Wednesday, February 26, 2025

FDA Accepts sNDA for Uzedy Extended-Release Injectable Suspension for Bipolar I Disorder

(2/25, Leah Kuntz, Psychiatric Times) ...The US Food and Drug Administration has accepted for filing Teva Pharmaceuticals' supplemental New Drug Application (sNDA) for risperidone (Uzedy) extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults. The sNDA is based on leveraging the existing clinical data for Uzedy along with previous findings of safety and efficacy of past risperidone formulations approved for treating bipolar I disorder... Full

FDA Accepts Teva and Medincell's Uzedy sNDA

(2/26, The Pharma Letter) ..."Since the FDA approval of Uzedy almost two years ago, it has proven to be an important treatment option for people living with schizophrenia," said Dr Eric Hughes, executive vice president of Global R&D and chief medical officer at Teva, adding: "Today's filing demonstrates the potential of Uzedy's clinical profile as a long-acting treatment for bipolar-I, a complex mental health disorder that significantly affects a person's mood, behavior, and overall state of mind. Debilitating manic and depressive symptoms and signs can also occur."... Sub. Req’d

FDA Accepts Teva's Application for Uzedy for Bipolar I Disorder

(2/25, Val Brickates Kennedy, Seeking Alpha) ...The drug, also known as risperidone, is currently approved for use every one or two months for the treatment of schizophrenia in adults. Teva will be responsible for potential commercialization of Uzedy for BP-I. Medincell will be eligible for royalties on net sales... Full

Hikma's Profit Jumps As Demand for Generic Medicines Booms

(2/26, Rupert Hargreaves, City AM) ...Generics generated over $1bn (£790m) in revenue for the first time as the group's market share increased in sodium oxybate, and the nasal spray franchise performed well. Core operating profit declined due to increased royalties on its authorised generic of sodium oxybate...Hikma said it expected another year of growth in 2025, with revenue growth of four to six per cent and core operating profit between $730m (£577m) and $770m (£608m). R&D investment was set to increase by 20 per cent across all three segments... Full

Germany's Fresenius Tops Profit Estimates in Fourth Quarter

(2/26, Tristan Veyet and Rafal W. Nowak, Reuters) ...German healthcare group Fresenius reported fourth-quarter earnings above market expectations on Wednesday, driven by a strong performance at its hospital drug unit Kabi... Full

Merck Says Keytruda Could Be Up Next for IRA Price Cuts

(2/26, Ayisha Sharma, Endpoints News) ...Merck said its "once-in-a-lifetime" drug Keytruda could be subject to price reductions under the Inflation Reduction Act, which would lead to a decline in sales. It expects Keytruda to be chosen for "government price setting" in 2026, which would become effective in 2028, according to an SEC filing published Tuesday... Full

Kashiv BioSciences, LLC Obtains Marketing Authorization for Pegfilgrastim Injection from Health Canada

(2/25, Kashiv BioSciences) ...PexegraTM is a long-acting G-CSF biosimilar indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs. The marketing authorization follows a rigorous regulatory review by Health Canada, ensuring that Kashiv's Pegfilgrastim Injection meets the stringent quality, safety, and efficacy standards comparable to the reference biologic... Full

AstraZeneca Therapy Improves Breast Cancer Survival in Key Trial

(2/26, Pushkala Aripaka, Reuters) ...Drugmaker AstraZeneca on Wednesday said that its experimental breast cancer treatment improved patient survival without the disease getting worse in a study, a positive outcome in the development of the therapy key to the company's pipeline...The trial update was a "material positive surprise" for AstraZeneca, which has indicated that camizestrant could generate peak sales of more than $5 billion following approvals, Barclays analysts said in a note... Full

J&J Slaps Samsung Bioepis With Stelara Lawsuit In US

(2/25, Dave Wallace, Generics Bulletin) ...In a statement provided to Generics Bulletin, J&J insisted that "we support biosimilar competition and we have in good faith entered into multiple early entry agreements that will allow up to seven ustekinumab biosimilars to launch in the US this year. In fact, the first biosimilar launched on the agreed upon settlement date of no earlier than January 1, 2025, and additional biosimilars have since launched."...In response to enquiries over the lawsuit, Samsung Bioepis told Generics Bulletin that "unfortunately, we cannot comment on ongoing litigations."... Global Sub. Full

‘Cannot Have It Both Ways': AAM Fights MSN's Corner In Entresto Patent Revival Appeal

(2/25, Dean Rudge, Generics Bulletin) ...The US Association for Accessible Medicines says it is looking to "protect the public's interests in ensuring that patents do not let inventors control more than they invented," as it moved to file in support of MSN Laboratories' legal tussle with Novartis over a key patent shielding the originator's $7.8bn Entresto blockbuster... Global Sub. Full

Purdue Pharma Says Sackler Opioid Payment Could Grow to $7 Billion

(2/25, Dietrich Knauth, Reuters) ...Purdue Pharma told a U.S. bankruptcy judge on Tuesday that it will finalize a new bankruptcy plan in March, with the company's Sackler family owners potentially paying more than their previously announced $6.5 billion commitment... Full

US Drug Overdose Deaths Drop to Lowest Levels Since June 2020, CDC Data Shows

(2/25, Mariam Sunny, Reuters) ...Nearly 87,000 Americans died from drug overdose in the United States in the 12-month period ending September 2024, a decline of about 24% from the previous year, according to preliminary data from the U.S. Centers for Disease Control and Prevention released on Tuesday... Full

Lawmakers Reintroduce Bill To Eliminate IRA's ‘Pill Penalty'

(2/25, Maaisha Osman, Inside Health Policy) ...The bill introduced Tuesday (Feb. 25), co-sponsored by Reps. Don Davis (D-NC) and Richard Hudson (R-NC), seeks to level the playing field between small molecule drugs-- typically oral medications -- and biologics by extending the period before Medicare price negotiations kick in. Under current law, small molecule drugs face price negotiations nine years post-approval while biologics get 13 years.... Sub. Req’d

IRA Negotiation Changes: Pharma's Focus Remains On Near-Term Legislative, Regulatory Options

(2/25, Cathy Kelly, Pink Sheet) ...Manufacturers still hope to advance legislation removing the "pill penalty" from the law, as well as changes they want included in the CMS guidance for the 2028 price implementation year...Manufacturers want the upcoming CMS guidance on the price negotiation program to change the agency's approach to aggregating drugs for the drug selection process and to create a broader exemption for orphan drugs... Global Sub. Full

AAM's Murphy Talks Kennedy, Impact Of Tariffs, IRA On Generics

(2/25, Jessica Karins, Inside Health Policy) ...Marty Makary, the nominee to serve as FDA's next commissioner, has spoken at AAM's conferences in the past, and generics stakeholders are hoping he could be a valuable ally in the new administration, though he's made few statements since his nomination. "We anticipate, based on the public remarks that Dr. Makary has made, that he'll be an advocate for FDA as a strong regulator, and that gives us a lot of hope that we can work constructively with him," Murphy said... Sub. Req’d

A Bill is Re-Introduced in Congress to Revise Provisions in Drug-Pricing

(2/25, Ed Silverman, STAT+) ...Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Act in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines. The legislation, known as the Ensuring Pathways to Innovative Cures Act, would allow Medicare to begin negotiating with pharmaceutical companies over the prices of small molecule medicines 13 years after they reach the market... Sub. Req’d

PBM Industry Makes Case Ahead of House Hearing

(2/25, Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech, The Hill) ...A measure to change how the pharmacy benefit manager industry operates failed to make it into the last government funding bill, but lawmakers are still turning up the pressure. The Hill spoke with JC Scott, president and CEO of the industry's lobbying group Pharmaceutical Care Management Association, ahead of a House hearing on PBM practices Wednesday... Full

PCMA Launches PBM Innovation Project to Showcase New Patient-Centered Programs

(2/25, PCMA) ..."While pharma is lobbying to defend their status quo pricing practices, PBMs are responding to consumer needs, market demands and not waiting for government interventions or unnecessary mandates," said JC Scott, president and CEO, PCMA. "PBMs have announced many new, innovative programs to help employers and unions offer competitive pharmacy benefits, while giving patients more convenient access to prescription drugs and lowering their out-of-pocket costs."... Full

Court Orders CVS to Comply with the FTC's PBM-Related Investigation

(2/26, Zachary Brennan, Endpoints News) ...The Federal Trade Commission is continuing its investigation into anticompetitive PBM practices, with a new court order that will require CVS Health to share more requested documents about its PBM...While the FTC contends that no new documents have been shared by CVS since September 2024, CVS said the requested documents have not been shared because the company is too busy working on the FTC's other requests, including a trial scheduled for August 2025, according to the court... Full

'Big Three' PBMs Seek Appeal in Legal Spat with Federal Trade Commission

(2/25, Paige Minemyer, Fierce Healthcare) ...CVS Health's Caremark, Cigna's Express Scripts and UnitedHealth's Optum Rx filed a notice of appeal on Friday after a Missouri District Court determined that the FTC's case could move ahead. The agency filed suit against the so-called "Big Three" in September, alleging that they played a key role in inflating the price of insulin... Full

In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

(2/26, John W.M. Claud, FDA Law Blog) ...So, yes, compliance and quality still matter, a lot. And they still matter to companies looking for certainty and security in turbulent times. Organizations should want to instill good habits in their employees to make compliance easy and rewarding, looking both internally and externally... Full

New York State Senate Passes Legislation to Lower Costs and Increase Pricing Transparency for New Yorkers

(2/25, The New York State Senate) ...The New York State Senate today passed a comprehensive legislative package to lower costs for New Yorkers and ensure greater transparency in pricing across essential goods and services from prescription drugs and energy to subscription services and groceries. The legislative package targets key cost drivers that burden New Yorkers daily, tackling hidden fees, deceptive pricing, and barriers to financial transparency. It includes measures to crack down on prescription drug price manipulation and requires disclosure of anti-competitive "pay-for-delay" agreements that keep generic medications off the market... Full

Kansas Hospital Sues HHS Over J&J Audit in Discount Drug Program

(2/25, Ganny Belloni, Bloomberg Law) ...The University of Kansas Hospital Authority's complaint filed Monday in the US District Court for the District of Columbia alleged that the Health Resources and Services Administration acted "outside the scope of its authority" when it approved J&J's request to review whether the hospital violated a provision of the 340B drug discount program... Sub. Req’d

Novartis' Bid to Block Missouri's Drug Discount Law Rejected

(2/25, Nyah Phengsitthy, Bloomberg Law) ...Novartis AG failed to show that it will suffer harm from a Missouri law that requires it to discount drugs to an unlimited number of pharmacies under the 340B Drug Pricing Program, a federal judge ruled. An order issued Monday by Judge Douglas Harpool of the US District Court for the Western District of Missouri ruled that Novartis hasn't shown "more than a mere possibility of irreparable harm," or a substantial likelihood of success on the merits to be granted a preliminary injunction against Missouri's law (S.B. 751)... Sub. Req’d

EU Product Liability Directive Could Spell Trouble For Non-EU Pharma Firms

(2/25, Eliza Slawther, Pink Sheet) ...The EU's new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies... Global Sub. Full

New Global GCP Standard Puts Proportionality In Focus For Trial Sponsors

(2/25, Vibha Sharmma, Pink Sheet) ...Pharma industry representative at the ICH expert working group that drew-up the new international good clinical practice standard is advising trial sponsors to focus on proportionality and a risk-based approach throughout their trial design, conduct, analysis and reporting... Global Sub. Full

[Reporter's Notebook] Concerta Shortage Demands Accountability from Supplier and Government

(2/26, Kim Chan-hyuk, Korea Biomedical Review) ...Its supplier Janssen Korea says the "timeline is uncertain due to supply and demand issues," and the government hasn't taken any real action to address the shortage. In the meantime, healthcare providers are being forced to consider prescribing alternative medications, and patients are feeling anxious about having their familiar medication changed. According to data submitted to the Ministry of Food and Drug Safety (MFDS) by Janssen Korea, which supplies the drug in Korea, all dosage forms of Concerta (18 mg, 27 mg, 36 mg, and 54 mg) will be in short supply sequentially throughout the first half of 2025... Full

Indian Pharma Needs to Make Shift from ‘Make in India' to ‘Discover in India for the World,' Says Amitabh Kant

(2/26, Swati Bharadwaj, Times Of India) ... The Indian pharma sector, known as the pharmacy of the world, has the potential to grow from $50 billion today to $150 billion by 2030 and $500 billion by 2047. However, for this to happen, it needs to shift gears from 'Make in India' to 'Discover in India for the world', former NITI Aayog CEO and G20 Sherpa Amitabh Kant said here on Tuesday... Full

Indian Drugmakers Join Forces to Boost National Biomanufacturing Sector  

(2/25, Anna Brown, Endpoints News) ...Several contract research, development and manufacturing organizations based in India are banding together to form a trade group with an aim to bolster the nation's production footprint and talent pool. The new consortium, dubbed the Innovative Pharmaceutical Services Organization (IPSO), was announced Tuesday and includes 11 companies like Syngene, Aragen Life Sciences, Piramal Pharma Solutions and Sai Life Sciences. Indian CRDMOs need to step up with a "competitive sense of urgency," Syngene CEO Peter Bains said in a Tuesday press release... Full

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