Thursday, July 18, 2024

Mark Cuban's Cost Plus to Import Penicillin to Address US Shortage

(7/17, Sneha S K, Reuters) ...Mark Cuban's Cost Plus Drug Company said on Wednesday that it is working with the U.S. Food and Drug Administration to import and distribute penicillin in the country temporarily...Cuban's Cost Plus will import Lentocilin brand penicillin powder marketed by Portugal-based Laboratórios Atral S.A... Full

Mark Cuban's Cost Plus Drug Co. to Import Syphilis Drug Amid Long-Running U.S. Shortage

(7/17, Ike Swetlitz, Bloomberg) ...Pfizer Inc. makes the only FDA-approved form of the drug and the company expects the supply limitations will last through the end of the year, according to the agency...The drug offered by Cuban's company will have a wholesale price of $15 a dose, Cuban said in an email. For comparison, the list price of Pfizer's drug is over $100 a shot depending on the strength, according to data provided by Elizabeth Finley, a spokesperson for the National Coalition of STD Directors... Full

GoodRx Teams with Boehringer On Humira Biosimilar

(7/18, Tina Reed, Axios) ...A new partnership between prescription savings platform GoodRx and drugmaker Boehringer Ingelheim will make the company's Humira knockoff available for a discounted cash pay price of $550...While it's still not cheap, the price tag for Boehringer's adalimumab-adbm injection represents a 92% discount from what brand-name Humira made by AbbVie generally costs at the pharmacy counter for those who pay cash. "It's all relative," Dorothy Gemmell, chief commercial officer at GoodRx, told Axios... Full

J&J Beats Wall St Estimates On Strong Drug Sales Ahead of Stelara Competition

(7/17, Patrick Wingrove and Bhanvi Satija, Reuters) ...Johnson & Johnson, opens new tab beat estimates for second-quarter profit and revenue on Wednesday, driven by strong sales of its drugs, including cancer treatment Darzalex and blockbuster psoriasis drug Stelara. Stelara has long been a key driver of revenue growth for J&J, with analysts forecasting sales of over $10 billion this year. But this could fall to about $7 billion in 2025 when as many as six close copies of the drug are due to launch in the U.S...J&J Chief Financial Officer Joe Wolk said he expected to finalize contracts within the next three months that would determine favorable U.S. insurance coverage for Stelara in 2025... Full

Novartis Raises Profit Guidance as Key Drugs Boost Sales

(7/18, Helena Smolak, The Wall Street Journal) ...The Swiss pharma major said Thursday that it now expects its core operating profit—one of its preferred metrics, which strips out exceptional items—for 2024 to grow in the mid to high teens, from a low double-digit to mid-teens range previously...Strong growth in sales of the company's Entresto drug, scheduled to lose patent protection next year in the U.S., and its Cosentyx psoriasis treatment, which both exceeded $1 billion in quarterly revenue, helped the top line. Generic competition had a negative impact of 2 percentage points, the company said... Sub. Req'd

Hikma Launches First US Sodium Acetate With CGT Exclusivity

(7/17, Adam Zamecnik, Generics Bulletin) ...Following on from a flurry of deal and launches, Hikma has released another product onto the US market with the first of its sodium acetate injections, bolstered by 180 days of Competitive Generic Therapy exclusivity...While Hikma has so far only launched sodium acetate injections with a 40mEq per 20ml vial concentration, the company is also planning the future rollout of 100mEq per 50ml and 200mEq per 100ml sodium acetate injections... Global Sub. Full

Zydus's ‘Transparency Failure' Leads To Block On Indian Perjeta Biosimilar

(7/17, Dean Rudge, Generics Bulletin) ...India's Delhi High Court has signed off an interim injunction blocking the sale of Zydus Lifesciences' Sigrima biosimilar version of Roche's Perjeta (pertuzumab), after the Indian firm failed to disclose to the court that it had earlier received a conditional approval for – and later launched – its biosimilar. Such action "suggests a strategic move by the defendant to establish a market presence before any potential judicial restrictions could be imposed," according to the court... Global Sub. Full

Xbrane Inching Closer To Cimzia Biosimilar Trials With Batch Production

(7/17, Dean Rudge, Generics Bulletin) ...Sweden's Xbrane Biopharma has delivered updates for two of its more long-term projects, including a proposed biosimilar to Bristol Myers Squibb's Opdivo for which it is actively seeking a partner. Xbrane Biopharma AB has disclosed progress for its Biogen-partnered BIIB801 proposed biosimilar to Cimzia (certolizumab pegol), producing the first drug substance scale-up batch with the firm's contract manufacturer ahead of plans to produce good manufacturing practice batches during the end of 2024 and beginning of 2025... Global Sub. Full

French Pharma Giant Sanofi Expands GCC in Hyderabad, to Create 1,600 More Jobs by 2026

(7/17, N. Ravi Kumar, The Hindu) ...French pharmaceutical giant Sanofi, through one of its entities in India, is expanding its Global Capacity Centre in Hyderabad with an investment of Euro 400 million (about Rs. 3,600 crore) spread over six years and create additional 1,600 jobs at the facility in the next two years... Full

45 Percent of Americans Unable to Afford or Access Healthcare: Survey

(7/17, Alejandra O'Connell-Domenech, The Hill) ...A new West Health-Gallup survey found that 55 percent of U.S. adults do not report having problems paying for or accessing the medical care and medications they need. In 2022, the percentage of Americans able to access and pay for the healthcare they need was six percentage points higher. Now, 37 percent of U.S. adults are "cost insecure" or "cost desperate," according to the survey, meaning they cannot pay for care or medicine or lack easy access... Full

Merck Asks DC Federal Court for IRA Decision 'As Soon As Practicable'

(7/17, Nicole DeFeudis, Endpoints News) ...Merck was the first pharmaceutical company to file suit against the Inflation Reduction Act in June 2023. But more than a year later, it still doesn't have a decision. On Wednesday, the company asked the US District Court for the District of Columbia to hurry up. Merck is now requesting that the court "give priority consideration to resolving this case as soon as practicable." This way, the company has time to appeal if necessary before the IRA's "regime of forced sales takes full effect in 2026."... Full

J&J Has its Final Offer in Hand from the Government Over IRA Pricing

(7/17, Katherine Lewin, Endpoints News) ...Johnson & Johnson said the final price offers it has received under the IRA won't affect the long-term sales growth projection it gave last year, making it the latest drugmaker to suggest it can manage the impact of the law...Drugmakers have been walking a fine line between arguing against the law in court, and reassuring investors that they can largely deal with its impacts through smart investing and management of their pipelines. "Whether it's IRA or part D redesign, things of that nature, we certainly can digest those because of the investments we make all along in R&D," CFO Joe Wolk said in an interview with Yahoo Finance later Wednesday... Full

J&J Keeps Growth Projections Afloat as it Braces for IRA Price Negotiation Impact

(7/17, Fraiser Kansteiner, Fierce Pharma) ...While J&J is "not in alignment" with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday. As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said... Full

Big Three PBMs Will Testify Before Congress Next Week, Following FTC Report

(7/17, Drew Armstrong, Endpoints News) ...Pharmacy benefit manager executives from Cigna, CVS Health and UnitedHealth Group are scheduled to testify before Congress on July 23, giving lawmakers a chance to question the companies after a critical report from the Federal Trade Commission earlier this month...CVS confirmed that it had agreed to testify... Full

Attorney General Josh Stein Fights for Drug Pricing Transparency

(7/17, Attorney General Josh Stein) ...Attorney General Josh Stein fought to increase drug price transparency for patients by urging the Court to uphold state laws that require pharmaceutical manufacturers to report information about new prescription drugs and historical information about pricing for existing drugs...The amicus brief filed before the Ninth Circuit Court of Appeals in Pharmaceutical Res. & Manufacturers of Am. v. Stolfi supports Oregon's defense of House Bill 4005, an Oregon law that requires pharmaceutical manufacturers to report certain information about specific new prescription drugs and historical information about pricing for existing drugs... Full

The Unscathed Middleman Fueling Drug Shortages and Challenges for Patients

(7/17, Marcia K. Horn, RealClearHealth) ...Even before patients face the burden of rising out-of-pocket costs at the pharmacy, they can be faced with another barrier that fundamentally impedes their ability to access care: drug shortages. While cancer has been mentioned frequently in recent conversations about how drug shortages upend treatment and care delivery, this challenge extends beyond just one disease area. Behind the challenges of drug shortages in chemotherapy, antibiotics, cardiovascular disease, and other common drug classes are an often-overlooked middleman in the healthcare supply chain... Full

PhRMA Launches New Ad in Campaign Exposing Ways Middlemen Drive Up Costs

(7/17, Alex Schriver, PhRMA) ...Today's announcement falls on the heels of groundbreaking investigations from the New York Times, Wall Street Journal and Federal Trade Commission detailing how the PBM industry is focused on profits at the expense of patients, community pharmacies, employers and others. This effort also makes clear: policymakers can't address medicine costs if they don't take on the middlemen. So, it shouldn't be a surprise that a new Morning Consult/PhRMA poll shows the vast majority of Americans are not only concerned about the harmful practices from PBMs and health insurers, they want policymakers to act... Full

Drug Middlemen in the Hot Seat: Q&A with USC Schaeffer Center's Erin Trish

(7/17, Jason Millman, USC Today) ...Research by USC Schaeffer Center for Health Policy & Economics over the past seven years has revealed the significant role pharmacy benefit managers play in drug prices. The researchers' findings have prompted recent in-depth media coverage and government scrutiny. USC News spoke with Erin Trish, co-director of the USC Schaeffer Center and an associate professor of pharmaceutical and health economics at the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, about the story of how these middlemen affect drug prices and what Congress and regulators may do about it... Full

PhRMA Touts Vaccine R&D Pipeline To Lobby Against Patent Reform, For PAHPA Passage

(7/17, Gabrielle Wanneh, InsideHealthPolicy) ...The brand drug lobby is hopeful a new report detailing the ongoing development of nearly 300 vaccines, including vaccines to train the immune system to fight off Alzheimer's disease and multiple forms of cancers, will ward off renewed interest on Capitol Hill in passing drug patent reforms and reignite efforts to reauthorize provisions in the Pandemic and All-Hazards Preparedness Act... Sub. Req'd

Trump Is Wrong in Claiming Full Credit for Lowering Insulin Prices

(7/18, Jacob Gardenswartz, KFF Health News) ...Trump can claim some credit for lowering insulin costs for seniors, as his administration advanced a voluntary program to do so. But his claim that Biden had "NOTHING to do with it" is patently false. The Inflation Reduction Act, which Biden signed into law, imposed a mandatory Medicare insulin price cap that applied across the program, benefiting a significantly larger number of insulin users — including people not enrolled in Medicare... Full

FDA Guidance Addresses Developing Treatments for Pediatric IBD

(7/17, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis and pediatric Crohn's disease, two types of inflammatory bowel disease. The guidance addresses study population, study design, efficacy considerations, and safety assessments. The guidance does not address extraintestinal manifestations, stricturing or fistulizing disease, or treatment of long-term complications of pediatric UC or CD... Full

Steady On For US FDA's Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

(7/17, Bridget Silverman, Pink Sheet) ...The US FDA approved 27 novel agents in the first half of 2024, behind the torrid approval pace set in 2023 but right on the average since 2016. Almost 40% of candidates with second half 2024 goal dates at the Center for Drug Evaluation and Research's have breakthrough therapy designations, similar to the first half approvals. The Center for Biologics Evaluation and Research has 5 second half goal dates for novel biologics, but would need to approve 11 to match 2023's record-setting total... Sub. Req'd

Vermont Latest State to Sue PBMs for Allegedly Driving Up Drug Prices

(7/17, Brendan Pierson, Reuters) ...Vermont's attorney general on Wednesday sued two of the largest U.S. pharmacy benefit managers, accusing them of driving up prescription drug prices for patients in order to enrich themselves, joining other states that have brought similar claims against the drug industry middlemen...CVS spokesperson Mike DeAngelis said in an email that PBMs bring down prices by negotiating with drugmakers, and do not determine what prices are charged by manufacturers. He said the company intended "to vigorously defend against this baseless suit."... Full

Drug Costs Are Hammering Maryland. This Board is Trying to Change That.

(7/17, Tom Hall, Teria Rogers, and Sam Bermas-Dawes, WYPR) ...Back in 2019, the Maryland General Assembly created the Prescription Drug Affordability Board. Their goal? Lowering the cost of drugs for Maryland residents...So, what is next? Dr. Gerard Anderson is a member of the PDAB and director of the Johns Hopkins Center for Hospital Finance and Management...Anderson joins us to talk about the work of the board and the tools at their disposal... Full

Angry Patients Spur New State Watchdogs to Bring Down Drug Prices

(7/18, Anna Claire Vollers, Virginia Mercury) ...Spurred by fed-up consumers, states are trying to curb spiraling prescription drug costs by assembling special public boards to investigate and regulate pricing...Over the past five years, 11 mostly Democratic-led states have created prescription drug affordability boards, and the model is picking up steam nationwide. Just this year, lawmakers in 14 more states proposed legislation to assemble their own boards... Full

EU Orphan Drugs: Pricing And Regulatory Barriers More Problematic Than Competitors

(7/17, Eliza Slawther, Pink Sheet) ...The EU is among several jurisdictions to have introduced a specific incentive framework for orphan medicines, but the current offering does not address some of the main hurdles faced by developers, according to Lincoln Tsang, head of law firm Ropes & Gray's European life sciences practice... Sub. Req'd

Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development

(7/17, Skylar Jeremias, The Center For Biosimilars) ...The World Health Organization's 2022 revisions to biosimilar approval guidelines, which allow non-local reference products, aim to save time and costs for manufacturers, impacting Middle East and North African regulatory frameworks. However, a recent review found that only Egypt has adopted these guidelines, with regional hesitancy to source comparators outside the US or Europe hindering market development... Full

Pharma Companies On Track with QR Codes to Combat Counterfeit Drugs

(7/17, Anjali Singh, Business Standard) ...As the drug regulator is set to crack down on companies to check compliance with printing QR codes on top-selling brands to curb counterfeiting, top pharma companies say they are on track. The pharma industry has welcomed the Drug Controller General of India (DCGI) mandate as they view it as a positive step to combat counterfeit drugs and ensure patient safety...Pharmaceutical companies have also highlighted the benefits of QR codes beyond just combating counterfeiting. They believe the system can enhance transparency throughout the supply chain and empower patients to make informed decisions about their healthcare... Full

Guideline Promotes Pharma Innovation

(7/18, Wang Keju, China Daily) ...Addressing the bottlenecks of pricing, payments and the dominance of incremental innovation are crucial steps for China to unlock the full potential of its pharmaceutical sector, analysts said, calling for the introduction of specific policy measures at an early date. The National Medical Products Administration has granted approvals for a total of 82 innovative drugs and 138 innovative medical devices from 2022 through the end of May this year. Notably, in the first five months alone, 20 innovative drugs and 21 innovative medical devices have received regulatory clearance... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.