Thursday, September 19, 2024

Fitch Upgrades Teva's Long-Term IDR to 'BB'; Outlook Positive

(9/18, Fitch Ratings) ...Fitch Ratings has upgraded Teva Pharmaceutical Industries Limited (Teva) and its subsidiary, Teva Pharmaceuticals USA, Inc.'s Long-Term Issuer Default Ratings (IDRs) to 'BB' from 'BB-'...The rating agency stated that the upgrade reflects Teva's significant progress in reducing its debt, returning to growth and improving operational efficiency. The Positive Outlook reflects Fitch's expectation that Teva will continue to reduce debt, grow and diversify its revenue base and minimize the costs associated with governmental and civil legal proceedings... Full

Sandoz Confirms US Natalizumab Delay Amid Push For Virus Test

(9/19, Dean Rudge, Generics Bulletin) ...Sandoz has confirmed that the planned US launch of its US Food and Drug Administration-approved Tyruko (natalizumab-sztn) biosimilar has been pushed back from late in 2024 to 2025, because of an ongoing delay in receiving an approval for a John Cunningham virus (JCV) assay. Developed in collaboration with Polpharma, Tyruko was approved by the FDA more than a year ago; and upon launch is set to become the first US biosimilar to treat relapsing forms of multiple sclerosis... Global Sub. Full

Lupin Receives US FDA Approval for Bumetanide Injection, USP

(9/18, Pharmabiz.com) ...Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for bumetanide injection USP, 1 mg/4 mL (0.25 mg/mL) single-dose vials and 2.5 mg/10 mL (0.25 mg/mL) multiple-dose vials to market a generic equivalent of Bumex injection, 0.25 mg/mL of Validus Pharmaceuticals, LLC. The product will be manufactured at Lupin's Nagpur facility in India... Full

Awaiting FDA Review, Medtronic Details Study of Adaptive Neurostimulation in Parkinson's Disease

(9/18, Conor Hale, Fierce Biotech) ...Medtronic is offering a peek into its ongoing, at-home trial of people with Parkinson's disease being treated with adaptive deep brain stimulation, a technology that's currently under review at the FDA...The study said that identifiable local field potential signals, strong enough to be used for triggering therapy, were found in about 84% of patients—regardless of their Parkinson's subtype—and they were largely not masked by medications... Full

Coherus Warns Of US Pegfilgrastim Supply Gap In October

(9/18, David Wallace, Generics Bulletin) ...News of the supply gap – which set to last from mid-October to early November – is a blow for Coherus given its leading position among pegfilgrastim biosimilars in the US... Global Sub. Full

Aurobindo to Acquire 49% Atake in GLS Pharma for Rs 22.5 crore

(9/18, Press Trust Of India) ...Aurobindo Pharma Ltd on Wednesday said it will acquire the balance 49 per cent stake in GLS Pharma Ltd for Rs 22.5 crore to make the latter a wholly-owned subsidiary...GLS is engaged in oncology products, which include orals and injectables used in chemotherapy for solid malignancies, chemotherapy for hematological malignancies and chemo-supportive products... Full

Astellas' Myrbetriq ER Patent Revived as Fed. Cir. Chides Judge

(9/18, Michael Shapiro, Bloomberg Law) ...The Federal Circuit vacated a decision axing an Astellas Pharma Inc. drug patent based on an argument not presented at trial and chastised the federal judge in Delaware who issued it...The judge commented that pharmaceutical companies had "perverted" the intent of the laws governing drug patents, and that "brand and generic drug manufacturers have colluded to protect weak or invalid patents and share in the startling profits."... Sub. Req’d

Eli Lilly Urges Court to Toss $183 Mln Medicaid Fraud Judgment

(9/18, Brendan Pierson, Reuters) ...Drugmaker Eli Lilly on Wednesday urged a federal appeals court to overturn a $183 million judgment against it in a case accusing it of defrauding Medicaid, arguing that it was being wrongly held liable despite following its reasonable interpretation of the government health insurance program's requirements... Full

GSK Settles Two California Lawsuits Related to Heartburn Drug Zantac

(9/18, Yadarisa Shabong, Reuters) ...British drugmaker GSK said on Wednesday it had agreed to settle two lawsuits in California that claimed its discontinued heartburn drug Zantac caused cancer. GSK does not admit to any liability in either settlement, it said in a statement... Full

A Second Zantac Cancer Trial Ends with Hung Jury

(9/18, Brendan Pierson, Reuters) ...The latest trial over claims that the discontinued heartburn drug Zantac causes cancer ended with a hung jury on Wednesday, as jurors in Chicago were unable to agree on whether Boehringer Ingelheim must pay damages to an Illinois man who said he developed prostate cancer as a result of taking the drug, according to the man's lawyer... Full

‘They Flooded This City': Baltimore Opens Opioid Lawsuit Trial Against Drug Companies

(9/18, Alex Mann, The Baltimore Sun) ...The city is asking the jury to determine that McKesson and AmerisourceBergen's actions amounted to an "unreasonable interference with a public right," which, in this case, he defined as residents' right to health and safety, and to award "millions and millions and millions" of dollars in damages at the end of a trial slated to run through November... Sub. Req’d

Studies Find Uneven Uptake of Biosimilars as Availability Increases

(9/18, Jeff Craven, Regulatory Focus) ...As biosimilars become increasingly available, they are creating a competitive market with originator products, but uptake of biosimilars among patients is varied and depends on factors like patient demographics, geography, site of care, prescriber specialty, and insurance type, according to two recent studies published in the journal Health Affairs. Molly Beinfeld, of Tufts University, told Regulatory Focus in an interview that she and her colleagues are "somewhat optimistic" about the biosimilar market... Full

Patients, Doctors and Pharmacists Share Tips for Lowering Costs as Prescription Drug Prices Soar

(9/18, Cindy Krischer Goodman, South Florida Sun Sentinel) ...Last year, prices increases for more than 4,200 drugs with an average hike of about 15%, according to Definitive Healthcare, a healthcare data analytics company. Floridians living with cancer, prediabetes or diabetes, and heart disease incur some of the highest out-of-pocket costs for medications...Across the Sunshine State, patients, pharmacists, and physicians are getting creative, using various methods to keep their spending as low as possible... Sub. Req’d

Here's What Today's Fed Rate Cut Means for Biotech, Pharma and Venture Capital

(9/18, Max Gelman, Endpoints News) ...For biotech, that's likely to make it easier for private and public companies to raise money, and to allow "many of these great innovation engines to get funded," former Alnylam CEO John Maraganore told Endpoints News...Stifel analyst Paul Matteis said any rate cut, no matter the size, is welcome news to biotech... Full

Drug Patent Debate Rekindled by Judiciary Markup

(9/18, Victoria Knight, Axios Pro) ...Senators are set to relaunch the debate over revamping the drug patent system Thursday, when the Judiciary Committee marks up a pair of bills that could raise the bar for who can challenge patents and what inventions are eligible for protection...The PREVAIL Act would change the process for challenging patents by requiring petitioners to have standing, either by having been sued or threatened with a patent infringement lawsuit... Sub. Req’d

Scoop: Coons' Plan to Address PREVAIL Concerns

(9/18, Victoria Knight, Axios Pro) ...Sen. Chris Coons plans to file an amendment to the PREVAIL Act during Thursday's Senate Judiciary markup aimed at addressing criticism that the legislation would largely benefit Big Pharma...Coons, the lead Democratic sponsor, said his amendment would enable patient advocacy groups and generic drug companies to bring challenges in administrative proceedings before the Patent Trial and Appeal Board... Sub. Req’d

Experts Debate Whether IRA Provisions Stifle Pharma Innovation at Senate Hearing

(9/18, Joyce Frieden, MedPage Today) ...The Inflation Reduction Act provisions aimed at lowering prescription drug prices will lead to more pharmaceutical innovation, not less, one witness said at a Senate Finance Committee hearing. "These reforms support innovation in a number of ways -- first, by expanding the use of drugs, greater profits in the industry should follow," Rena Conti, PhD, associate professor of markets, public policy, and law at Boston University, said Tuesday at a hearing on lowering Americans' healthcare costs... Full

Amid IRA Implementation, PBMs Continue to Deliver Value and Savings for Medicare Beneficiaries

(9/18, Tim Dube, PCMA) ...PBMs will continue to deliver value and savings for Medicare, providing affordable access to prescription drugs for the beneficiaries who need them. We would expect stakeholders to better understand the law and its interpretations without falling further into anti-PBM traps... Full

A Rare Good Day For PBMs On Capitol Hill

(9/18, Michael McCaughan, Pink Sheet) ...The Pharmacy Benefit Management sector remains nearly universally unpopular with both Democratic and Republican lawmakers in the US. But a September 11 hearing stands out as an event where at least the witnesses suggested that there is value in the PBM business model. The US pharmacy benefit management sector does not have a lot of defenders on Capitol Hill, but for one day at least Congress heard testimony suggesting that the PBM business model is not all bad... Sub. Req’d

NAM: Lower Costs Through PBM Reform, Not Price Controls

(9/18, The National Association of Manufacturers) ...To lower drug prices, Congress should undertake comprehensive reform of pharmacy benefit managers, not embrace price controls, the NAM told the Senate Tuesday..."Biopharmaceutical manufacturers are a critical part of the manufacturing economy," NAM Vice President of Domestic Policy Charles Crain said ahead of a Senate Finance Committee hearing on health care costs... Full

Durbin, Senate Democrats Urge USPTO, Drug Companies To Address Errors In Patent Term Adjustment To Prevent Unwarranted Pharma Monopolies

(9/18, U.S. Senate Committee On The Judiciary) ...U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, led a group of five Senate Democrats in sending a letter to the U.S. Patent and Trademark Office Director Kathi Vidal regarding recent research that found pharmaceutical companies may be benefitting from errors in USPTO's calculation of patent term adjustment...In addition to a letter to USPTO, the Senators also sent letters to three pharmaceutical companies—Biogen, Gilead, and GSK—that all received excess PTA on patents covering their medications to correct the errors and prevent ill-gotten gains... Full

Generic Medicines Increase Patient Access More Than Government Negotiated Price Controls

(9/18, AAM) ...AAM appreciates Chairman Sanders and his interest in generic competition, and AAM members are committed to increasing patient access through competition, including for GLP-1s as they lose patent protection in the coming years. However, government policies often stand in the way of such competition. Slow approvals of new generics, particularly complex generics, can delay market entry... Full

Harris' AG Past Hints at Tough Pharma Stance

(9/18, Ben Leonard and Chelsea Cirruzzo, Politico) ...Her aggressiveness might not go over well with pharmaceutical companies and others in the industry. Catherine Hill, a spokesperson for brand name drug lobby PhRMA, said that U.S. pharmaceutical innovation hinges on "robust [intellectual property] protections" and blamed drug costs on pharmacy benefit managers, the middlemen that negotiate drug prices on behalf of insurers and employers... Full

Biden-Harris Price Controls Causing Senior Drug Prices to Skyrocket

(9/18, Martin Hoyt, RealClearHealth) ...The IRA has failed to achieve its objectives in many ways. One significant problem involves the introduction of drug price controls, which take effect in 2026. Due to the IRA, the federal government now has wide-ranging authority to set the price of drugs through what's known as the Medicare Drug Price Negotiation Program. A recent analysis warns that these pricing provisions will likely lead to higher costs for millions of seniors and disabled Americans who rely on Medicare Part D... Full

Senators Tell FDA That ‘Greater Action is Needed' to Use Manufacturing Tech in US Supply Chains

(9/18, Anna Brown, Endpoints News) ...Sens. Marco Rubio (R-FL) and Angus King (I-ME) have told the FDA that "considerable work" needs to be done to address how advanced manufacturing technologies can be used to improve US domestic supply chains...Rubio and King have demanded the FDA up the ante on finalizing the program and have requested information on how the agency is encouraging manufacturers to partake... Full

Industry Seeks Phased-In Approach to Drug Supply Chain Tracking Requirements

(9/18, Mary Ellen Schneider, Regulatory Focus) ...Industry groups are calling on the US Food and Drug Administration to adopt a "phased, stepwise approach" to the implementation of the enhanced drug distribution security requirements under the Drug Supply Chain Security Act... Full

FDA Inspection Backlog Overseas Threatens New Drug Approvals

(9/18, Amy Baxter, PharmaVoice) ...Inspections of overseas drug manufacturers came to a standstill during the height of the COVID-19 pandemic lockdown. Years later, the backlog of inspections is still high, adding to a host of risks across the pharma industry. Roughly 2,000 pharma manufacturers haven't been inspected by the FDA since before the pandemic, according to a recent analysis from the Associated Press... Full

Patients Must Benefit from Cost Reviews by Maryland Drug Affordability Board

(9/18, Tiffany Westrich-Robertson, Maryland Matters) ...As the Maryland Prescription Drug Affordability Board (PDAB) examines high medication costs across the health system, board members must ensure that Maryland patients are ultimately the ones benefiting from any efforts to lower health care costs and realized savings... Full

EU Officials Discuss Advice Pathways, Return to Office at Convergence

(9/18, Joanne S. Eglovitch, Regulatory Focus) ...Andrea Laslop, head of the scientific office at the Austrian Medicines and Medical Devices Agency (AGES), said that seeking scientific advice from regulators on innovative products is a "well-defined and established process" and that such advice can be requested on any issue related to developing these products... Full

BGMA Urges New UK Government To Seize ‘Critical Opportunity'

(9/18, David Wallace, Generics Bulletin) ...In the wake of the Darzi review which set out the stark challenges facing the UK's National Health Service, local off-patent industry association the BGMA has urged the country's government to take advantage of a "critical opportunity" to broaden access to medicine while also saving money... Global Sub. Full

Ipsen On Working With The UK's Health Authorities To Make Industry's Voice Heard

(9/18, Eliza Slawther, Pink Sheet) ...Engaging with the UK government and health authorities to help shape policy and drive improvements that benefit both industry and patients is a key part of Ipsen's strategy, according to Ioana Parsons, general manager of UK & Ireland at Ipsen..."We want to partner with the health authorities and the government, and we will continue to do that," she told the Pink Sheet in an interview... Sub. Req’d

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