Wednesday, February 14, 2024

'Lending a Hand': Teva Employees Worldwide Donate Refurbished Computers to Israelis Affected by War

(2/14, The Jerusalem Post) ...Eli Gilboa, a high-ranking IT official at Teva in Israel, took it upon himself to reach out to Teva branches worldwide. His proposal was simple: gather unused computers, refurbish them, and donate them to those in need in Israel. Teva branches in the USA, Germany, and Spain were quick to join the cause, demonstrating their solidarity with the Israeli people. They collected and shipped hundreds of laptops that had been previously used, now repurposed to aid those affected by the conflict...The computers donated to the Israeli Trauma Coalition will be given to therapists in the south who are operating without a permanent office. The remaining computers will be given to the "Mathashim" association, which will distribute them to the displaced families... Full

Amgen's Amjevita US Sales On The Rise, Oncology Biosimilars Still In Slump

(2/14, Urte Fultinaviciute, Generics Bulletin) ...It seems that the first US Humira biosimilar is recovering from the predicted slow uptake, but Amgen's oncology biosimilars portfolio continues to deteriorate. Amgen's Amjevita (adalimumab) biosimilar finished the year on a better note compared to the earlier two-quarter slump in US sales. According to the recently reported financial results, Amjevita made $33m in US sales in Q4 2023... Global Sub. Full

Lupin Launches Generic Formulation for Ocular Pain in US Market

(2/13, Financial Express) ...Global pharma major Lupin Limited on Tuesday announced the launch of Bromfenac Ophthalmic Solution, 0.075%, after having received approval from the United States Food and Drug Administration. According to the company's press statement, Bromfenac Ophthalmic Solution, 0.075% is a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries Limited... Full

Biogen Revenue and Profit Shrink On Aduhelm Costs, Slumping Sales of Multiple Sclerosis Therapies

(2/13, Annika Kim Constantino, CNBC) ...Biogen on Tuesday reported fourth-quarter revenue and profit that shrank from a year ago, as it recorded charges related to dropping its controversial Alzheimer's drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the company's biggest drug category...The drugmaker said it expects 2024 sales to decline by a low to mid-single digit percentage compared with last year. But the company anticipates its pharmaceutical revenue, which includes product revenue and its 50% share of Leqembi sales, to be flat this year compared with 2023... Full

Biogen Receives Subpoena from DOJ On Business Operations in Foreign Countries

(2/14, Sriparna Roy, Reuters) ...Biogen has received a subpoena from the U.S. Department of Justice seeking information relating to the company's business operations in several foreign countries, the drugmaker disclosed in a filing on Wednesday...Biogen said in the filing it is providing information on foreign business operations to the U.S. Securities and Exchange Commission... Full

Aurobindo Pharma May Take a $20-Million Hit This Quarter

(2/13, Viswanath Pilla, The Economic Times) ...Aurobindo Pharma anticipates a hit of $20 million in the ongoing January-March quarter due to a temporary pause of manufacturing and distribution activities at its crucial Eugia Unit-III formulation facility in Telangana, following certain red flags raised by the US drug regulatory agency in the recently concluded inspections. The company said it is planning to resume manufacturing operations in a phased manner starting with non-aseptic lines... Sub. Req'd

Doctors and Parents Are Scrambling After Asthma Inhaler Switch Takes Popular Medication Off The Market

(2/13, Dr. Edith Bracho-Sanchez, CNN) ...Flovent, one of the most commonly prescribed childhood asthma medications, is no longer being manufactured in the United States. GSK, the pharmaceutical company that made it, took if off the shelves January 1 and replaced it with an identical generic version, fluticasone. But what seemed to be a straightforward swap has left some doctors, nurses and parents of children with asthma scrambling for medications to care for young patients... Full

Expert Discusses Quality Standards' Role in the Evolution of Biosimilars and Biologics Landscape

(2/13, Pharmacy Times) ...Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses how established quality standards, drawing from the realm of small molecule drugs and evolving to meet the complexities of biologics, play a pivotal role in fostering trust, accelerating regulatory approvals, promoting competition, and ultimately transforming patient care by enhancing access to biosimilars and biologics... Full

‘Is The Market Now Sustainable? The Answer Is Still Not': AAM's Haruvi On The Need To Fix The US Generics Industry

(2/13, Dean Rudge, Generics Bulletin) ...Dramatic downward pressure on prices will continue to impact supply for an industry already reeling from shortages, the Association for Accessible Medicines' newly appointed chair Keren Haruvi tells Generics Bulletin during an exclusive interview on the sidelines of the association's recent annual conference in Tampa...Next is the controversial Inflation Reduction Act. "I do think there is an opportunity on how we implement IRA and those are conversations that we are having with the Centers for Medicare & Medicaid Services," she says. One particular bugbear is the act's exemption from negotiation biologic products with a high likelihood of biosimilar entry within two years of the reference product being selected for negotiation... Global Sub. Full

PhRMA Lawsuit Challenging IRA Price Negotiations Dismissed On Jurisdictional Technicality

(2/13, Kevin Dunleavy, Fierce Pharma) ...In a decision that bodes well for the Biden administration's push to rein in drug prices, a federal judge in Texas has tossed a lawsuit from industry lobbying group PhRMA which challenged the legality of Medicare price negotiations as drawn up in the Inflation Reduction Act... Full

PhRMA's Loss in Drug Pricing Suit Eased by Focus On Jurisdiction

(2/13, Nyah Phengsitthy, Bloomberg Law) ...While the administration views the ruling as a victory, there's yet to be a decision on the merits of the case. The court's dismissal is expected to drag out the lawsuit's timeline until a decision is issued on the constitutional challenges brought on by PhRMA and its allies...Despite the dismissal, questions remain about the constitutional challenges PhRMA brought to court. Those challenges allege the drug price negotiation program violates the separation of powers doctrine, the Fifth Amendment's due process clause, and the Eighth Amendment's prohibition on excessive fines... Sub. Req'd

Federal Judge Tosses Lobbying Group's Lawsuit Challenging Medicare Drug Price Negotiations

(2/13, Annika Kim Constantino, CNBC) ...U.S. Judge David Ezra of the Western District of Texas sided with the Biden administration in dismissing the suit by PhRMA, the Global Colon Cancer Association and the National Infusion Center Association...Ezra specifically dismissed the National Infusion Center Association, or NICA, from the case, arguing that the court does not have jurisdiction over the group's legal challenge. He wrote that NICA's claims fall under the Medicare Act and could only be heard by a court following an administrative review by the federal agency... Full

ANALYSIS: Drug Price Fights Still Have Shot After One Suit Axed

(2/14, Alexis Kramer, Bloomberg Law) ...A federal district court in Texas Feb. 12 dismissed a lawsuit brought by the National Infusion Center Association and other industry groups for lack of jurisdiction. NICA's claims revolved around Medicare reimbursement for providers, and that led to its downfall. The eight other lawsuits winding their way through the courts don't involve providers, so even if they hit a roadblock, it likely won't be for the same reason... Full

AstraZeneca Argues Standing Before Judge in Drug Price Challenge

(2/13, Nyah Phengsitthy, Bloomberg Law) ...AstraZeneca told a federal judge it has constitutional and prudential standing to bring its due process claim in a lawsuit challenging a government price-setting program...The drugmaker said it has constitutional standing because it has demonstrated an injury in fact, traceablity, and redressability. Among its reasoning, AstraZeneca argues it will suffer "monetary harms" and "procedural harms." But AstraZeneca hasn't "devoted the same attention to their burden to show standing" in its due process claim, the government said in its filing. The DOJ has asked the court to enter a judgment in its favor on due process grounds... Sub. Req'd

Biden's Drug Pricing March-In Proposal Implications, Part 2

(2/13, Bloomberg) ...March-in rights allow the US government to grant patent licenses to other parties, in certain situations, where federal tax dollars helped fund the patent owner's research and development. But this effort is inconsistent with the legislative intent of the march-in framework, according to Joe Allen, Executive Director of the Bayh-Dole Coalition...Mr. Allen joins Bloomberg Intelligence analysts Duane Wright and Tish Walker on this episode of the Votes and Verdicts podcast to discuss why price shouldn't should be a factor for march-in rights and the implications for federally supported research and development... Full

A Year In, The U.S. is Still Not Taking Advantage of Lower-Cost Biosimilars for Humira

(2/14, Juliana M. Reed, STAT Plus) ...Biosimilars are a commonsense, bipartisan solution to one of the most important challenges facing Americans. According to the Department of Health and Human Services Office of Inspector General, Medicare Part D could save tens of millions of dollars if "biosimilar use becomes more widespread." Without a fair biosimilars marketplace that is built on competition, patients will continue to have fewer options for the treatments they need — and the promise of biosimilars could be lost forever... Sub. Req'd

Affordable Prescription Drugs Need Bipartisan Patent Reform

(2/14, Bobby Jindal and Charlie Katebi, Washington Examiner) ...America's patent system has promoted enormous pharmaceutical breakthroughs that have improved the lives of millions suffering from debilitating illnesses. Unfortunately, far too many drug manufacturers are filing patents so they can raise prices on patients, instead of improving their health. Thankfully, commonsense reforms will ensure drug manufacturers use our patent system for the good of patients and not to exploit them... Full

Group Hits Lone Democrat Over Drug Pricing Bill

(2/13, Peter Sullivan, Axios) ...The advocacy group Patients for Affordable Drugs Now is launching ads today against the lone Democrat on the Hill to support a drug industry-backed change to Medicare price negotiations...The move highlights the notable step that Rep. Don Davis took in cosponsoring the bill, and could serve as a warning to other Democrats. The Cook Political Report rates Davis' district a tossup... Sub. Req'd

FDA Hopes Renewed Call For Drug Manufacturing Data Will Stem Shortages

(2/13, Jessica Karins, InsideHealthPolicy) ...FDA drug officials hope their new final guidance asking manufacturers to report the amounts of drugs they manufactured will give more insight into the drug supply chain and help the agency take action to avoid shortages...Jacqueline Corrigan-Curay, principal deputy center director in FDA's Center for Drug Evaluation and Research, told Inside Health Policy last week CDER expects the guidance to increase compliance with reporting requirements and help FDA take actions to prevent shortages... Sub. Req'd

PhRMA Representatives say it's ‘Not The Time' to Expand Prescription Drug Affordability Board Authority

(2/13, Danielle J. Brown, Maryland Matters) ...Members of Pharmaceutical Research and Manufacturers of America, PhRMA, are long-standing opponents of state prescription drug affordability boards and argue that Maryland's PDAB has not shown that it can lower costs. "Maryland PDAB is still working to develop the upper payment limit action plan with their current patient pool. Now is not the time to expand," Charise Richard, senior director of state policy for PhRMA, told the Senate Finance Committee in opposition of SB 388. Laura Srebnik, director of state government affairs for Biotechnology Innovation Organization, said the board "has not impacted any patient out-of-pocket costs."... Full

The Truth About Nebraska's Price Setting Push

(2/13, Reid Porter, PhRMA) ...As Nebraska lawmakers consider consider Legislative Bill 833, a proposal to create a so-called "prescription drug affordability board," it's important to know the truth about how government price setting will affect Nebraskans. A price-setting board could limit access to critical medicines while inserting the government between patients and doctors. A recent poll found that 83% of adults in Nebraska agree that elected officials should ensure health insurance companies and pharmacy benefit managers are held accountable for their role in keeping patients from the medicines they need... Full

Nebraska Bill to Limit Costs of EpiPens, Inhalers Receives Support — Except from Insurance Providers

(2/13, Erin Bamer, Omaha World-Herald) ...The bill, introduced by State Sen. Eliot Bostar of Lincoln, would limit the out-of-pocket costs for a two-pack of epinephrine injectors (often referred to as EpiPens) to $60 for people with insurance, and requires insurance companies to cover authorized generic versions of inhalers...Bostar estimated that the cost of EpiPens can be $600 to $700 without insurance. On inhalers, Bostar took issue with insurance providers stopping coverage for a generic version of a previous brand-name inhaler that was pulled from the shelves earlier this year... Full

Drug Affordability Bills Pass in the Virginia House and Senate

(2/14, Olivia Whitehouse, WHSV) ...Bills aiming to make drugs more affordable were passed by the House and the Senate. Jared Calfee, State Advocacy Director for Virginia AARP said, "What the legislation would do is give the state the power to create a board of experts on pharmaceutical supply chain, health care industry, who could review certain high-cost prescription drugs." The board would conduct an affordability review prescription drug that are causing a cost burden on consumers, said Calfee... Full

The Effort to Tackle Prescription Drug Prices in New York State

(2/13, WKBW) ...The state senate recently passed a series of bills to tackle the price of prescriptions and among them, the New York Affordable Drug Manufacturing Act. NYS Senator Gustavo Rivera, a sponsor of the Drug Manufacturing Act and supporter of the package of bills, joined 7 Voices on Tuesday to discuss the bills... Full

FDA, EMA Officials say Diverse Pharmacovigilance Strategies, Long-Term Follow-Up Needed for ATMPs

(2/13, Joanne S. Eglovitch, Regulatory Focus) ...Advanced therapy medicinal products are complex products that require diverse pharmacovigilance strategies for monitoring their postmarket safety, said officials from the US Food and Drug Administration and the European Medicines Agency at the Drug Information Association's Global Pharmacovigilance and Risk Management Strategies Conference in Baltimore last week... Full

Thorny Clause in Ripening India-European Free Trade Association Deal May Hit Generic Drug Industry

(2/13, Jacob Koshy, The Hindu) ...A clause in a draft free trade agreement text being negotiated between India and the European Free Trade Association — Switzerland, Iceland, Lichtenstein and Norway — could delay access to affordable, generic versions of patented drugs in India by a minimum of six years, according to documents viewed by The Hindu... Full

Mexico Launches ‘Regulatory Certainty Strategy' For Biosimilars

(2/13, Francesca Bruce, Pink Sheet) ...Mexico's regulator, Cofepris, wants to drive local production and development of biosimilar medicines to increase access through a new regulatory and operational framework for these products. The plans include the creation of several new bodies, including a new Council for National Pharmaceutical Development... Sub. Req'd

Philippines FDA Slashes Generic Approval Timelines

(2/14, David Wallace, Generics Bulletin) ...The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices. Review timelines for generic drugs in the Philippines are set to be slashed dramatically, as part of efforts spearheaded by the country's president to speed up new drug approvals and bring down medicines prices... Global Sub. Full

WHO Tightens Up Guidance On Reserving Most Critical Antimicrobials For Humans Only

(2/13, Eliza Slawther, Pink Sheet) ...All new classes of antimicrobials for human use will fall within the World Health Organization's highest criticality category under its latest guidance on preventing antimicrobial resistance. The World Health Organization has updated its list of medically important antimicrobials to provide guidance to global regulators, drug companies and national authorities on which antimicrobials should only be used in humans due to the risk of antimicrobial resistance if these drugs are used in animals or crops... Sub. Req'd

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