concept, but was unsuccessful. In its request, Teva told officials earlier publications made it obvious that the patented method would work to treat the disorder... Full

Senate Dems' Inhaler Pricing Probe Adds Fuel To FTC Patent Listing Press

(1/9, Gabrielle Wanneh, InsideHealthPolicy) ...The letters sent Monday by the Senate health committee Democrats are a part of a larger investigation into the internal decision-making of AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva Pharmaceuticals to uncover why their inhalers, which are often purchased monthly, range from $200 to $600 in the United States while the same inhalers are made available at significantly lower costs in other wealthy Western countries. The continued charging of excessive prices for inhalers is a disservice to low-income Americans and underserved communities most likely to suffer from asthma and chronic obstructive pulmonary disease, the lawmakers say... Sub. Req'd

CT-Based Pharma Firm Faces Senate Probe On Inhaler Prices

(1/10, Paul Schott, CT Insider) ...BI, whose U.S. headquarters in Ridgefield supports its global headquarters in Ingelheim am Rhein, Germany, issued a written statement that defended its pricing of inhalers and denied that it was trying to repress generic competition. “Boehringer Ingelheim is committed to advancing the discussion on substantive policy reforms that are needed to benefit patients with respiratory illnesses," the statement said. "There are many reasons why there are few manufacturers of generic inhalers and other complex, drug-device products. These products are more costly and complicated to manufacture than pills and other small molecule drugs made by most generics companies and so there are various policy solutions the government could consider to enable generics manufacturers to successfully enter this category."... Full

Digital Innovation Can Help Israel Deal with October 7 Trauma. Here's How

(1/10, The Jerusalem Post) ...Speaking at the Israel Summit, Dr. Eran Harary, a psychiatrist and a Senior Vice President at Teva's Global R&D, explained how Israelis can overcome the shock and find themselves more resilient...In order to support the nation dealing with trauma, Teva has spearheaded a vast project called "Treating the soul," Harary explained. The project includes three pillars... Full

MedinCell's Partner Teva Announces Recruitment Completion of Phase 3 Clinical Study of mdc-TJK / Olanzapine Long-Acting Injectable (LAI)

(1/9, MedinCell) ...Teva Pharmaceutical Industries Ltd. announced the successful completion of the enrollment in the EU and US of the anticipated 640 participants of the ongoing Phase 3 clinical trial of mdc-TJK (TEV-44749) at the J.P. Morgan Healthcare Conference. Results of the study are expected in the second half of 2024...Teva remains fully responsible to lead the development and commercialization of olanzapine LAI globally... Full

Stada And Alvotech Eye Launch Date For Ustekinumab After EU Approval

(1/10, David Wallace, Generics Bulletin) ...Stada has revealed details of exactly when in 2024 it plans to launch its Alvotech-partnered Uzpruvo ustekinumab biosimilar to Stelara, having just been granted a pan-European marketing authorization...Alvotech is awaiting the outcome of an imminent US Food and Drug Administration inspection of its Reykjavik facility, scheduled for 10-January 19, after deficiencies observed by the agency led to a complete response letter. The firm has a settlement with Johnson & Johnson that will allow local marketing partner Teva to launch from February 21, 2025... Global Sub. Full

Celltrion Files for Biosimilar's FDA Interchangeable Designation

(1/10, Pulse) ...South Korea's Celltrion Inc. announced on Wednesday that it has applied for a modified approval with the U.S. Food and Drug Administration to obtain interchangeability between its autoimmune disease treatment biosimilar ‘Yuflyma' and the original product in the United States...If a biosimilar product is deemed interchangeable with the generic product in the United States, it can be substituted at pharmacies without involving doctors, thus securing market competitiveness... Full

Drug Firm Lupin Introduces Smoking Cessation Generic Product in US Market

(1/10, Press Trust Of India) ...Drug firm Lupin on Wednesday said it has launched a product, used as an aid to smoking cessation treatment, in the US market. The company has launched Varenicline tablets in strengths of 0.5 mg and 1 mg, after having received approval from the US Food and Drug Administration, the Mumbai-based drug maker said in a regulatory filing... Full

Amgen Forecasts ‘High Teens' Growth For Biosimilars

(1/9, David Wallace, Generics Bulletin) ...Amgen believes that the biosimilars market has the potential to grow in the "high teens" given the value of originator products going off-patent over the next ten years, chairman and CEO Bob Bradway told the J.P. Morgan Healthcare Conference in San Francisco this week. "We expect the market for biosimilars to be rapidly growing and to be large through the balance of the decade," Bradway set out as he talked about the firm's interests in biosimilars... Global Sub. Full

JPM24: Amgen CEO Hopes to Take a Bite of Competitive Obesity Market With Unique Approach

(1/9, Zoey Becker, Fierce Pharma) ...Amgen didn't "wake up one day and say gosh, there's a big market for obesity medicines, maybe we ought to jump in," CEO Robert Bradway remarked at the 42nd annual J.P. Morgan Healthcare Conference in San Francisco. Instead, the company has been eying the disease area over time and looking to "thoughtfully" make a play. That means developing "differentiated, complimentary ways to try and help address what is an enormous global burden, and one that we think we can make a big difference in," Bradway said... Full

Novartis CEO Plays Down Cytokinetics Buyout Rumors in CNBC Interview

(1/9, Max Gelman, Endpoints News) ...Novartis CEO Vas Narasimhan threw cold water on the rumors about his company's potential acquisition of the biotech Cytokinetics. In an interview on CNBC, Narasimhan told Jim Cramer that while he couldn't comment on specific deals, he said Novartis' focus is on "sub-$5 billion assets." Cytokinetics' market cap is about $9 billion to $10 billion. "While we look at larger deals, our M&A strategy is bolt-ons," Narasimhan said on Tuesday. "We did 15 deals last year, all under $3 billion. That's where our overall idea is to build a portfolio of medicines."... Full

Swiss Pharma Giants Plot Different Paths for Next Blockbusters

(1/10, Naomi Kresge, Bloomberg) ...Roche Holding AG and Novartis AG, dealing with individual scientific, corporate and management issues, embody opposing approaches to solving a fundamental puzzle: how to placate shareholders and keep growing in an industry where the hunt for the next blockbuster drug — often long and expensive — is paramount...Both drugmakers rose to prominence with cancer treatments, changing the course of the disease for tens of millions of patients. They are now in recovery mode, seeking to find the next superdrugs and regain past glories... Sub. Req'd

Paul Hudson is 'Open-Minded' to M&A As He Plots Sanofi's Transformation: #JPM24

(1/9, Nicole DeFeudis, Endpoints News) ...Sanofi CEO Paul Hudson reiterated his ambitions for the "new" Sanofi, including business development plans ahead of what some experts predict will be a busy year for M&A in the biopharma sector..."It has to be something that is really fundamentally going to change something for patients," he said. "We can take more risk in immunology, because we have such a stack of great medicines. We can be deliberate about carving out individual patient populations. But we're open-minded."... Full

JPM24: Lilly CEO David Ricks to Biotechs: 'We're Open for Business'

(1/9, Annalee Armstrong, Fierce Biotech) ...Eli Lilly CEO David Ricks, speaking to the slow and steady progress that brought tirzepitide to the world, says the Indianapolis pharma is now ready to open up the chocolate factory. "I know a number of biotechs are in the room at this conference so it's worth mentioning: we're open for business on external innovation," Ricks said at the J.P. Morgan Healthcare Conference Tuesday. That doesn't just mean gobbling up companies... Full

Walgreens' New CEO Unpacks How The Chain Will Survive As A Standalone Business: #JPM24

(1/10, Ngai Yeung, Endpoints News) ...Despite his background as the former chief executive of pharmacy benefit manager Express Scripts, now owned by Cigna, Wentworth told the audience at Endpoints News' event at the JP Morgan Healthcare Conference Tuesday that the company is better off without acquiring such a component, unlike rival CVS..."Vertically integrating into a health plan probably doesn't make sense. There's nothing at scale that we could do," he said. "Our independence actually makes us a preferred player with pharma because we don't operate a PBM."... Full

JPM24: Cigna's Top Brass Says PBM Express Scripts is Poised to Weather Industry Reform

(1/9, Paige Minemyer, Fierce Healthcare) ...Eric Palmer, CEO of Cigna's Evernorth, which houses the country's largest PBM in Express Scripts, said that while the company hasn't seen a spike in similar demand in the market, the team views the potential of "unbundling" as an opportunity. "We're positioned really well to tackle these different solutions," Palmer said Tuesday at the J.P. Morgan Healthcare Conference. Cigna CEO David Cordani likened it to a similar evolution in medical benefit models. Ultimately, plan sponsors and patients want predictability and affordability, with offerings that are simple to understand and manage... Full

DeepMind Spin-Off Aims to Halve Drug Discovery Times Following Big Pharma Deals

(1/10, Cristina Criddle, Hannah Kuchler and Madhumita Murgia, Financial Times) ...Speaking to the Financial Times, Demis Hassabis, who co-founded Google's AI unit and also leads the drugs offshoot Isomorphic Labs, said the goal was to reduce the discovery stage — when potential drugs are identified before clinical trials — from the average of five years to two. "I think that would be success for us and be very meaningful," he said. Hassabis stated the goal days after announcing Isomorphic Lab's first two pharmaceutical partnerships with Eli Lilly and Novartis, which came to a combined value of up to $3bn, in deals set to transform the finances of the unprofitable group... Full

Drugmaker Endo Cleared to Poll Creditors on Opioid Settlements

(1/9, Jonathan Randles, Bloomberg) ...Drug manufacturer Endo International Plc won bankruptcy court permission to poll its creditors on a plan that would hand control of the business to lenders and settle opioid liabilities in deals valued at more than $600 million...The opioid victims committee said in a Tuesday court filing that the net present value of the various settlements is more than $600 million and close to $800 million on a nominal basis. The committee said deals it struck with Endo aren't perfect and don't provide enough money to rectify the damage caused by the opioid crisis, but at least provide victims some compensation relatively quickly... Sub. Req'd

2024 Is the Year of Medicare Drug Price Negotiations

(1/10, John Tozzi, Bloomberg) ...The US is set to take a historic step in 2024: Medicare, one of the largest buyers of drugs on the planet, will negotiate the prices it pays for some of them...The prices go into effect in 2026 and the government will add more drugs to negotiate in future years. It's eventually projected to save Medicare about $100 billion over 10 years, according to the Congressional Budget Office. Analysts see the hit to pharma sales as manageable. Bloomberg Intelligence found most companies affected would likely face revenue declines of 1% or less... Sub. Req'd

Companies Bend Patent System to Head Off Competition Long-Term: Analysis

(1/10, Sunitha Chari, BioSpace) ..."The USPTO grants primary patents to incentivize innovation, and [typically grants] twenty years of market exclusivity," said S. Sean Tu, professor of law at West Virginia University College of Law and the co-author of two November Journal of American Medical Association publications looking at what the authors call patent gamesmanship by Big Pharma. Given their financial interest in preserving the profits garnered by their drugs, biopharma companies find loopholes in the patent system to extend the intellectual property lifecycle of their drugs and deter competition from entering the market, Tu told BioSpace in an interview... Full

Small Business Needs PBM Reform Now

(1/10, Angela Dingle, RealClearHealth) ...As every small business owner knows, competition helps keep prices low and customers satisfied. But the modern PBM landscape is anything but competitive. Thankfully, there's hope on the horizon for small business owners. One innovation is the rise of cash-only pharmacies, like Mark Cuban's Cost Plus Drug Company or Blueberry Pharmacy...Bottom-up changes in business practices also point the way forward for policymakers looking to support small business. There's an emerging bipartisan consensus among lawmakers in Congress to pass a suite of PBM reforms, including reporting requirements to achieve price transparency, mandated rebate pass-throughs to drive down out-of-pocket costs at the pharmacy counter, and delinking PBM compensation from the list price of drugs to remove harmful pricing incentives... Full

PCMA Report Details What PBMs Are Doing to Improve Health Equity

(1/9, PCMA) ...The Pharmaceutical Care Management Association today released a new, first-of-its-kind, progress report on the work PCMA member pharmacy benefit companies are doing to deepen the industry's commitment to promote health equity and reduce health disparities. This report highlights pharmacy-benefit-company-specific examples and provides resources to learn more about each company's efforts in this area. "The mission of our companies has always been to provide affordable access to prescription drugs for everyone," said JC Scott, PCMA President and CEO... Full

Americans Overwhelmingly Favor Health Care Price Transparency: Survey

(1/9, Joseph Choi, The Hill) ...nonprofit Patient Rights Advocate found that 94 percent of adults agreed that hospitals, insurance companies and doctors should "be legally required to disclose all of their prices, including discounted prices, cash prices, and insurance negotiated rates across hospitals and across plans in an easily accessible place online." This result were statistically the same across political parties, age groups, level of education attained, income level and region in the U.S... Full

FDA Novel Drug Report for 2023 Cites 84% First-Cycle Approvals – What About Generic Drugs?

(1/9, Bob Pollock, Lachman Consultants) ...The FDA report Advancing Health Through Innovation: New Drug Therapy Approvals 2023 outlines the progress that the Agency has made on the approval of novel drugs (those "which are for therapies that have not previously been approved in the U.S."), and provides a number of interesting statistics...I think the most interesting and relevant metric is that, of the 55 novel drug therapies approved in 2023, 49 or 84% were approved in the first review cycle...CDER describes the attributes that led to this success in the conclusion of the report... Full

FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers

(1/9, Patrizia Cavazzoni, M.D., U.S. Food & Drug Administration) ...The U.S. Food and Drug Administration's Center for Drug Evaluation and Research approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives...In 2023, CDER approved 55 novel drugs, as detailed in our annual New Drug Therapy Approvals report. The active ingredient(s) in a novel drug have not been previously FDA-approved. We also took other important actions, such as expanding the indications or patient populations of some previously approved therapies. In addition, we approved new dosage forms or drug formulations and made some prescription drugs available over-the-counter... Full

Dangerous Drug Importation Is Not a Silver Bullet for High Prices

(1/10, Mary Bono, RealClearHealth) ...The FDA recently approved Florida's proposal to import drugs from Canada despite concerns over safety and available supply in Canada. In the middle of a heated presidential campaign, perhaps the political calculations outweigh evidence that importing drugs from Canada, or anywhere else for that matter, is the silver bullet that will immediately bring down the price of prescription drugs. Federal law states that drug importation can only be allowed if there is "no additional risk" to safety and will "result in a significant reduction" in the cost of drugs. By any reasonable measure, Florida's plan fails on both counts... Full

Individuals to Drive Drug Imports, for Now

(1/9, David Lim and Lauren Gardner, Politico) ...Despite last week's FDA approval of Florida's plan to allow prescription drug imports from Canada, some drug price reform advocates say individual purchases of brand-name medicines from foreign pharmacies will still be the chief way imports bring down prices for some U.S. consumers. The likelihood that Florida will be able to import drugs soon — if at all — is slim, thanks to several actions the state must take before the FDA will allow any pills to be shipped, as well as united opposition from Canada and the pharmaceutical industry... Full

Va. lawmakers Introduce Proposal to Create Prescription Drug Affordability Board

(1/9, Tyler Englander, ABC 8 News) ...Delegate Karrie Delaney, D-Fairfax, said there will be opportunities for prescription drug companies to defend pricing decisions during the review process...If the board determines companies are charging more than they should, it can set a price cap — something manufacturers said could stifle innovation and make it harder for people to get the medications they need. "It stands in the way of innovation because it sets the price," Pharmaceutical Research and Manufacturers of America representative Stami Williams said... Full

N.M. Lawmaker Wants Drug Prices Made Public

(1/10, Austin Fisher, Source NM) ...Ahead of the upcoming legislative session, Rep. Pamelya Herndon (D-Albuquerque) prefiled House Bill 33, which would create the Prescription Drug Price Transparency Act. If passed by the Legislature and signed into law by the governor, HB 33 would require drug makers and distributors to turn in data every year to the state showing the costs of their most expensive drugs, profits from those products and how much patients ultimately pay out of pocket... Full

Wisconsin Lawmakers Look to Rein in Drug Brokers

(1/10, David Wahlberg, Wisconsin State Journal) ...A bill to regulate PBMs in Wisconsin would reduce drug costs by limiting the money PBMs get from the drug supply chain, according to supporters including pharmacists, patient groups, doctors, clinics and drug companies. But employer groups, insurers and PBMs oppose the measure, saying it would drive up costs by restricting their ability to negotiate drug discounts and control drug use... Full

Gallego Introduces Package of Bills to Lower Drug Prices for Hard Working Arizonans

(1/9, Celeste Gonzalez, KVOA) ...Today, Rep. Ruben Gallego introduced three pieces of legislation to hold pharmacy benefit managers, otherwise known as PBMs, accountable for their role in historically inflating drug prices for Arizona consumers...The provisions introduced today will also hold Medicare Part D plan sponsors accountable for pressuring neighborhood pharmacies into accepting new, unfavorable contract and reimbursement terms that could force them to close their doors, and refusing to work with independent pharmacies... Full

EU Regulators Bemoan Lack Of Trial Applications With Critical Decentralized Elements

(1/9, Vibha Sharma, Pink Sheet) ...Regulators in the EU are keen to harmonize their approach to the regulation of decentralized clinical trials, but say the lack of trial applications incorporating critical DCT elements means member states are not gaining experience and therefore not changing their perspective...AstraZeneca's David Wright, who also spoke at the DCT session, said while regulators are usually regarded as conservative, "often companies are conservative too" and do not want to take the risk of being the first one to fail... Sub. Req'd

Rising Prices and Serious Shortages: New Challenges in Managing Medicines Supply for Wales

(1/10, Angharad Lewis, The Senedd and Devolution in Wales) ...It's becoming increasingly difficult for the Welsh NHS to secure access to the medicines it needs. Economic instability, disrupted supply chains, and growing demand are making medicines more expensive and shortages more common. Maintaining the supply of medicines to the UK is a reserved matter and the responsibility of the UK Government. However, given powers and responsibilities for healthcare are generally devolved, managing the impact of any disruptions to that supply is the responsibility of the Welsh Government... Full

Indian Committee Identifies Underutilized Funds Meant to Boost Bulk Drug Production

(1/9, The Pharma Letter) ...A high-level committee, established to spearhead India's drive towards self-sufficiency in bulk drugs, has raised concerns about the substantial underutilization of allocated funds. Formed to reduce dependence on Chinese imports, the high-powered committee has urged the government to allocate additional funds for new initiatives. While expressing appreciation for the government's efforts in implementing the 'Promotion of Bulk Drug Parks' scheme at $360 million, the committee said it is hopeful that the entire allocated amount of $108 million for the fiscal year 2023-24 will be fully utilized... Sub. Req'd

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