Monday, July 8, 2024

Samsung Bioepis' Ustekinumab Biosimilar Demonstrates PK Equivalence in Healthy Adults

(7/6, Deana Ferreri, PhD, The Center For Biosimilars) ...A phase 2 study demonstrated pharmacokinetic (PK) bioequivalence of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the EU- and US-sourced reference products. The authors also reported safety, tolerability, and immunogenicity were "comparable" between the 3 groups... Full

U.S. Big Pharma Seeks to Block Indian Competition Through FDA

(7/7, Abhinandan Mishra, The Sunday Guardian) ...The 8 companies that have been served with Form 483 are Cipla, Torrent, Dr. Reddy's, Laurus, Eugia Pharma, Zydus, Alkem and Jubilant Generics. All sell their medicines in the US. In an effort at using the regulatory system to fight competition from Indian pharma companies, eight Indian pharma companies are amongst the 11 global companies that have been served with "Form 483" of United States Food and Drug Administration since the start of this year...The Form 483 notice, on the surface encourages pharma companies to significantly improve the quality standard on their production sites. In those cases where the motivation is not to battle competition, such moves also benefit the local markets and consumers in India by ensuring better quality drugs... Full

Lilly to Acquire Morphic to Improve Outcomes for Patients with Inflammatory Bowel Disease

(7/8, Eli Lilly and Company) ...Eli Lilly and Company and Morphic Holding, Inc. today announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for treatment of serious chronic diseases..."Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease," said Daniel Skovronsky, M.D., Ph.D., chief scientific officer of Lilly and president, Lilly Research Laboratories, president, Lilly Immunology... Full

AbbVie Dramatically Outspent its Pharma Company Rivals in 2023 to Promote its Drugs to Doctors

(7/5, Nicholas Florko and J. Emory Parker, STAT Plus) ...Pharmaceutical giant AbbVie paid health care providers roughly $145.7 million last year to promote its drugs, according to a STAT analysis of newly released government data...The payments, made public by the Centers for Medicare and Medicaid Services, provide an insight into AbbVie's marketing in the immediate aftermath of the company losing its monopoly on Humira, which dominated the company's balance sheets for the better part of the last two decades. The payments show that the company is being far more aggressive in targeting doctors than competitors of comparable size... Sub. Req'd

Diabetes Patients On GLP-1s Instead of Insulin Have Lower Cancer Risk, Study Shows

(7/5, Maggie Fick, Reuters) ...Patients with type 2 diabetes taking GLP-1 treatments, which include Ozempic, have a lower chance of developing 10 types of obesity-related cancers than those taking insulin and other diabetes drugs, according to a study published on Friday...The study did not specify which GLP-1 medicines the patients took, but the records were for patients on these medicines or insulin or the diabetes drug metformin between March 2005 and November 2018. Ozempic was only approved by the U.S. Food and Drug Administration in December 2017... Full

GLP-1 Agonists: A New Hope for Substance Use Disorders?

(7/5, Jeffrey Singer, RealClearHealth) ...GLP-1 agonists cause weight loss indirectly by slowing the movement of food through the stomach and intestines and directly by acting on GLP-1 receptors in the brain to reduce appetite and cravings and induce a feeling of satiety. Now, there is encouraging evidence that their effect on craving and satiety may help to treat substance use disorders. A study last year found that people using GLP-1s to lose weight also consumed less alcohol. National Institute on Drug Abuse Director Nora Volkow was a researcher in a study this year suggesting GLP-1 agonists may prevent relapse of alcohol use disorder... Full

Here's Why Eli Lilly, Pfizer and J&J Are in San Diego Looking for the Next Big Drug

(7/5, Natallie Rocha, The San Diego Union-Tribune) ...Historically, a lot of big pharma's top-selling drugs on the market started their life in the biotech space, explains Mike Ward, an industry analyst with Clarivate. But as many of these companies stare down patent expiration cliffs for revenue-generating drugs, he said there's a "land grab" for the next generation of promising technology and drug discovery platforms...That's what Pfizer is doing in its collaboration with Breakthrough Properties' StudioLabs San Diego, which offers turnkey private labs for startups... Sub. Req'd

Judge Rules Against Boehringer Ingelheim in Pharma's Latest Legal Loss On Medicare Negotiation

(7/5, Rachel Cohrs Zhang, STAT Plus) ...A federal judge ruled against Boehringer Ingelheim's challenge to the new Medicare drug price negotiation program, handing the pharmaceutical industry its latest in a string of legal losses. The company had argued before the U.S. District Court of Connecticut that the drug pricing law was unconstitutional under four different parts of the Constitution, and also that Medicare officials had violated procedural laws. Judge Michael Shea ruled against Boehringer Ingelheim on each point in a decision published late Wednesday... Sub. Req'd

Lawmakers, Policy Experts: Congress Should Seize Opportunity To Expand Authority Post-Chevron

(7/5, Sigi Ris, InsideHealthPolicy) ...The Senate health committee's top Republican wrote to federal agencies last weekend that lawmakers are now the primary driver of health care policy given the Supreme Court's landmark decision to end the Chevron principle of courts deferring to agencies' interpretations of ambiguous laws... Sub. Req'd

Report: Drug Makers' Spending In 2023 Failed To Prioritize R&D

(7/5, Gabrielle Wanneh, InsideHealthPolicy) ...As the drug industry and its supporters continue to push back against further implementation of government price controls, saying the controls will hinder investment in future treatments and cures, a report from a nonpartisan special interest watchdog group found the industry spends more on stock buybacks, marketing and other priorities than research and development...Cat Hill, spokesperson for the brand drug lobby Pharmaceutical Research and Manufacturers of America, told Inside Drug Pricing the Accountable.US report focuses on cherry-picked information and ignores billions of dollars the industry invests into bringing about new drugs... Sub. Req'd

Changes to Medicare Could Make It More Expensive

(7/5, Kirsten Axelsen, RealClearHealth) ...With any change in law, there are some desired and expected outcomes and likely unexpected downsides. In this case, the shifting financial incentives in the Inflation Reduction Act are expected to erode the attributes that make the Medicare drug benefit or "Part D" well-liked. Academics, actuaries, and business leaders anticipate the upcoming changes will result in more restrictive drug formularies and fewer part D plans. Moreover, the Inflation Reduction Act will not reduce drug costs meaningfully for most Medicare beneficiaries and will increase out-of-pocket costs for many... Full

Opinion: The Inflation Reduction Act is Not What it Was Promised to Be for Seniors

(7/8, John Calkins, CT Mirror) ...It's predicted that the government price controls created by the IRA are going to seriously diminish innovation in the pharmaceutical sector. That only stands to reason, as it now costs an average of more than $2 billion to develop and test new drug therapies. Pharmaceutical companies are going to be very reluctant to invest that kind of money in a drug that could be subject to price fixing mandates based more on what the government wants to pay than the true cost of R&D, manufacturing, and marketing... Full

E&C GOP Probes Whether Undue Influence Behind Variability Of FDA Foreign Inspections

(7/5, Jessica Karins, InsideHealthPolicy) ...Republican leaders on the House Energy & Commerce Committee want answers from FDA by Monday (July 8) on why there is so much variability in the agency's foreign inspections, telling FDA in a recent letter they question the skill levels and integrity of the agency's inspectorate and are probing whether some employees conducting oversight of Chinese and Indian facilities may have been unduly influenced or even accepted bribes, though they don't provide evidence... Sub. Req'd

US FDA Advisory Committee Open Public Hearing Changes Urged

(7/5, Sue Sutter, Pink Sheet) ...Patient groups say more time and attention should be paid to the experience of patients, clinical trial participants and investigators during the open public hearing of advisory committees. Consumer groups and academics want more transparency into OPH speakers' conflicts and financial interests. Several speakers said the FDA should publicly release background briefing documents before OPH speakers are required to submit their presentation slides... Sub. Req'd

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

(7/5, Bridget Silvermna, Pink Sheet) ...The US first-approver advantage over the European Union remains stark, with eight of ten novel agents first cleared by the US Food and Drug Administration, according to a Pink Sheet analysis of recent novel approvals by the FDA and European Medicines Agency. During 2023 and through April 2024, 108 novel products received approval from at least one of the US or European Union's central regulators, with 48 receiving approval as a new active drug substance, new molecular entity or novel biologic from both the US FDA and EMA, data from the suite of Pink Sheet regulatory performance trackers show... Sub. Req'd

How Would the Inclusion of Specialty Drugs Impact CPI-Rx?

(7/5, Jason Shafin, Healthcare Economist) ...How would including physician-administered drugs impact the CPI-Rx? That is the question a paper by Hicks, Berndt and Frank (2024) aims to answer. The authors argue that including the largely physician-administered specialty drugs is important because specialty drugs comprised 55% of U.S. drug spending in 2021, which was nearly double the 28% share from a decade earlier. Over half (52%) of specialty drug spending was on oncology; the next largest category was inflammatory diseases (e.g., rheumatoid arthritis) at 9%... Full

Connecticut to Help Develop Model Making Healthcare Affordable, Accessible

(7/5, Mike Savino, NBC Connecticut) ...Connecticut will receive up to $12 million dollars over the next five years as part of a federal program aimed at making healthcare more affordable and easier to access. Connecticut is one of three states selected for the Centers for Medicare and Medicaid Services' All-Payer Health Equity Approaches and Development, or AHEAD, Model...Connecticut will test the idea of global budgeting, or giving Medicaid and Medicare funding in block payments, as a way to encourage hospitals and other providers to keep costs down... Full

New Rhode Island Law Protects Patients Who Rely On Specialty Infusion Drugs

(7/8, Alexander Castro, Rhode Island Current) ...Ge Bai, a professor of accounting and health policy at Johns Hopkins University, told Rhode Island Current that efforts to eliminate white bagging may not be "purely patient-centered." Hospital lobbying plays a role, as do government programs like 340B reimbursements, which are meant to subsidize care for low-income people via deep discounts for hospitals' pharmaceutical purchases. But the program's reporting standards are inexact, leading one 2023 study to conclude the subsidies are probably not helping their intended audience... Full

EU Pharma Legislation Will Shape the Future of R&D

(7/8, The Pharma Letter) ...The European Federation of Pharmaceutical Industries and Associations noted in a posting on its website that European Union legislation will shape the future pf research, development and manufacturing in Europe for decades to come. This notes that, unless changes are made, Europe will become reliant on other regions' medical innovation and EU citizens will wait longer for the latest advances in care... Sub. Req'd

How EU Pharma Reform Changes Could Affect The ATMP ‘Hospital Exemption'

(7/5, Ian Schofield, Pink Sheet) ...One of the key challenges facing the Hungarian presidency of the Council of the EU in the second half of 2024 will be the proposals for an overhaul of the EU pharmaceutical legislation, which were amended by the European parliament in April. In the latest in a series of articles on progress with the reform, the Pink Sheet examines the issues surrounding the hospital exemption for advanced therapies... Sub. Req'd

EU Offers Research Funding For Regulatory Sandboxes And Novel Endpoint Projects

(7/5, Eliza Slawther, Pink Sheet) ...The EU Innovative Health Initiative (IHI) has called for research to be undertaken in the EU to explore how regulatory sandboxes can be developed for health care innovations and integrated into regulation and policy. The regulatory sandbox topic is one of four to be included in the eighth IHI call, launched on June 25,. The other three topics are reducing cardiovascular death in Europe, the development of novel digital endpoints for osteoarthritis, and the development of patient-centered clinical study endpoints derived using digital health technologies... Sub. Req'd

U.K. Trade Group Scolds Novo, Novartis, Pfizer, and Otsuka for Violating Industry Codes

(7/5, Ed Silverman, STAT Plus) ...Four large drugmakers — Novartis, Pfizer, Novo Nordisk, and Otsuka Pharmaceutical — were scolded by a U.K. industry trade group for violating a voluntary code that is designed to bolster marketing practices. In each case, the companies were chastised for discrediting — and reducing confidence in — the industry...The most serious breach involved Novo Nordisk, which voluntarily admitted its failure to disclose approximately $10 million that was provided to more than 150 organizations and individuals — including health care providers and institutions, patient groups and members of the public, including journalists — between 2020 and 2022... Sub. Req'd

New Zealand Gets Cracking On NZD$604M Drug Funding Boost; Starts Repealing Landmark Law

(7/5, Neena Brizmohun, Pink Sheet) ...Two targeted treatments for six different types of cancer and two antifungal drugs are the first products that Pharmac has proposed should be funded after it received a boost to its budget in June. Separately, the government is seeking feedback on a bill to repeal the sweeping new therapeutic products law that was passed by its predecessor... Sub. Req'd

India Set to Witness Obesity Pill Revolution? As Patents Near Expiry, Pharma Giants Gear Up for Market Boom

(7/8, Sushmita Panda, Financial Express) ...A recent report by Reuters revealed that India is planning to offer incentives to promote local manufacturing of GLP-1 drugs used to treat diabetes and obesity in 2026 citing a top government official..."The prevalence of obesity is acute in urban centres and we are observing an upward trend in its prevalence in both adults as well as children. With the majority of India's urban population living with obesity, and rapidly increasing, innovative treatment options with proven results for sustained weight loss are the need of the hour. This is important because obesity directly increases the risk of diabetes, cardiovascular diseases, and even certain cancers among others," Vikrant Shrotriya, Managing Director, Novo Nordisk India told Financial Express.com... Full

Indian Drugmakers Seek Govt Tax Reliefs, Incentives to Spur Innovation

(7/6, Rishika Sadam and Kashish Tandon, Reuters) ...India's pharmaceutical companies are hoping for tax incentives and financial assistance for research on innovative drugs as Prime Minister Narendra Modi's government readies a federal finance budget likely to be presented in July...Indian drug manufacturers must focus on developing complex drugs beyond the usual generic variety if the country is to continue being renown for being the 'pharmacy of the world' for its affordable medicines, experts say... Full

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