Monday, July 15, 2024

Federal Court Blocks Immediate Delisting Of Teva Inhaler Patents

(7/12, Jessica Karins, InsideHealthPolicy) ...A district court order for Teva Pharmaceuticals to delist several of its inhaler patents from FDA's Orange Book has been stayed pending further notice by the U.S. Court of Appeals for the Federal Circuit. The ruling in Teva's appeal of a New Jersey court ruling is a blow to the Federal Trade Commission, which has weighed in on the case as part of its broader, high-profile effort to prevent combination product makers from using Orange Book device patent listings to delay generic competition... Sub. Req'd

U.S. Senate Passes Bill to Trim Big Pharma "Patent Thickets"

(7/12, Val Brickates Kennedy, Seeking Alpha) ...The bill, called the Affordable Prescriptions for Patients Act, was sponsored by U.S. Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT). The legislation moves next to the U.S. House for consideration...Blumenthal added, "Our bipartisan, commonsense measure to crack down on Big Pharma's shameless abuse of the patent system will protect competition and reduce prices at the pharmacy." Leading generic drugmakers include Teva, Dr. Reddy's, Viatris, Sandoz, Amneal and Amphastar... Full

Generics Bulletin Explains: After Humira Biosimilars, Will It Be Groundhog Day For Stelara?

(7/15, David Wallace, Generics Bulletin) ...So far, US launch dates under publicly-disclosed settlements include frontrunner Amgen with January 1, 2025; followed by Alvotech and Teva on February 21,; alongside Sandoz and Samsung Bioepis a day later, on February 22...Recalling that "when adalimumab biosimilars were launched in Europe, there was double-digit volume growth for multiple years in a row," [Alvotech chief strategy officer Ming Li] said "we expect something similar in the Stelara market, being that it's potentially underserved in many markets around the world." Tom Rainey, Teva's senior vice president of US market access, concurred. "This is a really big opportunity, I think, for Teva to reduce healthcare costs," he told Generics Bulletin... Global Sub. Full

Fresenius Follows US Denosumab Filing With EU Acceptance

(7/15, David Wallace, Generics Bulletin) ...Fresenius Kabi's denosumab biosimilar filing has been accepted by the European Medicines Agency, coming hot on the heels of a US submission...Celltrion has previously disclosed an FDA filing for its CT-P41 candidate, while Teva has an in-house-developed denosumab biosimilar in Phase III trials. And Samsung Bioepis late last year reported positive Phase I and Phase III trial results for its SB16 proposed denosumab biosimilar... Global Sub. Full

AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Giant Cell Arteritis

(7/12, AbbVie) ...AbbVie today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration and European Medicines Agency for upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA)... Full

FDA Approves Lupin's Topiramate Extended-Release Capsules

(7/15, The Pharma Letter) ...India-based generic drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for topiramate extended-release capsules, 25mg, 50mg, 100mg, and 200mg...Lupin also announced that it has received the Establishment Inspection Report from the US FDA for its manufacturing facility located in Dabhasa, Gujarat. The EIR was issued post the last inspection of the facility conducted from April 8 to April 12, 2024... Sub. Req'd

Alembic Pharma Gets Tentative US FDA Nod For Pulmonary Arterial Hypertension Treatment

(7/12, Shreya Sur, NDTV Profit) ...The company has received approval for its abbreviated new drug application, Selexipag for Injection, 1,800 mcg per vial, according to an exchange filing. The approved ANDA is therapeutically equivalent to the reference listed drug product, Uptravi for Injection, 1,800 mcg/vial, of Actelion Pharmaceuticals US, Inc... Full

Indivior Axes Schizophrenia Drug and Shrinks Revenue Guidance

(7/12, Max Bayer, Endpoints News) ...On Tuesday, the company said that it was cutting its revenue projections to $1.15 billion to $1.215 billion, down from the $1.24 billion to $1.33 billion it projected in late May.  In the statement, CEO Mark Crossley cited "a combination of transitory factors" for the cut, including a decreasing number of people covered through Medicaid. Indivior also said it was experiencing "lower-than-expected stocking levels" of its lead drug, and said the cyberattack on UnitedHealth's Change Healthcare had "a greater than expected impact."... Full

Lilly Says Lupus Drug Dropped from Pipeline Failed to Show Efficacy

(7/12, Max Bayer, Endpoints News) ...An experimental BTLA agonist that Eli Lilly cut from its pipeline for lupus late last year failed to show strong enough efficacy in a mid-stage trial, the company confirmed to Endpoints News...Lilly has said it remains invested in treating lupus, and Paul Klekotka, Lilly's VP of medical immunology, told Endpoints in June that the disease remained "in scope" despite previous trial failures... Full

AstraZeneca Closes Acquisition of Amolyt Pharma

(7/15, Amolyt Pharma) ...The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism... Full

BMS' Long-Standing Leukemia Blockbuster Stares Down its First Generic

(7/12, Amy Baxter, PharmaVoice) ...BMS settled with XSpray last year, settling all pending litigation, but also paving the way for XSpray to launch a generic dasatinib as soon as Sept. 1, 2024...The contested patents were not set to expire until Sept. 28, 2026. However, XSpray has a PDUFA date of July 31 for its "optimized version of dasatinib," Dasynoc. If Dasynoc is OK'd, it will join dozens of new generics approved across indications in 2024, including several cancer drugs. With this wave of generics, branded oncology treatments could see a price drop overall, according to IDP Analytics. There are more dasatinib generics in development from a handful of other pharma companies, including Biocon and Teva... Full

Abecma Competition, Sotyktu Pricing Pressure and IRA: Analysts Outline Bristol Myers' Top Challenges

(7/12, Angus Liu, Fierce Pharma) ...A Leerink team led by David Risinger has lowered its revenue forecast for several important BMS growth products from 2025 and beyond. The TYK2 anti-inflammation drug Sotyktu, the S1P receptor modulator Zeposia, the multiple myeloma CAR-T Abecma, the immunotherapy fixed combo Opdualag, and the newly acquired antipsychotic candidate KarXT each face their own challenges, the team said. In addition, industry watchers will have a better idea on the price-reduction impact of the Inflation Reduction Act for BMS' Pfizer-partnered megablockbuster blood thinner Eliquis later this year... Full

IPD Analytics' Jeffrey Casberg Discusses Recent Biosimilar Approvals

(7/14, Cameron Santoro, The Center For Biosimilars) ...Jeffrey Casberg, MS, RPh, senior vice president of pharmacy at IPD Analytics, discussed the FDA approvals of new drugs and what these new launches could mean for drug pricing. He also spoke to the approach pharmacy and therapeutics committees take to reviewing new pipeline drugs... Full

Study: Most Drug Products Recouped Development Costs Within a Decade of Approval

(7/12, Jeff Craven, Regulatory Focus) ..."Our findings suggest that most products had net discounted sales that exceeded the average costs of development within 10 years of approval. For these products, patents, data protection, and other regulatory exclusivities appear to provide brand-name drug makers with generous market protection," Olivier J. Wouters, assistant professor of health policy at the London School of Economics and Political Science, and colleagues wrote... Full

Eighth Annual Navitus Drug Trend Report Reveals How Plan Sponsors Save on Prescription Drugs Amid Rising Costs and Inflation

(7/15, Navitus) ...Navitus, an innovative pharmacy benefit manager, released its 2023 Drug Trend Report today. The eighth annual report shows a year-over-year trend of 6.8% within the commercial book of business. 29% of Navitus commercial clients paid less for prescription drugs in 2023 than they did the previous year - even with inflation and the growing use of expensive new medications like GLP-1s... Full

House GOP Approps Blast March-In, Push 340B Reform & Tweaks To Drug Negotiation, Medicaid Rebate Rule

(7/12, Gabrielle Wanneh, InsideHealthPolicy) ...GOPA report accompanying House appropriators' HHS 2025 spending bill lays out Republicans' stance on a handful of key health care issues...The spending report echoes the drug industry's concerns that allowing the government to use march-in rights to lower drug costs would adversely impact innovation of future treatments and cures... Sub. Req'd

Groups: CMS Has Tools To Fix IRA Formulary Issues That Limit Part D Savings To Patients

(7/12, Sigi Ris, InsideHealthPolicy) ...CMS has tools at its disposal to protect Part D beneficiaries from insurance policies the drug industry lobby says could limit patients' ability to benefit from lower prices negotiated under the Inflation Reduction Act, according to a report from the Alliance of Aging Research and Manatt. The Alliance and Manatt suggest CMS set general minimum standards for plans participating in Part D, including regulating which drugs are put on plans' specialty tiers, and improve the beneficiary appeals process... Sub. Req'd

Medicare Drug Pricing Rules Will Delay Access to Promising Therapies

(7/15, Peter Rheinstein, STAT) ...Medicare's new guidelines cover how it will conduct the drug price negotiations authorized by the Inflation Reduction Act. Unfortunately, the Centers for Medicare and Medicaid Services is interpreting the law in a way that will discourage companies from finding new uses — sometimes lifesaving new uses — for existing drugs. It will also deter companies from doing research on existing medicines to create improved versions that are more effective and have fewer side effects... Full

How The IRA Factored Into Akebia's Price For Vafseo

(7/12, Alaric DeArment, Pink Sheet) ...Akebia said that it had set the price for Vafseo, recently approved for anemia in CKD patients on dialysis, at $1,278 for a 30-day supply...[Akebia CCO Nik Grund] "Our expectation is that our medical and regulatory teams will engage with the FDA this year on a path forward to potentially making the product available for non-dialysis patients. We expect we will be reimbursed by Medicare Part D and commercial plans. This was an important consideration when making this strategic pricing decision."... Sub. Req'd

Novo Nordisk Faces Scrutiny On Capitol Hill for Pulling Levemir Insulin from US Market

(7/12, Maggie Fick, Ahmed Aboulenein, Reuters) ...Democratic U.S. Senate aides will meet with Novo Nordisk executives on Tuesday to discuss fallout from its decision to stop selling one of its long-acting insulins in the country, two sources familiar with the meeting told Reuters. Novo Nordisk will meet with the aides for Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren... Full

Counting On Insulin Manufacturers To Do The Right Thing Is Not A Good Policy Prescription To Avert Shortages

(7/12, Melissa Barber, Athena Sofides and Reshma Ramachandran, Health Affairs) ...The continued policy neglect around drug discontinuations - the rare emergency for which health systems can anticipate and plan - is a missed opportunity. Policymakers should work to close these gaps and ensure policies and resources are in place to prevent discontinuations from affecting patients... Full

Senate Unanimously Endorses Legislation Targeting Pharma 'Patent Thickets'

(7/12, Zoey Becker, Fierce Pharma) ...Thursday, the Senate unanimously the bipartisan Affordable Prescriptions for Patients Act, which looks to limit the number of patents drugmakers can assert in litigation on individual biological products. The bill aims to fight "patent thicketing," a tactic the branded drug industry uses to delay or thwart competition... Full

Curbs On Patent Thicketing Welcomed by Campaigners

(7/12, The Pharma Letter) ...Concerns have been expressed by trade association the Pharmaceutical Research and Manufacturers of America (PhRMA), but campaign group Patients For Affordable Drugs Now (P4ADNow) has hailed the passage of S-150, describing it as significant progress toward ensuring that all Americans can access the drugs they need at prices they can afford... Sub. Req'd

Biosimilars Council Applauds Senate Passage of Cornyn-Blumenthal Patent Thicket Legislation

(7/12, Biosimilars Council) ..."The Biosimilars Council and AAM applauds unanimous Senate passage of the Cornyn-Blumenthal legislation," said Craig Burton, Executive Director of the Biosimilars Council. "Patent thickets are used by brand pharmaceutical companies to maintain high prices and deny patients access to lower-cost medicines. This legislation is a great step in curbing these abuses and will help increase competition and access for biosimilars. We encourage the House to take up this legislation and for Congress to continue working to help lower costs for patients."... Full

The Real Reason Drug Costs Are So High in America

(7/14, Paul Alexander, The Hill) ...Earlier this month, President Biden and Sen. Bernie Sanders (I-Vt.) published an oped about "the outrageous prices that the pharmaceutical industry charges the American people for prescription drugs."...Actually, there is a fairly straightforward reason why Americans are paying more for drugs in general - and Ozempic in particular - compared to other countries. The problem is the Pharmacy Benefit Manager, commonly known as a PBM... Full

At the Breaking Point: The Unsustainable Future of Government Drug Discount Programs

(7/12, Adam J. Fein, Ph.D., Drug Channels) ...The current model isn't working. Without greater collaboration and better alignment of incentives, the corrosive existing mistrust among stakeholders will make the drug discount system more dysfunctional, resulting in more revenue leakage and lost opportunities. Patients need and deserve better... Full

Shaheen Reintroduces Bill to Stop Big Pharma from Exploiting Advertising Tax Loophole

(7/12, U.S. Senator for New Hampshire Jeanne Shaheen) ...U.S. Senator Jeanne Shaheen (D-NH) recently reintroduced the No Tax Breaks for Drug Ads Act to prohibit pharmaceutical drug manufacturers from claiming tax deductions for expenses on advertising directly to consumers. Under current law, drug manufacturers are allowed to deduct the cost of advertising expenses from federal taxes, meaning taxpayers pay more of their hard-earned money for life-saving drugs while drug manufacturers get a tax break. U.S. Representative Elissa Slotkin (MI-07) introduced a companion bill in the House of Representatives... Full

Life After Chevron: User Fee Cycle May Help US FDA In Era Of Uncertainty

(7/12, Michael McCaughan, Pink Sheet) ...The US Supreme Court's June 28, decision overturning the so-called "Chevron Doctrine," which guided judicial review of agency actions for decades, opens up new avenues to challenge FDA policies and practices. At a minimum, the agency can expect more litigation in the coming years and the very real prospect that seemingly settled regulatory precedents may be suddenly unsettled... Sub. Req'd

How SCOTUS' Decision in Chevron Could Change the Way the FDA Regulates Biopharma

(7/12, Zachary Brennan, Endpoints News) ...What might be affected? Experts pointed to the recent example of proposed FDA regulations for lab-developed tests. The agency's latitude in interpreting the law has been challenged and may be further challenged. The House Appropriations Committee this week even went so far as to instruct the FDA to "suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs."... Full

FDA Stakeholders See Large Cuts Lurking In Both Chambers' Approps Bills

(7/12, Jessica Karins, InsideHealthPolicy) ...The leading organization of FDA stakeholders is disappointed with both the House and Senate versions of fiscal 2025 funding legislation for FDA, saying they fail to account for the agency's mandatory pay raises and increasing regulatory responsibilities and would amount of a de facto funding cut between $100 million and $150 million... Sub. Req'd

IGBA Identifies Streamlined Development Through Reduced Comparative Clinical Studies and Appropriate Use of Global Comparator Product as Key to Greater Biosimilar Access

(7/12, IGBA) ..."Comparative clinical studies lack scientific validity and offer no new information to regulators or health care providers. The savings in time and resources from eliminating these duplicative requirements could have a meaningful impact on patient access. Education of all stakeholders will continue to be important," says Gillian Woollett, Co-Chair, IGBA Biosimilars Committee... Full

Rise In Threats Prompts Call To Shield Expert Identities Under EU Access To Document Policy

(7/12, Vibha Sharma, Pink Sheet) ...Regulators in the EU are being urged to refrain from their practice of revealing to third parties the names of individuals with legally defined roles and responsibilities in marketing authorization applications when they deal with requests for access to documents. The move is needed because of the risk to the security of the individuals concerned according to the European industry federation, EFPIA, which is calling for the change... Sub. Req'd

Pharma Regulation Reforms Would ‘Heavily Impact' Ireland, Government Told

(7/15, Jack Power, The Irish Times) ...Ireland would be "heavily impacted" by plans to change how the European Union regulates the pharmaceutical industry, Pfizer and other big pharma companies have privately warned Taoiseach Simon Harris...Teva Pharmaceutical, an Israeli multinational firm based in Ireland, also lobbied Minister for Health Stephen Donnelly on the reforms, according to correspondence released to The Irish Times under the Freedom of Information Act. The company said some elements of the EU proposals would "aggravate" medicine shortages across Europe in a March 8th letter...The company said the proposed new rules would not help solve the problem of lack of access to medicines... Full

Germany Inches Closer to Confidential Pricing for Drugs

(7/15, Phil Taylor, Pharma Phorum) ...Germany's recent adoption of the Medical Research Act means that, for the first time, it could become possible for drugmakers to keep their reimbursement price negotiations with the statutory health insurance funds under wraps, as occurs in other European markets including the UK... Full

Pharma Industry Seeks Relief from Price Cap Rule for Cheap Drugs

(7/15, Teena Thacker, The Economic Times) ...The pharmaceutical industry has sought exemption from the government on fixation of ceiling prices for all low-priced formulations or those that are priced at up to ?5 per unit. At a meeting last week, the Federation of Pharma Entrepreneurs (FoPE) lobby group also asked for the exemption of patented drugs from price control for 10 years instead of the existing five. According to FoPE, in the absence of a 10-year exemption, many companies are conducting research outside the country... Full

Govt Proposes New Rules for Tighter Oversight of Antibiotics and Diabetes Drugs

(7/15, Neetu Chandra Sharma, Business Today) ...The Indian government plans to introduce stricter regulations to ensure the safety and efficacy of commonly used drugs such as antibiotics and diabetes medications through proposed amendments to the Drugs and Cosmetics Rules, 1945. The proposed amendments focus on introducing a new Schedule G, which is expected to list specific drugs under heightened regulatory scrutiny. The inclusion of drugs in this schedule will necessitate additional compliance measures and potentially stricter oversight... Full

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