Monday, October 21, 2024

The Middlemen: The Powerful Companies Driving Local Drugstores Out of Business

(10/19, Reed Abelson and Rebecca Robbins, The New York Times) ...P.B.M. executives deny that they are underpaying small pharmacies. And they say they are not to blame for drugstore closings, which they attribute to other factors like changing consumer habits and high labor costs... Full

Accord Follows US Approval With EU Nod On Ustekinumab

(10/18, Dave Wallace, Generics Bulletin) ...The latest meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use has resulted in positive opinions for Accord Healthcare's Stelara (ustekinumab) biosimilar as well as a buprenorphine hybrid film for Neuraxpharm and an eltrombopag generic for Viatris... Global Sub. Full

CHMP Recommends EU Approval for Dong-A ST's Stelara Biosimilar

(10/21, Lee Han-soo, Korea Biomedical Review) ...Accord Healthcare, a subsidiary of Dong-A ST's partner Intas Pharmaceuticals, had submitted the marketing authorization application (MAA) to the EMA in June 2023. The CHMP evaluates the scientific data related to the quality, safety, and efficacy of medicines and provides its recommendations to the EMA. This positive opinion from CHMP plays a critical role in the final decision of the European Commission (EC). The EC will now review the recommendation before making a formal decision on Imuldosa's marketing authorization... Full

Roche's Big Bet On Big Diseases

(10/20, Jessica Davis Plüss and Pauline Turuban, Swissinfo.ch) ...Basel-based Roche is the latest pharma giant to announce a revamp of its investment strategy to focus on developing "transformative" drugs, treatments that have a groundbreaking impact on chronic illnesses such as multiple sclerosis, Alzheimer's, or lung cancer that affect large swathes of the world's population. Roche has homed in on 11 diseases in five therapeutic areas, including three — cardiovascular-metabolic disorders such as obesity, along with oncological and neurological diseases – which it estimates will account for more than 50% of the global disease burden in the next ten years... Full

Mankind Pharma Sharpens its Focus On Specialty Products

(10/20, PT Jyothi Datta, The Hindu BusinessLine) ...It is looking at chronic areas including heart failure, for example, besides launching products like its insulin glargine this year. Having started its dedicated specialty business during the pandemic, Mankind Specialties has in four years grown from two to nine therapeutic segments, says Atish Majumdar, Senior President (Sales and Marketing), Mankind Pharma. A 3600-member strong field-force supports its expanded specialty business, comprising cardiology, diabetes, respiratory, gastroenterology, neurology, oncology and urology... Full

Alembic Pharma Gets USFDA Nod for Generic Hypertension Treatment Capsules

(10/21, Press Trust Of India) ...Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Diltiazem Hydrochloride extended-release capsules used to treat hypertension. The approval by the US Food & Drug Administration is for the abbreviated new drug application Diltiazem Hydrochloride extended-release capsules of strengths 120 mg, 180 mg, and 240 mg, the company said in a statement... Full

Latest Twist In US Entresto Case Sees MSN Triumph Over Novartis

(10/18, Dave Wallace, Generics Bulletin) ...The latest twist in MSN's legal fight with Novartis over Entresto has seen a US court rule that the FDA was correct to approve MSN's skinny-label generic, which carves out certain protected Entresto indications. However, an appeal has already been filed and an imminent generic launch looks unlikely... Global Sub. Full

Lilly Sues Online Vendors, Medical Spa Over Copycat Weight-Loss Drugs

(10/21, Patrick Wingrove, Reuters) ...The new lawsuits, which name Pivotal Peptides, MangoRx and Genesis Lifestyle Medicine of Nevada, are the first related to copycat tirzepatide filed since the U.S. Food and Drug Administration took the drug off its list of medicines in short supply earlier this month... Full

B. Braun Takes Steps to Secure the Supply of Critical IV Fluids in the US

(10/18, B. Braun) ...B. Braun Medical Inc., a leader in smart infusion therapy and pain management, provided an update today on the company's efforts to secure supplies of critical IV fluids in response to Hurricane Milton and damage caused by Hurricane Helene to a large IV fluids manufacturing plant in North Carolina... Full

Drug Repurposing Firm Every Cure Bags $60M Investment

(10/18, Urte Fultinaviciute, Generics Bulletin) ...Backed by AI and former FDA official Janet Woodcock, Every Cure is set to identify approved drugs for patients who don't have treatment options around the world. Every Cure has received a five-year $60m investment to advance its artificial intelligence-based platform identifying generic and off-patent drugs that could be repurposed for various diseases... Global Sub. Full

Walmart Reaches Settlement Agreement for Opioid-Related Lawsuits

(10/18, Connor Hart, The Wall Street Journal) ...The settlement doesn't include any admission of liability and is subject to court approval, the retailer said in a Securities and Exchange Commission filing Friday. Under its terms, insurance carriers would pay the $123 million in cash, minus any fees awarded to plaintiffs' counsel and litigation expenses, to an escrow account. Also as part of the agreement, the company would maintain certain corporate governance practices for at least five years... Sub. Req’d

Celltrion's Biosimilar CT-P47 Demonstrates Equivalence to Actemra in P3 Study

(10/21, Lee Han-soo, Korea Biomedical Review) ...Celltrion said the phase 3 clinical trial results CT-P47, a biosimilar referencing Roche's Actemra (ingredient: tocilizumab), have been published in Rheumatic & Musculoskeletal Disease (RMD Open). Roche's Actemra is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in causing inflammation in the body, generating global sales of about 2.63 billion French francs (4 trillion won)... Full

Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis

(10/19, Deana Ferreri, PhD, The Center For Biosimilars) ...Most biologics for inflammatory diseases, including psoriasis, are inhibitors of tumor necrosis factor (TNF)-a, but ustekinumab is the first of newer biologics focused on other targets, the authors said. Ustekinumab, an inhibitor of interleukins 12 and 23, is used to treat psoriasis, psoriatic arthritis, and inflammatory bowel disease. The authors cited advantages of ustekinumab over anti-TNF biologics, such as less frequent dosing and "perhaps a better safety profile."... Full

Male Contraception — A Growing Business with Game Changers?

(10/20, Aline Spantig, Deutsche Welle) ...The last major push happened over a decade ago. German pharmaceuticals giant Bayer tested a male contraceptive on humans, and it was found to be both "effective and with tolerable side effects." Despite this success, Bayer stopped all research into male fertility control. In a statement to DW, Bayer explained they doubted the product would be a commercial success. Abbvie and Pfizer said they are not in the male contraceptive business and did not comment on plans to invest in it. Other companies DW reached out to — like Johnson & Johnson or Teva — had not responded to a request for comment at the time of publication... Full

Addressing Hesitance in Biosimilar Adoption

(10/20, Skylar Jeremias, The Center For Biosimilars) ...In an interview, Sophia Humphreys, PharmD, discusses how the expansion of biosimilars into new therapeutic areas, such as immunology, endocrinology, and ophthalmology, has led to increased hesitance compared to the quicker adoption seen in cancer treatment. This is due to the maintenance nature of many therapies, making it harder to switch patients to biosimilars... Full

The Promise of a Direct-to-Patient Model—Breaking Down What's Really Needed for Better Patient Access

(10/18, Adam J. Fein, Ph.D., Drug Channels) ...Today's guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA. Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure, combined with clinical and reimbursement support specialists, can improve patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes... Full

Novartis Loses Challenge to Block Biden Drug Price Negotiations

(10/19, Nyah Phengsitthy, Bloomberg Law) ...Judge Zahid N. Quraishi of the US District Court for the District of New Jersey on Friday ruled against Novartis' claims that the Medicare Drug Price Negotiation Program takes property, compels speech, and violates the excessive fines clause... Sub. Req’d

NJ Judge Tosses Novartis' IRA Lawsuit in Another Win for Government

(10/18, Nicole DeFeudis, Endpoint News) ...Novartis told Endpoints News Friday that it plans to appeal the decision, reaffirming its stance that the "drug price-setting provisions in the IRA are unconstitutional and will have long-lasting negative consequences for patients." Other pharma companies are likewise racing to appeal the decisions before negotiated prices under the IRA take effect in 2026... Full

Mileage of FTC Suit Against PBMs May Vary, Experts Suggest

(10/18, Leslie Small, Pink Sheet) ...The FTC is often wrong in its witch hunts, but in this rare instance, its actions against PBMs are warranted. We can all agree that transparency and competition improve services and lower prices. Hopefully, the FTC has taken the first step in doing just that... Global Sub. Full

FTC's PBM Suit A Stopped Clock is Right Twice a Day

(10/18, Andrew Langer and David Safavian, RealClearPolicy) ...Driven by collaborators in government and at the AARP, the healthcare oligopoly is harming American consumers. The FTC is often wrong in its witch hunts, but in this rare instance, its actions against PBMs are warranted. We can all agree that transparency and competition improve services and lower prices. Hopefully, the FTC has taken the first step in doing just that... Full

PhRMA Urges HRSA Not to Impede New 340B Pricing Approaches to Improve Transparency and Integrity

(10/18, Drew Voytal, PhRMA) ...In a letter submitted to the Health Resources and Services Administration last week, PhRMA expressed serious concerns regarding the agency's recent public statements about use of rebates to offer 340B ceiling prices to covered entities. PhRMA's letter detailed persistent abuses and instances of some covered entities breaking the law in the 340B drug pricing program — and how the 340B statute contemplates manufacturers implementing alternative approaches to providing 340B prices that increase transparency and improve program integrity... Full

Sales from Controversial Drug Discount Program Rose to $63 Billion Last Year

(10/18, Ed Silverman, STAT Plus) ...Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $63 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program... Sub. Req’d

FDA Clarifies Compounding, ASPR Initiates Airlifts In Hurricane Shortage Response

(10/18, Jessica Karins, InsideHealthPolicy) ...Continuing to response to IV drug shortages exacerbated by recent hurricanes, HHS said it is assisting with airlifting and distributing international product to health facilities beginning this weekend, and FDA clarified that hospitals and health systems compounding their own drugs under temporary enforcement discretion will not be obligated to use up the drugs produced within 24 hours... Sub. Req’d

Amid Backlash, FDA Changes Course Over Shortage of Weight-Loss Drugs

(10/19, Daniel Gilbert, The Washington Post) ...The FDA's sudden shift highlights challenges regulators and the pharmaceutical industry have faced amid unprecedented demand for the blockbuster weight-loss drugs. "The credibility of the FDA in this case has suffered," said Mariana Socal, a Johns Hopkins professor who specializes in drug shortages. She attributed the agency's flip-flop to its surveillance system, which by law relies heavily on information from drugmakers and is geared toward identifying disruptions to supply rather than spikes in demand... Sub. Req’d

Repeal The Biden-Harris Expensive IRA

(10/18, Peter Mihalick, RealClearPolicy) ...The United States has been the worldwide leader in medical innovation for decades. That is because drug companies can earn profits on their products, so they are encouraged to experiment and develop new drugs. In other countries, such as Canada, they simply import the wonder drugs which American companies develop. The long-term effect of price controls would be fewer and less effective drugs for everyone, everywhere. And this IRA tax could mean a doubling of the price of many important treatments... Full

Amy Klobuchar Joins Lanon Baccam for Fundraiser, Conversation On Prescription Drugs

(10/18, Brianne Pfannenstiel, Des Moines Register) ...U.S. Sen. Amy Klobuchar joined Lanon Baccam in Des Moines Friday for a fundraiser and roundtable discussion focused on prescription drug costs as the contentious battle for Iowa's 3rd Congressional District enters its final weeks...The conversation, conducted without an audience, included Baccam, Klobuchar and John and Terri Hale, owners of The Hale Group, an Ankeny-based advocacy firm focused on older Iowans... Full

PhRMA Submission Calls for USTR to Correct Course On Trade Policy, Enforcement

(10/18, Brian Picone, PhRMA) ...To safeguard American jobs and global leadership in the biopharmaceutical sector, the next Administration must correct course by aggressively pursuing trade agreements and enforcement actions that protect IP and provide fair access to foreign markets... Full

Warren, Welch, Schakowsky Push to Increase Funding for Medical Research, Require Law-Breaking Drug Companies to Reinvest in NIH and FDA

(10/18, United States Senator Elizabeth Warren) ...U.S. Senators Elizabeth Warren (D-Mass.) and Peter Welch (D-Vt.), along with Representative Jan Schakowsky (D-Ill.) introduced the Medical Innovation Act of 2024 to increase funding for medical innovation by requiring large pharmaceutical companies that are accused of breaking the law and settle with the federal government to reinvest a small percentage of their profits into the National Institutes of Health (NIH) and the U.S. Food and Drug Administration... Full

European Commission to Work More Closely with European Medicines Agency

(10/18, Zachary Brennan, Endpoints News) ...The European Commission said Friday that it has officially adopted a new regulation explaining how it will cooperate more closely with the European Medicines Agency on health technology assessments, which typically review the cost and benefits of new drugs... Full

Hemophilia Drug Alhemo Among 10 New Drugs Set For EU Approval

(10/18, Eliza Slawther, Pink Sheet) ...Novo Nordisk's Alhemo and Ionis/AstraZeneca's orphan drug Wainzua are among 10 new medicines that the European Medicines Agency has recommended for pan-EU approval this month... Global Sub. Full

Swiss Agency Optimizes Fast-Track Review, Temporary Authorization Routes

(10/18, Neena Brizmohun, Pink Sheet) ...Switzerland's drug regulator, Swissmedic, has streamlined its procedure for companies seeking a fast-track evaluation or a temporary authorization of their products by dispensing with the need for them to take part in accelerated application hearings (AAAs) in certain cases... Full

Greek Pharma Industry Faces Funding Gap Despite New Measures

(10/21, The Pharma Letter) ...The Greek pharmaceutical industry is grappling with severe underfunding, as recent government adjustments fall short of resolving a critical hospital drug financing gap. New figures reveal that in the first half of 2023, pharmaceutical companies covered nearly 83% of the cost of hospital drugs priced over 30 euros ($32)... Sub. Req’d

Dutch Medicine Expenditure Remains Stable

(10/21, The Pharma Letter) ..."The new key figures from the NZa show that Dutch expenditure on expensive medicines remains stable," says Mark Kramer, chairman of the Association of Innovative Medicines (VIG), adding: "That is good news from a social perspective." Expenditure on expensive medicines fell from 2.67 billion euros ($2.9 billion) in 2021 to €2.53 billion in 2022. This is evident from the 'Key figures for intramural expensive medicines' , which the NZa published last week... Sub. Req’d

Generic and Biosimilar Medicines Industries Welcome Ontario Government's Investment in Next Phase of Life Sciences Strategy

(10/18, CGPA) ...The following is a statement from Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA) and its Biosimilars Canada division, on the Ontario government's $146-million investment in the next phase of the Life Sciences Strategy: "The CGPA and its Biosimilars Canada division welcome the Ontario government's announcement of a $146 million investment in the next phase of its Life Sciences Strategy to help position the province as a global leader in life sciences... Full

Generic Medicines Tend to Be Cheaper Than Brand Names. Here's How Much You Could Save

(10/18, Hanan Dervisevic, ABC News) ...Any Australian who has filled a prescription at the chemist will have been asked if they want a branded product or the generic version. And with consumers looking to cut costs wherever they can, asking for the generic version could save you money... Full

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