Wednesday, January 15, 2025

Teva Plots Out 2026 Launch For 'Night And Day' Olanzapine Long-Acting Injectable

(1/14, Dean Rudge, Generics Bulletin) ...Eric Hughes, Teva's head of global R&D and chief medical officer, told attendees to the conference that, based on the company's clinical findings, the company's TV-44749 olanzapine candidate was "night and day" compared to its main competitor. "We have in vitro data that shows that even in the worst-case scenario, if you inject this into serum, it aggregates rapidly - compared to the competitor out there, which dissolves very quickly," Hughes noted... Sub. Req’d

Mounjaro and Zepbound Sales Disappoint, and Eli Lilly's Stock Is Dropping

(1/14, Tomi Kilgore, Dow Jones) ...Shares of Eli Lilly & Co. were headed for their worst day in nearly four years on Tuesday after the drugmaker provided a fourth-quarter revenue outlook that was below expectations, citing slower-than-expected growth in sales of its diabetes and weight-loss drugs. "While the U.S. incretin market grew 45% compared to the same quarter last year, our previous guidance had anticipated even faster acceleration of growth for the quarter," said Chief Executive David Ricks... Full

JPM25: CEO Predicts Kisqali Could Become Biggest Selling Novartis Drug Ever

(1/14, Simon King, FirstWord Pharma) ...This would represent a remarkable turnaround for Kisqali, which initially struggled to gain a sizeable foothold in metastatic HR-positive, HER2-negative breast cancer following its launch in 2017. Pfizer's then-dominant competitor Ibrance (palbociclib) has subsequently fallen out of favour — after it failed to demonstrate an overall survival benefit — which has positioned Kisqali and Eli Lilly's competing agent Verzenio (abemaciclib) as preferred CDK4/6 inhibitors for women with advanced disease... Sub. Req’d

Merck Speeds Up Launch of New Keytruda Version as Patent Expiration Nears

(1/14, Josh Nathan-Kazis, Barron's) ...Merck is speeding up plans to launch a new version of its top-selling cancer drug Keytruda, with less than three years to go before the patents protecting the original version expire. Keytruda sales account for roughly 40% of Merck's revenue, and the company has been focused on the 2028 patent expiration for years. Analysts currently expect Merck's earnings per share to fall 6.4% in the year after the patent expires... Full

JPM25: BMS, Pfizer and Merck CEOs Address Key Patent Cliffs and Plans to Replace Sales

(1/14, Eric Sagonowsky, FiercePharma) ...Each year at the J.P. Morgan Healthcare Conference, pharma CEOs are tasked with assuring and convincing investors that they've positioned their companies to overcome expected challenges. Monday, three Big Pharma leaders took center stage and addressed concerns about future patent expirations head-on. In separate presentations, the CEOs of Bristol Myers Squibb, Pfizer and Merck laid out their plans to overcome high-profile losses of exclusivity (LOEs) slated to dent sales through the end of the decade... Full

Amneal Expects to Meet or Top Annual Guidance

(1/15, Preeti Singh, Seeking Alpha) ...Amneal Pharmaceuticals expects to meet or exceed its financial guidance for full year 2024...The company expects to meet its net revenue ($2.70 billion - $2.80 billion), adjusted EBITDA ($610 million - $630 million), and adjusted diluted EPS guidance ($0.57 - $0.63), exceed its operating cash flow guidance ($280 million - $320 million), and exceed (incur less than) its capital expenditures guidance ($60 million - $70 million)... Full

Hikma Partners with Emergent for the Sale of KLOXXADO in the U.S. & Canada

(1/14, Charlie Sternberg, Contract Pharma) ...KLOXXADO was approved by the US Food and Drug Administration (FDA) in April 2021 for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. Emergent distributes NARCAN Nasal Spray 4 mg, which is the first FDA-approved over-the-counter naloxone product for the emergency treatment of opioid overdose... Full

Biocon Malaysia Facility Clearance Could Pave Way For US Biosimilar Approvals

(1/15, Dave Wallace, Generics Bulletin) ...Announcing that the FDA had classified the company's insulins facilities in Johor Bahru, Malaysia as "voluntary action indicated," Biocon Biologics said the designation "relates to the current good manufacturing practice inspection conducted by the agency between 15-27 September 2024." "The inspection scope had included several biologics manufacturing units comprising one drug substance and one drug product manufacturing units, one medical device assembly unit, one analytical quality control laboratory, two microbiological control laboratories and two warehouses," Biocon set out. The firm said that Biocon Biologics "remains committed to global standards of quality and compliance."... Sub. Req’d

Novartis Battles MSN, FDA to Block Launch of Entresto Drug Copy

(1/14, Christopher Yasiejko, Bloomberg Law) ...Novartis' injunction motion seeks to prevent MSN from launching its copy until at least July 16, one day after Entresto's six-month pediatric exclusivity period expires, the Monday filing in the US District Court for the District of Delaware said. It cited the US Court of Appeals for the Federal Circuit's Jan. 10 decision reviving US Patent No. 8,101,659, which is related to the composition of the drug's active compound, a combination of sacubitril and valsartan... Sub. Req’d

Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab

(1/14, Skylar Jeremias, The Center for Biosimilars) ...The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption. A nationwide mandatory switch from originator (Humira) to biosimilar adalimumab in Denmark did not increase total health care costs over 9 months, with hospital costs even decreasing for biosimilar switchers, according to an observational cohort study... Full

The Pharma Man's Negative Reputation is Fair

(1/14, Amal Naj, Rolling Stone) ...The Pharma Man's reputation is only going to get worse as President-elect Donald Trump takes office and tries to fulfill his promise to bring down drug prices. And there is the specter of Robert F. Kennedy Jr. bringing his unconventional ideas to American health care in the new Trump administration; he has already publicly called for capping drug prices. Ironically, it had been the Democrats who made the industry — a financial hotbed of Republican support — a whipping boy in blaming America's failure to deliver affordable health care to its citizens. But Mr. Trump has outshouted them all. He famously declared that pharma companies were "getting away with murder" and singled out Pfizer Inc. and publicly shamed the company and forced the CEO to roll back planned price increases... Full

FTC Finds Middlemen Inflate Specialty Generic Drug Prices by Billions of Dollars

(1/14, Tami Luhby, CNN) ...Pharmacy benefit managers, which serve as the middlemen between drug makers, insurers and pharmacies, reaped $7.3 billion in revenue from marking up the prices of dozens of specialty generic drugs between 2017 and 2022, the Federal Trade Commission said in an interim report issued Tuesday. The practice came at a time when spending on drugs by patients, employers, insurers and others rose significantly... Full

FTC Alleges Generic Price Gouging Netted Major PBMs At Least $7.3B

(1/15, Pavan Kamat, FirstWord Pharma) ...The second interim staff report by the FTC revealed that UnitedHealth's OptumRx, CVS' Caremark Rx and Cigna's Express Scripts pocketed approximately $7.3 billion in excess revenue between 2017 and 2022 through significant price markups at their affiliated pharmacies. The figure "is the difference between what they are reimbursing themselves and what it is estimated to cost them to acquire the drug," an FTC spokesperson explained, adding that the amount was "probably an underestimate."... Sub. Req’d

Largest Pharmacy-Benefit Managers Hiked Up Drug Prices, FTC Says

(1/14, Joseph Walker and Liz Essley Whyte, The Wall Street Journal) ...The largest pharmacy-benefit managers hiked the prices of dozens of drugs dispensed through their own pharmacies, according to a new report by the Federal Trade Commission released on Tuesday. The markups helped the PBMs reap $7.3 billion from 2017 to 2022, the FTC found. The PBMs—owned by insurers Cigna, CVS Health and UnitedHealth Group—are supposed to help keep drug costs low for employers and other clients... Full

FTC Signals PBM Oversight To Continue With Bipartisan Staff Report Bashing Middlemen

(1/14, Gabrielle Wanneh, Inside Health Policy) ...The Federal Trade Commission made clear it plans to continue its aggressive oversight of pharmacy benefit managers under incoming GOP Chair Andrew Ferguson when it unanimously voted Tuesday (Jan. 13) to release a staff report finding the country's top three pharmacy benefit managers and their affiliated pharmacy businesses gleaned more than $7.3 billion in dispensing revenue on specialty generic drugs in excess of the products' acquisition costs... Sub. Req’d

This Year, PBM-Directed Fury May Once Again Signify Nothing

(1/14, Leslie Small, Pink Sheet) ..."At the federal level, I would not be surprised to see a package of PBM reforms similar to the one that was initially included in the December continuing resolution reemerge when Congress returns to appropriations this spring," said Matthew Fiedler, a senior fellow at the Brookings Institution's Center on Health Policy. "Beyond that, however, I do not expect PBMs to be a major focus for lawmakers during 2025. It's conceivable that they could turn their attention back to PBMs once 2026 rolls around."... Sub. Req’d

E&C Republicans Mull Health Policies For Reconciliation Package In Closed-Door Meeting

(1/14, Jalen Brown, Inside Health Policy) ..."Everything was discussed," Carter told reporters Tuesday, adding that members are "still in the process of just throwing mud up against the wall to see what sticks." According to the health panel chair, the meeting covered a range of Medicaid reform options, including lowering the minimum 50% Federal Medical Assistance Percentage (FMAP) match rate, reducing Medicaid expansion matching rates, and implementing Medicaid per capita caps -- the latter of which Carter described as "absolutely" his preference... Sub. Req’d

Public Citizen Seeks Seat On DOGE Commission, Wants To Cut Medicare Advantage

(1/14, Jalen Brown, Inside Health Policy) ...The Department of Government Efficiency (DOGE) operation fails to meet federal balance requirements, Public Citizen co-presidents Robert Weissman and Lisa Gilbert said in a letter requesting to be appointed as members. The letter, sent Monday (Jan. 13) to Trump transition team co-chairs Howard Lutnick and Linda McMahon, alleges DOGE's current membership of wealthy business figures violates the Federal Advisory Committee Act (FACA) by excluding consumer-focused perspectives, which Public Citizen says the law requires to ensure balanced and unbiased recommendations... Sub. Req’d

How Trump's Greenland Demands Could Impact Ozempic Costs

(1/14, Joseph Choi, The Hill) ...President-elect Trump's threat to tariff Denmark if it resists his acquisition plans for the island territory of Greenland could disrupt one export that is wildly popular in America: Ozempic. Trump added Denmark to his growing list of tariff targets — including Canada, Mexico and China — as he has increasingly spoken of the U.S. taking Greenland off Denmark's hands. Danish multinational pharmaceutical giant Novo Nordisk is the sole owner of semaglutide, the active ingredient in both Ozempic and Wegovy. A month's supply of Ozempic is close to $1,000 without insurance, though manufacturer coupons and patient assistance programs are available... Full

Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says

(1/14, Fiona Rutherford, Bloomberg) ...Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report. Biogen's Aduhelm, Sarepta's Exondys 51, along with Covis Pharma's Makena were all cleared quickly by the US Food and Drug Administration despite weak evidence and disagreements among reviewers, according to the report Tuesday from Department of Health and Human Services' Office of Inspector General. In one case, documentation about key decisions was missing, the report found... Full

NIH Finalizes Affordable Drug Access Policy Before Bertagnolli Steps Down

(1/14, Maaisha Osman, Inside Health Policy) ..."As of June 1, 2025, organizations applying to NIH for certain commercial patent licenses will be required to submit Access Plans to NIH outlining steps they intend to take to promote patient access to those licensed products. NIH will continue working with industry partners to develop additional resources and guidance in support of these efforts," NIH said in announcing the decision on Jan. 10. Bertagnolli previously told Inside Health Policy that she prefers collaboration with the pharmaceutical industry on access plans over invoking march-in rights to ensure affordability of NIH-funded medical innovations... Sub. Req’d

Addressing Blind Spots In Assuring Therapeutic Equivalence

(1/14, Ajaz S. Hussain, Ph.D., independent subject matter expert, Pharmaceutical Online) ...One indicator of concern regarding the FDA's ability to generate needed assurances is when the Pentagon starts independent generic drug safety tests.2 This raises fundamental questions: Why is the DOD seeking independent drug testing, and why do they wish to explore quality scoring? Why isn't FDA approval sufficient? This commentary explores whether these actions reflect isolated issues (special causes) or suggest systemic vulnerabilities (common causes) within the current regulatory framework... Full

Prescription Drug Board Proposal Clears House Committee

(1/14, Markus Schmidt, Virginia Mercury) ...A Virginia House committee on Tuesday advanced a bipartisan proposal to create a Prescription Drug Affordability Board, renewing efforts to tackle skyrocketing medication costs after Gov. Glenn Youngkin vetoed an identical measure last year. House Bill 1724, sponsored by Del. Karrie Delaney, D-Fairfax, and Del. Ellen Campbell, R-Rockbridge, passed the House Commerce and Labor Committee on a 12-9 party-line vote. The legislation now heads to the House Appropriations Committee for further consideration... Full

Why The NHS Needs to Maximise the Impact of Biosimilars

(1/15, Tony Johnstone, pharmaphorum) ...Ensuring the long-term sustainability of the NHS increasingly appears to be an unfathomable prospect. The rise of chronic diseases, such as diabetes, cancer, and autoimmune conditions, continues to challenge healthcare systems across Europe, exacerbating budgetary pressures and making it difficult to consistently provide the best outcomes for patients. In England alone, more than 15 million people – a quarter of the population – suffer from a long term health condition, with care for these patients accounting for about 70% of the money spent on health and social care... Full

Medicines Patent Pool Doubles Down On Increased Access To HIV Treatments

(1/14, Adam Zamecnik, Generics Bulletin) ...The past year has seen a number of developments in HIV drug development and research that made headlines across the media, most notably with Gilead's publication of glowing clinical data from two Phase III trials of its twice-a-year pre-exposure prophylactic lenacapavir. Only 12 years since the initial approval of Gilead's daily oral PrEP pill Truvada (emtricitabine/tenofovir disoproxil fumarate), the potential approval of lenacapavir's use as PrEP could dramatically improve the lives of those at risk of contracting HIV... Sub. Req’d

Broad New China Policies Aim To Improve Market Access

(1/15, Xu Hu, Pink Sheet) ...China's State Council announced on 3 January a series of broad policy incentives covering multiple aspects of both biopharma and medical device development, including R&D, regulatory review times, exclusivity periods, value chain management and the further opening up of the country's market. Three aspects of the new measures echo changes in the policy and regulatory sphere last year, aimed at shortening review times for investigational new drug (IND) applications, derestricting non-end-to-end manufacturing of certain biologics, as well as the pricing and insurance coverage of innovative drugs... Sub. Req’d

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