Friday, June 14, 2024

Teva Sues Corcept Over Mifepristone 'Monopoly' for Rare Disorder

(6/13, Mike Scarcella, Reuters) ...Teva Pharmaceuticals sued rival drugmaker Corcept Therapeutics in federal court in San Francisco on Thursday, accusing it of monopolizing the market for mifepristone-based Korlym, used to treat a rare hormonal disorder called Cushing's syndrome...Teva in a statement said that Corcept's anticompetitive conduct "has prevented patients with Cushing's syndrome from accessing lower-cost generics to treat their debilitating disease."... Full

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

(6/14, Sara W. Koblitz, FDA Law Blog) ...The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months...Though some drug companies have been reluctant to delist certain patents from the Orange Book, the District Court of New Jersey just ordered Teva to delist 5 of its patents that it deemed improperly listed...Teva has noticed its appeal of the delisting decision. We're confident that FTC will file another amicus brief at the appellate court, which doesn't bode well for the future of listing device patents in the Orange Book, as the District Court makes clear that the FTC's position is compelling... Full

Richter Swallows Up Estetrol Franchise And More From Stricken Mithra

(6/14, Dean Rudge, Generics Bulletin) ...Gedeon Richter is looking to chart its own path in women's healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium's Mithra... Global Sub. Full

Pfizer Expects 8 Blockbuster Cancer Drugs to Come from Each of 4 Focus Areas: Exec

(6/13, Angus Liu, Fierce Pharma) ...During a recent investor event dedicated to the newly expanded oncology business, Pfizer unveiled a goal to have eight blockbuster cancer drugs by 2030 but fell short of naming specific products. That contribution of blockbusters will come from each of Pfizer Oncology's four focused therapeutic areas, Suneet Varma, the division's commercial president, told Fierce Pharma in an interview on the sidelines of American Society of Clinical Oncology annual meeting in Chicago. The four fields are breast, genitourinary, hematology and thoracic cancers... Full

Dr. Reddy's Aurigene Unit Opens New Indian Biologics Facility

(6/13, Adam Zamecnik, Generics Bulletin) ...Dr. Reddy's CRDMO Aurigene Pharmaceutical Services has opened a new biologics facility in India designed to provide process and analytical development services alongside small scale manufacturing of antibodies and other recombinant proteins in preclinical and early-stage clinical research... Global Sub. Full

Celltrion Presents Clinical Results of ACTEMRA Biosimilar at EULAR

(6/14, Jung So-yeon, Korea IT Times) ...At the conference, Celltrion presented interim results from a global phase 3 clinical trial for the intravenous formulation of CT-P47, conducted over 32 weeks with 471 rheumatoid arthritis patients. The results demonstrated that CT-P47 met the predefined equivalence criteria in the primary efficacy endpoints compared to the original drug, ACTEMRA, confirming equivalent efficacy. Additionally, safety and pharmacokinetic characteristics were similar... Full

Samsung Bioepis Touts Phase III Results for Epysqli at EHA

(6/14, The Pharma Letter) ..."This post-hoc analysis supports the previously demonstrated comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients, with no significant difference in reducing transfusion burden compared to reference eculizumab," said Hyejin Kim, vice president and medical and lifecycle safety team leader at Samsung Bioepis. "Our dedication to make a meaningful difference to our patients remain steadfast. We will continue to work collaboratively with clinicians and physicians to further expand the treatment options for patients with orphan diseases."... Sub. Req'd

AbbVie Licenses FutureGen IBD Drug in $1.7Bn Deal

(6/14, Phil Taylor, Pharma Phorum) ...AbbVie is paying $150 million upfront for rights to Chinese biotech FutureGen Biopharmaceutical's FG-M701, described as a next-generation antibody that binds to tumour necrosis factor-like ligand 1A (TL1A), which has emerged as a popular new target in IBD with several candidates in a race to market... Full

AbbVie Joins TL1A Race via $150M Upfront Deal with China's FutureGen

(6/13, James Waldron, Fierce Biotech) ...AbbVie's move is just the latest in a string of intriguing expeditions into the TL1A space by Big Pharma. In addition to Roche's Telavant buy last year, Merck paid $11 billion for Prometheus, while Sanofi also entered the arena when it paid Teva around $500 million for the opportunity to co-develop a candidate further back in the race... Full

Lupin Announces Closure of US FDA Inspection

(6/14, Express Pharma) ...The inspection of the facility was carried out from June 10 to June 13, 2024, and concluded with zero 483 observations. Nilesh Gupta, Managing Director, Lupin said, "We are pleased to have a successful outcome of the U.S. FDA inspection at our Nagpur injectable facility with zero observations. This reflects our dedication to uphold the highest quality and compliance standards across our facilities."... Full

CDC Warns Access to ADHD Meds May Be Disrupted After Arrests of Health-Care Startup Executives

(6/14, Jacqueline Howard, CNN) ...On Thursday, the US Centers for Disease Control and Prevention issued an official health advisory warning about a "potential disrupted access to care among individuals taking prescription stimulant medications and possible increased risks for injury and overdose." Around the same time, the US Department of Justice announced a federal health-care fraud indictment against two executives from the digital health company Done Global, whose website describes it as "making high quality psychiatric chronic care management more accessible and affordable for patients." The indictment's effect on patients "is unknown at the time," according to the CDC's advisory... Full

Biosimilar Introduction Reduces Biologic Prices in the US and Globally

(6/13, Chelsie Derman, HCP Live) ...Prior research showed biologics prices reduced after introducing biosimilars in the market.2 However, the studies analyzed this with insurance claims data, failing to show negotiations and discounts between healthcare providers and insurers. The new study, led by Hui-Han Chen, MHS, BS, from the UNC Eshelman School of Pharmacy at the University of North Carolina, used annual global sales in the IQVIA MIDAS® database to examine the price fluctuations after introducing biosimilars... Full

Progressive Group To Drug Price Control Advocates: Prep To Prevent IRA Unraveling Should GOP Win Elections

(6/13, Gabrielle Wanneh, InsideHealthPolicy) ...A progressive policy group says prescription drug price control advocates at the federal and state level should start prepping now for the possibility that a years-long conservative effort to reshape the federal government could undo Democrats' flagship Medicare prescription drug reforms should Republicans win in November, warning at least 18.5 million beneficiaries potentially could lose new cost-savings on their medications... Sub. Req'd

Project 2025 Prescription Drug Plan Would Increase Costs for as Many as 18.5 Million Seniors and Others With Medicare

(6/13, Nicole Rapfogel, Center for American Progress) ...Project 2025's drug pricing agenda calls for repealing the Inflation Reduction Act, primarily to end the law's Medicare drug price negotiation provision, which would significantly lower the prices Medicare pays for select drugs and finally counter Big Pharma's unrestricted power to demand excessive Medicare drug prices. However, Project 2025 treats seniors' access to affordable drugs as collateral damage. This dangerous agenda prioritizes Big Pharma's bottom line at the expense of millions of Medicare Part D enrollees who, if Project 2025 is enacted, may once again have to pay more out-of-pocket for the medications they need, impeding both access and affordability... Full

$2,000 Cap On Out-Of-Pocket Drug Costs To Help Millions Of Medicare Beneficiaries

(6/13, Joshua Cohen, Forbes) ...Cancer patients' high out-of-pocket cost burden is sometimes described as "financial toxicity." Already faced with a life-threatening illness, financial toxicity can cause economic pain but also further mental and emotional anguish for U.S. patients. One in five adults over the age of 65 forgo their prescriptions due to cost. The Inflation Reduction Act's cap of $2,000 on annual out-of-pocket spending on outpatient drugs will help alleviate the issue for Medicare beneficiaries... Full

Biden Plan to Save Medicare Patients Money On Drugs Risks Empty Shelves, Pharmacists Say

(6/13, Susan Jaffe, Missouri Independent) ...Months into a new Biden administration policy intended to lower drug costs for Medicare patients, independent pharmacists say they're struggling to afford to keep some prescription drugs in stock. "It would not matter if the governor himself walked in and said, ‘I need to get this prescription filled,'" said Clint Hopkins, a pharmacist and co-owner of Pucci's Pharmacy in Sacramento, California. "If I'm losing money on it, it's a no."... Full

Elevating the Value of the Employer-PBM Relationship

(6/13, JC Scott, RealClearHealth) ...To achieve a more affordable, higher quality future for our health care system, the policy debate cannot ignore the critical perspective of the employers who collectively sponsor health insurance benefits for 86 percent of employees working in the private sector. That's why The Pharmaceutical Care Management Association is launching a new campaign, "How PBMs Work," to elevate the collective understanding of the value that PBMs provide by lowering prescription drug costs and enabling employers, unions, and other plan sponsors to provide healthcare benefits to patients... Full

Major New NACDS Ad Campaign: "Time Is Now" for PBM Reform

(6/13, National Association of Chain Drug Stores) ..."Congress needs to stand strong and get this done. We are here to remind them of that." The National Association of Chain Drug Stores (NACDS) is making it unmistakable: pharmacy benefit manager reform is must-pass legislation in the 118th Congress. The Association today launched a major new seven-figure national and local advertising campaign timed for this specific moment... Full

US NIH And Drug Pricing: Still Seeking A Balance

(6/13, Michael McCaughan, Pink Sheet) ...The NIH seemingly was purposefully vague in outlining its proposed "Access Plans" policy for sponsors of products that were licensed from the agency. The plan's mention of international price comparators may be concerning, but is one of several examples of ensuring affordability in the plans. Ultimately, the proposal suggests the NIH is not interested in becoming a price regulator... Sub. Req'd

Expanding Our Definitions of Out-of-Pocket Costs: Three Imperatives for Biopharmaceutical Manufacturers

(6/14, Adam J. Fein, Ph.D., Drug Channels) ...Today's guest post comes from Christine Juday, Head of Market Access at Real Chemistry. Chris discusses new research on how patients perceive out-of-pocket costs. As she explains, many patients and unpaid caregivers consider out-of-pocket costs for medication within the context of their total spending. She then recommends three ways that manufacturers can improve patients' access and affordability... Full

Pharma Industry Praises Supreme Court's Rejection of Abortion Pill Challenge

(6/13, Nicole DeFeudis, Endpoints News) ...The Court on Thursday held that the plaintiffs failed to prove they would be injured by FDA label revisions that have broadened access to mifepristone. The ruling marks a win for the FDA and pharmaceutical industry, who have argued that siding with plaintiffs would upend the current drug approval process and allow courts to challenge the agency's scientific expertise. "We are pleased that FDA's authority to review and approve new medicines for patients has been preserved," industry group BIO told Endpoints News. "Regulatory certainty is critical to ensuring that vital research can make it from the lab bench to a patient's bedside."... Full

SCOTUS Ruling On Mifepristone Could Have Lasting Impact On FDA Regulation: Experts

(6/13, Nadine El-Bawab, ABC News) ...While experts and advocacy groups applauded the U.S. Supreme Court's decision Thursday to not restrict nationwide access to the abortion pill mifepristone, they warn access to medication abortion remains at risk -- as does the very foundation of the Food and Drug Administration's regulation of all medications...Had the Supreme Court ruled differently it could have been "catastrophic" for drug development and regulation in the U.S., [Sanket Dhruva, assistant professor at the University of San Francisco School of Medicine] said. "It could have potentially cast out on the FDA being the determinant of what drugs meet the safety and effectiveness threshold to be on the United States market," Dhruva said... Full

Information On DSCSA Exemptions Until November 2026 and Other Possible Waiver Exemptions for Small Dispensers

(6/13, Bob Pollock, Lachman Consultants) ...The FDA expects all entities to be fully compliant with the Drug Supply Chain Security Act (DSCSA) by November 27, 2024; however, there are certain exemptions for what the Agency describes as "small dispensers" that may be available to ensure sufficient time to comply with the Act. This is outlined in a newly published document titled Drug Supply Chain Security Act Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Small Dispensers Until November 27, 2026... Full

FDA Grants Small Dispensers Two-Year Delay for DSCSA Tracking Rules, Opens Door for Exemption Requests

(6/13, Joanne S. Eglovitch, Regulatory Focus) ...FDA's Michael Levy, deputy director of the Office of Compliance (OC) in the Center or Drug Evaluation and Research said the exemption is "not intended to provide, and should not be viewed as providing, a justification for delaying efforts by small dispensers to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act." Instead, the agency "strongly urges small dispensers to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements."... Full

Billions at Stake as National Battle Over Drug Pricing Plays Out in Missouri

(6/13, Rudi Keller, Missouri Independent) ...On the last day of this year's legislative session, the Missouri House passed a bill making it illegal for pharmaceutical manufacturers to refuse to supply the discounted medications to qualifying hospitals and health clinics and their contracted pharmacies. Pharmacy manufacturers, who are playing defense on similar bills across the country, want Gov. Mike Parson to veto the legislation because the discounted prescriptions are often sold to patients at full retail price... Full

Editorial: Capping Colorado's Prescription Costs Will Backfire

(6/13, The Gazette) ...As reported Monday in The Gazette by the Colorado Chamber of Commerce's Sum & Substance news service, the board's action was directed at Stelara, a medication that treats anti-inflammatory diseases affecting joints and bowels. It was developed and is manufactured by pharmaceutical giant Johnson & Johnson, and demand for it has been on the rise...Never mind that the board acknowledged the drug is a victim of its success — its efficacy driving demand. Or that there are similar drugs in the prescription market to which at least some of those who are priced out of Stelara could turn... Full

Here Are Four Reasons Medicare Drug-Price "Negotiation" in NJ isn't Truly a Negotiation.

(6/13, Sandip Shah, APP) ...Under the Inflation Reduction Act, the federal government received new authority to start "negotiating" the price of prescription drugs in Medicare. The Centers for Medicare & Medicaid Services began its Drug Price Negotiation Program with ten drugs this year. The program will expand annually, reaching 20 new drugs each year starting in 2029. But the IRA's terminology isn't right. The process won't be a "negotiation" at all. I've been at the table in drug price negotiations between manufacturers and payers, and this is nothing of the kind. Rather, the framework the IRA sets out gives CMS price-setting power, whether drug makers like it or not... Full

UK's New Netflix-Style Funding Model for Antibiotics Goes Live

(6/14, Heidi Vella, Pharmaceutical Technology) ...Paul Catchpole, the value and access policy director at the Association of the British Pharmaceutical Industry says the pharma sector is ‘very pleased' with the final details of the model that was published on the May 8..."If everybody participates it makes it even more powerful, because it's the UK speaking with a single voice to say, ‘look, we have arrangements and we send a strong signal globally'. This will help other countries see the need to move," Catchpole says... Full

EU Regulators Clarify How ‘Super-Grouping' Under New Variations Rules Will Work

(6/13, Neena Brizmohun, Pink Sheet) ...Revised guidelines that shed more light on the EU's newly strengthened and streamlined rules governing how companies make post-authorization changes to the terms of their drug marketing authorizations are now available for public comment. The revisions reflect amendments to the Variations Regulation that are due to come into force in January 2025... Sub. Req'd

European Antitrust Watchdog Accuses API Manufacturer Alchem of Engaging in Price-Fixing Scheme

(6/13, Kevin Dunleavy, Fierce Pharma) ...Eight months after convincing five companies to pay fines to settle antitrust claims, the European Commission has zeroed in on another firm, active pharmaceutical ingredients (API) manufacturer Alchem International, which decided not to participate in the original settlement deal. The EC has accused India-based Alchem of engaging in a price-fixing cartel over the key ingredient found in a decades-old antispasmodic drug, Buscopan, and its generic versions. The treatment is for stomach cramps, including those associated with irritable bowel syndrome... Full

Swiss Senate Approves Package to Combat Rising Healthcare Costs

(6/13, Swissinfo.ch) ...Half of the savings potential, estimated at CHF800 million ($892 million) per year, related to medicine prices. The government will in future be able to establish bulk discounts for medicines with a large market volume. This measure is aimed at a small number of established products which, however, account for a significant proportion of the cost of medicines. The proposal has not yet been discussed by the government or the House of Representatives... Full

Novo's Blockbuster Obesity Drug Wegovy Under Fire in Denmark

(6/13, Sara Sjolin and Naomi Kresge, Bloomberg) ...A Danish drug oversight panel advised doctors to restrict prescriptions of Novo Nordisk A/S's blockbuster obesity drug Wegovy, saying the medicine is so expensive that it would cost about $870,000 to prevent a single heart attack, stroke or other severe cardiac problem. Wegovy shouldn't be a doctor's first choice, and they should only start a "few" patients on the treatment, the Danish Health Authority's Institute for Rational Pharmacotherapy said in a report released on June 6. Though the institute is influential, doctors have wide leeway to disregard its advice... Full

Govt Allows Global Tenders to Access 120 Key, Patented Drugs

(6/14, Teena Thacker, The Economic Times) ...In what could ease access to some patented medicines, the government has allowed global tenders to be floated for procurement of 120 drugs, including anti-diabetic medication Semaglutide, after the health ministry raised concerns over lack of domestic options...With this, it will become easier for people in India to procure medicines which are either not available in the country because they are patented, or are not being produced here due to technological barriers. "This will open doors to various such products and will benefit the Indian patient," said an industry insider... Full

IPA To Host 9th Global Pharmaceutical Quality Summit Focusing On Patient Centricity

(6/13, BW Healthcare World) ...The theme for this year's event is "Advances in Manufacturing and Quality – Patient Centricity." The two-day flagship summit will delve into how the industry can leverage technology to enhance pharmaceutical operations and manufacturing for the next decade. The press statement further informed that Nilesh Gupta, Chair of the Quality Forum at IPA and Managing Director of Lupin, will inaugurate the Summit. Attendees will include stakeholders from the government, industry, and global experts... Full

Why India's Pharma Industry Must Prioritise Patient Safety and Innovation to Sustain Momentum

(6/14, Dr. Daya Krishan Mangal, CNBC TV 18) ...The Indian pharmaceutical industry may further strengthen its position as a global leader in quality and patient safety by tackling several of its existing problems and leveraging new trends, writes IIHMR University's Adjunct Professor, and a Senior Associate at Bloomberg School of Public Health, Dr. Daya Krishan Mangal, in his exclusive column... Full

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