Wednesday, October 9, 2024

Teva Files For Prolia Biosimilar In The US And Europe – But Not Xgeva

(10/9, Dean Rudge, Generics Bulletin) ...Teva has broken new ground by filing its first independent biosimilar to the US Food and Drug Administration, for a proposed biosimilar to Amgen's Prolia treatment for osteoporosis in postmenopausal women. However, the Israeli firm made no mention of its proposed Xgeva biosimilar, which it states is in Phase III clinical trials... Global Sub. Full

Teva Prolia Biosimilar Accepted for Review by FDA and EMA

(10/8, The Pharma Letter) ..."The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva's commitment to broadening global access to biosimilars in both regions," said Steffen Nock, head of biosimilars and chief scientific officer at Teva... Paid Sub. Req'd

Tirzepatide Shortage Resolved; Compounder Sues FDA; Menopause Mistaken as Dementia

(10/8, Kristen Monaco, MedPage Today) ...Teva Pharmaceuticals announced the launch of the first generic of octreotide acetate for injectable suspension (Sandostatin LAR Depot) for the treatment of acromegaly...Teva Pharmaceuticals' biosimilar candidate to the osteoporosis drug denosumab (Prolia) is under FDA review, the company said... Full

Senate Orders FTC To Probe PBM-Made Biosimilars, Slams FDA Over Orange Book Mismanagement

(10/9, Urte Fultinaviciute, Generics Bulletin) ...The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job...Even though not mentioned in the letter, Quallent has also signed a deal with Teva Pharmaceuticals and Alvotech, distributing Simlandi (adalimumab-ryvk) under its private label. The senators argued that the nature of these agreements is not clear as the available information suggests that "PBMs are merely consulting services to the pharmaceutical manufacturers they are partnering with," but it may also mean another attempt by PBMs to control additional parts of the supply chain... Global Sub. Full

Amneal Pharma Expands Operations in India with Two New Manufacturing Facilities

(10/8, Express Pharma) ...Amneal Pharmaceuticals, a U.S.-based global pharmaceutical company, has announced plans to build two new manufacturing facilities in Ahmedabad, India. This expansion marks the company's continued growth in the country, where it has operated since 2008. The investment, which is projected to be between USD$150 million and $200 million, will take place over the next four to five years and will focus on peptide synthesis and advanced sterile fill-finish manufacturing... Full

GlaxoSmithKline Pharma to Enter Oncology Market, Launch Adult Vax

(10/9, Rupali Mukherjee, The Times Of India) ...GlaxoSmithKline Pharma, in its centenary year in India, is transforming into a specialty-driven company and building a preventive healthcare ecosystem led by adult vaccines. As the country's second-largest drug MNC with nearly 30 crore prescriptions annually, GSK Pharma plans to enter the oncology market with the launch of two major high-value therapies, expanding beyond its 'legacy' offerings in general medicine, its managing director, Bhushan Akshikar, told TOI in an exclusive interview... Full

GSK, Pfizer RSV Vaccine Sales Fall in US As Millions Fewer People Line Up

(10/8, Michael Erman, Reuters) ...Some independent pharmacists said demand during the autumn vaccination season for respiratory syncytial virus shots has fallen as much as two-thirds from a year ago. So far, volumes reported by healthcare data company IQVIA and published in several Wall Street analyst notes roughly match that mark. The shots are important for both Pfizer and GSK as they look to build new franchises before top-selling drugs face generic competition later this decade... Full

Novo Settles Ozempic Patent Fight With Three More Generic Makers

(10/8, Annelise Gilbert, Bloomberg Law) ...Novo Nordisk A/S settled a patent lawsuit and related validity challenge over copies of its blockbuster weight-loss and diabetes drug Ozempic with generic pharmaceutical companies Sun Pharmaceutical Industries Inc., Dr. Reddy's Laboratories Ltd., and Apotex Inc... Paid Sub. Req'd

Gilead Seals VLs For Lenacapavir Amid Concerns Around Price, API Supplies

(10/8, Anju Ghangurde, Generics Bulletin) ...Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions...The licensees - Dr. Reddy's Laboratories Ltd., Emcure Pharmaceuticals. and Hetero. from India, Egypt's Eva Pharma, Pakistan-based Ferozsons Laboratories and Mylan, a subsidiary of Viatris Inc. – were selected based on "rigorous criteria", given the manufacturing complexities for a drug like lenacapavir... Global Sub. Full

Biogen to Seek Approval for High-Dose Spinraza After Unveiling New Data

(10/8. Lei Lei Wu, Endpoints News) ...Clinical trial data unveiled on Tuesday suggest, but don't definitively show, that a higher dose regimen could improve outcomes compared to the currently approved one. The study reports that the higher dose regimen improved motor skills compared to a historical sham control group taken from the original study that led to Spinraza's approval in 2016... Full

Bio-Thera and Richter Execute Exclusive Commercialization Agreement for BAT2206, A Proposed Stelara® Biosimilar, For EU Countries, UK, Switzerland and Other Selected Countries

(10/9, Bio-Thera Solutions) ...Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Gedeon Richter announce today they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Stelara® (ustekinumab)... Full

Fresenius Looking to Boost Output After Hurricane Damage at Rival Baxter

(10/8, Ludwig Burger and Christy Santhosh, Reuters) ...Germany's Fresenius said it was checking options to speed up the start of new production lines of medical equipment at a North Carolina facility to help mitigate potential shortages from hurricane damage to rival Baxter's site in the same state... Full

Pfizer, Bracing for Hurricane Milton, Pledges Aid to Emergency Services and Health Support

(10/8, Fraiser Kansteiner, Fierce Pharma) ...Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Milton touches down this week, the company's CEO, Albert Bourla, Ph.D., said in a post on X (formerly Twitter) Tuesday...In light of the impending natural disaster, Bourla said Pfizer is pledging all it can to support the community during this trying time. To contribute during the storm, Pfizer will provide financial assistance to the American Red Cross and International Medical Corps, Bourla explained... Full

Scoop: Medicare Pilot Aims for $2 Generic Drugs

(10/9, Maya Goldman, Axios) ...The administration is asking for feedback on its list of 101 generic drugs that could be covered by the pilot, officials told Axios. The list covers common prescriptions like penicillin, metformin, lithium and albuterol asthma inhalers. Thirty-five of the drugs treat blood pressure and other cardiovascular conditions... Full

Biden Administration to Release List of Drugs to Medicare Recipients for $2, Axios Reports

(10/9, Rishabh Jaiswal and Bhanvi Satija, Reuters) ...The report added drugs on the list will not be subject to requirements such as prior authorization or quantity limits...It would also include common drugs for high cholesterol, high blood pressure and other chronic conditions. The program is not expected to start until January 2027, the report said... Full

On Drug Prices, Harris Pushes for Deeper Cuts While Trump Offers Few Specifics

(10/8, Reed Abelson and Rebecca Robbins, The New York Times) ...Most industry observers say Ms. Harris is more likely to pose a greater threat to drugmakers' profits, but they don't rule out the possibility that Mr. Trump could also be bad for their interests... Full

Mark Cuban Says Kamala Harris Will Tackle ‘Criminal' Healthcare Pricing Schemes

(10/8, Chris Matthews, MarketWatch) ...Billionaire Mark Cuban has told Vice President Kamala Harris that one of her first priorities as president should be to require pharmaceutical companies and pharmacy-benefit managers to be more transparent about what they are charging consumers and insurance companies for drugs. Vice President Harris "told me specifically that she likes the idea of transparency, and she sees that as a winner," Cuban told reporters at an event hosted by KFF, a nonpartisan healthcare-policy organization, in Washington on Tuesday... Full

Mark Cuban is Pushing His Anti-PBM Agenda with Kamala Harris — and it's Working

(10/8, Rachel Cohrs Zhang, STAT Plus) ...Generally, congressional budget experts have not estimated that price transparency proposals alone would save the federal government significant sums of money. But Cuban pointed to research published last year that showed that Medicare plans could have saved up to $2.2 billion per year if they had bought seven generic drugs through Cuban's company. As evidence that the status quo could be shifting, Cuban cited lawsuits filed against big companies such as Wells Fargo and Johnson & Johnson challenging whether the pharmacy benefit managers the companies hire truly have their employees' best interests at heart... Paid Sub. Req'd

Senators Demand Another Antitrust Investigation into Pharmacy Middlemen

(10/9, Marty Schladen, Ohio Capital Journal) ...The health conglomerates that own CVS Caremark and Express Scripts already own businesses that occupy huge swaths of the health care space. The co-manufacturing agreements mean that they'll extend their tentacles into yet another, and that won't be good for consumers, said a letter sent to the FTC last week by two Democratic senators, Sherrod Brown of Ohio and Ron Wyden of Oregon... Full

FTC And Congress Ramp Up Efforts To Rein In Drug Patent Evergreening

(10/8, Joshua P. Cohen, Forbes) ...One area of particular concern for the FTC is biosimilars...Biosimilars are typically at least 30% lower in terms of list price compared to their original biologic counterparts. More optimal use could reduce prescription drug spending in the U.S. by more than $100 billion in the next five years. But to realize these savings, it will be necessary to remove so-called patent thickets that impede biosimilar uptake... Full

CVS, UnitedHealth Say FTC Should Take Lina Khan and Two Commissioners Off Drug Middlemen Case

(10/9, Annika Kim Constantino, CNBC) ...CVS Health and UnitedHealth Group are demanding Federal Trade Commission Chairwoman Lina Khan and two other commissioners recuse themselves from a lawsuit accusing the companies and other drug middlemen of boosting their profits while inflating insulin costs for Americans. In separate motions filed Tuesday night with the FTC, CVS and UnitedHealth argued that all three commissioners have an extensive track record of making public statements that indicate "serious bias" against the companies' so-called pharmacy benefit managers... Full

UnitedHealth, CVS Ask Judge to Remove Lina Khan from FTC's Insulin-Price Lawsuit

(10/9, Bob Herman, STAT Plus) ...Attorneys for UnitedHealth's Optum Rx and CVS Caremark contend Khan, Rebecca Kelly Slaughter, and Alvaro Bedoya "have made repeated incorrect prejudgments" about the PBMs as well as their group purchasing organizations that aggregate rebates from drug manufacturers, according to legal filings dated Tuesday night... Paid Sub. Req'd

Obesity Drugs Could Cost US Health Insurance System $35Bn, Study Finds

(10/8, Liver Barnes, Financial Times) ...Covering weight-loss drugs for elderly Americans on the state-backed Medicare health insurance programme would cost the US government $35bn over the next nine years, a congressional analysis has found. Currently, Medicare, which provides prescription drugs to about 54mn over-65s in the US, only covers anti-obesity medications, such as Novo Nordisk's blockbuster Wegovy, for patients suffering from another comorbidity, such as stroke risk, heart disease or sleep apnoea... Paid Sub. Req'd

Bipartisan E&C Leaders Request FDA Briefing for More Details About Counterfeit Ozempic

(10/8, Energy & Commerce Chair Rodgers) ...In a letter today to Food and Drug Administration Commissioner Robert Califf, M.D., a bipartisan group of House Energy and Commerce Committee Leaders requested a briefing about the presence of counterfeit Ozempic and other semaglutide products in the United States' medical supply chain... Full

Compounding Group Sues FDA for Removing Lilly's Obesity Drug from its Shortages List

(10/8, Ed Silverman, STAT Plus) ...The Outsourcing Facilities Association argued that a shortage of the drug, known as tirzepatide, actually still exists and the agency action was a coup for the company that came at the expense of the public. Moreover, the trade group maintained the FDA move was "unlawful," because it failed to follow so-called rule-making procedures and provide proper notice of its plans. The lawsuit follows an FDA announcement last week that Lilly determined its manufacturing capacity can meet "present and projected" national demand after a sustained shortage of the drug... Paid Sub. Req'd

Remember the Prescription Drug Shortages from Last Year? The Problem Hasn't Gone Away

(10/8, Alex Ford and Noreen O'Donnell, NBC) ...David Gaugh, the interim president of the Association for Accessible Medicines, said that with the consolidation of the PBMs, a number of generic drugs have been pushed out of the market or never made it to the market at all. When drugs are dropped for various reasons, there are not ready replacements, he said.. Full

Lawmakers Urge FDA to Consider Broad Exemptions from DSCSA to Minimize Supply Chain Disruptions

(10/8, Joanne S. Eglovitch, Regulatory Focus) ...Members of Congress are urging US Food and Drug Administration (FDA) Commissioner Robert Califf to consider establishing a broad category of exemptions from the enhanced tracing requirements under the Drug Supply Chain Security Act (DSCSA) to allow more time for trading partners to stabilize data exchanges and to avoid drug shortages once the law takes effect on November 27... Full

U.S. Supreme Court Asks Solicitor General for Views On Controversial Oklahoma Law for Regulating PBMs

(10/8, Ed Silverman, STAT Plus) ...Amid ongoing scrutiny of pharmacy benefit managers, the U.S. Supreme Court has asked the solicitor general to weigh in on an Oklahoma law that seeks to regulate the retail networks created by these controversial middlemen in the pharmaceutical supply chain... Paid Sub. Req'd

Medicines for Europe Delegation Leads On Manufacturing, Sustainability and Access at CPHI Congress

(10/9, Medicines for Europe) ...On critical medicines manufacturing, Medicines for Europe supports an ambitious EU Critical Medicines Act in the first 100 days after of the European Commission taking office. The Act would ensure equitable access to high-quality, safe, effective and affordable critical medicines, 90% of which are off-patent. Our members are dedicated to co-investing in EU manufacturing of critical medicines and Active Pharmaceutical Ingredients (APIs) as highlighted in the panel co-hosted by DG HERA entitled "Safeguarding the Future of Medicines".... Full

CPHI Milan 2024: Everything You Need to Know

(10/8, European Pharmaceutical Review) ...CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma...CPHI Milan will present a comprehensive conference agenda on topics such as sustainability and pharma, next generation mRNA vaccines, European regulation, biomanufacturing, and more. These sessions aim to offer valuable insights and influence the industry's future... Full

Could US-Style Priority Review Vouchers Drive European Neglected Disease R&D?

(10/8, Francesca Bruce, Pink Sheet) ...A moral obligation to those in need and the onset in Europe of diseases traditionally found in the developing world are just two reasons why the EU should be driving investment in neglected diseases, according to Rosa Castro, senior advocacy officer at Deutsche Stiftung Weltbevölkerung, an international non-profit development organization... Global Sub. Full

Bulgaria Pitches Fast Domestic Authorisation of Innovative Drugs to Attract Pharma Firms

(10/8, Antonia Kotseva and Krassen Nikolov, Euractiv) ...Bulgaria will rely on the speed and efficiency of its domestic authorisation procedures for innovative drug therapies to attract the interest of pharma companies to its small domestic market, the Ministry of Health told Euractiv... Full

India Tightens Oversight Of CROs With Mandatory Registration

(10/8, Vibha Sharma, Pink Sheet) ...Contract research organizations in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them... Global Sub. Full

India's Pharma, Meditech Exports Expected to Sustain Momentum Despite Global Slowdown: Official

(10/8, Press Trust Of India) ...India's pharmaceutical and meditech exports continue to grow despite global economic slowdown, with robust double-digit growth. Government-backed drug development initiatives have 16 blockbuster molecules in the pipeline for cancer, diabetes, HIV, and more. The industry is also expanding in imaging devices, body implants, and diagnostics... Full

Indian Pharma Anxious About Israel-Iran Conflict Disrupting Supply Chains

(10/9, Pharmabiz.com) ...Though the immediate impact may be limited, the evolving nature of the conflict necessitates vigilance. It is sad for Indian pharma to confront this after the Ukraine and Russia battle. Pharma companies will need to monitor closely and prepare for potential disruptions in the coming weeks. Being proactive in risk management and strategic planning are needed to navigate this complex landscape, pointed out Archana Dubey, chief operating officer, Bal Pharma... Full

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