Monday, July 1, 2024

Not Only Generic: Teva Strengthens Cooperation With Academia in Developing the Next Branded Drugs

(6/30, Assaf Levanon, Haaretz) ...Novel antibodies for cancer immunotherapy, personalized Crohn's and colitis medicine, and drug development for neurodegenerative diseases. Teva returns to its roots and cooperates with academia to develop innovative medicines. "I believe that the more we increase the synergy between the universes of pharma and academia, the more successful we will be," says Dr. Dana Bar-On, Teva's Head of Academic Affairs. "Cooperation between Teva and academia is a win-win for all parties," said Dr. Dana Bar-On, Head of Academic Affairs in the global R&D division of Teva... Full

Data from Study of Teva's Ajovy Suggests Change to Migraine Treatment Pause Protocols

(6/28, Patrick Lavery, PharmTech.com) ..."This new sub-analysis may challenge the rationale for mandatory treatment pauses and highlights the potential for these breaks to diminish the benefits achieved in reducing migraine for some patients," said Pinar Kokturk, MD, vice president and head of medical affairs for Teva in Europe... Full

Teva Announces Data from Fourth Interim Analysis of PEARL Study of AJOVY

(6/28, The Fly) ...Teva Pharmaceutical announced new data from the 4th interim analysis of the PEARL migraine prevention study with AJOVY that may challenge the rationale for treatment pauses with calcitonin gene-related peptide monoclonal antibodies mandated or recommended by some reimbursement authorities after one year of continuous use. The sub-analysis from the PEARL real world data explored the impact of fremanezumab treatment cessation and reinitiation on monthly migraine days in adult patients with episodic or chronic migraine... Full

Federal Court Allows Vanda's HETLIOZ Patent Lawsuit to Proceed

(7/1, The Fly) ...Vanda Pharmaceuticals announced that the U.S. District Court for the District of Delaware denied the motions for judgment on the pleadings that were filed by Teva Pharmaceuticals USA and Apotex and Apotex and ordered that Vanda's HETLIOZ patent lawsuit may proceed... Full

Prescription Medication Used to Treat Skin Itching, Inflammation Recalled

(6/28, Daily Hive Canada) ...The recall affected a specific lot of ratio-Ectoson (Teva-Ectosone) 0.05% mild lotion, a corticosteroid treatment sold in 60 ml bottles. The Drug Identification Number (DIN) is 00653209, and the lot number is 688519. The product expires this month. The lotion's manufacturer, Teva Canada Ltd., tested the affected product and said it contained an impurity called betamethasone enol aldehyde above the accepted limit...Health Canada says it is currently monitoring Teva Canada Ltd.'s implementation of any necessary corrective and preventative actions to prevent the issue from reoccurring... Full

Withdrawal of Application for the Marketing Authorisation of Dabigatran Etexilate Teva (Dabigatran Etexilate)

(6/28, European Medicines Agency) ...Teva GmBh withdrew its application for a marketing authorisation of Dabigatran etexilate Teva as an anticoagulant medicine (a medicine that prevents blood clotting)...Based on the review of the data and the company's response the Agency's questions, at the time of the withdrawal, concerns remained on the presence of nitrosamine impurities in the medicine and its provisional opinion was that Dabigatran etexilate Teva could not have been authorised for the requested indication. Therefore, at the time of the withdrawal, the Agency's opinion was that the benefits of Dabigatran etexilate Teva did not outweigh its risks... Full

Alvotech Announces Record Preliminary Results for Revenues and EBITDA for the Second Quarter of 2024

(7/1, Alvotech) ...Strong preliminary revenue growth with total revenues for the second quarter between $196 - $201 million. Preliminary total revenues for the first six months are $233 - $238 million, an approximately 10-fold increase compared to total revenues for the same period in 2023... Full

FDA Approves Biosimilar Pyzchiva® (Ustekinumab-Ttwe), to be Commercialized by Sandoz in US

(7/1, Sandoz) ...Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration has approved biosimilar Pyzchiva® (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion...Sandoz intends to launch Pyzchiva® in the US in February 2025, in accordance with the settlement and license agreement with Janssen Biotech Inc. previously announced by Samsung Bioepis Co., Ltd. Pyzchiva® is expected to be among the first wave of ustekinumab biosimilars to launch in the US... Full

FDA Grants Approval for Eylea®1) Biosimilar FYB203/AHZANTIVE®2) (Aflibercept-Mrbb)

(6/28, Formycon AG) ...Formycon AG and its licensing partner Klinge Biopharma GmbH announce that the U.S. Food and Drug Administration today approved FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®... Full

Celltrion Receives European Approval Recommendation for Autoimmune Disease Treatment 'Stekeyma'

(7/1, Jung So-yeon, Korea IT Times) ...Celltrion announced on July 1 that it has received a recommendation for approval from the Committee for Medicinal Products for Human Use, a subcommittee of the European Medicines Agency, for the biosimilar 'Stekeyma' (development name: CT-P43), which is a biosimilar to the autoimmune disease treatment 'Stelara' (active ingredient: ustekinumab)... Full

Newbury Secures Approval For Victoza Generic In Denmark

(6/28, Adam Zamecnik, Generics Bulletin) ...Newbury Pharmaceuticals has snatched up approval for its generic liraglutide pre-filled pen in type 2 diabetes from regulators, paving the way for further greenlighting in Scandinavia. Marketed under the name Milmiga, the drug is a bioequivalent version of Novo Nordisk's type 2 diabetes treatment Victoza...Notably, Teva Pharmaceuticals launched its authorized Victoza generic in the US... Global Sub. Full

Alembic Pharmaceuticals Receives USFDA Tentative Approval for Bosutinib Tablets

(7/1, Business Standard) ...Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration for Bosutinib Tablets, 100 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V... Full

Zydus Life, Dr Reddy's Partner to Co-Market Pertuzumab Biosimilar for Breast Cancer Treatment

(6/28, Jomy Pos Pullokaran, CNBC TV 18) ...Generic drugmaker Zydus Lifesciences Ltd on Friday (June 28) said it has entered into a licensing agreement with Dr Reddy's Laboratories to co-market the Pertuzumab biosimilar, a critical treatment for HER2 positive breast cancer, in India...This collaboration aims to broaden access to this essential medication for patients across India, leveraging the strengths of both companies in distribution and market reach... Full

Sanofi Eyes Investment of Up to $1.6 Billion in Germany, Handelsblatt Says

(7/1, Ludwig Burger, Reuters) ...French drugmaker Sanofi is nearing a decision to invest between 1.3 billion euros and 1.5 billion euros ($1.4-$1.6 billion) at a major production site in Frankfurt, Germany, where it makes insulin brand Lantus, newspaper Handelsblatt reported on Monday... Full

GSK Reaches Settlement in Illinois Zantac Lawsuit

(6/28, Najat Kantouar, Dow Jones) ...GSK said it reached a confidential settlement with a plaintiff over its discontinued drug Zantac, resolving the case in an Illinois state court. The British pharmaceutical company said Friday that it won't admit any liability in this settlement, and added that the scientific consensus didn't find any consistent or reliable evidence that ranitidine, commonly sold under the brand name Zantac, increases the risk of any cancer... Full

Jeffrey Casberg of IDP Analytics' Gives Insight On Specialty Drugs in the Pipeline

(6/30, Cameron Santoro, The Center For Biosimilars) ...In an interview with Jeffrey Casberg, RPh, MS, he discusses 3 promising specialty drugs coming through the pipeline. Casberg explains these drugs offer new treatment options for major diseases and stakeholders should watch for their potential impact on the market...He also touches on the FDA Advisory Committee and speaks about the obstacles that have delayed approvals for these medications... Full

Breaking Down Medication Access and Affordability Barriers

(6/28, Adam J. Fein, Ph.D., Drug Channels) ...From claim rejection barriers at the pharmacy to financial constraints, pharma companies need a strategic collaborator that understands the unique challenges their brands face. It starts with experience and expertise to develop a tailored approach for effective, data-informed program designs that can break down the most common access and affordability barriers... Full

Attitude, Education Among Non-Economic Barriers Hinder Adoption of Biosimilars

(6/28, Luke Halpern, Pharmacy Times) ...Attitudinal, practical, psychological and economic factors have hindered more widespread uptake and adoption of biosimilar drugs and must be addressed if biosimilars are to achieve their potential in decreasing costs of treatment and increasing patient access, according to a review published in the Journal of the American Medical Association Oncology... Full

Why Walgreens, CVS and Rite Aid Are Closing Thousands of Drug Stores Across America

(6/28, Nathaniel Meyersohn, CNN) ...Drug store chains are struggling because of falling reimbursement rates for prescription drugs, according to analysts who cover the industry. The majority of drugstores' sales comes from filling prescriptions. But their profits from that business have dropped in recent years because of lower reimbursement rates for prescription drugs and higher fees... Full

Drug Pricing, Obamacare Rules Vulnerable After Chevron Ruling

(7/1, Ian Lopez, Bloomberg Law) ...Federal oversight of transgender care, abortion services, drug pricing, and other health policies are more open to legal challenges following the US Supreme Court's decision to scrap a test for when courts should uphold agency regulation under vague laws...The Centers for Medicare & Medicaid Services will also be more vulnerable without Chevron, particularly with activity around Medicare drug price negotiations, "especially because the pharmaceutical industry has been trying to challenge this from as many angles as possible," said Reshma Ramachandran, an assistant professor at the Yale University School of Medicine... Sub. Req'd

Deference No More: More Suits Against US FDA Coming After High Court Tosses Chevron Doctrine?

(6/28, Sue Sutter, Pink Sheet) ...The Supreme Court's 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say...In a dissenting opinion, Associate Justice Elena Kagan highlighted the impact that the majority's opinion will have on scientific agencies such as the FDA. Kagan cited a 2020 US District Court decision in a Teva Pharmaceutical Industries Ltd. lawsuit challenging the FDA's regulation of Copaxone (glatiramer) as a drug under the Food and Drug Cosmetic Act as an example of a "typical Chevron question."... Sub. Req'd

Drugmakers Resist FTC, Lawmaker Efforts to Remove Drug Patents

(7/1, Ian Lopez and Nyah Phengsitthy, Bloomberg Law) ...Boehringer Ingelheim, Novo Nordisk A/S, and GlaxoSmithKline PLC are among the manufacturers that have declined requests to remove listings from a government drug patent registry that lawmakers and others say are driving up drug costs and blocking competition..."Removing a patent from the Orange Book doesn't change the fact it's still a legally valid patent that a company could assert in court," said Cat Hill, spokesperson for the Pharmaceutical Research and Manufacturers of America. And "listing patents often benefits generic companies because they have notice of the patent and can efficiently resolve any potential disputes."... Sub. Req'd

Lawmakers Seek Balance Between Drug Costs and Innovation

(6/28, Eden Teshome, The Hill) ...Reps. Scott Peters (D-Calif.) and Mariannette Miller-Meeks (R-Iowa) said policy makers need to strike a balance between savings and innovation in the wake of the Inflation Reduction Act, which was passed about two years ago...While Peters supported the IRA, he warned that if lawmakers went too far in restricting profits, drug makers would not have an incentive to spend on development of new drugs. "They can't make a return, they won't make those investments," he said of drug producers... Full

Pharmacy Benefit Companies Are More Valuable Now Than Ever

(6/28, JC Scott, Medium) ...Policymakers have an opportunity to deliver what patients really need when it comes to prescription drugs — lower costs and better access. By rejecting the bait from self-interested stakeholders that only want to increase their profits, and instead encouraging the market to continue innovating to address these needs and tailoring public policy to promote competition and build on this progress, we can work together to help patients have affordable access to the drugs they need... Full

Spanberger Raises Concerns About Express Scripts Leveraging Exclusive Government Contract to Stifle Competition & Harm Service Members

(6/28, Congresswoman Abigail Spanberger) ...U.S. Representative Abigail Spanberger joined a bipartisan group of more than 20 U.S. House and U.S. Senate colleagues in raising concerns over Express Scripts' exclusive contract to administer pharmacy benefits to active duty servicemembers and Veterans... Full

Medicare Should Wait On Approving Coverage for New Obesity Drugs

(7/1, Alissa S. Chen, STAT) ...While researchers like me work to understand the effect of these medications on older adults, Medicare should wait to cover them for people with obesity until there's enough data to support their use. I know that is frustrating for patients and family members awaiting a cure for obesity — I hear it from them all the time — but it is the safest option... Full

Critical Chemo Drug No Longer in Shortage

(7/1, Axios) ...Supplies of the widely used chemotherapy drug cisplatin now exceed demand, ending a national shortage that shook cancer care and highlighted supply chain vulnerabilities, especially for sterile injectables...While it's encouraging news for patients, ongoing shortages of other drugs are driving a debate over reliance on overseas manufacturing and FDA authority... Full

Societal Value of Generics

(6/28, Martha Ni Chuanaigh, Lachman Consultants) ...Provision of healthcare is a key topic globally with increasing populations worldwide, increasing healthcare system costs, multiple humanitarian crises, and supply chain concerns. Two weeks ago in Dublin, Medicines for Europe brought together industry leaders and experts to discuss better access to medicines in hopes of addressing at least some these issues... Full

First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

(6/28, Vibha Sharma, Pink Sheet) ...The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back... Sub. Req'd

EMA's CHMP Recommends 10 New Drugs as Pierre Fabre Overactive Bladder Med Wins Approval

(6/28, Max Bayer, Endpoints News) ...Pierre Fabre's overactive bladder medication won approval in Europe on Friday as a panel of experts at the European Medicines Agency separately recommended 10 others for first-time nods...Separately, experts at the European Medicines Agency recommended that 10 new drugs should be approved, including Moderna's RSV shot, mResvia, and Merck's pulmonary arterial hypertension med, Winrevair. The Committee for Medicinal Products for Human Use also recommended 11 new label expansions. One application, Teva's generic anticoagulant med dabigatran etexilate, was withdrawn for commercial reasons, the company said in a letter... Full

EU Panel Gives Thumbs Up to AbbVie, Regeneron Lymphoma Therapies

(6/28, Anna Bratulic, FirstWorld Pharma) ...The drug advisory panel of the European Medicines Agency (EMA) has recommended approval of a pair of CD20xCD3 bispecifics – AbbVie/Genmab's Tepkinly (epcoritamab) and Regeneron's odronextamab – to treat forms of relapsed/refractory lymphoma... Full

EU: ‘Urgent Action' Needed From Industry & Member States To Curb GLP-1 Shortages

(6/28, Eliza Slawther, Pink Sheet) ...The off-label "cosmetic" use of GLP-1 receptor agonists such as Ozempic and Wegovy is contributing to global shortages of these drugs, prompting the European Medicines Agency to ask member states and manufacturers to "control and optimize" their use..."Since 2022, we've been seeing shortages not just at the EU level, but also in many countries across the globe," Emer Cooke, executive director of the European Medicines Agency, said during a June 26, press briefing... Sub. Req'd

India's Drug Regulatory Apparatus Set For ‘Big Ticket' Changes

(7/1, Anju Ghangurde, Pink Sheet) ...Addressing the Global Pharmaceutical Quality Summit in Mumbai, Dr Rajeev Raghuvanshi, Drugs Controller General of India, outlined plans for a massive digitization effort that will "cover the complete regulatory value chain in the country," along with a regulatory rationalization initiative that aims to examine both internal processes and redundancies in the regulatory framework. Both "big ticket projects" could likely to have a significant impact on the functioning of the Indian drug regulatory apparatus... Sub. Req'd

India's Drug Price Regulation Leads to Decline in Availability of Essential Medicines, Study Finds

(6/30, Neetu Chandra Sharma, Business Today) ...The Drug Price Control Order 2013, India's key drug regulation aimed at making essential medicines more affordable, has inadvertently led to a decline in the availability of these regulated drugs, according to a study published in the Journal of Marketing... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.