Wednesday, July 24, 2024

Gross-to-Net Bubble Update: 2023 Pricing Realities at 10 Top Drugmakers

(7/23, Adam J. Fein, Ph.D., Drug Channels) ...This year's review includes the following 10 companies: Bristol Myers Squibb, Eli Lilly and Company, Genentech, GlaxoSmithKline, Merck, Novo Nordisk, Sanofi, Takeda, Teva, and UCB...When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2023. For the companies that experienced net price gains in their portfolios, net prices grew more slowly than—or only slightly faster than—the overall inflation rate...For the eight companies with multiple years of data, the gross-to-net difference in price changes remained sizable... Full

Boehringer Offers 92% Discount On Adalimumab Via GoodRx

(7/24, David Wallace, Generics Bulletin) ...Boehringer Ingelheim is partnering with GoodRx in the US to offer a version of its Humira biosimilar at a 92% discount to the brand's list price. Generics Bulletin spoke with Chris Marsh, Boehringer's senior vice president of value and access, about the initiative... Global Sub. Full

Hikma Extends Recall of Pain Drug Due to 'Potential Presence' of Sedative, Reports Adverse Event

(7/23, Zoey Becker, Fierce Pharma) ...After Hikma initiated a recall of one batch of acetaminophen injection earlier this month, the company is extending the nationwide recall to the consumer level. The company started the recall due to the "potential presence" of a bag labeled dexmedetomidine HCL injection inside packaging labeled for acetaminophen injection, a pain med. Dexmedetomidine is a sedative often used before or during surgery... Full

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU

(7/24, Bio-Thera Solutions Ltd.) ...Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara® (ustekinumab) seeking a commercial license in the United States of America. In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union... Full

The Obesity Drug Race is Being Fought On the Manufacturing Floor As GLP-1 Rivals Make Plans to Catch Leaders

(7/23, Anna Brown, Endpoints News) ...While Lilly and Novo have the market to themselves for now, their competitors are making their own plans. Boehringer Ingelheim and Zealand Pharma are closest to market with their Phase 3 drug survodutide, while Roche and Amgen are in Phase 2...Both Boehringer and Roche also told Endpoints they are open to using third-party manufacturers...Viking Therapeutics is also "open to engaging" with other companies that can advance its GLP-1 assets, a spokesperson said. Investors have pegged Viking as an attractive acquisition target for large pharma companies looking to add a GLP-1 asset to their pipeline... Full

Novo Nordisk's Wegovy Gets UK Approval for Use to Lower Heart Risks

(7/23, Leroy Leo and Maggie Fick, Reuters) ...Novo Nordisk's weight-loss drug Wegovy secured the UK regulator's approval for its use to reduce the risk of serious heart problems or strokes in overweight and obese adults, the agency said on Tuesday...The MHRA's decision makes Wegovy the first GLP-1 weight-loss drug to be prescribed for prevention of cardiovascular events in people with obesity, the agency said... Full

Gland Pharma, Zydus Lifesciences Secure USFDA Approvals for Key Medications

(7/23, Business Standard) ...Two major approvals of medications from the US Food and Drug Administration have come today. Gland Pharma and Zydus Lifesciences have received crucial approvals for Latanoprostene Bunod Ophthalmic Solution (eye drops) and Valsartan Tablets (treats hypertension)... Full

Alembic Pharma Gains Up to 10% After it Gets USFDA Nod for Antipsychotic Drug

(7/24, CNBC TV 18) ...Shares of Alembic Pharmaceuticals Ltd surged nearly 10% to trade at a 52-week high of 1,192.75 apiece on the BSE on Wednesday after the company announced securing approval from the United States Food and Drug Administration for its antipsychotic drug. Alembic Pharmaceuticals informed the exchanges in a filing that it has received final approval from the US drug regulator for its Abbreviated New Drug Application for Fluphenazine Hydrochloride Tablets USP 1 mg, 2.5 mg, 5 mg, and 10 mg... Full

Pharma Aims to Deliver Personalized Cancer Therapies More Quickly

(7/24, Michael Erman, Reuters) ...Big pharmaceutical companies that make personalized blood cancer treatments are working to cut the manufacturing turnaround time by as much as half in coming years, as they try to deliver them sooner in a patient's disease course...Novartis is aiming for 10 days or less in the U.S. for its next generation of treatments through its rapid manufacturing platform T-Charge...J&J in a statement said it doubled its CAR-T manufacturing capacity last year and is striving to double it again in 2024. It said it is working to further reduce treatment times... Full

Merck & Co.'s mAB Prevents RSV in Infants, Teeing Up Talks with Regulators

(7/23, James Waldron, Fierce Biotech) ...Moderna recently became the latest biopharma to score an approval to prevent respiratory syncytial virus, but Merck & Co. hopes to be the next in line with new data showing a monoclonal antibody reduced the incidence of RSV-related infections in infants... Full

GSK, Pfizer and Moderna Face RSV Vaccine Sales Slump

(7/23, Ian Johnston and Oliver Barnes, Financial Times) ...GSK, Pfizer and Moderna together face an almost threefold reduction in adult respiratory syncytial virus vaccine sales in the US, according to new forecasts, after a health committee narrowed its recommendation for the drug's use. The US market for RSV in elderly adults could shrink from $4.7bn a year by 2030 to $1.7bn, according to new analysis by data provider Airfinity, after a US Centers for Disease Control and Prevention committee restricted its endorsement to older patients and those most at risk, and opted not to recommend booster vaccines for adults... Sub. Req'd

Torrent Pharma Q1 Results | Net Profit Misses Estimates, Rises 20% to 457 Crore

(7/23, Jomy Jos Pullokaran, CNBC TV 18) ...Torrent Pharmaceuticals Ltd on Tuesday (July 23) reported a 20.1% year-on-year (YoY) increase in net profit at ?457 crore for the first quarter that ended June 30, 2024. In the corresponding quarter, Torrent Pharmaceuticals posted a net profit of 378 crore, the company said in a regulatory filing. The CNBC-TV18 poll had predicted a profit of 458 crore for the quarter under review... Full

Big Pharma Earnings: Johnson & Johnson and Novartis

(7/23, The Campaign for Sustainable Rx Pricing) ...Last week, brand name drug giants Johnson & Johnson and Novartis reported earnings for the second quarter of the year. Both companies topped Wall Street analysts' earnings expectations after hiking prescription drug prices earlier this year. Novartis' earnings were so strong that the company raised its forecast for the year – the second time this year the company has done so as a business-as-usual approach to price-gouging patients continues to pay off for Big Pharma giants... Full

The Future of Biosimilars: Q&A with Matt Erick

(7/24, Mike Hollan, PharmExec.com) ...The biosimilars market may be off to a slow start, but experts expect 2024 to be a big moment for the market. Matt Erick, chief commercial officer of advanced markets at Biocon Biologics, discusses the current state of the market and how it may change in the coming months... Full

RxLink and ConnectiveRx Partner to Further Expand Patient Medication Affordability

(7/23, RxLink and Connective Rx) ...This collaboration takes a patient-first approach, enabling healthcare providers to help patients reduce their out-of-pocket prescription costs by providing access to available savings options from pharmaceutical manufacturers and sending those directly to the patient via text... Full

Prescription-Drug Middlemen Face Mounting Bipartisan Criticism On Capitol Hill

(7/23, Eleanor Laise, MarketWatch) ...Top executives at the largest U.S. pharmacy-benefit managers sought to defend their business practices on Capitol Hill on Tuesday, as lawmakers on both sides of the aisle excoriated the industry's impact on the cost and accessibility of prescription drugs...The hearing underscored the market power of prescription-drug intermediaries that are well off the radar screen for most U.S. consumers... Full

PBMs Defend Business Practices — But Lawmakers Aren't Convinced

(7/23, Noah Tong, Fierce Healthcare) ...When they were asked repeatedly about steering patients, increased drug prices and pharmacy closures, the company executives largely refuted claims thrown at them...But its explanations were met with disbelief by lawmakers that felt they were being lied to. Lawmakers consistently brought data and anecdotes from patients and pharmacies, showing that its practices were increasing drug prices and driving pharmacies out of business... Full

PBM Executives Dodge Grilling in House Committee Hearing

(7/23, Zachary Brennan, Endpoints News) ...At the hearing, lawmakers and PBMs brought up the example of Humira, AbbVie's blockbuster drug that has long eluded competition from cheaper versions...In a statement to Endpoints News after the hearing, Express Scripts said, "we strongly disagree with the report's unsubstantiated conclusions, which are not reflective of the thousands of documents we submitted and only included portions that serve a biased, incomplete narrative."... Full

PBM Execs Stay On Message Amid Growing US Congressional Frustration At Hearing

(7/23, Cathy Kelly, Pink Sheet) ...Committee Chair James Comer, R-KY, disputed the PBM executives' assertions that their operations already are transparent, arguing that the companies' establishment of subsidiaries abroad during the last five years shows they are interested in avoiding transparency and US government oversight... Sub. Req'd

PCMA Statement On House Oversight Hearing

(7/23, PCMA) ..."We encourage the U.S. House Oversight Committee lawmakers to engage in a balanced discussion that accurately considers the cost-reducing role of PBMs and the value they deliver for health plan sponsors, taxpayers, employers, and patients," said JC Scott, president and CEO of PCMA... Full

CVS Caremark® Defines Future of Pharmacy Benefit Management

(7/23, CVS Caremark) ...CVS Caremark®, the nation's leading pharmacy benefit manager and a CVS Health® company, today announced a renewed pledge to American businesses, unions, and health plans — building on what the company is doing to deliver greater transparency, lower drug costs, and better clinical care for the most utilized health benefit... Full

The FTC Goes Evidence-Free

(7/23, Joel Zinberg, The Wall Street Journal) ...My own study for the Competitive Enterprise Institute, as well as studies by University of Chicago economist Casey Mulligan, found that PBMs foster competition that lowers drug costs. Mr. Mulligan estimates that PBMs produce at least $145 billion in annual value to society beyond their resource costs...The new FTC report doesn't explain what changed from earlier FTC findings or provide research supporting its new conclusions. As FTC Commissioner Melissa Holyoak writes in a dissenting statement, the agency's new report fails to examine the basic question of "how PBM practices affect consumer prices."... Sub. Req'd

Advocates Meet with White House to Urge Inclusion of Adderall, Other Stimulants in Upcoming Telehealth Prescribing Rule

(7/23, Emma Beavins, Fierce Healthcare) ...The American Psychiatric Association presented at the White House meeting and told the administration it should not create a blanket in-person visit requirement for the prescription of controlled stimulant medications like Adderall, Concerta and Ritalin. It also urged it to deliver the proposed telemedicine rulemaking before there are more complications for practices. "Any further delay in the rule could pose challenges for a lot of practices and organizations," a member of APA's Committee on Telepsychiatry and practicing psychiatrist, Shabana Khan, told Fierce Healthcare... Full

RELEASE: Industrial Policy To Reduce Prescription Generic Drug Shortages

(7/23, Center for American Progress) ...Shortages of prescription generic drugs, which account for nearly 90 percent of prescriptions, are frequent and can last for several months and at times for years. A new Center for American Progress report examines economic conditions affecting generic drug supply and identifies policy interventions—including a coordinated set of public-private actions—to reduce shortages and avert patient harm... Full

Industrial Policy To Reduce Prescription Generic Drug Shortages

(7/23, Marc Jarsulic, Center for American Progress) ...The structure of demand and supply contributes to quality problems and production disruption for generics. Competitive conditions among producers and the market power of buyers discourage investment in capacity and inventories needed to sustain reliable sources of critical drugs, making generic supply quite vulnerable. Policy intervention, including creating national buffer inventories of priority generics and encouraging large-scale public-private partnerships either to direct demand to reliable low-cost suppliers or to support the creation of reliable nonprofit production, can reduce shortages and help avoid patient harm... Full

Former J&J Employee Urges Court to Keep Drug Cost Suit Alive

(7/23, Lauren Clason, Bloomberg Law) ...A past-employee of Johnson & Johnson Inc. urged a federal court to nix the company's attempt to toss her complaint over excess prescription drug costs in its health insurance plan, arguing that higher premiums and copays justify her lawsuit... Sub. Req'd

U.S. Patent Office Software Mistakes Extend Patent Life for Drugs and Need to Be Fixed, Researchers Say

(7/23, Ed Silverman, STAT Plus) ...Amid concerns that the pharmaceutical industry abuses the U.S. patent system, a new paper suggests one way to crack down on the problem — amend a little-known method for correcting mistakes that lengthen the life of a patent and, consequently, can greatly add to the cost of medicines. The idea is to improve the way administrative delays are handled at the U.S. Patent & Trademark Office... Sub. Req'd

Cassidy Introduces Bill That Would Further Restrict Agencies Post-Chevron

(7/23, Sigi Ris, InsideHealthPolicy) ...Senate health committee ranking Republican Bill Cassidy (LA) introduced legislation Tuesday (July 23) that would place further restrictions on federal regulations following SCOTUS' overturn of Chevron deference last month. Cassidy introduced the Upholding Standards of Accountability Act, which would give Congress more oversight over federal agencies... Sub. Req'd

Lawmakers Wary As Experts Advocate For New Congressional Regulatory Office Post-Chevron

(7/23, Sigi Ris, InsideHealthPolicy) ...Lawmakers seemed unconvinced of the feasibility of setting up a new regulatory office to help chart paths forward for Congress in the wake of SCOTUS' overturn of Chevron deference, as exerts pitched the idea at a House Administration hearing Tuesday (July 23)... Sub. Req'd

Reed, Whitehouse Seek to Put a Stop to Rx Drug Makers Getting Tax-Reduction Benefits for Advertising

(7/23, U.S. Senator for Rhode Island Sheldon Whitehouse) ...To prioritize patient well-being and promote professional health guidance over commercial interests, Senators Reed and Whitehouse are teaming up with Senator Jeanne Shaheen (D-NH) and colleagues in offering the No Tax Breaks for Drug Ads Act (S.4691). This legislation would close special interest tax loopholes and prohibit pharmaceutical drug manufacturers from claiming tax deductions for expenses on advertising directly to consumers... Full

Brand-Backed ASBM Pushes Back On Biosimilar Reforms

(7/23, David Wallace, Generics Bulletin) ...Brand-backed association the Alliance for Safe Biologic Medicines has expressed caution over FDA findings that bolster the case for biosimilar switching and suggest a reduction in the need for switching studies to support interchangeability...The pushback from the ASBM comes against the backdrop of recent US Food and Drug Administration moves to reduce the need for switching studies to demonstrate biosimilar interchangeability, or even eliminate the interchangeability distinction altogether... Global Sub. Full

Colorado PDAB Wants More Rebate Info, Patient Input, Lower Cost Thresholds

(7/23, Luke Zarzecki, InsideHealthPolicy) ...Colorado's prescription drug affordability board recommends the state legislature take steps to strengthen consumer input, change eligibility thresholds and include more rebate data in the board's process of reviewing prescription drugs in a report on its 2023 activities released this month... Sub. Req'd

Attorney General Ellison Secures More Low-Cost Insulin for Minnesotans

(7/23, Attorney General Keith Ellison) ...Today, Attorney General Keith Ellison announced a settlement with Sanofi-Aventis U.S. LLC which guarantees that all Minnesotans, with or without insurance, can buy Sanofi's insulin products for $35 per month for the next five years...The terms of the settlement will come into effect within 90 days of July 19, 2024... Full

AbbVie Files Lawsuit in Missouri Federal Court Over 340B Contract Pharmacies

(7/23, Nicole DeFeudis, Endpoints News) ...The Chicago pharma giant on Monday filed suit in Missouri over a new state law that would keep drugmakers from imposing restrictions around 340B, a federal drug discount program created to help hospitals serving low-income populations. The program has grown significantly in recent years and as a result, some drug companies — including AbbVie — have set their own limits on discounts to third-party pharmacies, also known as contract pharmacies... Full

CVS and its PBM Agree to Pay $45 Million to Illinois for Failing to Pass Drug Rebates

(7/23, Ed Silverman, STAT Plus) ...CVS Caremark, one of the largest pharmacy benefit managers in the country, agreed to pay at least $45 million to the state of Illinois to settle allegations that rebates were not passed through during a recent four-year period, according to a document obtained by STAT...A CVS spokesman wrote to say that, "in this matter, there was a dispute about a definition and related payment obligations, and while we did not agree with the State's position, the issue has been resolved. The state of Illinois recently renewed its contract with CVS Caremark, and we look forward to continue working with the state for the benefit of its employees."... Sub. Req'd

Maryland Unveils New Dashboard to Track Drug Overdose Data

(7/23, Scott Maucione, WYPR) ...The Maryland Department of Health released a new online drug overdose dashboard Tuesday, that will allow visitors to home in more deeply into demographic and geographic data. The dashboard is a new iteration of the state's previous site, which was maintained by Maryland's Office of Overdose Response... Full

Environmental Risk Assessments To Loom Larger In EU Drug Reviews

(7/23, Ian Schofield, Pink Sheet) ...The European Parliament's amendments to the "pharmaceutical package" include stricter obligations on pharma firms in terms of environmental risk assessments. Key changes include widening the scope of the ERA to include the manufacturing stage, and a requirement to publish the entire ERA rather than just a summary...One industry executive believes that "by no means" should marketing authorizations be revoked or refused on the basis of an ERA... Sub. Req'd

Post Budget Analysis - Impact On The Healthcare Industry

(7/24, Kavi Bhandari, BW Healthcare) ...At the ‘Union Budget 2024 - Road to Viksit Bharat, BW Businessworld - Day 2', experts joined Harbinder Narula, CEO, BW Healthcare World & BW Wellbeing World, who moderated a panel discussion on the impact of this year's Union Budget on the healthcare sector... Full

Not Much to Cheer About the Health Budget, A Mere 2 Percent Rise

(7/23, Kavita Bajeli-Datt, The New Indian Express) ...The health budget for the fiscal year 2024-25 received only a modest two percent increase, raising concerns among experts about its adequacy in addressing India's healthcare needs. In her budget speech, Finance Minister Nirmala Sitharaman made a single reference to healthcare, the exemption of three cancer medicines from customs duty. While this move was welcomed, experts emphasized the need for more comprehensive measures, particularly in light of India's rising cancer rates, which have earned it the title of the "cancer capital of the world."... Full

Relief for Patients as Budget Exempts Three More Cancer Medicines from Customs Duties

(7/23, Kavita Bajeli-Datt, The New Indian Express) ...The three medicines are Trastuzumab Deruxtecan, Osimertinib and Durvalumab. Experts and cancer specialists welcomed the move to exempt the medicines from customs duties, considering the rising incidence of cancer in India. Dr. Mandeep Singh Malhotra, Director of Surgical Oncology at C K Birla Hospital, Delhi, said, "Exempting these drugs from basic customs duty will lower their import costs, making them more affordable for patients."... Full

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