Monday, May 20, 2024

Top Indian Drug Makers Accused of Fixing Prices

(5/19, Teena Thacker, Mint) ...Seven Indian drug makers, including Sun Pharmaceutical Industries Ltd and Dr Reddy's Laboratories Ltd, and five of their executives have been named in a US lawsuit that accuses Israel's Teva Pharmaceutical Industries Ltd of orchestrating a conspiracy to raise medicine prices...In a statement, Kelley Dougherty, a Teva vice-president, said, "The allegations in this new complaint and in the litigation more generally, are just that—allegations."... Full

Compatibility Issues Found with Autoinjectors, FDA Says

(5/17, Paige Twenter, Becker's Hospital Review) ...Teva Pharmaceuticals' Copaxone does not have a compatible autoinjector device and can only be used as the prefilled syringe; Sandoz' Glatopa is solely compatible with Glatopaject; and Viatris/Mylan's glatiramer acetate injection is only compatible with WhisperJECT. The FDA said these are the only therapies with compatibility constrictions... Full

ADHD Drug Shortage Shows Signs of Letting Up, But Some Patients Still Struggle

(5/19, Berkeley Lovelace Jr., NBC News) ...Many of the ADHD medication shortages that have plagued the U.S. for the last two years have now been resolved, the Food and Drug Administration says. Yet some doctors and patients report they are still struggling to get prescriptions filled...A total of nine manufacturers now have ADHD medications back in stock, according to the FDA's drug shortage database, up from six last September. Teva Pharmaceuticals, a major manufacturer of ADHD medications, has resolved all of its shortages after certain doses were unavailable for several months, according to the agency's database. A 5-milligram dose of one of its medications remains in limited supply, however... Full

Drug Shortages Impacting Patients Nationwide

(5/17, Paul LaGrone, ABC News) ...Right now, there is a shortage of medication nationwide, and the list in extensive. From diabetes medications to Adderall to cancer drugs and more. ABC Action News anchor Paul LaGrone talked to Dr. Fahmi Farah about the shortage, why we are seeing it, and if there is a solution to the problem... Full

MS Pharma Bags Formycon's Eylea Biosimilar Rights In MENA

(5/17, Urte Fultinaviciute, Generics Bulletin) ...Klinge Biopharma, Formycon's exclusive license holder for its aflibercept biosimilar, has chosen MS Pharma as its commercialization partner in the Middle East and North Africa region. MS Pharma will have exclusive rights to license, commercialize, and produce FYB203, the biosimilar candidate to Regeneron's Eylea, locally at its new biosimilar site in Saudi Arabia. The firms did not specify which countries are covered in the agreement but noted that commercialization rights for all other territories remain with Klinge... Global Sub. Full

'Future Fit' Cipla: Play In Oligonucleotides, Obesity Amid Promoter Stake Action

(5/20, Anju Ghangurde, Generics Bulletin) ...Cipla is stepping into the oligonucleotides space, where it also hopes to help shape the regulatory environment. Action is also anticipated in ‘big, identified areas' such as obesity that may see potential partnering opportunities with Eli Lilly, with which the Indian firm has an existing alliance for diabetes therapies..."Oligo offers us the opportunity to perhaps help shape the regulatory environment as well as benefit from going in before the others. That is our plan in oligo. I think we see skills that we developed during peptides, skills that we have from characterization that we think we could benefit from in the work with oligonucleotides," Vohra told Generics Bulletin sister publication Scrip in an interaction with the media... Global Sub. Full

Biocon Group CEO Sees Enormous Opportunities in Weight Loss Drugs Market

(5/17, Ekta Batra, CNBC TV 18) ...Peter Bains, Group CEO of Biocon, discussed the past quarter, future debt reduction plans, and the extensive pipeline of diabetes and weight management drugs, including Liraglutide, Semaglutide, and Tirzepatide, in an interview with CNBC-TV18. "The scale of the market opportunity is enormous. Market estimates would suggest that the GLP market will reach and exceed $100 billion by the end of this decade," he said... Full

Acceleration of Biosimilar Business, Debt Reduction to Be Key Priorties in FY25: Biocon Chief

(5/18, Viswanath Pilla, The Economic Times) ...Mazumdar-Shaw anticipates expanding its market share for biosimilar products across the US, Europe, and emerging markets, coupled with the possibility of introducing new products in the fiscal year 2025. Biocon's executive chairperson Kiran Mazumdar-Shaw on Friday said she expects consolidation and acceleration of biosimilar business along with further reduction of debt taken to fund the $3.3-billion acquisition of Viatris biosimilar business to be key priorities in FY25. "FY24 was a very transformational year for us, because we made a very successful transition of the (Viatris biosimilar business) acquisition in a seamless way," Mazumdar-Shaw said in an interview to ET... Full

Biocon's Biosimilar Business Set For Strong Growth: CEO Shreehas Tambe

(5/18, Shreya Sur, NDTV Profit) ...Biocon Ltd's biosimilar arm surpassed its goal of becoming a billion-dollar revenue company by March 2024, buoyed by its fourth-quarter earnings, said Shreehas Tambe, chief executive officer and managing director of Biocon Biologics Ltd..."All the financial metrics are signalling in the right direction," Tambe told NDTV Profit in an interview, in which he spoke about executing the company's "foundational strategy". "This is the first full quarter since we completed the acquisition (of Viatris' biosimilars business) and Biocon Biologics is running the business."... Full

ATS: Amgen, AZ Say Data Backs Tezspire's Role in COPD

(5/20, Phil Taylor, Pharma Phorum) ...Amgen and AstraZeneca have said their severe asthma therapy Tezspire could have a role to play in chronic obstructive pulmonary disease (COPD) – a key target indication for the drug – despite missing its primary objective in a clinical trial... Full

Drug Makers Dr Reddy's, Sun Pharma, Aurobindo Recall Products in US Market

(5/19, Press Trust Of India) ...Dr Reddy's Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children...The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections, in the US market...Similarly, "Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, in the American market... Full

U.S. FDA Issues Two Observations for Dr. Reddy's Formulations Facilities in Vizag

(5/17, The Hindu) ...The observations were issued by U.S. FDA on completion of "a routine GMP inspection at our formulations manufacturing facilities (FTO-7 and FTO-9) in Duvvada, Visakhapatnam," Dr. Reddy's said in a filing on Friday. "The inspection was conducted from May 8-17. We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," it said... Full

Pfizer Wins $107.5 Million from AstraZeneca in US Cancer Drug Patent Trial

(5/17, Blake Brittain, Reuters) ...AstraZeneca owes Pfizer $107.5 million in damages, a Delaware federal jury said on Friday after finding that AstraZeneca's blockbuster lung cancer drug Tagrisso violated its Wyeth unit's patent rights...An AstraZeneca spokesperson said the company was disappointed with the verdict but is "confident in our IP (intellectual property) position in relation to Tagrisso" and will "vigorously defend" its rights... Full

Parents of Opioid Victims Have Claims Trimmed in McKinsey Case

(5/17, Quinn Wilson, Bloomberg Law) ...Children of opioid users who suffered Neonatal Abstinence Syndrome had some of their claims tossed in the sprawling litigation against McKinsey & Co. alleging liability for its role facilitating opioid sales. Judge Charles R. Breyer , of the US District Court for the Northern District of California, dismissed five of the NAS victims' various claims alleging a conspiracy to push opioid sales on behalf of pharmaceutical companies. The NAS plaintiffs, who are 11 victims across eight states, allege that McKinsey is liable under negligence per se, public nuisance, and fraud theories... Sub. Req'd

Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health's 2024 Biosimilar Report

(5/19, Skylar Jeremias, The Center For Biosimilars) ...Your host, Skylar Jeremias, assistant managing editor of The Center for Biosimilars®, and guest Dracey Poore, director of biosimilars at Cardinal Health, delve into the crucial themes that emerged from the conference discussions, mainly, the essential role of sustainability in the biosimilar industry... Full

High Drug Prices and Pharmacy Deserts: Protesters Blame Drug Middlemen, Demand Regulation

(5/17, Emily Le Coz, USA Today) ...Discouraged by a lack of action from Congress, leaders from America's largest pharmacy associations marched with dozens of demonstrators Friday outside the St. Louis-based headquarters of Express Scripts, a major prescription drug middleman whose practices the group accuses of harming everyday Americans...Based on the turnout and the success of the event, however, [Loretta Boesing, founder of Unite for Safe Medications, and organizer of the Express Scripts protest] said she wants to organize similar protests outside the headquarters of CVS Caremark in Rhode Island and OptumRX in California. "We need action now," she said. "So we will keep doing this until we get it."... Full

Brand Drug Shortages Complicate US FDA Messaging To Congress

(5/17, Michael McCaughan, Pink Sheet) ...The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different...FDA Commissioner Robert Califf tried to distinguish different types of drug shortages for members of Congress. Califf also reminded the congressional committees that some economic factors outside the FDA's control create shortage problems. Califf said that the entire world, not just the US, needs a reliable source of generic medicine... Sub. Req'd

Crapo, Wyden Release Draft Legislation to Combat Prescription Drug Shortages

(5/17, U.S. Senator for Idaho Mike Crapo) ...The proposal, released as a discussion draft, would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries (such as group purchasing organizations, or GPOs) and drug manufacturers to meet ambitious, proactive standards in securing a sustainable, high-quality supply of essential medicines for patients from all walks of life... Full

Senators Draft Bipartisan Bill Streamlining Rx Drug Prior Auth Requirements

(5/17, Dorothy Mills-Gregg, InsideHealthPolicy) ...A bipartisan group of five senators are continuing to focus on ensuring prior authorization requirements aren't used to ration coverage to care, announcing Friday (May 17) they are introducing a bill that would streamline access to prescription drugs that require a health plan's approval... Sub. Req'd

Bernie Sanders May Have Reached the Limits of His Pharma Pressure Campaign

(5/20, Rachel Cohrs Zhang, STAT Plus) ...The newest frontier in Sanders' war on the pharmaceutical industry prompts the question of what success really looks like. Is it lower list prices? Lower costs for patients? Simply putting pharma industry executives in the spotlight? Peter Maybarduk, the access to medicines director at the progressive group Public Citizen, argues that even though Sanders may not be making systemic policy change, that doesn't mean the effort has been for naught... Sub. Req'd

Wegovy is Becoming Too Essential for its Elite Price

(5/17, John Gapper, Financial Times) ...Health systems are waking up to the full potential of medicines that were first developed to address diabetes: Eli Lilly's Zepbound anti-obesity injectable was only approved in the US last year. "These drugs are doing more than just one thing and producing benefits across a range of diseases," Naveed Sattar, a Glasgow University professor who chairs the UK government's Obesity Mission, tells me...There are sound reasons for optimism: the tensions are, after all, produced by the fact that the drugs seem to be very effective. Sattar believes they could not only contribute to raising workforce productivity, but address conditions from kidney disease to dementia, if current progress continues... Sub. Req'd

Drug Pricing Now and to Come – It's Complicated

(5/17, Richard Payerchin, Medical Economics) ...Two experts offered their explanations and a few predictions in "Solving the US drug pricing problem," a panel discussion held May 16, 2024, in the Financial Times US Pharma and Biotech Summit. Sarah Emond, MPP, president and CEO of the Institute for Clinical and Economic Review, and John O'Brien, PharmD, MPH, president and CEO of the National Pharmaceutical Council, offered their views speaking with Financial Times Science Editor Michael Peel. As of 2024, some industry observers say the payment system for pharmaceuticals hasn't caught up with the science, Peel said. O'Brien said he agreed 100%... Full

Q&A: FTC's Top Healthcare Enforcer On Pharma M&A, Company Growth and PBMs

(5/17, Drew Armstrong, Endpoints News) ...At Thursday's Financial Times–Endpoints News US Pharma and Biotech Summit, Endpoints Executive Editor Drew Armstrong spoke with FTC Deputy Director of the Bureau of Competition Rahul Rao about the regulator's antitrust approach in biopharma, how it views the PBM industry, and more... Full

FTC Is Taking A Tougher Stance On Pharma, A Deputy Director Explains Why

(5/17, Jessica Merrill, Pink Sheet) ...Rahul Rao, the deputy director of the FTC Bureau of Competition, discussed the agency's thinking on recent pharma deals that it viewed as anti-competitive...FTC Bureau of Competition Deputy Director Rahul Rao no seismic event lead to the agency's recent actions on pharma deals. Rao said more scrutiny of pharma deals has stemmed, in part, from "pain points" in the market and the economy. Consolidation in the sector remains an FTC concern given that several dominant players capture a majority of the profits... Sub. Req'd

EU Pharma Reform Amendments: More Shortage Reporting Obligations For Companies & Regulators

(5/17, Ian Schofield, Pink Sheet) ...In the third of a series of articles on the European Parliament's changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors... Sub. Req'd

Regulatory Expert: EU Needs To ‘Get Things Moving' On Rolling Reviews

(5/17, Eliza Slawther, Pink Sheet) ...Dynamic regulatory assessments, also known as rolling or phased reviews, could see medicines granted marketing authorizations more quickly, but the EU is lagging behind the US and UK in implementing them, Gilead's EU regulatory policy lead has said...He added that the "only benefit" the UK regulator, the MHRA, has had from Brexit "is that they've managed to introduce a rolling review themselves, whereas in the European dimension, they're still talking about it." The UK rolling review process is intended for novel medicines and biosimilars, not just emergency situations... Sub. Req'd

MHRA Chief On How The UK Agency Is Overhauling Its Processes To Overcome Post-Brexit Challenges

(5/17, Dame June Raine, Pink Sheet) ...The Medicines and Healthcare products Regulatory Agency has introduced a series of changes, including an upcoming overhaul of its clinical trial legislation, to enhance its performance in the future, chief executive Dame June Raine writes... Sub. Req'd

Why Are New Cancer Drugs Available to Private Patients Nut Not Public Patients?

(5/20, Shauna Bowers, The Irish Times) ...Prof Michaela Higgins, a consultant oncologist at St Vincent's University Hospital, and current president of the Irish Society of Medical Oncology, said a decade ago the time between EMA approval and HSE approval was much shorter. However, the "avalanche of new and very sophisticated oncology drugs", as well as resourcing in the National Centre for Pharmoeconomics has resulted in these delays, she said... Full

Indian Pharma Majors Rally for Strong US-India Trade Alliance

(5/20, The Pharma Letter) ...As the Indian pharmaceutical industry is propelled by government initiatives to transition from its traditional focus on generic drug production to the development of high-value, innovative products, domestic pharma majors are advocating for a robust US-India trade partnership. Drug producers emphasize that India's substantial contributions, particularly its supply of 47% of all generic prescriptions in the USA, highlight the critical need and significance of this bilateral collaboration, reports The Pharma Letter's India correspondent... Sub. Req'd

Indian Pharma Firms Supplied 47% of All Generic Prescriptions in US in 2022

(5/17, Sanket Koul, Business Standard) ...Citing the IQVIA report, the Indian Pharmaceutical Alliance had recently urged for a strong India-USA pharmaceutical trade partnership to reduce reliance on foreign sources for both nation's pharmaceutical supply chains and achieve affordable medicine resilience. Speaking on the need for an affordable medicine partnership between the two countries, Sudarshan Jain, Secretary General of the IPA, said that while Indian companies play an important role in providing affordable medicines to the United States, 70 per cent of our API components come from China... Full

New KRPIA Chair Highlights Vision and Challenges Ahead for Multinational Pharma in Korea

(5/20, Lee Han-soo, Korea Biomedical Review) ...In February, Bae Kyung-eun, the general manager of Sanofi-Aventis Korea, Australia, and New Zealand, became the Korea Research-based Pharmaceutical Industry Association (KRPIA) chair...Korea Biomedical Review met with Bae on May 9 to listen to her vision and goal as the new chair of KRPIA. Bae especially emphasized the alignment between KRPIA's objectives and recent government policies, particularly the inclusion of "recognizing the value of new drugs" in the government's Second Comprehensive National Health Insurance Plan... Full

6.9% CAGR Forecast for Japan's Generic Drug Market

(5/20, The Pharma Letter) ...Looking forward, international market research group IMARC Group expects the market to reach $21.4 billion by 2032, exhibiting a growth rate (CAGR) of 6.9% during 2024-2032. Japan represents the world's eighth biggest market for generic drugs in terms of value. Generic drugs, however, have traditionally enjoyed a relatively lower penetration in Japan compared to other developed markets such as the USA and Europe... Sub. Req'd

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