Monday, January 8, 2024

Essential Pharma Acquires European Rights to Colobreathe® (Colistimethate Sodium) from Teva

(1/8, Essential Pharma) ...Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically well-established pharmaceutical products across key therapeutic areas, announces that it has completed the acquisition of European rights to Colobreathe® from Teva Laboratories UK Limited...Under the terms of the acquisition, Essential Pharma has acquired the rights to Colobreathe® across European markets; the product is currently marketed across more than 20 countries in Europe, including the UK... Full

Samsung Bioepis Executives Weigh US Biosimilar Progress

(1/5, David Wallace, Generics Bulletin) ...In an exclusive Q&A interview with Generics Bulletin, two Samsung Bioepis executives – Tom Newcomer, vice president and head of US market access; and Gillian Woollett, vice president and head of regulatory strategy and policy – talked about key recent developments in the market as well as what the future holds for US biosimilars... Global Sub. Full

Another Stelara Settlement Revealed As Accord Files US Biosimilar

(1/5, David Wallace, Generics Bulletin) ...Accord BioPharma has revealed the latest US settlement deal over Stelara (ustekinumab) in the US, with the firm disclosing an October 2023 agreement with originator Janssen that will give it the right to launch a biosimilar "no later than May 15, 2025," assuming US Food and Drug Administration approval. Other terms of the settlement remain confidential...Accord's US settlement means that six such deals are now public, giving biosimilar ustekinumab developers US launch dates as follows, assuming FDA approval: Amgen on January 1, 2025, Alvotech and Teva on February 21, 2025, Sandoz and Samsung Bioepis on February 22, 2025, Celltrion on March 7, 2025, Fresenius Kabi and Formycon on April 15, 2025 and Accord on May 15, 2025... Global Sub. Full

Hikma and Guardant Health Sign Exclusive Partnership Agreement to Bring Transformative Cancer Diagnostic Technology to the Middle East and North Africa

(1/8, Hikma Pharmaceuticals) ...Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, today announces an exclusive agreement with Guardant Health, Inc., a leading precision oncology company. Through the agreement, Hikma has the exclusive rights for commercialisation and marketing of Guardant Health's portfolio of liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumor mutation profiling across all solid cancers in the Middle East and North Africa... Full

Cipla's EU Arm, Kemwell Biopharma to Establish JV Company in USA

(1/6, Money Control) ...Cipla, the fully owned subsidiary of Cipla, entered into a joint venture agreement with Kemwell Biopharma UK and MNI Ventures, Mauritius, for the establishment of a joint venture firm in the USA on January 5, 2024. The JV business is being created with the intention of selling innovative cell treatment products in the EU, Japan, and the USA... Full

Merck Is in Advanced Talks to Buy Cancer Drugmaker Harpoon Therapeutics

(1/8, Cynthia Koons and Michelle F. Davis, Bloomberg) ...A deal could be announced within days assuming talks don't fall apart, the people said, asking not to be identified because the information was private. Merck is discussing paying roughly $23 a share for South San Francisco-based Harpoon, the people said. Harpoon shares more than doubled in trading before US exchanges opened. The drugmaker is looking for new sources of growth as its top-selling medicine, the cancer immunotherapy Keytruda, is likely to face pricing pressure at the end of this decade. Keytruda generated $20.9 billion in 2022, making it one of the best-selling drugs in the world... Sub. Req'd

Beleaguered Theravance Logs Head-To-Head Trial Loss for Yupelri Against Boehringer's Spiriva

(1/5, Fraiser Kansteiner, Fierce Pharma) ...In the phase 4 PIFR-2 study, Theravance and Viatris' Yupelri, delivered via standard jet nebulizer, failed to demonstrate greater lung function improvement versus Spiriva delivered by a dry powder inhaler, Theravance said Friday. Despite the trial miss, Theravance remains optimistic about the opportunities in store for Yupelri moving forward, the company's CEO, Rick Winningham, said in a statement. Theravance plans to roll out additional details from the PIFR-2 study following additional data analyses, he added... Full

Dr Reddy's Recalls Over 8,000 Bottles of Generic Drug in US Due to Packaging Error

(1/7, Press Trust Of India) ...Dr Reddy's Laboratories is recalling over 8,000 bottles of a generic medication used to prevent rejection of a transplanted organ from the US market due to a packaging error, according to the US Food & Drug Administration. The Hyderabad-based drug major is recalling 8,280 bottles of Tacrolimus capsules from the US market for "presence of foreign tablets/capsules" in the affected lot... Full

Eli Lilly's Direct Drug Sales Alone May Not Upend The Industry, But Others Could Follow Suit

(1/5, Annika Kim Constantino, CNBC) ...The company's direct-to-consumer push announced Thursday, the first of its kind for a big drugmaker, won't necessarily upend the pharmaceutical industry and the prescription drug supply chain alone, according to some analysts. But other drugmakers could follow suit with their own direct-to-consumer models, according to some analysts. That could add more pressure on what many critics call a complex system for distributing, pricing and prescribing drugs in the U.S. — a structure they say has led to higher prices and fewer choices for patients... Full

New Walgreens CEO Signals Pharmacy Giant Will Shift to New Drug Pricing Models

(1/5, Heather Landi, Fierce Healthcare) ...In his first earnings call since taking over as CEO of Walgreens, Tim Wentworth signaled the drugstore retail giant is exploring new pharmacy models as cost-plus drug pricing gains momentum...Wentworth expects to see payment model changes in the next year or two, he told analysts. "We are prepared and already have sat down and had conversations to support these models, and we could convert to a cost-plus model overnight.We are a willing player in terms of what we would need to do to compete and win patients on a cost-plus basis," he said... Full

Late M&A Bonanza Stokes Healthcare Dealmakers Ahead of JPMorgan Conference

(1/6, David Carnevali, Reuters) ...The four-day JPMorgan Healthcare Conference beginning on Monday is expected by organizers to attract over 8,000 people, including delegations from the world's largest drugmakers, a signal of a return to business as usual after fewer participants were invited last year over COVID-19 concerns. Last month alone, drugmakers including AbbVie, Bristol Myers Squibb and AstraZeneca announced roughly $25 billion worth of U.S.-listed biotech deals, according to data provider LSEG Deals Intelligence... Full

Biden's Action on Drug Pricing Set for Legal Battles in 2024

(1/8, Ian Lopez, Bloomberg Law) ...The pharmaceutical industry's resistance to the Biden administration's program for lowering what Medicare pays for costly drugs is expected to broaden this year, though resolution is unlikely as different lawsuits wind their way through several courts...In addition to the drug price program, scrutiny of other administration actions indicate 2024 is likely to play host to significant shakeups on the drug pricing front. Among them are "important rulings at the district court level" addressing "the wide range of constitutional and statutory claims being pursued by the pharmaceutical industry," said Zachary Baron, director of the Health Policy and the Law Initiative at Georgetown University's O'Neill Institute... Full

Heritage GOP Agenda: Fight Shortages By Shoring Up Generic Drug Quality

(1/5, Jessica Karins, InsideHealthPolicy) ...The Heritage Foundation recently released its "Mandate for Leadership" document, which is part of a coalition of conservative groups' Project 2025 presidential transition project, aiming to give a theoretical Republican president taking office in January 2025 a guidebook for implementing conservative policy. It includes recommendations for each federal agency. Multiple Republican candidates have been vocal critics of FDA policy... Sub. Req'd

US FDA Adds Capacity For Bioequivalence Studies That Could Help Build Trust In Generics

(1/5, Bowman Cox, Pink Sheet) ...The US Food and Drug Administration is putting itself in a better position to check whether, and under what conditions, generic drugs it has approved remain bioequivalent to their brand counterparts by contracting for more capability to run its own clinical bioequivalence trials. Such studies could help build trust among providers and patients in the quality of generic drug products, while also building trust among agency and industry scientists in the growing array of in vivo and in silico methods used to predict in vivo performance... Sub. Req'd

US FDA to Allow Florida to Import Cheaper Drugs from Canada

(1/5, Khushi Mandowara and Deena Beasley, Reuters) ...Florida on Friday won authorization from the U.S. Food and Drug Administration to directly import prescription drugs from Canada, the first state to get such approval for a strategy that could lower prices for medicines. U.S. drug costs are higher than in Canada and other countries where government-run healthcare systems negotiate prices for individual prescription drugs... Full

F.D.A. to Issue First Approval for Mass Drug Imports to States from Canada

(1/5, Christina Jewett, Sheryl Gay Stolberg, The New York Times) ...The approval, issued in a letter to Florida Friday, is a major policy shift for the United States, and supporters hope it will be a significant step forward in the long and largely unsuccessful effort to rein in drug prices. Individuals in the United States are allowed to buy directly from Canadian pharmacies, but states have long wanted to be able to purchase medicines in bulk for their Medicaid programs, government clinics and prisons from Canadian wholesalers. Florida has estimated that it could save up to $150 million in its first year of the program... Sub. Req'd

FDA's Authorization Of Florida Drug Importation Plan Draws Heat From US, Canadian Trade Groups

(1/6, Fraiser Kansteiner, Fierce Pharma) ...Still, industry representatives at home and abroad have been quick to strike back against Governor DeSantis' importation plan. Innovative Medicines Canada (IMC), which represents major drugmakers in the country, said it was "deeply concerned" by the FDA's authorization. "Canada simply can't supply drugs to Florida, or any other U.S. states, without significantly increasing the risk and severity of drug shortages nationwide," David Renwick, interim president of IMC, said in a statement... Full

Drug Pricing Experts Skeptical That Florida's Drug Import Plan Will Work

(1/5, Nicole DeFeudis, Endpoints News) ...PhRMA president Stephen Ubl said Friday in a statement that the industry trade group is "considering all options for preventing this policy from harming patients." The organization has previously raised safety concerns around the importation of "unapproved medicines, whether from Canada or elsewhere in the world."...AARP's Florida state director Jeff Johnson said the decision is useful in starting a conversation about "how to calibrate pricing across countries around the world."... Full

Sorry, But The ‘Drugs From Canada' Don't Work

(1/5, Peter J. Pitts, New York Post) ...Canada is already facing a serious problem with drug shortages. There are close to 1,800 drugs in short supply, per Canada's health ministry. And in a recent survey of more than 1,700 pharmacists, 79% said they believed the frequency of drug shortages had "greatly increased" over the past three to five years. Meanwhile, the Florida Plan would undoubtedly send many Americans to existing scam "drugs from Canada" websites...Canadian regulators have warned Americans that importation could be risky. One official at Health Canada said the regulator "does not assure that products being sold to US citizens are safe, effective and of high quality and does not intend to do so in the future."... Full

Pharmacist Talks New Illinois Law That Prevents Generic Drug Pricing Gouging

(1/5, Dillon Valencia , WREX) ...The new Illinois Drug Pricing Fairness Act prevents drug manufacturers from price gouging generic drugs. Put into effect on January 1st, 2024, the law specifically sets pricing and percentage thresholds at which drug manufacturers cannot increase their prices over a certain period of time. "Prescription drugs don't work if people can't afford them, said Anusha Thotakura, the Deputy Director for Citizen Action Illinois... Full

Health Care Legislation Preview: Maryland Advocates Want to Focus On Access, Patients in 2024 Session

(1/8, Danielle J. Brown, Maryland Matters) ..."We really want to talk about the patient," said Gene Ransom, CEO of MedChi, The Maryland State Medical Society, discussing the organization's priorities for the upcoming session. "This year, I'm hoping will be the year that we talk about access and patients, and that will be the thing we focus on," he said. There will likely be several health-focused bills considered during the 2024 legislative session. But in a fiscally constrained budget year, Gov. Wes Moore (D) has said that he and the legislature will have to make "tough choices" regarding funding initiatives... Full

The European Union Cannot Jeopardise Patient Access to Generic Medicines Through the Urban Wastewater Treatment Directive

(1/8, Medicines for Europe) ...Medicines for Europe is deeply concerned about the Extended Producer Responsibility system in the Urban Wastewater Treatment Directive under discussion in trilogue negotiations...The Commission feasibility study for the Urban Wastewater Treatment Directive recognised that the price impact of the EPR fee could be up to 45% for paracetamol, and this calculation is based on a dramatic underestimation of the real wastewater treatment costs, as shown by the German government's cost estimates above. Moreover, the EPR scheme will be profoundly unfair for generic medicine manufacturers... Full

The Impact of Biosimilar Competition in Europe 2023

(1/8, IQVIA) ...The 9th iteration of the 'Impact of Biosimilar Competition in Europe' report describes the effects on price, volume, and market share following the arrival of biosimilar competition in Europe. The report consists of observations on competitive markets, and a set of Key Performance Indicators (KPIs) to monitor the impact of biosimilars in 23 European markets. The report has been a long-standing source of information on the status of the biosimilars market... Full

UK Regulator Seeks Consent To Share Drug Filing Details With Health System Partners

(1/5, Neena Brizmohun, Pink Sheet) ...The UK medicines regulator, the MHRA, wants to start sharing administrative information about the marketing applications it receives with health technology assessment bodies and other British health system partners in a bid to minimize delays in patient access to newly authorized treatments... Sub. Req'd

SKCDA Urges Centre to Revoke Blanket Exemption Granted Under DPCO to Generic Drugs

(1/8, Nandita Vijayasimha, Pharmabiz.com) ...The Suvarna Karnataka Chemists & Distributors Association (SKCDA) has urged the Union government to revoke the blanket exemption granted under the DPCO, 1995 to the generic drugs. The Association said that it has been continuously reminding the government for this withdrawal in the last couple of years... Full

India Orders New Drug-Making Standards After Overseas Deaths

(1/6, N. Das, Reuters) ...Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load. Jolted by a string of overseas deaths linked to Indian-made drugs since 2022, Prime Minister Narendra Modi's government has stepped up scrutiny of pharmaceutical factories to clean up the image of the $50 billion industry... Full

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