Friday, November 1, 2024

Teva Slapped with €463M Fine Over Accusations it Stymied Copaxone Competition in Europe

(10/31, Fraiser Kansteiner, Fierce Pharma) ...The European Commission (EC) has fined Teva 462.6 million euros ($503 million) over allegations that the Israeli-American pharmaceutical giant "[abused] its dominant market position to delay competition" to Copaxone...Teva said it will appeal the judgment and fine, adding that it's financially prepared to mount a defense if needed... Full

Teva Fined $503 Million for Disparaging a Rival and Using Patents to Thwart Competition

(10/31, Ed Silverman, STAT Plus) ...A Teva spokeswoman sent us a statement saying the company "disagrees with the European Commission decision, which is based on legal theories that the company believes are extreme, untested, and factually unsupported. The company intends to appeal the outcome and is fully prepared to mount its defense."... Sub. Req’d

Teva Fined Half A Billion Dollars Over European Copaxone Antitrust Breach

(10/31, Dave Wallace, Generics Bulletin) ..."Teva works to the highest ethical standards with all our external experts and do so in a highly regulated environment," the firm underlined, insisting that it "conducts its business lawfully and ethically and has been a strong partner to Europe, its patients, economy and healthcare systems." "This misguided decision will not distract Teva from its unwavering support for patients living with MS and their families."... Global Sub. Full

Teva, in Partnership with Direct Relief, Honored by U.S. Chamber of Commerce Foundation for Mental Health Efforts

(10/31, Direct Relief) ...The U.S. Chamber of Commerce Foundation announced Teva Pharmaceuticals as a winner of the 25th Annual Citizens Awards, a long-standing program that honors businesses for their leadership in solving the world's biggest challenges. Teva was nominated for the "Best Health and Wellness Program" award for its efforts in conjunction with Direct Relief to promote health equity in mental health... Full

Panelists Stress Stakeholder Education to Build Confidence in Biosimilars

(10/31, Skylar Jeremias, The Center For Biosimilars) ...Mary Pietryga, vice president of global marketing at Teva Pharmaceuticals who has 3 decades of experience working in biopharmaceuticals, described the challenges in expanding biosimilar uptake. Patient and provider education gaps, she noted, continue to limit the full realization of biosimilars' benefits, and improved awareness could accelerate adoption and cost savings...Pietryga detailed that while the IRA's cost-saving intentions are commendable, its effects might limit biosimilar competitiveness unless paired with sustainable reimbursement... Full

Two Generic Drugmakers Pay $49 Million to Settle Price-Fixing Charges

(10/31, Ed Silverman, STAT Plus) ...Two generic drugmakers, Apotex and Heritage Pharmaceuticals, have agreed to pay a combined $49 million to settle allegations they fixed prices on numerous medicines, the first such agreements since state attorneys general began probing price-fixing in the generics industry a decade ago...The state officials maintained that, as a result of the conspiracies, consumers paid more for the generic drugs than they would have otherwise if the U.S. marketplace had functioned competitively. And the attorneys general also alleged that the companies — which also included Teva Pharmaceutical and Dr. Reddy's Laboratories — profited illegally... Sub. Req’d

Drugmakers Apotex, Heritage to Pay $49 Mln to Resolve States' Price-Fixing Claims

(10/31, Mike Scarcella, Reuters) ...The first trial in the multidistrict litigation is likely in 2026, according to Connecticut, and includes 26 corporate defendants. The defendants in that case include Teva, Pfizer and Sun Pharmaceuticals. They have denied the claims. Representatives did not immediately respond to requests for comment on Thursday. Teva and others are fighting related price-fixing antitrust claims from drug distributors, including Rochester Drug Cooperative, and other plaintiffs in federal court in Pennsylvania... Full

Japan's Takeda Raises Full-Year Profit Forecast Amid Restructuring

(10/31, Rocky Swift, Reuters) ...Operating profit in the three months through September stood at 184.2 billion yen ($1.21 billion), the company said, versus a loss of 49.3 billion a year prior and a consensus profit estimate of 93.6 billion in an LSEG survey of four analysts. Takeda raised its full-year operating profit guidance to 265 billion yen from 225 billion, citing a stronger than expected first-half performance and updated currency assumptions... Full

As New Drugs Deliver, Bristol Myers CEO Looks to 'Further Improve Productivity and Efficiency'

(10/31, Angus Liu, Fierce Pharma) ...BMS management is "reviewing overall spending and prioritizing investments that will deliver the best long-term returns," CEO Chris Boerner, Ph.D., said during a call Thursday. The New Jersey-based pharma is on track to deliver on its existing $1.5 billion cost-saving target by the end of next year, the CEO confirmed... Full

Bristol Myers Earnings Beat Expectations, Driven by Sales of Older Drugs

(10/31, Michael Erman, Reuters) ...Bristol Myers Squibb reported a higher-than-expected third-quarter profit on Thursday, citing strong sales of established drugs like blood thinner Eliquis and cancer treatment Revlimid as well as newer products such as heart medicine Camzyos and cancer cell therapy Breyanzi... Full

Merck CEO Robert Davis On Q3 Results: Our Portfolio Sets Us Up for a Good Finish to the Year

(10/31, CNBC) ...Merck CEO Robert Davis joins ‘Squawk Box' to discuss the company's quarterly earnings results, which topped expectations as the company saw strong sales from its top-selling cancer drug Keytruda, recently launched treatments and its animal health business, the company's drug pipeline outlook, and more... Full

Merck Sees Gardasil China Woes Carrying into 2025

(10/31, Michael Erman, Leroy Leo, Reuters) ...Merck & Co said on Thursday that weak sales of Gardasil in China are likely to carry over into 2025 as the vaccine's distributor there reduces inventories amid low demand, and the U.S. drugmaker's shares fell 3%..."It is both a demand issue driven by the economy, some impact on promotional activity we think related to concerns about anti-corruption, as well as continuing adjustment of inventory levels in the marketplace," Chief Executive Rob Davis said of Gardasil's China sales in an interview... Full

Amgen Sees Plenty Of Interest In US Eylea Biosimilar, Buoyed By Strong Supply Chain

(10/31, Dean Rudge, Generics Bulletin) ...The California-based player has spoken of its prospects in the wet-AMD space, including a desire to chart its own path amid supply shortages for Avastin...The California-based biotech expects "strong interest" in its Pavblu (aflibercept-ayyh) biosimilar, following confirmation last week that Regeneron's failure to secure an injunction against the biosimilar pending appeal had provided the green light to roll Pavblu out across the US... Global Sub. Full

Regeneron's Eylea HD Makes Progress But Doesn't Dent the Momentum of Roche's Vabysmo

(10/31, Kevin Dunleavy, Fierce Pharma) ...With U.S. sales of $392 million in the third quarter, Regeneron's high-dose version of Eylea is closing in on blockbuster sales in its first full year on the market. The bad news for the company, however, is that while sales from Eylea HD increased by 29% sequentially, this didn't translate to a similar bump in overall U.S. revenue for the Eylea family of eye medications. From Q2 to Q3, franchise sales increased only marginally—from $1.535 billion to $1.537 billion... Full

AbbVie Slaps Mankind Away Until 2027 On US Lumigan Generic

(10/31, Dean Rudge, Generics Bulletin) ...Abbreviated new drug application sponsor Mankind Pharma and originator AbbVie have moved jointly to dismiss pending paragraph IV patent-infringement litigation over Lumigan (bimatoprost) 0.01% ophthalmic solution, with the generics firm conceding to infringement and validity of the key patent-at-issue in the case expiring in June 2027... Global Sub. Full

Novo Nordisk Hit with FDA Write-Up Over Production Issues at Critical Semaglutide Plant

(10/31, Joseph Keenan, Fierce Pharma) ...Inspectors found the facility lacked records that indicated the water used in drug production was adequately controlled for certain microorganisms. Additionally, the agency found the facility didn't have written procedures in place for the production, processing or packing in order to assure identity, strength, quality and purity of a drug substance which had its name redacted in the filing...Novo's spokesperson said the issues around the insulin product—approved in places like Canada, Europe and Japan as Awiqli—are unlikely to be resolved this year... Full

Baxter Restarts IV Solutions Manufacturing Line at Hurricane-Hit Facility

(10/31, Sriparna Roy and Christy Santhosh, Reuters) ...Medical device maker Baxter International said on Thursday it has restarted the highest-throughput intravenous solutions manufacturing line at its North Carolina facility, which was impacted by hurricane-related flooding... Full

Lundbeck Reports Strong Trial Results for Vyepti in Migraine Prevention

(10/31, The Pharma Letter) ...Based on the trial results Lundbeck plans to initiate discussions with relevant regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia. Vyepti is already approved for migraine prevention in a number of countries including the USA and Europe... Sub. Req’d

Meitheal Pharma Licenses Biosimilars from Hong Kong King-Friend Industry

(10/31, Contact Pharma) ...Meitheal Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (HKF) to market and distribute three biosimilars in the U.S... Full

Purdue Pharma Nears New Bankruptcy Deal with Sacklers, Mediator Says

(10/31, Dietrich Knauth, Reuters) ...Purdue Pharma is close to a new bankruptcy settlement with its owners, members of the wealthy Sackler family, and state and local governments that have filed lawsuits alleging that its painkiller OxyContin spurred a deadly opioid-addiction crisis in the U.S., a court-appointed mediator said on Thursday... Full

U.S. Drugmakers Are Breaking Up With Their Chinese Supply-Chain Partners

(11/1, Jared S. Hopkins and Ciarence Leong, The Wall Street Journal) ...From big pharmaceutical companies such as AstraZeneca to small biotechnology firms like Amicus Therapeutics of New Jersey, which is looking for a non-Chinese company to supply raw materials for its rare-disease treatment, the companies say it is time to reduce China risk. Industry officials say one consequence could be slower drug rollouts and higher costs in the U.S. because the shift takes time and money... Sub. Req’d

Out-of-Pocket Costs for MS, Parkinson's, Alzheimer's Meds Keep Rising

(10/31, Ernie Mundell, HealthDay News) ...A person battling multiple sclerosis spent an average of $750 in out-of-pocket fees on medicines in 2012, but by 2021 that same patient spent $2,378 annually, a new report finds. Out-of-pocket costs for drugs for neurologic diseases such as MS, Parkinson's and Alzheimer's disease are climbing sharply, according to research led by Amanda Gusovsky, of Ohio State University in Columbus... Full

Mark Cuban On Pharmacy Prices, Health Care, and 'Good' Billionaires

(11/1, Eric Boehm, Reason) ...Billionaire entrepreneur, co-host of ABC's Shark Tank, and Dallas Mavericks co-owner Mark Cuban's latest venture is the Mark Cuban Cost Plus Drug Company. It aims to tackle the high cost and lack of transparency in the pharmaceutical industry by offering cheap generic drugs. When Cuban spoke with Eric Boehm for the second season of Reason's limited series podcast Why We Can't Have Nice Things, he shared the origins of Cost Plus Drugs, the challenges of disruption in the health care sector, and what it means to be a "good" billionaire... Full

Republicans Take Aim at FTC Chair Lina Khan

(10/31, Benjamin S. Weiss, Courthouse News Service) ...House Republicans on Thursday formalized their attacks on Federal Trade Commission Chair Lina Khan, accusing the government's top consumer protection regulator in a committee report of carrying water for the White House... Full

Race for Top Spot On E&C Health Heats Up

(10/31, Victoria Knight, Axios Pro) ...Three Republicans are vying for their party's top spot on the House Energy and Commerce Health subcommittee in the 119th Congress as current Chair Brett Guthrie eyes the full E&C gavel, Victoria reports...The panel would be the likely starting point for legislation addressing health price transparency and PBMs. If Republicans keep control of the House, it could also shape an overhaul of public health agencies and a rollback, or more oversight over, Medicare drug price negotiations... Sub. Req’d

Grappling with Supply-Chain Crunch

(10/31, Chelsea Cirruzzo and Ben Leonard, Politico) ...Many lawmakers, including Rep. Brad Wenstrup (R-Ohio), have made the case that relying too heavily on China presents national security risks. They're pushing the BIOSECURE Act, which would effectively bar Chinese biotech companies from doing business in the U.S. The companies named in the legislation argue they've been unfairly targeted... Full

Judge Gives Hawaii Chance to Update Drug Price Suit Against PBMs

(10/31, Celine Castronuovo, Bloomberg Law) ...Judge Leslie E. Kobayashi of the US District Court for the District of Hawaii on Wednesday said the state failed to adequately satisfy the court's standards for claiming violations of state laws prohibiting deceptive commercial acts and practices and unfair methods of competition in the government's amended complaint against CVS Health's Caremark, UnitedHealth Group's OptumRx, and Cigna Group's Express Scripts... Sub. Req’d

To Mitigate Drug Shortages, A New Study Suggests Looking at Canada

(10/31, Ed Silverman, STAT Plus) ...Of 104 reports of supply chain issues with dozens of drugs, meaningful shortages were 40% less likely to occur in Canada than in the U.S., a new study found, and the difference was largely attributed to the approach taken by the Canadian government to the problem... Sub. Req’d

New Report Highlights Market Access Barriers for EU Based Generic and Biosimilar Companies in Third Countries

(10/31, Medicines for Europe) ...Medicines for Europe is launching a study of market barriers faced by EU generic and biosimilar pharmaceutical companies operating in 11 key third-country markets. The analysis looks at the barriers that EU-based companies experience in different markets. The findings confirm that major trading partners are pro-actively investing in pharmaceutical manufacturing, with targeted support for the sector... Full

Remove Barriers for EU Firms Trading in Other Markets, Group Says

(10/31, The Pharma Letter) ...The analysis found the main barriers to include public procurement rules, where domestic suppliers are prioritized in tenders and access is limited for EU companies, along with local manufacturing preferences and rules on pricing and reimbursement... Sub. Req’d

Belgian MEP Calls for An EU Women's Health Strategy, Says EU Pharma Reform Can Go Further

(10/31, Nicole Verbeeck, Euractiv) ...Belgian social democrat MEP Estelle Ceulemans has raised concerns about the Commission's demotion of health from its leading priorities. It underscores, she says, the need to promote women's health and to further revise the EU Pharma Package... Full

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