Wednesday, August 7, 2024

Celltrion's Q2 Sales Hit Record-High Level Thanks to Biosimilar Growth

(8/7, Kim Ji-hye, Korea Biomedical Review) ...The company said Wednesday its second-quarter sales reached 874.7 billion won, up 66.9 percent from the same period of last year. It was the first time Celltrion's quarterly sales exceeded the 800 billion-won mark. Celltrion attributed its performance to the strong sales of its biosimilar products and the balanced revenue growth of its new products. The biosimilar sector, a core area for the company, generated 774 billion won in sales, up 103.6 percent year-on-year... Full

Lupin Shares Touch 52-Week High as Q1 Profit Surges 77%

(8/7, Vidhi Taparia, Fortune India) ..."We have had a strong quarter, with performance driven by new products, key geographies, and improvement in our operating margin and profitability," said Nilesh Gupta, Managing Director of Lupin Limited. Of the total sales in this quarter, over 6% went to investments in R&D amounting to 350 crore, personnel costs were 17.6% at 971 crore and manufacturing and other expenses accounted for 29% at 1,598.5 crore... Full

India's Gland Pharma Posts Surprise Fall in Q1 Profit On Soaring Employee Costs

(8/6, Varun Hebbalalu, Reuters) ...India's Gland Pharma an injectables manufacturer, posted a surprise drop in quarterly profit on Tuesday, hurt by high employee costs and lower prices for its products in the United States...The company's U.S. sales increased 27% to 7.63 billion rupees, its slowest growth in four quarters. Employee benefit expenses, which account for about 29% of total costs and is the second-largest expense, shot up 40%... Full

Indivior Hit With Shareholder Suit Over Drug Revenue Forecasts

(8/5, Matthew Bultman, Bloomberg Law) ...Indivior Plc was sued by an investor who alleges the drugmaker overstated the financial prospects for various products, including its flagship opioid addiction treatment Sublocade...Indivior's stock price fell almost 34% on the news, according to the complaint filed Friday in the US District Court for the Eastern District of Virginia... Sub. Req'd

Bayer Looks Ahead to Nubeqa, Kerendia Expansions Amid Xarelto's Downward Sales Spiral

(8/6, Zoey Becker, Fierce Pharma) ...Considering blood thinner Xarelto's 11% sales decline during the second quarter, those expansions are becoming all the more important. As Bayer's Xarelto falls prey to generics, the drugmaker is putting more weight behind oncology blockbuster hopeful Nubeqa and ophthalmology mainstay Eylea, among other meds. In total, the company's pharma division pulled in 4.6 billion euros ($5 billion) during the second quarter, good for 4.5% growth on a year-over-year basis... Full

Sun Drops Suggestion That Halol Reinspection Request May Be Close

(8/6, Dean Rudge, Generics Bulletin) ...Sun Pharma may be close to requesting a long-sought US Food and Drug Administration reinspection for its key, stricken manufacturing facility in Halol, though the firm remains unable to pinpoint an exact date for the wheels to begin turning. Speaking to investors during the Indian firm's financial first quarter earnings call, Sun's managing director Dilip Shanghvi said during the Q&A segment: "I think the idea is that once we are clear, which should be shortly, we will request the FDA for a re-audit of the facility."... Global Sub. Full

Supply Issues Weigh On Novo Nordisk as Drugmaker Stumbles with Quarterly Report

(8/7, Andrew Joseph, STAT Plus) ...An underwhelming earnings report and ongoing questions about increasing competition in the booming obesity medicine field sent Novo Nordisk's shares down early Wednesday, as the company sought to project its ability to reach more patients by increasing the supplies of its medicines...Novo on Wednesday contended that some of the drags on its revenue and outlook were one-off obstacles... Sub. Req'd

US FDA Says Two More Doses of Novo Nordisk's Weight-Loss Drug Now Available

(8/6, Christy Santhosh,Chandni Shah, Reuters) ...Two more doses of Novo Nordisk's weight-loss drug, Wegovy, is now available, the U.S. Food and Drug Administration's updated shortages list showed on Tuesday...According to the FDA's website, Wegovy's smallest dose of 0.25 milligram (mg) is listed under limited availability, while all other doses are listed as available. All doses of Ozempic are available in the United States. Novo Nordisk said late Tuesday that four of the five dose strengths of WeGovy are now available in the United States, but the company will continue to manage shipments of the drug's initial dose of 0.25 milligram (mg)... Full

Compounders Doubt Eli Lilly's Availability Of GLP-1 Drugs Will Fulfill Demand, Continue Compounding

(8/6, Maaisha Osman, InsideHealthPolicy) ...While Eli Lilly says its blockbuster weight-loss drugs Zepbound and Mounjaro are now available, a pharmacy compounding group tells Inside Health Policy the term "available" is misleading as its not certain whether the company will be able to fulfill the demand of patients, and compounding is continuing...Lilly's spokesperson tells IHP that the supply chain is complex and there may be several reasons for a pharmacy not to have a particular dose of medicine in stock. "This significant step forward reflects our efforts to expand manufacturing capacity and meet the demand for these medicines," the spokesperson says... Sub. Req'd

Alembic Pharma Shares Gain 3% On USFDA Nod for Psoriasis Treatment Drug

(8/7, CNBC TV 18) ...Alembic Pharma on Wednedsay, July 7 said it had received final approval from the United States Food and Drug Administration for Acitretin Capsules to treat psoriasis...The approved ANDA is a therapeutic equivalent of the reference-listed drug product of Stiefel Laboratories, Inc.'s product Soriatane Capsules in the same doses of 10 mg, 17.5 mg, and 25 mg, said Alembic Pharma in a filing. The Acitretin Capsules are prescribed for the treatment of severe psoriasis in adults... Full

FDA Hits Aurobindo's Eugia Unit with 'Official Action Indicated' Label in Wake of Plant Inspection

(8/6, Joseph Keenan, Fierce Pharma) ...The FDA hit Eugia, a unit of Indian drugmaker Aurobindo, with a classification of "Official Action Indicated" in the wake of a plant inspection at its Bhiwadi Unit II facility in April and May. The classification, which is the most severe of the three inspection recommendations issued by the FDA, was revealed by Aurobindo in an Aug. 5 corporate announcement. Aurobindo said it "remains committed to work closely with the U.S. FDA and continues to enhance its compliance on an ongoing basis."... Full

Samsung Biologics Joins the Pharmaceutical Supply Chain Initiative as Supplier Partner

(8/6, Samsung Biologics) ...Samsung Biologics will commit to PSCI principles that address five areas of responsible business practice – ethics, labor, health & safety, environment, and management systems. Samsung Biologics expects the partnership to help further advance the company's steadfast dedication to sustainable growth and strengthen its Environmental, Social, and Governance management... Full

Pfizer's $108 Million Verdict On AstraZeneca's Tagrisso Survives

(8/6, Christopher Yasiejko, Bloomberg Law) ...A Pfizer Inc. unit's $107.5 million verdict will stand, as a federal judge rejected AstraZeneca Plc's request for a new trial after a Delaware jury found AstraZeneca's blockbuster cancer drug Tagrisso infringes two patents for Pfizer's competing Vizimpro... Sub. Req'd

Biosimilar Market Expected to Grow to $92 Billion by 2031, Data Show

(8/6, Ashley Gallagher, Pharmacy Times) ...The global biosimilar market was approximately generating $27.3 billion in 2023, with this number projected to reach $92 billion by 2031, with a compound annual growth rate of 16.4% during this period, according to a report from SkyQuest Technology. The largest segment with the fastest growth rate is expected to be in the oncology space... Full

The Generics Bulletin Top 50, Part Three: Firms Fall Out Of Final Grouping

(8/7, David Wallace, Generics Bulletin) ...After the first part of this year's Generics Bulletin Top 50 showed a stable top ten of generics and biosimilars firms – albeit with much happening under the surface – and the second part reflected some ups and downs for our mid-table players, this third section of our annual feature shows a couple of companies exiting the ranking altogether at the bottom of the table in 2023. At the top of our final table in 31st position is Samsung Bioepis, which now reports its results as a distinct unit within Samsung Biologics, so is eligible for our ranking... Global Sub. Full

As Governor, Walz Signed Bill Creating PDAB, Prohibition On ‘Excessive' Generic Drug Price Hikes

(8/6, Luke Zarzecki, InsideHealthPolicy) ...Newly tapped Democratic vice presidential contender Tim Walz has a history as Minnesota governor addressing prescription drug costs, including signing state legislation with two sweeping drug-pricing reforms. In 2023, Walz signed legislation that prohibited generic drug manufacturers from increasing prices beyond a certain amount and established a prescription drug affordability board... Sub. Req'd

What Tim Walz Means for Health Policy

(8/6, Peter Sullivan,Victoria Knight, Axios) ...Walz has a record of taking on the health care industry over costs, though many of the efforts are still in the early stages and it remains to be seen how they pan out...Walz and the legislature also ran into opposition from the Mayo Clinic, the state's crown jewel hospital, over a proposed health care affordability board with power over hospital and other provider costs...The legislature and Walz also created a state-based public option last year. That proposal has yet to fully take off, and started out with a study and actuarial analysis, as Axios reported last year... Sub. Req'd

Give Pharmaceutical Execs the Benefit of Doubt — But They Need to Work for It

(8/7, Fred D. Ledley, STAT) ...I expect that the pharmaceutical industry can develop products that are affordable, universally available, and effective at reducing inequities in health outcomes and the global burden of disease without compromising their profits. To achieve that, industry leaders must be held accountable for doing the work that is required, for executing effective strategic management and investment practices, and for implementing the innovations in science and business that will enable them to fulfill both their stated mission of advancing health and their responsibilities to shareholders. The pharmaceutical leaders I know are up to the task and need to be given the benefit of doubt; their track record suggests that these multiplex expectations can be achieved... Full

Biosimilars Continue to Drive Market Competition and Increase Savings for Seniors

(8/6, Lindsey Seidlitz, PhRMA) ...A new issue brief from Cencora provides additional insight into the OIG report on the aggregate level, underscoring the important role biosimilars play in lowering overall prices and costs for the Medicare Part B program and its beneficiaries...The U.S. biosimilars market has demonstrated its ability to lower drug costs for patients and Medicare through robust market competition. To continue realizing these benefits, it's critical that policymakers reduce barriers to the uptake of biosimilars and continue to foster a competitive biologics and biosimilars marketplace... Full

Follow the 340B Prescription Dollar: How PBMs Profit from 340B Contract Pharmacies (Video)

(8/6, Adam J. Fein, Ph.D., Drug Channels) ...In the video excerpt below, I walk through a brief history of 340B contract pharmacies. I then document how five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers-Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart-continue to dominate the 340B contract pharmacy market... Full

The Anti-Competitive Middlemen Harming Pharmacies And Patients

(8/6, Wayne Winegarden, Forbes) ...Replacing our current third-party payer system with a patient-driven healthcare system is the most effective way to roll back the power of PBMs. Short of comprehensive reforms, which are unlikely, reforms should prohibit spread pricing, increase transparency, eliminate the disincentives for preferring higher priced medicines, and address the problem of patient steering... Full

CDC Chief Says New RSV Guidance Was Meant to Be ‘Clear' and ‘Actionable'

(8/6, Max Bayer, Endpoints News) ...CDC Director Mandy Cohen says that new guidance for respiratory syncytial virus vaccination was meant to be easier to implement than last year's advice, explaining some of the thinking behind a decision earlier this year that disappointed vaccine makers...Cohen said the RSV recommendations, first made by agency advisors before the CDC signed off, were guided by new data on who would benefit the most from an RSV vaccine... Full

July 2024 Unofficial ANDA Approval Actions – Not Quite What We Predicted Mid-Month

(8/6, Bob Pollock, Lachman Consultants) ...It seems that the pace of approvals in July 2024 slowed and, as a result, our mid-month estimate of possibly hitting 90 approvals was dashed by a late-month drop in approval actions. The OGD did, however, unofficially issue 63 full-approval actions and 12 tentative-approval actions for a total of 75... Full

ICH Adopts M13A Guideline On Bioequivalence Testing

(8/6, Joanne S. Eglovitch, Regulatory Focus) ...The International Council for Harmonisation (ICH) recently adopted its M13A guideline, which aims to harmonize the framework for assessing the bioequivalence (BE) of immediate-release (IR) solid oral dosage forms and assessing BE after postapproval changes. ICH also released a questions and answers (Q&A) document to provide more clarity on the concepts in the guideline... Full

Standing Rulings May Help Preserve FDA Authority After Chevron

(8/6, Jessica Karins, InsideHealthPolicy) ...The Supreme Court's recent case over the abortion pill mifepristone, which found that plaintiffs must show a direct injury in order to sue FDA over its regulatory decisions, could be a shield in some cases against the weakened agency authority established by the court's overturn of Chevron deference, according to a regulatory lawyer... Sub. Req'd

Data Integrity is ‘Biggest Issue' for Drug, API Firms During Inspections, FDA Official Says

(8/6, Jeff Craven, Regulatory Focus) ...Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during inspections of manufacturers, according to a US Food and Drug Administration official who spoke at the Orange County Regulatory Affairs Discussion Group annual conference last week... Full

PhRMA Seeks Supreme Court Review On State Discount Drug Limits

(8/6, Nyah Phengsitthy, Bloomberg Law) ...PhRMA and the Arkansas Insurance Department have been at odds over the use of contract pharmacies under Section 340B of the Public Health Service Act—a federal law that requires drugmakers to discount drugs for qualifying hospitals, clinics, and providers that treat low-income and uninsured patients, known as covered entities... Sub. Req'd

Pharma Industry Ramps Up Legal Fight of State Drug Discount Laws

(8/7, Nyah Phengsitthy, Bloomberg Law) ...Drugmakers Novartis AG, AstraZeneca PLC, AbbVie Inc., and trade group Pharmaceutical Research and Manufacturers of America have filed a combined 23 lawsuits against eight recently enacted state laws that prohibit the companies from restricting the supply of discounted drugs to certain pharmacies under the federal 340B Drug Pricing Program... Sub. Req'd

Arkansas Orders Four Pharmacy Benefit Managers to Pay $1.47M in Fines for Underpaying Drugstores

(8/6, Tess Vrbin, Arkansas Advocate) ...Arkansas officials on Tuesday ordered four nationwide pharmacy benefit managers to stop paying Arkansas pharmacies below the legally required amount for prescription drugs and to pay a cumulative $1.47 million in fines for having done so, according to a news release from Gov. Sarah Huckabee Sanders' office... Full

Arkansas Insurance Department Goes After Pharmacy Benefit Managers with Hearings, $1.5 Million Penalties

(8/6, Alex Kienlen, KNWA FOX 24) ...Arkansas is going after pharmacy benefit managers that the insurance department claims are violating state laws...The release said the state is focusing on four major PBMs: Caremark, Magellan, Express Scripts, and MedImpact... Full

Pharmacy Middlemen Face New Allegations of Skimming

(8/7, Marty Schladen, Ohio Capital Journal) ...When shadowy pharmacy middlemen started in 2019 to create yet another layer of middlemen, critics suspected they would be used to avoid transparency and skim even more money from the interstices of arcane — but wildly lucrative — drug transactions. Now evidence is accumulating that it might be happening. Two government investigations this year accused the giant health conglomerates that own the middlemen of doing precisely that: hiding millions that were supposed to go to payers and pocketing the money themselves... Full

Pennsylvania Pharmacy Bill: One fight Won, 'Many Fights to Come'

(8/6, Roger DuPuis, WVIA) ...Independent pharmacy owner Tom DePietro is relieved that Pennsylvania has approved legislation to increase transparency and accountability of pharmacy benefit managers. He's also among those who feel Gov. Josh Shapiro's signing of Act 77 is an important first step — but only a first step — in the battle to address PBM practices that are widely faulted for making it harder for drugstores like his Dunmore-based DePietro's Pharmacy to stay in business... Full

EU Helps Firms To Prioritize Submission Of Data On ‘Critical' Drugs

(8/6, Ian Schofield, Pink Sheet) ...The European Medicines Agency has published a new list of "critical medicines" intended to help companies and national regulators map the drugs in its Product Management Service. Manufacturing authorization holders can prioritize the medicines in the list for the submission of specific product information relating to pack sizes and manufacturing, while national competent authorities can use it to "facilitate the prioritization of product mapping within their national systems," the EMA said... Sub. Req'd

Sanofi: England Needs ‘Flexible' Pricing For Multi-Indication Drugs

(8/6, Eliza Slawther, Pink Sheet) ...Sanofi, Alexion and Eli Lilly argue for changes in England's health technology assessment and medicine pricing processes that could help patients to access more medicines...Fleur Chandler, head of market access at Sanofi, told the Pink Sheet that NHS England "largely operates a uniform approach to medicines pricing" that only allows one price per medicine to be agreed across all indications for which it is approved, which means that patients in England "lose out on promising new innovations."... Sub. Req'd

Drug Companies Want New Pricing Policy to Spur Innovation

(8/7, Manu Kaushik, Financial Express) ..."We have suggested that the new policy should focus on both affordability and innovation which is a shift from the current Drug Prices Control Order 2013 which is largely centered on affordability. The discussions concluded a few weeks ago, and we are expecting the new policy to come out this year," said Viranchi Shah, national president of Indian Drug Manufacturers' Association... Full

China Pilots Scheme To Halve IND Review Time For Innovative Drugs

(8/6, Dexter Yan, Pink Sheet) ...China's top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country's innovative drug sector... Sub. Req'd

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