Wednesday, June 19, 2024
Top News
Teva and US Government Discuss Settling Kickback Lawsuit Over Copaxone
(6/18, Katherine Lewin, Endpoints News) ...Teva and the US government are in talks to settle a lawsuit against the company alleging a kickback scheme for its blockbuster multiple sclerosis drug Copaxone. In court documents filed over the weekend with the United States Court of Appeals for the First Circuit, Teva wrote that both the company and the US government "are actively engaged in settlement negotiations and Teva is optimistic that the parties can reach a resolution, but additional time is needed to do so."... Full
Corcept Therapeutics Weakness a Buying Opportunity, Says Canaccord
(6/18, The Fly) ...Canaccord believes the Teva's legal filing is a result of not having gotten the traction they expected from their launch of generic mifepristone. Teva claims that Corcept's relationship with Optime, the specialty pharmacy distributor for Korlym, is a monopoly which Canaccord believes lacks basis... Full
Teva Secures Stay On Orange Book Inhaler Patent Delisting
(6/18, Marisa Woutersen, Life Sciences Intellectual Property Review) ...Teva Pharmaceuticals has convinced a New Jersey judge to grant a 30-day stay to an order that seeks the removal of its patents from the US Food and Drug Administration's Orange Book. Teva filed a notice of appeal and motion to stay, on June 11, after Judge Stanley Chesler ruled in favour of Amneal Pharmaceuticals and ordered Teva to remove five patents for its ProAir HFA asthma inhaler from the list of approved drugs. The court granted Teva's motion for a period of 30 days on June 13... Sub. Req'd
Industry News
Hikma Strikes $185M Deal For Xellia Injectables Portfolio, Manufacturing Facility
(6/18, Dean Rudge, Generics Bulletin) ...Hikma is continuing to beef up its major injectables business, striking a deal worth up to $185m to bring on board a collection of assets from Xellia in the US, including a portfolio of products, a US manufacturing facility, and an R&D center in Croatia. Subject to US Federal Trade Commission approval, the deal will add significant scale to Hikma's US operations, enhance its US injectable manufacturing capabilities and portfolio by adding complex technologies, and deliver "significant future value to our Injectables business, supporting growth over the medium term," the London-listed firm believes... Global Sub. Full
AbbVie Adds Ulcerative Colitis to Skyrizi Label
(6/18, Max Gelman, Endpoints News) ...Edward Loftus, the trial investigator of AbbVie's pivotal studies in UC, told Endpoints News that the increasing number of newly-approved UC treatments and experimental drugs targeting TYK2 and TL1A has led to a "paradox" for physicians and patients, with so many options to choose from. But he noted that Skyrizi's safety profile makes it an appealing pick for treatment-naïve and already-treated patients compared to some drugs with boxed warnings... Full
'Roche's MS Treatment Ocrevus Targets Disease Progression Beyond Symptom Relief'
(6/19, Kim Ji-hye, Korea Biomedical Review) ..."Continuous relapses may become less frequent, but the recovery slows significantly, and inflammation worsens," said Professor Kim Ho-jin, a clinical neurology professor at the National Cancer Center (NCC), who has been studying MS for 20 years. "Patients might appear outwardly normal, but the disease is silently progressing." At Roche Korea's press conference on Tuesday, Professor Kim commemorated the domestic approval of Ocrevus (ocrelizumab), a monoclonal antibody designed to selectively target CD20-expressing B cells in MS patients... Full
Alembic Pharma Gets USFDA Nod for Dabigatran Etexilate Capsules
(6/18, Press Trust Of India) ...Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic Dabigatran Etexilate capsules 75 mg and 150 mg used to reduce risk of stroke and blood clots in adults with a certain medical condition. The US Food & Drug Administration has also granted tentative approval for the Abbreviated New Drug Application for Dabigatran Etexilate capsules 110 mg, Alembic Pharmaceuticals, said in a statement... Full
Lilly and Novo's Brand Values Soar as GLP-1 Drugs Raise Their Profiles
(6/18, Nick Paul Taylor, Fierce Pharma) ...Barnstorming GLP-1 drugs have sent Eli Lilly and Novo Nordisk rocketing up the list of the most valuable pharma brands. The leading weight-loss players were the two big winners in the latest report by Brand Finance, which found the value of the two brands jumped by more than 50% over the past year... Full
AstraZeneca Loses Bid to Block Soliris Biosimilar During Appeal
(6/18, Christopher Yasiejko, Bloomberg Law) ...AstraZeneca Plc lost its request for an order blocking a biosimilar version of Soliris while it appeals a federal judge's denial of a preliminary injunction in its patent-infringement lawsuit against a Samsung Biologics Co. subsidiary over the blockbuster treatment... Sub. Req'd
Johnson & Johnson Pays $123.34 Million to State, Local Governments Following AG Ferguson Opioid Lawsuit
(6/18, Attorney General Bob Ferguson) ...Attorney General Bob Ferguson announced today that the state, city and county governments in Washington state received a $123.34 million lump sum payment from opioid manufacturer Johnson & Johnson. The funds are the latest payments from Ferguson's litigation against companies that fueled the opioid crisis, and must be split evenly between state and local governments. Ferguson directed the funds must be used to combat the opioid epidemic... Full
Fierce Competition Expected Among Biosimilar Developers As Keytruda Faces Looming Patent Expiration
(6/18, Choi Mun-hee, Business Korea) ...Keytruda, developed by MSD, has become the top-selling drug in the global pharmaceutical market. Last year, it achieved global sales of $25 billion (approximately 35 trillion won), marking a 19% increase from the previous year and surpassing the previous top-seller Humira ($14 billion). However, the patent expiration of Keytruda, the immunotherapy drug that has earned the title of "world's top-selling pharmaceutical," is approaching, setting the stage for fierce competition among biosimilar developers. Keytruda's material patent is set to expire in the U.S. in 2028 and in Europe in 2031. This impending expiration has attracted numerous biosimilar developers eager to tap into Keytruda's vast market... Full
NIPTE Announces Call to Achieve US Pharmaceutical Independence by Building On-Shore Capacity and Capabilities
(6/18, National Institute for Pharmaceutical Technology and Education) ...Today, the US depends on imports from China and other overseas sources for a majority of the active pharmaceutical ingredients used to make drug products critical to US patients. The National Institute for Pharmaceutical Technology and Education (NIPTE) today announced a strategy for mitigating this risk to the US pharmaceutical supply chain and the US population who depend on access to these life-saving medicines... Full
U.S. Policy & Regulatory News
Exclusive: Sanders Hopes "Spotlight" Will Lower Ozempic Cost
(6/18, Peter Sullivan, Axios) ...Sanders will grill the Novo CEO Lars Fruergaard Jørgensen, which makes those drugs, at a Senate HELP hearing in early September. Sanders acknowledged in an interview that it will not be easy to get the company to go along, but said the "spotlight" can make a difference...Asked if he would like to hold a committee markup on additional PBM legislation this year, Sanders said, "I would like to...I think our prescription drug system is dysfunctional and broken, and I want to do as much as I possibly can." Sanders also left the door open to calling in Novo's rival Eli Lilly to testify about its Zepbound and other GLP-1 drugs... Sub. Req'd
WH Official: Drug Buyers Should Be Incentivized To Prioritize Resiliency
(6/18, Maaisha Osman, InsideHealthPolicy) ...The White House official's commentary aligns with HHS' proposal, released in April, that aims to set up a program to rate the quality and supply chain resiliency of generic drugs. The proposed program would incentivize hospitals through Medicare payments and penalties to contract with high-scoring manufacturers, and to institute programs to protect against shortages. The idea faced backlash from the major hospital group, the American Hospital Association... Sub. Req'd
USP Urges Tweaks To Drug Shortage Bills, Finds Cheap Generics Most Affected
(6/18, Gabrielle Wanneh, InsideHealthPolicy) ...Drug shortages are lasting longer and hitting hardest for drugs that are cheap to produce, according to independent experts at the U.S. Pharmacopeia (USP). The organization says legislative proposals currently before Congress could help cut down on shortages of generic drugs, but the bills should include incentives for drug makers to invest in quality controls and advanced manufacturing technologies...Anthony Lakavage, senior vice president for global external affairs at USP, told Inside Drug Pricing the Senate Finance Committee's draft bill to address drug shortages includes several concepts that align with the organization's recommended solutions... Sub. Req'd
FTC Backs Plan to Target More Patent Settlements it Sees as Anticompetitive
(6/18, Zachary Brennan, Endpoints News) ...The Federal Trade Commission on Tuesday offered up support for a proposed rule from the US Patent and Trademark Office that could help regulators more closely track pharma patent settlements that might be anticompetitive...Megan Van Etten, senior director of public affairs at PhRMA, told Endpoints News in an emailed statement, "PhRMA strongly suggests that the USPTO address settlement agreements through a separate rulemaking process that adequately considers how best to manage the confidentiality concerns around sensitive business information included in these settlement agreements that could harm the parties if made public."... Full
Mark Cuban's D2C Pharmacy Won't Beat Most Insured Patients' Out Of Pocket Drug Prices, One Study Finds
(6/18, Dave Muoio, Fierce Healthcare) ...Insured patients are often better off buying their generic prescriptions through their health insurance benefits than through Mark Cuban Cost Plus Drug Company, though those without insurance could find cost savings in over a quarter of their pharmacy fills, according to a study published Friday in JAMA Health Forum... Full
Lawmakers Press CMMI's Fowler On Lack of Cost Savings for Alternative Payment Models
(6/18, Emma Beavins, Fierce Healthcare) ...Republicans on the House Energy and Commerce Committee lambasted the failure of CMS' Innovation Center to save U.S. healthcare dollars during a recent hearing on value-based care...Republican Chair of Energy and Commerce Cathy McMorris Rodgers, R-Wash., said CMMI is "unsustainable" and said she has, "a hard time believing any objective observer could look at the results thus far and describe CMMI as a success." Republicans tempered their criticisms with recognition that CMMI's Accountable Care Organization REACH model has been successful in driving ACO creation and bringing more value-based care into the system... Full
DIA: Pharma Expert Offers Advice On AI Best Practices for Industry
(6/18, Joanne S. Eglovitch, Regulatory Focus) ...Best practices for artificial intelligence in the pharmaceutical industry don't need to be built from scratch, and instead could be based on guidelines developed by government entities and standards organizations, said Rose Purcell, director of global regulatory policy and innovation at Takada, at the DIA 2024 Global Annual Meeting... Full
FDA Finalizes New Final Guidance On Facility Readiness and Goal Dates
(6/18, Bob Pollock, Lachman Consultants) ...The FDA received no comments on the draft guidance titled Facility Readiness: Goal Date Decisions Under GDUFA, and, as such, has finalized the guidance with only minor editorial changes... Full
Judge Sends California's Suit Over Insulin Prices Back for a Rewrite
(6/18, Hillel Aron, Courthouse News Service) ...A Superior Court Judge, on Tuesday, told lawyers for the state of California that they would have to revise their lawsuit challenging insulin drug prices, sustaining two motions for demurrer filed by drug makers and pharmacy benefit managers. Last year, California Attorney General Rob Bonta sued the nation's largest insulin makers — Eli Lilly, Novo Nordisk and Sanofi — for driving up the cost of insulin, a drug which enables diabetics to regulate their blood sugar levels... Full
Bill Aims to Lower Prescription Drug Prices
(6/18, Cape Gazette) ...Senate President Pro Tempore Dave Sokola, D-Newark, recently filed a bill to lower prescription drug costs for Delawareans – building on the Delaware General Assembly's ongoing efforts to rein in healthcare costs in the First State. Research shows people in the United States typically pay more for their prescription drugs than other developed countries...Senate Bill 332 would help tackle this issue by directing the Delaware Department of Health and Social Services to design and implement a program that allows the First State to import eligible prescription drugs from Canada, where wholesale prescription drugs are significantly less expensive... Full
International News
Prioritising Access and EU Solidarity Should Drive Health Ministers' Agenda in Next EU Talks
(6/19, Medicines for Europe) ...Ministers of Health will meet in Brussels on Friday 21st June to discuss EU coordination on health. Ahead of this meeting, Medicines for Europe calls on Member States, including small Member States and Central Eastern Europe Countries, to prioritise equitable access for all patients... Full
Revised EU Trial Transparency Rules Go Live With Last Minute Changes To Address Confidentiality Concerns
(6/18, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has met the deadline for launching a new version of the Clinical Trials Information System to allow earlier public access to information on authorized studies. However, new concerns raised by commercial sponsors means the publication of certain information fields in CTIS is temporarily suspended... Sub. Req'd
EU Goes After Alchem Over Participation In Buscopan Ingredient Cartel
(6/18, Urte Fultinaviciute, Generics Bulletin) ...The European Commission has accused Alchem International of breaching antitrust rules by allegedly participating in a cartel concerning the pharmaceutical ingredient N-Butylbromide Scopolamine/Hyoscine, also known as SNBB...According to the Commission, Alchem, which produces the pharmaceutical ingredient, may have coordinated and agreed with other market players to fix the minimum sales price of SNBB to customers, such as distributors and generic drug manufacturers, and to allocate quotas... Global Sub. Full
UK Early Access Scheme 'A Success,' But Industry Wants Improvements
(6/18, Leela Barham, Pink Sheet) ...The Association of the British Pharmaceutical Industry has suggested that new guidance could help companies who want to take advantage of the UK's Early Access to Medicines Scheme (EAMS) in the future, and says that it wants to help shape such guidance. Dan O'Connor, director of regulatory and early access policy at the ABPI, said: "We hope for a clearer understanding of EAMS's role in the regulatory framework and to contribute to new guidance that might better support companies with their future applications."... Sub. Req'd
Lower Innovative Drug Costs Not Being Passed On by Pharma Firms, Say Dutch Researchers
(6/18, Christoph Schwaiger, Euractiv) ...Lower drug pricing does not follow from an expansion of innovative medicine indications, according to Dutch researchers. They claim pharma companies often fail to pass on their financial gain to patients and health services. If more patients are prescribed a certain medicine, the price could be reduced because pharmaceutical companies can recoup the research costs incurred more quickly, researchers from Erasmus University Rotterdam and the Erasmus Medical Centre Rotterdam claim... Full
What's Behind Switzerland's Push for Drug-Pricing Secrecy?
(6/18, Jessica Davis Plüss, Swissinfo.ch) ...Last week the Swiss senate voted in favour of a sweeping package of measures to stem spiralling healthcare costs. Among them is a series of proposals intended to lower drug prices and improve access to new, high-priced treatments. The federal government and the other chamber of parliament still have to weigh in on the latest version of the cost-containment package, but public health and legal experts are already sounding the alarm on specific drug-pricing proposals. They warn that some measures won't just fail to rein in costs but could lead to higher drug prices in the long term and have consequences for drug prices globally... Full
British Columbia's Biosimilar Switching Program Saves $732 Million in 5 Years
(6/18, Skylar Jeremias, The Center For Biosimilars) ...British Columbia's Biosimilars Initiative successfully saved about $732 million over 5 years by switching over 40,000 patients from reference biologics to biosimilars, while maintaining equivalent health outcomes and reinvesting the savings into the province's public payer program (BC PharmaCare) to enhance drug coverage and health care services... Full
Expert Panel to Soon Weigh Plan to Use Generics for Prescription Drugs
(6/19, Teena Thacker, The Economic Times) ...The proposal has become a bone of contention between the Indian Pharmaceutical Alliance (IPA), which represents the country's big drug makers, and the All India Drug Action Network (AIDAN), a network of several health organisations. The IPA is opposing the proposal to allow government-run Jan Aushadhi Kendras to dispense substitutes of prescription medications, claiming that it would open floodgates of similar demands by trade channels, such as general pharmacy stores, "which will not be in the interest of patients"... Full
Ozempic Frenzy Lures Rich Indians to Brave the Gray Market
(6/18, Satviki Sanjay, Bloomberg) ...The obesity drugs are now a global phenomenon and often in short supply. They've won over the rich and famous and blown open a new market for weight loss drugs. Novo Nordisk has "no plans" to launch Ozempic in India but is working to make Wegovy available, a spokesperson said in an email...In India, the only drug available is Novo Nordisk's Rybelsus pill, which contains the same ingredients as Wegovy and Ozempic but comes in pill form...Locally, India's largest pharma firm Sun Pharmaceutical Industries Ltd. is developing its own weight-loss formulation, while Cipla Ltd. and Dr. Reddy's Laboratories Ltd. are working on generic drugs... Full
Pharmexcil Moots More India-Russia Pharma Ties for Self-Reliance
(6/19, G Naga Sridhar, The Hindu BusinessLine) ...An Indian delegation led by R Uday Bhaskar, Director-General, Pharmexcil, participated in the recently held 27th St Petersburg Economic Forum meeting. "We have conveyed that by combining our strengths, India and Russia can create a powerful partnership that will enable both the nations to reduce our dependence on imports of active pharmaceutical ingredients by synergising each other's efforts and policy measures towards self-reliance,'' Bhaskar told BusinessLine. Indian pharma's $130-billion Vision 2030 target and Russia's Pharma Policy 2030 aim to increase their respective global footprint... Full
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