Thursday, September 26, 2024

Teva Settles Opioid Suits in Israel

(9/26, Amiram Gil, Globes) ...The opioid affair in which Israeli drugmaker Teva Pharmaceutical Industries Ltd. has been embroiled has now been settled in Israel. The economic court in Tel Aviv has approved suits filed against Teva Israel on the matter and among other rulings has decided that insurance companies will pay Teva $40 million - the highest amount ever achieved in a derivatives case in Israel... Full

FTC Weighs in On Reverse-Payment Generic Delay Case Involving Gilead, Teva

(9/25, Seeking Alpha) ...The Federal Trade Commission has filed an amicus curiae brief in a case being heard in a U.S. appellate court involving an alleged scheme by Gilead Sciences that paid Teva Pharmaceutical Industries to delay generic versions of the former's HIV meds, Truvada and Atripla... Full

The Energize Program Celebrates Landmark Multi-Buyer PPA Deal To Decarbonize Healthcare Supply Chains

(9/25, Schneider Electric) ...Three Energize program sponsors Takeda, Teva Pharmaceutical, and UCB, along with five industry suppliers, have signed a multi-buyer PPA with developers Zelestra and Bruc adding more than 280 MW of new solar capacity to the European grid..."As a collaborator of this virtual Power Purchase Agreement, we are demonstrating leadership and commitment to renewable energy not only within our industry but also as a key member of initiatives like Energize. By covering most of our electricity needs in Europe and nearly half globally, we are setting the standard for responsible energy use and driving toward our long-term goal of net zero emissions," said Amalia Adler Waxman, Head of Sustainability at Teva Pharmaceuticals... Full

Amgen Bucks Trend For US Eylea Biosimilars By Avoiding Regeneron Injunction

(9/25, David Wallace, Generics Bulletin) ...Amgen has broken away from the pack of other US biosimilar challengers to Eylea in the US, by avoiding an injunction requested by originator Regeneron that would block the launch of its aflibercept rival. However, with litigation ongoing, any launch would be at risk... Global Sub. Full

FDA Approves Accord's Higher Strength Herceptin Biosimilar

(9/25, Adam Zamecnik, Generics Bulletin) ...Following the FDA's approval of A 150mg version of Accord' Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival...According to the president, Accord will soon launch multiple biosimilars in the US, including a Stelara (ustekinumab) rival DMB-3115...Importantly, Accord has already secured a May 15, 2025 launch date as part of a settlement deal with Johnson & Johnson, placing it a little later than an earlier group that includes Amgen at the start of the year and versions from Alvotech/Teva, Biocon and Samsung Bioepis/Sandoz in February... Global Sub. Full

FDA Eyes First Schizophrenia Drug Shift in Decades

(9/26, Maya Goldman, Axios) ...Bristol Myers Squibb's KarXT uses a different mechanism that clinical trials suggest doesn't cause serious adverse events — and has the potential to be used to treat psychosis associated with Alzheimer's disease and bipolar disorder...Even if the FDA approves the drug, it may not be accessible to everyone. BMS hasn't announced a price point for the drug, but ICER calculated a price benchmark of $16,000 to $20,000 per year. People living with schizophrenia and their caregivers told ICER they were optimistic KarXT could offer better treatment of symptoms with fewer side effects... Full

Polpharma And MSN Labs Team Up On Distribution

(9/25, David Wallace, Generics Bulletin) ...Polpharma has announced a collaboration with Indian player MSN Laboratories that will see the Polish firm distribute MSN's hospital portfolio in its home market...Terms of the alliance were not disclosed, but the firms underlined that the partnership "enhances Polpharma's already excellent offering with products from a globally acting and very reliable high-quality partner, MSN Labs."... Global Sub. Full

Exclusive: J&J Folds Cardiovascular and Metabolic Drug Unit

(9/25, Max Bayer, Endpoints News) ...Johnson & Johnson is winding down its pharma division's cardiovascular and metabolic unit, Endpoints News has learned. The decision primarily impacts the sales, marketing and medical affairs teams, which were notified Wednesday, a person familiar with the matter said. In a statement, a company spokesperson said that "we must adapt and evolve our businesses in the midst of a complex and rapidly changing external environment."... Full

Novo Nordisk's Diabetes Drug Ozempic May Lower the Risk of Opioid Overdoses, Study Says

(9/25, Annika Kim Constantino, CNBC) ...Novo Nordisk's blockbuster diabetes drug Ozempic may decrease the risk of opioid overdoses in certain patients, according to a new study. The results suggest semaglutide, the active ingredient in Ozempic, could potentially become a new alternative treatment for opioid use disorder, which could help address the ongoing opioid epidemic... Full

5 Ozempic Updates

(9/25, Paige Twenter, Becker's Hospital Review) ...On Sept. 24, Novo Nordisk CEO Lars Fruergaard Jørgensen testified at a Senate committee hearing about the costs for Wegovy and Ozempic...Novo Nordisk has previously told Becker's the net price of Ozempic has fallen 40% since launching in the U.S., more than 99% of commercial plans cover Ozempic, and 80% of insured Americans pay $25 or less each month. Here are four other updates on Ozempic, Wegovy and other GLP-1 medications... Full

Gilead Recalls 1 Lot of COVID-19 Drug Veklury Due to Presence of Glass Particle in Vial

(9/25, Joseph Keenan, Fierce Pharma) ...Gilead Sciences has issued a voluntary recall of one lot of COVID-19 antiviral Veklury, also known as remdesivir, after confirming "the presence of a glass particle" in a vial...Gilead hasn't received any reports of adverse effects related to the recall, the company said... Full

US Firms Reaching Out As Biosecure Act Closes In, Piramal Pharma Says

(9/25, Satviki Sanjay, Bloomberg) ...The Mumbai based firm — one of the expected beneficiaries of the US legislation which was passed by the US House earlier this month —- is already seeing an increase in request for proposals this year for its contract drug manufacturing business, Nandini Piramal, chairperson for Piramal Pharma said in a media briefing in Mumbai on Wednesday... Full

Mark Cuban to Employers: Save Millions with 1 Move

(9/25, Paige Twenter, Becker's Hospital Review) ...Mr. Cuban, who entered the pharmaceutical industry as a disruptor in January 2022 with his company, Mark Cuban Cost Plus Drugs, shared his thoughts on pharmacy benefit managers with Becker's on Sept. 25... Full

The Simple Stories About the Opioid Epidemic Are Wrong

(9/25, David Wallace-Wells, The New York Times) ...This spring, national data began to show that overdose death rates were, after more than three decades of very steady increases, no longer growing. In fact, they were beginning to drop. By now that fall is clear and striking — suggesting perhaps 10 percent fewer Americans dying from overdoses this year than last, according to a report published last week by NPR. Some leading researchers believe the data is trailing the story, and the decline is even bigger than the backward-looking indicators suggest — perhaps 15 percent year over year... Sub. Req’d

Health Care: Swapping Made Simpler

(9/25, Victoria Knight and Peter Sullivan, Axios Pro) ...A biosimilars bill due to be marked up in the Senate HELP Committee on Thursday marks the latest step in congressional efforts to make it easier to swap the products for brand-name biologics to address high drug prices..."The bill would do away with important safeguards that protect patient safety without addressing the anticompetitive behavior by pharmacy benefit managers," said Andrew Powaleny, a senior director of public affairs at PhRMA, in a statement... Sub. Req’d

PCMA Urges HELP Committee to Pass Legislation to Increase Biosimilar Competition

(9/25, PCMA) ..."We urge the Senate HELP Committee to pass bipartisan legislation that would help remove barriers to increased competition within the U.S. biosimilar market and improve access to more affordable alternatives to brand name prescription drugs."... Full

FTC's Pattern of Abuses Will Lead to Higher Drug Prices for America's Patients

(9/25, William Jay, Biosimilars Council) ...Today's Biosimilars Council guest blog by William Jay provides expert analysis of the constitutionality of Senate legislation under consideration... Full

Who's Really Keeping Ozempic and Wegovy Prices So High?

(9/25, Lisa Jarvis, Bloomberg) ...On Tuesday, congressional leaders spent two hours taking to task Novo Nordisk Chief Executive Officer Lars Fruergaard Jørgensen over the high price of the company's diabetes and obesity drugs, Ozempic and Wegovy. Now the question is whether those prices will change...Unfortunately, without fixing the broken system of drug pricing in the country — not one kink in the chain, but all of them — the potentially profound long-term impact on our nation's health will remain out of reach... Sub. Req’d

Amid Questions Over Cost of Weight Loss Shots, Atlanta Doctors Offer Cheaper Options

(9/25, Michael Scaturro, The Atlanta Journal-Constitution) ...While Congress debates the high cost of brand-name diabetes and weight loss drugs, Atlanta doctors are selling lower-cost alternatives made by compounding pharmacies...Dr. Alex Roig offers patients in metro Atlanta semaglutide injectables made by a compounding pharmacy at a cost of $274 per month with a three-month commitment. He said the treatments are highly effective, but the goal is to wean patients off the weight loss injectables after they have developed healthier eating and exercise habits... Sub. Req’d

IRA Reimbursement Impact On Biosimilars Minimal Despite Rising Market Share

(9/25, Skylar Jeremias, The Center For Biosimilars) ...Oncology and supportive care biosimilars have secured significant market share and saved the US health care system millions, with the Inflation Reduction Act (IRA) providing a modest boost through Medicare reimbursement, although its impact has been limited by existing market competition, according to a new white paper from Centara... Full

New Prescription Drug Price Hikes Hit Black Patients Hard

(9/26, Claretta Bellamy, NBC News) ...One in 3 Americans cannot afford their prescription drugs, the report states, and these high drug prices particularly affect Black and Latino patients aged 65 and over — who can be twice as likely to report difficulty in affording their medication, according to the report... Full

New AAM CEO Looking To ‘Force Multiply' For US Generics Industry

(9/25, Derrick Gingery, Pink Sheet) ...John A. Murphy III, former chief policy officer at BIO, will become the president and CEO of the Association for Accessible Medicines. Murphy said in an interview that he wants to increase and amplify the voices advocating for the generic industry. AAM once again looked to the brand industry for its leader. Chip Davis, who came from PhRMA, ran the group from 2015-2020... Sub. Req’d

Congress Should Maintain Current FDA Biosimilars Standards

(9/25, Michael Reilly, RealClearHealth) ...An interchangeable designation makes almost 60% of physicians more comfortable with a biosimilar substitution at the pharmacy, knowing a stable patient won't be put at risk by third party-switching...Congress has a responsibility to retain the rigorous standards for interchangeability that have kept U.S. patients safe, earned the trust of physicians, and lowered health care costs. A failure to do so will put patient health outcomes, and physician trust in these important medicines, in jeopardy... Full

Industry Concerned Over Hurdles in FDA's Biosimilars Manufacturing Changes Guidance

(9/25, Jason Scott, Regulatory Focus) ...Biosimilars trade groups and manufacturers have expressed concern about what they say are "unnecessary hurdles" present in the US Food and Drug Administration's recent draft guidance on biosimilar postapproval manufacturing changes released in July...In its comments to the agency, Samsung Bioepis took aim at the existence of the guidance itself, arguing such an additional document creates new risks for biosimilar developers... Full

EU Critical Medicines Act Must Protect Secure Supply of Essential Medicines

(9/26, Medicines for Europe) ...Today, Medicines for Europe is hosting a panel at the European Health Forum Gastein, addressing the urgent issue of access to critical medicines. The session aims to foster a multi-stakeholder dialogue to strengthen critical medicine supply chains and improve patient access to medicines across Europe through collaborative solutions and insights at both regional and national levels... Full

Pharma Industry Stresses Importance Of Getting EU Health Data Opt-Out Right

(9/25, Eliza Slawther, Pink Sheet) ...EU citizens will have the option to oppose their data being used anonymously for secondary purposes once the European Health Data Space (EHDS) regulation enters into force, despite many stakeholders warning that this could undermine the aims of the new framework... Sub. Req’d

New ABPI Code To Address Serious Complaints About Companies More Quickly

(9/25, Neena Brizmohun, Pink Sheet) ...The newly published revised code of practice from the UK drug industry association moves certain elements from "guidance" to "mandatory" status, includes an option for providing prescribing information via QR codes, and promises to resolve complaints faster... Sub. Req’d

Sanofi: Poland's EU Presidency - Paving the Way for a Competitive Pharmaceutical Industry

(9/25, Sanofi) ...As Poland prepares for its EU Presidency, health needs to be a major focus, given its crucial role in Europe's prosperity and global competitiveness. Predictable pharmaceutical legislation is essential for creating a stable regulatory environment that fosters innovation and investment, ensuring the availability of critical medicines and vaccines and the development of innovative treatments to address future health challenges... Full

Paracetamol Among 53 Drugs to Fail Quality Test, Raises Safety Concerns

(9/25, India Today) ...More than 50 drugs, including calcium and vitamin D3 supplements, anti-diabetes pills, and high blood pressure medicines have failed quality tests by India's drug regulator. In its latest monthly drug alert list, the Central Drugs Standards Control Organisation (CDSCO) declared 53 drugs as "Not of Standard Quality (NSQ) Alert."... Full

Antacid Pan D, Paracetamol, Glimepiride Among Over 50 Drugs That Fail Quality Test

(9/25, Kavita Bajeli-Datt, The New Indian Express) ...Among the medicines flagged as NSQ are paracetamol tablets (500 mg), the anti-diabetic drug Glimepiride, high blood pressure medication Telma H (Telmisartan 40 mg), acid reflux medication Pan D, and calcium supplements Shelcal C and D3. The list also includes the widely used antibiotic Metronidazole, manufactured by HAL, and Shelcal, distributed by Torrent Pharmaceuticals and produced by Pure & Cure Healthcare in Uttarakhand... Full

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