Monday, April 15, 2024

Teva Announces Phase 3 Study of Ajovy for Prevention of Migraine Achieves Primary and All Secondary Endpoints

(4/12, Pharmabiz.com) ...Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. announced results from a phase 3 study evaluating the efficacy and safety of Ajovy for the prevention of migraine in adult Chinese patients...[Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva] "China has the largest migraine population worldwide, and Teva is committed to research on a global scale that helps address unmet need where it exists and ensure that the role of treatment innovations like Ajovy are better understood."... Full

The Top 20 Pharma Companies by 2023 Revenue

(4/15, Kevin Dunleavy, Fierce Pharma) ...Replacing Moderna and BioNTech in the top 20 are generics powers Teva, which generated sales of $15.8 billion last year, and Viatris, which pulled in $15.4 billion...Teva expects to continue the sales upturn in 2024, though only by a small measure as it projects revenue to come in at between $15.7 billion and $16.3 billion... Full

Califf: Orange Book Frivolous Patent Enforcement Up To FTC

(4/12, Luke Zarzecki, InsideHealthPolicy) ...The issue came up at a Thursday (April 11) hearing by the House Committee on Oversight and Accountability, where Califf was grilled on numerous topics, including Orange Book enforcement. Rep. Ro Khanna (D-CA) raised the concern of frivolous patents and pointed to Teva Pharmaceuticals asking for more patents for Copaxone, a treatment for multiple sclerosis for which multiple Orange Book patents have been removed after litigation. Khanna asked whether FDA could refuse to list patents it believes are invalid... Sub. Req'd

Europe Sees Surge in Generic Medicines Withdrawals; UK Faces Doubling of Drug Shortages

(4/12, Longjam.Dineshwori, Pharmacy Business) ...In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals' recent analysis of IQVIA data...While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted... Full

Drug Shortages in America Reach a Record High

(4/12, Liz Essley Whyte and Peter Loftus, The Wall Street Journal) ...Supplies are low for everything from lifesaving injections to diabetes medications, according to data from the University of Utah Drug Information Service, which tracks shortages. Among the medicines affected are the popular diabetes drug Ozempic; the lifesaving allergy treatment epinephrine; child-friendly forms of a common antibiotic, amoxicillin; chemotherapy medications; and injections hospitals commonly use in intensive care. A total of 323 drugs were in shortage in the first quarter of 2024, up from the previous high of 320 in 2014, according to the Utah data published by the American Society of Health-System Pharmacists... Sub. Req'd

Formycon's Lucentis Biosimilar Enters Swiss and Canada Markets

(4/12, Urte Fultinaviciute, Generics Bulletin) ...Formycon continues to secure launches in global markets for its ranibizumab biosimilar FYB201 as the German firm introduces the Lucentis rival in Canada and Switzerland, where it will be marketed as Ranopto and Ranivisio, respectively...Commenting on the Canadian and Swiss launches, Formycon's chief business officer Nicola Mikulcik said: "Teva is a strong commercialization partner with a proven track record in successfully launching FYB201 across major European markets and – like us – is convinced of the great potential of our biosimilar."... Global Sub. Full

Convincing Overall Performance – Formycon Reports Preliminary Results for the Financial Year 2023 and Exceeds Forecast

(4/12, Formycon AG) ...Formycon AG today announced preliminary, unaudited consolidated figures for the 2023 financial year and overall looks back on the past year very positively. The year was characterized by further market launches of the biosimilar FYB201 and important progress in the development of the biosimilar candidates FYB202 and FYB203, for which regulatory applications have been submitted in both the USA and Europe. Milestone payments from the FYB202 project, revenue share from FYB201 sales, and income from development services are reflected in rising revenues... Full

Lupin Bags First US Rival To $1.6Bn Ingrezza – But Launch Will Have To Wait

(4/12, David Wallace, Generics Bulletin) ...Lupin has announced the first US Food and Drug Administration approval for a generic version of Ingrezza (valbenazine) 40mg and 80mg capsules, noting at the same time that as a first-to-file challenger, the firm will be "eligible for 180 days of shared generic exclusivity." Citing IQVIA data, Lupin said Ingrezza 40mg and 80mg had estimated annual US sales of $1.62bn in the year to February 2024... Global Sub. Full

AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine

(4/12, AbbVie) ...AbbVie today announced an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine. The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days... Full

Glenmark Pharma Recalls 6,528 Bottles of Blood Pressure Drug in US

(4/14, Press Trust Of India) ...Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market due to failed dissolution specifications, the US health regulator said...Glenmark initiated Class II recall of the drug across the US on March 26 this year... Full

USFDA Inspection of Lupin's Dabhasa Facility Completed; No Observations Reported

(4/12, Financial Express) ..."We are pleased to announce the successful completion of the U.S. FDA inspection of our Dabhasa facility," said Nilesh Gupta, Managing Director, Lupin. "This accomplishment underscores our unwavering dedication to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of excellence in delivering high-quality, affordable healthcare for all."... Full

Aurobindo Pharma Shares Drop Amid 3 USFDA Observations to Company's Eugia Sterile Unit

(4/15, CNBC TV 18) ...Aurobindo Pharma shares dropped more than 2% on Monday after the United States Food and Drug Administration issued Form 483 to the company's Eugia Sterile unit with three critical observations...During the inspection, the USFDA team found shortcomings in key areas of the plant's operations, raising concerns about the adequacy of procedures to prevent microbiological contamination of drug products. Additionally, the review highlighted a lack of verification processes for data accuracy and the absence of established control procedures... Full

Celltrion, Samsung Bioepis Vie for Prolia Biosimilar Leadership

(4/15, Baek Byung-yeul, The Korea Times) ...Celltrion, Samsung Bioepis and other global pharmaceutical companies are racing to take a share of the biosimilar of Amgen's osteoporosis drug Prolia, worth around 8 trillion won ($5.8 billion) in terms of global market size, which will open up next year, according to the companies, Monday...Swiss pharmaceutical company Sandoz recently received an approval from the U.S. Food and Drug Administration for its biosimilar, marking the first success story, and Celltrion and Samsung Bioepis also expect they will soon receive approvals. On Monday, Celltrion announced that it had presented the 78-week clinical study results of its Prolia biosimilar CT-P41 at the World Congress on Osteoporosis held in London until Sunday... Full

Endo Slams FDA's ‘Improper Rationalization' In Adrenalin Rival's ‘Unlawful Approval'

(4/12, Dean Rudge, Generics Bulletin) ...Endo's Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs..The US-based player seeks a temporary restraining and a preliminary injunction order suppressing the February 2024 approval for Belcher Pharmaceuticals and its BPI Labs subsidiary's 505(b)(2) epinephrine product in a 30mg/30ml multi-dose vial presentation... Global Sub. Full

The Role of Pharmacy Benefit Managers and Payers in Accessing Adalimumab Biosimilars

(4/12, Jamie T. Brogan, MSN, APRN, FNP-BC, Kostas Botsoglou, MD, The Center For Biosimilars) ...The conversation delves into the role of payers and pharmacy benefit managers in facilitating patient access to biosimilars. PBMs primarily manage formularies, and despite numerous biosimilar launches in the United States, uptake has been relatively low. This is attributed to formulary restrictions imposed by PBMs, leading physicians to prefer biosimilars but encountering barriers due to patient insurance... Full

Califf: FDA Could Use Algorithms To Predict Drug Shortages

(4/12 Jessica Karins, InsideHealthPolicy) ...Califf testified Thursday (April 11) that the list of authorities FDA has requested from Congress as part of its fiscal 2025 budget, including more notification requirements for manufacturers, could help "put together predictive algorithms" that would give FDA more insight into the drug supply chain and help anticipate shortages. He said the agency also needs new authorities to mandate product recalls and oversee food safety... Sub. Req'd

FDA Commissioner Tells Lawmakers His Agency Needs More Authority to Prevent Drug Shortages

(4/12, Zoey Becker, Fierce Pharma) ...After investigations into the FDA's response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency's commissioner Robert Califf, M.D., on a wide range of issues at a Thursday hearing...Califf agreed that "we need to pick up the pace" of inspections...To better respond to drug shortages, the agency needs additions to the "rulebook" that would give it more visibility into the complex pharmaceutical supply chain, Califf explained... Full

Drug Shortages – No Solution in Sight!

(4/12, Bob Pollock, Lachman Consultants) ...You can't go a day without seeing news articles about drug shortages...It does not seem that we are any closer to universally solving the problem as there are no universally acceptable solutions that can be agreed upon... Full

Medicare Reaffirms Faith In Formulary Review Process Ahead Of Part D Changes

(4/12, Michael McCaughan, Pink Sheet) ...The US Medicare agency is confident that its existing formulary review process will be sufficient to assure that private drug insurance plans do not unduly restrict access to medicines in response to the dramatic changes to the Medicare Part D benefit design that will take effect next year, the Centers for Medicare & Medicaid Services affirmed in its final implementing guidance to plans for the 2025 plan year... Sub. Req'd

Fight Brewing Over Health Benefits Preemption Gets House Hearing

(4/15, Sara Hansard, Bloomberg Law) ...The growing tension between state law and federal preemption over regulating drug benefits will be high on lawmakers' agenda at an upcoming House hearing on strengthening the Employee Retirement Income Security Act as the law turns 50...Groups testifying at the hearing Tuesday will likely encourage the committee to draft legislation as it revisits the 1974 law that sets minimum standards for most voluntarily established retirement and health plans in private industry and generally prevents states from regulating the plans. An estimated 153 million employees and dependents are covered by employer-sponsored health plans, which are governed by ERISA... Full

Commentary: Pharmacy Benefit Managers, Not Big Pharma, Responsible for High Drug Prices

(4/15, William S. Smith and Robert Popovian, Boston Business Journal) ...The media has written extensively about GSK's decision to stop selling its branded asthma inhaler Flovent and to replace it with a generic version. Outlets such as Fox Business and U.S. News and World Report have reported on the topic, but, remarkably, the stories fail to enlighten readers on why GSK chose to switch to a cheaper generic version of its inhaler... Full

How to Pay for 21st Century Medicine

(4/12, Rep. Michael Burgess [R-Texas], The Hill) ...To save more lives, our payment innovations must match our medical innovations. We need a fresh approach — the creation of new payment pathways — that addresses the problem of affordability and access for these new therapeutics without heavy handed, innovation-killing price controls...We need a moonshot for cures and treatments, not a scattershot collection of rules and roadblocks. House Republicans have begun the process of developing reforms that will ensure affordability and access without stifling innovation... Full

Opinion: Why Prescription Drugs Cost So Much

(4/12, The Washington Post) ...Avik Roy and Gregg Girvan argued that Medicare's new authority to demand lower prices from drug manufacturers will not result in the development and approval of fewer new drugs. Because most biotech innovation comes from smaller firms, they wrote, reducing revenue to Big Pharma will have minimal impact on drug creation. No one contests that most pharmaceutical innovation begins with start-ups, often working on a single promising compound. But the ability of these start-ups to attract essential investment is inseparably tied to the lifetime revenue a successful new medication will generate... Full

US Intensifies Drug Discount Debate in Latest Regeneron Lawsuit

(4/12, Ben Penn, Bloomberg Law) ...New Justice Department allegations that Regeneron Pharmaceuticals Inc. artificially inflated Medicare reimbursement rates on a high-earning eye treatment are likely to trigger copycat complaints at other manufacturers...Unlike the prior two pending FCA cases against Regeneron, one of which DOJ isn't litigating, the government opted for a simpler complaint that excluded the common false claims predicate accusation of violating the Anti-Kickback Statute. That's despite allegations that doctors racked up massive American Express Co. rewards of often six-figures per year by purchasing the macular degeneration drug, Eylea, at a reduced price financed by Regeneron... Full

Defending the Bayh-Dole Act, or Why Governments Shouldn't Dictate the Cost of Drugs

(4/13, Nigel Rawson and John Adams, The Hill) ...Increased march-in rights would also create a pathway for governments and companies in other countries to exploit the process, demanding access to U.S. intellectual property. This would not only hurt American businesses and patients but those in other industrialized countries too. The National Institute of Standards and Technology should cancel its ill-conceived proposal. Continued research into new treatments that benefit not only Americans but patients around the world needs to be protected, especially for those with health needs... Full

FDA Officials Discuss Strategies for Answer-Ready Controlled Correspondence

(4/12, Joanne S. Eglovitch, Regulatory Focus) ...To ensure that the US Food and Drug Administration (FDA) address questions raised by the generic drugmakers through controlled correspondence, sponsors need to ensure that sure that submissions are complete, have a valid letter of authorization, and have valid formulation information... Full

Colorado Lawmakers Revise Effort to Exempt Rare Disease Drugs from State Cost Caps

(4/12, Ed Silverman, STAT Plus) ...In response to controversy, a group of Colorado lawmakers is abandoning a bill that would have required a new state board — which is chartered with setting caps for the cost of medicines — to create exemptions for rare disease drugs. Instead, the lawmakers introduced a watered-down version to require the Prescription Drug Affordability Board to consider different uses of any medicine with a so-called orphan designation, which refers to treatments for rare diseases. The new legislation would also allow another state entity, the Rare Disease Advisory Council, to review such drugs in hopes of giving more voice to patients... Sub. Req'd

Maryland Drug Affordability Board Moving Forward with Eight Medications for Possible Caps

(4/12, Scott Maucione, WYPR) ...The board selected a handful of drugs it thinks fit the criteria of being cost prohibitive to Marylanders who are on state-run health insurance plans. The drugs include the diabetes and weight loss medication Ozempic, ADHD drug Vyvance and Dupixent, a medication that's used to treat asthma. Others selected are Trulicity, Jardiance, Farxiga, Skrizi and Bikarvy... Full

Opinion: Proposed Prescription Drug Legislation Will Hurt the Patients Legislators Aim to Help

(4/15, Dawn Holcombe, CT Mirror) ...While I understand the concern that Gov. Ned Lamont and members of the Connecticut General Assembly have regarding the affordability of health care, and that proposed legislation is well-intended, the actual consequences of the creation and actions of any type of Prescription Drug Advisory Board (PDAB), 340B Mandate, or drug importation will likely have the opposite effect for both patients and those who deliver care to them in Connecticut... Full

Medicines are Manufactured for Patients Not for Stockpiles: The EU Must Act!

(4/15, Medicines for Europe) ...To tackle shortages, some EU Member States (France, Germany, Czech Republic, Austria, Greece, Denmark and Poland) are increasingly instructing medicine manufacturers to stockpile, undermining EU solidarity and counterintuitively exacerbating the risk of shortages. Stockpiling mandates prevent manufacturers from reallocating medicines to another EU country to solve a shortage. They also undermine the economic viability of many inexpensive generic medicines by adding warehouse costs and increasing the risk of wasteful stock write-offs... Full

UK Industry Gets More Time To Adapt To Post-Brexit Import Rules

(4/12, Ian Schofield, Pink Sheet) ...The BioIndustry Association has welcomed a decision to delay the deadline for compliance with new regulations on the classification of imported materials used in drug production, but says the border rules are still not proportionate for life science products... Sub. Req'd

Ireland's Pharmaceutical Industry Launches Innovation-Focused EU Election Manifesto

(4/14, Brian Maguire, Euractiv) ...The Irish Pharmaceutical Healthcare Association launched its manifesto for the European Midlands-Northwest constituency at a public event hosted at Jazz Pharmaceuticals in Athlone. Four key elements form the manifesto core: better health for all Europeans; creating jobs that matter; supporting innovation; and encouraging sustainability... Full

UK Charities Condemn Continued Drug Shortages

(4/12, Akosua Mireku, Pharmaceutical Technology) ...Epilepsy drugs like Novartis' Tegretol (carbamazepine) and GSK's Lamictal (lamotrigine) have been difficult to access in 2024, as per Epilepsy Action. Parkinson's therapies such as Teva Pharmaceuticals' carbidopa and Co-benaldopa, a generic version of Roche's Madopar, will also experience shortages until June 2024, according to Parkinson's UK. The charities asked for a more robust system to tackle the ongoing problem, as per a April 11, press release... Full

Bayer's Patent for Blood Thinner Xarelto Invalid, UK Court Rules

(4/12, Sam Tobin, Reuters) ...Bayer's patent covering its best-selling blood thinner Xarelto is invalid, London's High Court ruled on Friday in a blow to the German drugmaker. The company's blockbuster Xarelto drug generated nearly $4.1 billion in revenue in 2023, according to research firm Statista..."We are seeking permission to appeal this decision and seeking interim injunctive relief to prevent the launch of 10mg, 15mg and 20mg generic rivaroxaban products," a Bayer spokesperson said in a statement... Full

Japanese Pharmaceutical Regulations Under Review to Resolve Drug Shortages and Ensure Stable Supply

(4/13, Nikkei Biotechnology & Business) ...A committee established last July by Japan's Ministry of Health, Labour and Welfare has been reviewing pharmaceutical regulations in Japan, looking at revisions to the requirements for orphan drugs, promoting the development of pediatric medicines and the necessity of data from Japanese participants, and also the issue of drug shortages... Full

India Needs to Devise Practical Tests to Develop ‘Botsimilar' On Similar Lines of Biosimilars: Dr DBA Narayana

(4/15, Pharmabiz.com) ...India needs to move towards developing practical and implementable tests that can give larger number of data points for the development of botanical biosimilars (Botsimilar) on similar lines that of biosimilars. The pharma industry in the country is making a strategic shift towards botanicals or phytopharmaceutical formulations of medicinal plants and herbs. This is because of the dwindling new chemical entity pipeline which is driving an increased interest to go back to nature, said Dr DBA Narayana, CSO, Ayurvidye Trust... Full

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