Monday, May 6, 2024

Teva and Alvotech Further Strengthen Their Relationship, Reach Biosimilar Commercialization Deal

(5/3, Nicholas Saraceno, Pharmaceutical Commerce) ..."At Teva, we continue to be focused on creating cost savings across the healthcare system and providing affordable options, like the high-concentration interchangeable adalimumab, for patients who need them," noted Thomas Rainey, SVP, US Market Access at Teva. "The strategic partnership between Teva and Alvotech has already yielded two approved critical biosimilars, from a portfolio of nine partnered products. Two partnered biosimilar candidates are coming out of clinical development this year."... Full

Teva's Digihaler Discontinuations: Not Enough Uptake of Digital Device

(5/3, Walter Alexander, MDedge) ...Teva's recent announcement that it will discontinue U.S. distribution of its Digihaler® products is adding concern and complication to patients' and physicians' efforts to manage asthma symptoms. "It is unfortunate to hear that more asthma inhalers are being discontinued," Asthma and Allergy Foundation of America President and CEO Kenneth Mendez, said in an interview. The impact of Teva's June 1 discontinuations of its Digihaler portfolio (ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler), he added, is only partially softened by Teva's reassurance that its still-available RespiClick devices deliver the same drug formulations via the same devices as the ProAir and AirDuo products — because they lack the innovative digital component... Full

Drugmaker Amneal Agrees to $270 Million U.S. Opioid Settlement

(5/3, Nate Raymond, Reuters) ...Amneal Pharmaceuticals said on Friday it had reached a deal valued at more than $270 million to resolve claims it helped fuel the deadly U.S. opioid epidemic, becoming the latest drug company to settle lawsuits over the addiction crisis brought by states and local governments... Full

Endo Health Solutions Will Pay Over $1.5 Billion in Opioid Criminal Case

(5/3, Ben Glickman, Dow Jones) ...Endo Health Solutions was ordered to pay over $1.5 billion to resolve its criminal case related to its role in the opioid epidemic...The Justice Department said that opioid manufacturer Endo had pleaded guilty to one misdemeanor count on selling misbranded drugs. The company admitted that certain sales representatives touted supposed safety characteristics of its opioid Opana, which weren't supported by clinical data. Endo will pay $1.09 billion in criminal fines and $450 million in criminal forfeiture... Full

4 Burning Questions About Amgen's Obesity Drug, A Potential Wegovy and Zepbound Competitor

(5/3, Elaine Chen, STAT Plus) ...Amgen's comments Thursday that it's "very encouraged" by interim Phase 2 data for its obesity drug have quickly sparked immense investor interest in what could be a potential contender with Novo Nordisk's Wegovy and Eli Lilly's Zepbound. The injectable drug MariTide, designed to be given monthly, could be a more attractive option than Wegovy and Zepbound, which are both dosed weekly... Sub. Req'd

Cipla, Glenmark Recall Drugs from US Over Manufacturing Issues: USFDA

(5/5, Press Trust Of India) ...Drug makers Cipla and Glenmark are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administratio, a New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution...USFDA also said that Glenmark Pharma is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules indicated for high blood pressure. The US-based arm of the company -- Glenmark Pharmaceuticals Inc, USA -- is recalling the medication due to "failed dissolution specifications"... Full

Aurobindo Pharma's Rajasthan Unit Gets 7 Observations from US FDA

(5/3, Asmita Pant, CNBC TV 18) ...Aurobindo Pharma, on Friday, May 3, said it has received seven observations from the United States Food and Drug Administration for its unit-II formulation manufacturing facility located in Bhiwadi, Rajasthan. The FDA conducted an inspection of the pharmaceutical company's facility from April 25 to May 3, 2024. The US FDA has issued seven observations for the facility... Full

Rite Aid Closes a Quarter of Stores as It Navigates Bankruptcy

(5/3, Jonathan Randles, Bloomberg) ...Since filing Chapter 11 in October, Rite Aid has said it will close more than 520 locations, according to a Bloomberg News analysis of court records. The closures, which could increase, represent nearly a quarter of the 2,111 stores Rite Aid operated when it entered bankruptcy. The closings are happening as Rite Aid continues to face competition from larger drugstore chains CVS Health Corp. and Walgreens Boots Alliance Inc. and major discount retailers like Walmart Inc. and Target Corp., which offer pharmacies in their stores. Closing stores could help Rite Aid cut costs and boost some of its remaining shops by transferring impacted customers to a single pharmacy within a city or town, said David Silverman, a senior director at Fitch Ratings... Full

Could Better Inhalers Help Patients, and the Planet?

(5/6, Martha Bebinger, NPR) ...His pulmonologist, Dr. Miguel Divo, explains that the familiar boot-shaped respiratory inhalers, which represent nearly 90% of the U.S. market for asthma medication, save lives but also contribute to climate change. Each puff from that type of inhaler releases a hydrofluorocarbon gas that is 1,430 to 3,000 times as powerful as the most commonly known greenhouse gas, carbon dioxide... Full

HHS Issues Draft Guidance For Next Round of Drug Price Talks

(5/3, Nyah Phengsitthy and Ian Lopez, Bloomberg Law) ...The Biden administration Friday rolled out its draft guidance for the next cycle of drug price negotiations, spurring pushback from the pharmaceutical industry...Fifteen Medicare Part D drugs will be selected for the second negotiation round. The agency is expected to announce the list of Medicare Part D drugs no later than Feb. 1, 2025. Those agreed to negotiated prices will go into effect in 2027... Sub. Req'd

CMS Ushers In Draft Guidance For Second Drug Price Negotiation Cycle

(5/3, Gabrielle Wanneh, InsideHealthPolicy) ...Once drug makers have signed the manufacturer agreement and submitted the required information, CMS intends to host various engagement opportunities for public, patient-focused input and at least one additional engagement opportunity to meet with drug makers during the spring of 2025. By June 1, 2025, CMS will send out its initial price offers with a clear justification to each participating drug maker, and the drug makers will have until July 1, 2025, to either accept the offer or propose a counteroffer... Sub. Req'd

Medicare Negotiation Second Cycle Draft Guidance Offers Options For ‘Effectuating' Prices

(5/3, Cathy Kelly, Pink Sheet) ...Along with the draft guidance, CMS released a revised information collection request to identify drugs that may qualify for the small biotech exception in the law, as well as biologics with a high likelihood of biosimilar market entry, which could be eligible for the delay for 2027. The information request has a 60-day comment period. The Pharmaceutical Research and Manufacturers of America is not happy with the draft guidance. Alex Schriver, senior VP of Public Affairs, said "CMS' draft guidance fails to meaningfully improve transparency in the process, ignores patient and provider concerns around how prices are set and turns a blind eye to insurers who are choosing to limit coverage options for seniors."... Sub. Req'd

Wyden and Crapo Release Draft Legislation to Combat Prescription Drug Shortages

(5/3, United States Senate Committee On Finance) ...Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a draft legislative proposal to address persistent economic problems leading to shortages of generic medicines plaguing America's health care system, including chemotherapy drugs and ADHD medications... Full

Bipartisan Senate Panel Proposes New Drug Shortages Legislation

(5/3, Gabrielle M. Etzel, Washington Examiner) ...The Medicare Drug Shortage Prevention and Mitigation Program would create new incentives for industry drug purchasers, including hospitals, physicians, and group purchasing organizations, to change their buying practices for essential drugs. The program would also incentivize drug manufacturers to meet "ambitious, proactive standards in securing a sustainable, high quality supply of essential medicines," according to the committee's press release on the new bill... Full

Bipartisan Draft Bill Would Pay Hospitals More to Combat Drug Shortages

(5/3, Anna Brown, Endpoints News) ...The Senate Finance Committee released a new bipartisan draft legislation on Friday morning that would incentivize generic manufacturers and healthcare providers, like hospitals and clinics, to mitigate generic drug shortages by prioritizing drug quality and transparency... Full

Senator Claims GSK Pulled Popular Asthma Med to Dodge Inhaler Price Caps

(5/3, Fraiser Kansteiner, Fierce Pharma) ...On Tuesday, the U.S. Federal Trade Commission further cracked down on "junk patent listings," including those related to a quartet of GSK inhalers using the company's Ellipta device. And now, to cap off the week, Sen. Margaret Hassan, D-New Hampshire, is calling out the British drugmaker for pulling a popular childhood asthma medication from the market in an alleged attempt to "price-gouge families."... Full

Mendez: Price Caps On Inhalers Won't Do Enough

(5/4, Kenneth Medez, Boston Herald) ...The price caps on inhalers are a win for people with asthma. These price caps will provide real financial relief and, it is hoped, more access to the medications people need...While it's nice to see drug companies making medicines more affordable through price caps, here is the bad news: When drug companies lower prices, people with asthma may have to pay more for their drugs. For example, GSK introduced a clinically identical but cheaper generic version of its popular Flovent inhaler last year. But people with asthma who were longtime users of Flovent were forced to take a different medication because CVS Caremark, one of the three largest Pharmacy Benefit Managers, did not cover this cheaper generic version... Full

Biden Accomplishments Threatened by Revised Rules On Patents

(5/3, Howard Dean, RealClearHealth) ...The president's chief legislative achievement, the Inflation Reduction Act, capped out-of-pocket prescription costs for seniors, set a monthly out-of-pocket price limit of $35 on insulin for Medicare enrollees, and allowed the government to negotiate drug prices for the first time...Unfortunately, the Biden administration recently proposed another drug-related policy that -- while well-intentioned -- is neither easy to understand or implement. Instead of directly addressing drug prices, it's at best a bank shot that could weaken America's world-leading research universities and cause serious unintended consequences in a variety of high-tech industries... Full

Public Citizen Hits Eli Lilly For Not Disclosing Lobbying Expenses Ahead Of Shareholder Vote

(5/3, Maaisha Osman, InsideHealthPolicy) ...As a handful of key Senate Democrats and consumer advocates engage in a broader effort to get companies to disclose lobbying expenses, Public Citizen on Friday (May 3) blasted drug maker Eli Lilly for not making all its expenditures public in the run-up to its annual meeting next week where shareholders are slated to hold a vote demanding transparency. The shareholders suggest Lilly's public statements, including that it supports lowering drug prices, may clash with the lobbying data it has not disclosed... Sub. Req'd

US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg

(5/3, Sue Sutter, Pink Sheet) ...Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said...The most significant change as part of the reorg will involve relocating ORA's current compliance functions to the product centers, Rogers said during a May 1, webinar sponsored by the Alliance for a Stronger FDA... Sub. Req'd

Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim

(5/3, U.S. Food & Drug Adminstration) ...Welcome to "Q&A with FDA," where we aim to answer some of the most frequently asked questions that we've received from the public. My name is Dr. Sara Roach, and today we will be discussing biosimilar drug products, switching between biosimilars and their reference or brand name counterparts, and safety outcomes associated when switching. Here with me today is Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research... Full

FDA Exploring Model Master Files to Expedite Generic Drug Development

(5/3, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) is exploring the use of model master files to enable sponsors to use the same modeling approach to support different generic drug development programs, potentially from different sponsors, in lieu of conducting clinical studies, according to officials who spoke at a May 3, workshop... Full

Hearing Set to Consider Penalties for Pharmaceutical Company Over Arkansas Law

(5/5, Dale Ellis, Arkansas Democrat Gazette) ...A battle between the Arkansas Insurance Department and pharmaceutical manufacturers is heating up with the announcement of a hearing this summer to consider administrative penalties against AstraZeneca Pharmaceuticals LP, the drug manufacturing giant that filed a lawsuit against the state earlier this year over Act 1103 of 2021 -- the 340B Drug Pricing Nondiscrimination Act... Full

Euro Convergence 2024: From AI to Supply Chain Management

(5/3, Mary Ellen Schneider, Regulatory Focus) ...This year's Euro Convergence conference focuses on the theme of "regulatory collaboration through unification" as regulatory professionals across Europe come together to learn about challenges and potential solutions related to supply chains, artificial intelligence, and the implications of IVDR implementation and the EU Pharma legislation... Full

EU Urban Wastewater Directive Update ‘Unfairly Targets Pharmaceutical Industry'

(5/3, Francesca Bruce, Generics Bulletin) ...German pharmaceutical industry groups claim the updated EU directive on urban wastewater that will oblige pharmaceutical and cosmetic industries to pay for removing micropollutants from waste water will place a heavy and disproportionate burden on companies. The directive, which is set to be published in the Official Journal of the EU later this year is also contradictory to moves to strengthen the EU's pharmaceutical industry, say four industry groups, which represent innovative and off-patent sectors... Global Sub. Full

Drug Costs a Top Concern for Consumers As Over-The-Counter Medicine Prices Rise

(5/6, Ian Curran, The Irish Times) ...Almost half of Irish adults say the price they pay for everyday, over-the-counter medicines has increased sharply over the past 12 months, according to a new survey from Azure Pharmaceuticals, as pharmacies pass on the cost of medicines shortages and rising business expenses...Over-the-counter treatments containing paracetamol, including Solpadeine, aspirin and eye drops for treating seasonal allergies are in short supply at the moment, according to the HPRA's database, along with many others... Full

Warning Over Asthma Drug After 500 Neuropsychiatric Reactions Reported in Young Children

(5/4, Jon Ungoed-Thomas, The Guardian) ...The Medicines and Healthcare products Regulatory Agency announced last week that more prominent warnings would be added to the information provided on boxes of the asthma drug montelukast, sold under the brand name Singulair. Officials announced the move after concerns were raised by families over reported side effects, which can include sleep disorders, aggression and depression. Many parents say they were not properly warned of the risks... Full

Swissmedic Gets New Grant For Regulatory Strengthening In LMICs

(5/3, Ian Schofield, Pink Sheet) ...The new agreement, running until May 6, 2027, involves a total contribution by the BGMF of $900,000, split into three yearly tranches. The contributions are earmarked for specific purposes such as salary payments for Swissmedic staff, instructors and travel expenses. According to the agency, the overall aim of the agreement is to "bring high-quality, life-saving medicines to patients as quickly as possible."... Sub. Req'd

PHARMAP 2024 Held in Amsterdam, Marks its Fourth Edition

(5/6, Express Pharma) ...According to its statement, PHARMAP 2024 brought together over 330 professionals from across the industry's value chain. Among the attendees, contract manufacturing organisations, service providers and experts were present. Representatives from leading pharmaceutical companies such as Merck, Bayer AG, Novartis, Takeda and Pfizer also participated in the Congress...In an overview, the event comprised a business programme packed with sessions, roundtables and panel discussions. Topics of sessions delved into the future of pharmaceutical manufacturing, focusing on Industry 4.0 advancements like MES and robotics. Attendees discussed innovative models for production and packaging, sustainable eco-packaging solutions and strategies for optimising the pharmaceutical supply chain... Full

India Raises Issue of Pharma Pricing Control in Australia On Generic Drugs

(5/4, Press Trust Of India) ...India has raised the issue of pharmaceutical pricing control in Australia, particularly on generic medicines, during a recent bilateral meeting between the officials of the two countries. The two sides have decided to work closely on timely resolution of market access issues, deepen people-to-people contacts, and create an institutional mechanism for sharing of preferential import data, the commerce ministry said on Saturday... Full

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