Monday, December 9, 2024

Teva Divests from Japanese JV with Takeda

(12/9, Shiri Habib-Valdhorn, Globes) ...Over the years Teva Pharmaceutical Industries Ltd. has struggled to break into the Japanese market and over the weekend the Israeli company announced that it is divesting from its joint venture in Japan. Teva has agreed to sell its stake in Teva Takeda Pharma to private equity firm J-Will Partners, which has established a company called JKI. Teva set up the joint venture with Japanese company Takeda nine years ago. Teva believes that the sale will help it focus on bringing innovative branded drugs to the Japanese market and says that the deal fits with its strategic growth plan... Full

Teva, Takeda Sell Generics Joint Venture in Japan to Focus On Innovative Drugs

(12/6, Angus Liu, Fierce Pharma) ..."This is another step in our Pivot to Growth strategy to focus the business," Mark Sabag, Teva's commercial chief of international markets, said in a statement Thursday. "Furthermore, we are confident that this agreement with JKI will ensure the continued delivery of high-quality, affordable medicines to patients in Japan."... Full

Teva to Divest Teva Takeda Pharma JV in Japan to JKI

(12/6, Manish Kumar, World Pharmaceutical Frontiers) ...The divestiture includes Teva Takeda Pharma's generics and legacy products. Israel-based Teva announced plans to explore strategic options in Japan, including a potential divestment of its business venture with Takeda. This move is part of Teva's Pivot to Growth strategy, allowing the company to focus more on its new medicines in the Japanese market... Full

Teva to Divest Business Venture in Japan; Layoffs at Rome Therapeutics 

(12/6, Endpoints News) ...Teva will divest its Japan business venture to private equity firm: The company said Friday that it agreed to transfer all shares of Teva Takeda and its subsidiary Teva Takeda Yakuhin — its businesses that sell generics in Japan — to JKI, a fund managed by J-Will Partners. According to Teva, the divestment will allow Teva to focus on its innovative medicines business in Japan... Full

Warning Not to Share ADHD Medicine, As Shortage Bites

(12/8, RNZ) ...ADHD New Zealand spokesman Darrin Bull said some people have had to pick which days they take their medicine, to try to make their prescription last longer. While some had been asking others to lend them some of their medicine, which needs to stop, he said. A worldwide shortage of methylphenidate, prescribed under the brand names Ritalin, Concerta or Teva, has lasted more than a year... Full

Sawai Goes After Xarelto, Plaquenil With New Japanese Listings

(12/6, Dave Wallace, Generics Bulletin) ...Sawai has teed up multiple new launches in Japan after reporting the listing of five generics across ten presentations in the country's National Health Insurance drug price list. The new registrations come after the firm reported lukewarm first-half results amid ongoing domestic supply issues... Global Sub. Full

MS Pharma Becomes Partner for the Commercialization of FYB202 / Ustekinumab in the MENA Region

(12/9, Formycon AG) ...Formycon AG and MS Pharma jointly announce that they have entered into a licensing and supply agreement for the commercialization of FYB202, Formycon's Biosimilar to Stelara®1 (ustekinumab), in the Middle East and North Africa ("MENA region")... Full

Health Canada Approves Celltrion's Omricleo for Allergic Asthma and Chronic Urticaria

(12/9, Jasmine Choi, Business Korea) ...Celltrion's treatment for allergic asthma and chronic idiopathic urticaria, Omricleo, has received product approval from Health Canada, marking a significant milestone for the South Korean biopharmaceutical company. This approval, announced on Dec. 9, positions Omricleo as the first biosimilar of Xolair to be approved in Canada, a major market in North America... Full

ASH: AstraZeneca Proposes Fixed-Duration Calquence Combos in Chronic Lymphocytic Leukemia

(12/8, Angus Liu, Fierce Pharma) ...Calquence, given alongside venetoclax both with and without Roche's Gazyva for a finite period, was able to significantly extend the time before tumor progression or death compared with traditional chemoimmunotherapy in fit patients with treatment-naïve CLL. The results, from the phase 3 AMPLIFY trial, will be presented at the American Society of Hematology 2024 annual meeting... Full

Lupin's Win Over Galderma in Oracea Patent Case Survives Appeal

(12/6, Christopher Yasiejko, Bloomberg Law) ...Lupin Ltd. can continue selling its copies of Galderma Laboratories LP's Oracea drug in the US after a federal appeals court upheld a March ruling that found the generic doesn't infringe two patents for the rosacea treatment... Sub. Req’d

Valisure and Picket Pharmaceuticals Announce a Partnership for Independent Certification of Injectable Drugs

(12/6, Valisure) ...Valisure and Picket Pharmaceuticals have announced a strategic partnership to integrate Valisure's independent chemical analysis and certification program into Picket Pharmaceuticals' injectable drug product offerings. This collaboration aims to help address the primary market failure of generic drugs where a lack of transparency to quality combined with "race to the bottom" pricing has led to record levels of drug shortages in the United States... Full

Popular US-Based Weight Loss Drug Maker Eli Lilly Plans to Launch Medicine in India Next Year

(12/9, The Economic Times) ...Eli Lilly will launch Mounjaro in India in 2025. The drug treats type 2 diabetes and obesity. Lilly received marketing authorization in July. It is working on additional approvals. Mounjaro's global sales exceeded $3.1 billion in Q3 2024. Lilly will expand its diabetes portfolio in India with this launch. It has partnerships with Lupin and Cipla for other diabetes products... Full

Penn Medicine Partners with Mark Cuban's Drug Company

(12/6, Paige Twenter, Becker's Hospital Review) ...The Philadelphia-based organization will buy the 100 most frequently dispensed medicines through the company's Cost Plus Marketplace for its retail pharmacy network. Penn Medicine's 16 retail pharmacies fill more than 1.5 million prescriptions every year. This marks the third health system to announce a partnership with Cost Plus Drugs... Full

Out-of-Pocket Costs for MS Medications Rise While They Drop for Other Neurologic Conditions

(12/6, Rosanna Sutherby, Pharm.D., Managed Healthcare Executive) ...The out-of-pocket cost for MS disease-modifying therapies jump by 217% going from $750 per year in 2012 to $2,378 per year in 2021. Since the approval of the first disease-modifying therapy (DMT) for multiple sclerosis (MS) thirty years ago, the landscape for the treatment of this chronic inflammatory disease has changed significantly. Clinical guidelines now recommend starting DMTs soon after diagnosis to slow disease progression and disability accumulation and curtail neuronal damage caused by inflammation... Full

Americans Face Challenges as Health Insurance Costs Rise and Delays Mount

(12/9, Stephanie Kelly and Julie Steenhuysen, Reuters) ...Police are still hunting for the man suspected of killing Brian Thompson, chief executive of UnitedHealthcare, and have not determined a motive. But the attack called fresh attention to deepening frustrations over health coverage. Recent data show that patients are now even more likely to have their claims denied, pay more for premiums and medical visits, and face unexpected costs for care they thought was covered by their health plan. Rising costs are attributed in part to consolidation of doctors' practices, hospitals and insurers... Full

A Majority of Americans Fear Losing Easy Access to Essential Medications, Survey Finds

(12/6, Sandra Levy, Drug Store News) ...New data from Wolters Kluwer Health's third Pharmacy Next: Health Consumer Medication Trends survey reveals how systemic changes in the pharmacy and retail healthcare environment are profoundly affecting consumers' attitudes toward their care. With more drugstore and retail clinic closures announced, American consumers are worried about accessing affordable care nearby while many are more open to new technologies like AI chatbots and QR codes to support their medication needs... Full

AI-Powered Solutions for Streamlining Biosimilar Prescribing and Monitoring

(12/8, Skylar Jeremias, The Center for Biosimilars) ...Steve Pickette, PharmD, BCPS, chief clinical pharmacist at InpharmD, highlighted the transformative role of artificial intelligence (AI) in managing biosimilars and generics. He explains that AI can significantly reduce the workload for clinical and pharmacy staff by streamlining the analysis required for prescribing and formulary changes, enabling better engagement with health care providers... Full

The Global Surge in Generic Drug Usage

(12/6, Straits Research) ...Generic drugs have long been a mainstay of the pharmaceutical industry since they provide more economical options to brand-name pharmaceuticals. It is anticipated that the generic drug market will reach USD 546.03 billion by 2031. Because of trademark regulations, generic medications may look different from their brand-name counterparts, but they must be bioequivalent in terms of how the body metabolizes them, with an active component change of no more than 3.5% permitted. Because of their equal efficacy, generic medications are becoming a popular choice for patients all over the world... Full

Pfizer, Eli Lilly and PhRMA CEOs Joined Trump for Mar-a-Lago Dinner to Talk Collaboration, Cures for Cancer: Axios

(12/6, Zoey Becker, Fierce Pharma) ...Amid ongoing speculation about how the biopharmaceutical sector will fare under Donald Trump's second presidency, the President-elect hosted several prominent industry leaders at his Mar-a-Lago residence to discuss topics such as finding cures for cancer, Axios reports. Joined by his incoming chief of staff Susie Wiles and HHS secretary nominee Robert F. Kennedy Jr., Trump dined with Pfizer CEO Albert Bourla, Eli Lilly CEO David Ricks and the head of the Pharmaceutical Research and Manufacturers of America (PhRMA), Stephen Ubl, according to the report... Full

Former Senate Republican Health Leader Not Concerned About Anti-Pharma Stance of Trump's HHS Appointees

(12/6, Sarah Karlin-Smith, Pink Sheet) ...Former Sen. Richard Burr told the Pink Sheet that he was not concerned about the anti-pharma industry stance of some of President-elect Trump's expected HHS nominees. Burr said Trump's picks were qualified for their roles, but believes they will have less power to enact their personal agendas than people expect. The industry appears to be handling the potential threats delicately by communicating its values when disagreements with a Trump appointee emerge, but not directly attacking them... Global Sub. Full

1 Big Thing: Searching for Drug Discount Fixes

(12/7, Victoria Knight, Axios) ...The federal 340B program may not command many headlines, but it's one of the biggest government drug programs. It is also growing at a rapid clip, with discounted drug purchases hitting a record of $66.3 billion in 2023. The program is mired in litigation and administrative disputes, with drugmakers and providers accusing each other of gaming the system...Pharma manufacturers impatient with how 340B has rapidly expanded over the years have been trying to clamp down on how discounts are issued to providers... Full

Inflation Reduction Act Price Controls and the 340B Program

(12/6, William S. Smith and Robert Popovian, RealClearHealth) ...Under the multi-billion-dollar 340B program, drug manufacturers must provide deep discounts to certain hospitals and clinics. However, federal law explicitly prohibits "double dipping" schemes where manufacturers must give both a steep 340B discount to hospitals and substantial rebates to State Medicaid programs for the same dispensed drug to the same patient. This practice, known as a "duplicate discount," is unlawful. So, if these duplicate discounts are unlawful, why isn't the prohibition of the double-dipping scheme being enforced?... Full

Biosecure Bill is Left Out of End-of-Year Defense Package, Dealing Blow to Chances

(12/7, Jared Whitlock, Endpoints News) ...Legislation targeting popular Chinese biotech contractors like WuXi AppTec wasn't included in must-pass defense legislation that represented its best chances as this session of Congress draws to a close. On Saturday evening, lawmakers unveiled a deal to move forward the National Defense Authorization Act, one of the last pieces of legislation expected to advance this year. Supporters of the Biosecure Act had hoped to use the package as a vehicle for their legislation... Full

Trump's Tariffs Could Put More Pressure On the U.S. to Produce Generic Drugs. Are We Ready?

(12/6, Meagan Parrish, PharmaVoice) ...As the incoming Trump administration prepares for a new term in the White House, the president-elect has promised 60% tariffs on goods from China. While the impact would be far-reaching across industries, the drug market, which escaped the reach of tariffs enacted by Trump during his first term, is lined up for a direct hit. And because of China's chokehold on the market for active pharmaceutical ingredients, large tariffs are likely to raise the cost of generic drugs in the U.S., which has struggled to bring more production facilities online in recent years... Full

EMA Encourages Swift Data Insertion As European Shortages Monitoring Platform Goes Live

(12/6, Anabel Costa-Ferreira, Pink Sheet) ...Marketing authorization holders are being encouraged to insert their data on shortages of centrally authorized medicines in the new platform before it becomes mandatory to do so in February 2025..."The launch of the ESMP requires MAHs to be compliant with their shortage reporting obligations," in line with previously published EMA guidance, a spokesperson for the agency told the Pink Sheet. "Information on shortages across the EU [are] underreported to EMA, and reporting is often delayed. The ESMP will enable MAHs to notify and update shortage information in bulk," the spokesperson added... Global Sub. Full

EFPIA Outlines Recommendations for New Framework

(12/9, The Pharma Letter) ...The European Federation of Pharmaceutical Industries and Associations (EFPIA) has proposed nine key recommendations aimed at maximizing the program's impact. "Implementing these recommendations would not only optimize the investment in research and innovation but also position the EU at the forefront of health R&I globally," said Magda Chlebus, executive director of science policy and regulatory affairs... Sub. Req’d

Maximizing Impact of Biosimilar Meds Requires Strategic Action in Europe

(12/6, The Pharma Letter) ...A surge in biologics losing market exclusivity creates an opportunity to increase access to treatment, free up vital healthcare resources, enhance budget sustainability thanks to effective market competition. The latest research underscores critical challenges that must be addressed to unlock the potential of this important segment of the European biotech industry... Sub. Req’d

Swiss Pharmacies Brace for Shake-Up as Deregulation Looms

(12/9, Jessica Davis Plüss, Swissinfo.ch) ...People in Switzerland are used to going to their local pharmacy not just to pick up or buy medicine but for health advice for common ailments from skin rashes to digestive issues. In contrast to the United States, where pharmacies are embedded in retail shops selling candy and greetings cards, Swiss pharmacies are more like medical establishments. Regardless of these differences, brick-and-mortar pharmacies have been essential parts of healthcare systems. But in many countries, they are in crisis. Costs have gone up for everything from energy to staffing, rising healthcare spending has patients, insurers, and health authorities looking for ways to save money, while online retailers are grabbing a larger share of the market... Full

Govt Provides Updates On Measures to Encourage Domestic Manufacturing

(12/9, Express Pharma) ...The Government of India has taken several measures to encourage domestic manufacturing in the pharmaceutical sector including bulk drugs and medical devices to reduce import dependence, boost domestic manufacturing and attract large investments... Full

Is India Reliable? Addressing Challenges in the Pharma Industry

(12/9, Shreeyashi Ojha, BioProcess International) ...At CPHI India, Rhonda Duffy, chief operations officer (COO) at Biocon Biologics spoke to BioProcess Insider emphasizing the country's need to realign its approach with global standards, particularly leadership, infrastructure, and investment. "India needs to move away from its British heritage and colonial mindset," Duffy said. "It's time to move beyond old practices and focus on reliability, which is the key to attracting foreign investment."... Full

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