Friday, December 6, 2024

Pharma Firm Teva to Divest its Business Venture in Japan

(12/5, Sriparna Roy, Reuters) ...Israel-based Teva's deal with JKI will transfer all the shares of the unit Teva-Takeda and its subsidiary Teva Takeda Yakuhin to the firm...The world's largest generic drugmaker, Teva, expects the divestiture to be completed by April 1, 2025... Full

Teva to Divest Japanese Venture Teva Takeda

(12/6, Pavan Kamat, FirstWord Pharma) ...The development follows closely on Teva's recent announcement stating its willingness to explore strategic options in Japan, including potentially divesting Teva Takeda. The Israeli pharma noted that the divestment aligns with its "Pivot to Growth" strategy, focusing resources on advancing and commercialising its pipeline of innovative products while offloading its generic and legacy products business in Japan..."We are confident that this agreement with JKI will ensure the continued delivery of high-quality, affordable medicines to patients in Japan," said Mark Sabag, EVP of Teva's international markets commercial... Full

Teva to Divest Teva-Takeda Business Venture in Japan to JKI

(12/6, Seeking Alpha) ...The divestment, which includes generics and legacy products, will allow Teva to focus on bringing its innovative medicines to the Japanese market. The divestment aligns with Teva's Pivot to Growth strategy to focus its business...All the employees of the business venture in Japan will remain employed, subject to the terms of the agreement... Full

Teva to Divest Teva-Takeda Business Venture in Japan

(12/5, The Fly) ...Teva Pharmaceutical has entered into an agreement with JKI, established by the fund managed and operated by J-Will, whereby all shares of Teva Takeda Pharma and its wholly owned subsidiary Teva Takeda Yakuhin will be transferred to JKI... Full

Takeda Pharmaceutical to Sell Generic JV

(12/6, Jiji Press) ...Takeda Pharmaceutical Co. said Friday that it will sell all of its 49 pct stake in generic joint venture Teva Takeda Pharma Ltd. to Israeli partner Teva Pharmaceutical Industries Ltd. for about 55 billion yen... Full

Teva's Ajovy Shows Positive Results in Preventing Pediatric Migraines

(12/5, John Pinching, PharmaTimes) ...Teva Pharmaceutical Industries has presented positive data from its Phase 3 SPACE study, demonstrating the efficacy and safety of AJOVY (fremanezumab) in preventing episodic migraines in children and adolescents aged 6-17 years. The trial showed that fremanezumab significantly reduced monthly migraine and headache days compared to placebo over 12 weeks. "This is an important milestone for clinicians and young patients living with episodic migraine who currently have few treatment options available to them," said Professor Patricia Pozo-Rosich, one of the lead investigators of the trial... Full

Ajovy Demonstrates Safety, Efficacy in Pediatric Migraines

(12/5, Lauren Biscaldi, Drug Topics) ..."Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licensed treatments to manage this debilitating condition in children," said Eric A. Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva Pharmaceuticals. "We've already seen the benefits of [fremanezumab] in adults, and the SPACE trial has confirmed that children with episodic migraine can also benefit from Ajovy."... Full

Fremanezumab Safe and Effective for Prevention of Episodic Migraine in Children: Phase 3 Data Announced

(12/5, Grace Halsey, Patient Care) ...Findings from the phase 3 SPACE trial found a significantly greater number of children (47.2%) reached a 50% response rate to fremanezumab vs to placebo (27.0%) over 12 weeks with a safety profile and efficacy consistent with results in pivotal phase 3 and real-world evidence studies in adults, Teva said. The benefits of treatment were similar across age groups and between sexes as well... Full

Teva Jumps On Ajovy's Impact in Children

(12/5, The Pharma Letter) ...Shares in Teva Pharmaceutical Industries closed more than 5% higher on Wednesday. The Israeli drugmaker earlier presented positive data from its Phase III SPACE study evaluating the efficacy and safety of Ajovy (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged six to 17 years... Sub. Req’d

Stanford, Essentia and Other Health Systems Join Civica

(12/5, Alex Kacik, Modern Healthcare) ...Stanford Health Care, Essentia Health, Winona Health and Boulder Community Health have joined Civica, a nonprofit company that looks to increase access to generic drugs and stem persistent shortages...Civica focuses on sterile injectable drugs, such as saline and epinephrine, which are often in short supply. Nearly half of the 95 new drug shortages that surfaced this year were sterile injectables, according to data from the American Society of Health System Pharmacists. Shortages can increase costs, limit access and worsen patient outcomes... Sub. Req’d

MSN Has Green Light To Launch US Entresto Competition, With Trial Around The Corner

(12/5, Dean Rudge, Generics Bulletin) ...Just days before trial is set to begin in overarching patent-infringement proceedings, MSN Laboratories has again dodged an attempt by Novartis to enjoin the Indian firm's US Food and Drug Administration-approved generic version of the originator's $3bn Entresto (sacubitril/valsartan) heart failure brand, setting up the potential for an ‘at-risk' launch... Global Sub. Full

Indoco Targets UK Market With Clarity

(12/5, Dave Wallace, Generics Bulletin) ...Indoco has set its sights on the UK market, striking a deal with local distributor Clarity Pharma that the Indian firm says will allow it to launch 20 products into the UK market over the next 18 months... Global Sub. Full

Novo Nordisk to Cut US List Prices of Two Insulin Products by More Than 70%

(12/5, Louise Breusch Rasmussen, Reuters) ...Danish drug maker Novo Nordisk said on Thursday it will reduce the U.S. list prices of two insulin products by more than 70% from January of 2026. The list prices of its insulin drug Fiasp will be reduced by 75%, while the list prices of its Tresiba insulin will be reduced by 72.2%, Novo said in a statement. As a result, Novo will discontinue Tresiba's unbranded biological versions by the end of 2025, it added... Full

AstraZeneca Scores FDA Nod for Imfinzi as First Immunotherapy for Limited-Stage Small Cell Lung Cancer

(12/5, Kevin Dunleavy, Fierce Pharma) ...AstraZeneca has picked off another label expansion for its cancer blockbuster Imfinzi (durvalumab) as the FDA has blessed the PD-L1 inhibitor for limited-stage small cell lung cancer (LS-SCLC) patients who have not had disease progression after concurrent chemotherapy and radiation treatments... Full

Lupin Receives U.S. FDA Tentative Approval for HIV Treatment Generic

(12/6, Express Pharma) ...Lupin has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg. The approval allows Lupin to market a generic version of ViiV Healthcare's Triumeq PD Tablets for Oral Suspension... Full

Lilly Invests $3 Billion to Expand Wisconsin Plant As Obesity Drug Demand Soars

(12/5, Patrick Wingrove, Reuters) ...The new investment in the factory, which it acquired from Nexus Pharmaceuticals, will help boost production of Lilly's powerful weight-loss drug Zepbound as well as its diabetes treatments and other medicines, the company said... Full

GoodRx, Leading PBMs Accused by Pharmacists of Price Fixing

(12/5, Ganny Belloni, Bloomberg Law) ...The lawsuit filed Wednesday by the Philadelphia Association of Retail Druggists in the US District Court for the District of Rhode Island claims that CVS Caremark, Express Scripts, Medimpact Healthcare Systems, and Navitus Health Solutions, conspired to "share real time pricing data with one another" using GoodRx as a clearinghouse "to avoid paying the reimbursement rates that PBM Defendants negotiated with pharmacies on behalf of insurers."... Sub. Req’d

Less Than 4% of Long Island's Opioid Lawsuit Settlement Millions Spent as Overdose Deaths Continue

(12/5, Robert Brodsky and Anastasia Valeeva, Newsday) ...A Newsday investigation showed that out of 3.5 million in settlement money available on Long Island to date, Nassau and Suffolk counties have issued a collective $97.2 million in contracts and grants since 2022, but only $8.1 million has been distributed...A lack of urgency to get opioid settlement funds to vendors, bureaucratic red tape and a cumbersome grant reimbursement process appear to have slowed the pace of distribution in both Nassau and Suffolk, according to some county legislative leaders and a budget watchdog... Sub. Req’d

Beyond Basics

(12/5, Debby Garbato, Drug Store News) ...Plagued by a cavalcade of "me-too" products and rock bottom competitive pricing, suppliers are taking several steps to diversify offerings beyond standard generics to boost profits. Some are emphasizing niche products and complex pharmaceuticals. Others are moving more manufacturing processes in house, letting them lower prices without sacrificing margins. And a handful of companies are aggressively targeting the biosimilars market, where products are costly to develop but yield big rewards. Patient services are another focus, including financial assistance, support groups and last mile delivery... Full

Resources Forced Withdrawal of Double-Patenting Proposed Rule, US PTO Says

(12/5, Dave Wallace, Pink Sheet) ...The US Patent and Trademark Office withdrew a proposed rule intended to fight patent thickets because of "resource constraints." The regulation would have added a new requirement that acceptable terminal disclaimers must overcome non-statutory double patenting. Stakeholders had criticized the proposed rule, but the Campaign for Sustainable Rx Pricing said it was disappointed about the withdrawal... Global Sub. Full

USPTO Withdraws Proposed Patent Rule Criticized by Pharma Industry

(12/5, Nicole DeFeudis, Endpoints News) ...The proposal received more than 300 public comments, including harsh criticism from the pharmaceutical industry. Multiple drugmakers, including AbbVie and Amgen, argued that the rule would have a chilling effect on innovation. Federal agencies argued that it would prevent patent thickets and encourage competition... Full

Bipartisan, Bicameral Lawmakers Plug PBM Reform As GOP Floats Lame-Duck Package

(12/5, Gabrielle Wanneh, InsideHealthPolicy) ...A bipartisan, bicameral group of 17 lawmakers, spearheaded by Rep. Buddy Carter (R-GA), touted a need for Congress to pass legislation requiring more transparency from pharmacy benefit managers and delinking PBM compensation from the list prices of prescription drugs, just as Republican lawmakers on Wednesday (Dec. 4) proposed to use PBM reforms to help pay for a lame-duck offer to Democrats that includes a three-year extension of key Medicare telehealth flexibilities and the Acute Hospital Care at Home program, a physician payment patch and much more... Sub. Req’d

National Survey Finds Employers Overwhelmingly Satisfied With PBMs' Transparency, Flexibility, And Savings

(12/5, PCMA) ...A recent survey of nearly 700 employers across the country conducted by NORC at the University of Chicago found that employers are overwhelmingly satisfied with PBMs' transparency, flexibility, and savings. The survey results should make Congress question the necessity of so-called PBM reform legislation... Full

Miller-Meeks, Lawmakers Demand Action On DRUG Act

(12/5, Jeff Wilford, The Oskaloosa Herald) ...Rep. Mariannette Miller-Meeks (R-LeClaire) was one of those lawmakers. She and the others spoke in favor of passing the DRUG Act, which would ban practices by pharmacy benefits managers that they said threaten pharmacies and hurt patients. "Patients everywhere … deserve a more transparent healthcare system where patients always come first," Miller-Meeks said. Standing with her John Nicholson, owner of Mahaska Drug... Full

Rep. Malliotakis, Staten Island Pharmacist Owner Push for Crackdown On Pharmacy Insurance Giants

(12/5, Paul Liotta, SILive) ...An independent Staten Island pharmacist joined Rep. Nicole Malliotakis (R-Staten Island/South Brooklyn) Wednesday in Washington D.C. to push for a crackdown on healthcare giants they say are killing businesses like his. Robert Annicharico, owner of Delco Drugs in Eltingville, said he wants to see the passage of legislation that advocates say would rein in pharmacy benefit managers, which are the businesses that manage prescription drug plans... Full

Biosecure Compromise Could Add Executive Review Process for Named Companies, Sources Say

(12/5, Jared Whitlock, Zachary Brennan and Max Bayer, Endpoints News) ...A compromise version could add an executive branch review to the process, giving the White House or federal agencies final say on the enactment of restrictions, according to one person who had seen a version of changes circulating earlier this week, and according to several other people who were familiar with the potential changes. There was no indication that another core provision, grandfathering in existing contracts, had been changed... Full

Accelerated Approval: FDA Revises Guidance to Reflect Revised Withdrawal Procedures

(12/5, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways to reflect changes to the accelerated approval program brought on by recent legislation... Full

Maximising the Impact of Biosimilar Medicines Requires Strategic Action in Europe

(12/5, Medicines for Europe) ...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... Full

Antibiotics Business Model Should Be the Flipside of Pharma Norm, Says Shionogi Europe CEO

(12/6, Christoph Schwaiger, Euractiv) ...Companies producing antibiotics should invert the traditional pharma business model. Antibiotic manufacturers' main incentive should be to sell the least amount of antibiotics possible, Shionogi Europe CEO Huw Tippett said at the European Health Summit in Brussels... Full

Nordic Countries Launch ‘English-Only' Packaging Pilot To Tackle Medicine Shortages

(12/5, Neena Brizmohun, Pink Sheet) ...Denmark, Finland, Iceland, Norway, and Sweden will start a five-year pilot in 2025 to explore whether exempting the use of the various Nordic languages on the packaging and printed package leaflets of certain medicines will improve their availability. The pilot will start on January 1, and applies to 20 critical products that are produced in low volumes and are used in hospitals and administered by health care professionals. Drug companies are being encouraged to apply to take part in the pilot... Global Sub. Full

NICE Endorses Neuraxpharm's Ublituximab for Treating MS

(12/5, John Pinching, Pharma Times) ...Neuraxpharm Group has announced that the National Institute for Health and Care Excellence (NICE) has recommended ublituximab (BRIUMVI®) for the treatment of relapsing-remitting multiple sclerosis (RRMS)...Ublituximab, developed by TG Therapeutics and licensed by Neuraxpharm outside the US, targets CD20-expressing B cells. Clinical studies show it significantly suppresses relapses and disease activity measured by MRI, compared with oral teriflunomide... Full

Swiss Health Insurance Spent More On Medicine Than Ever in 2023

(12/5, Lucia Theiler, SRF, Swissinfo.ch) ...Last year, Swiss health insurance companies spent CHF9 billion ($10.2 billion) on medicines for compulsory insurance, almost 6% more than in the previous year. And more than ever before. Why have medication costs risen? There are various reasons: more patients, more medication per person and new, expensive therapies. According to Swiss insurance company Helsana, the general price level of new preparations has even doubled in recent years. "A little quantity and a lot of price," concluded the authors of the Helsana Drug Report published this week... Full

France: Government Collapses As Controversial Price-Cutting Finance Bill Rejected

(12/5, Francesca Bruce, Pink Sheet) ...France's 2025 social security financing bill (PLFSS) that would have enforced €1bn ($1.06bn) of price cuts on medicines has been rejected after a vote of no confidence toppled the government on December 4. Critics of the bill said it would lead to greater austerity and a weakening of social safety nets... Global Sub. Full

The Impact of Stronger Drug Dosing Patents On Canadian Drug Access

(12/5, J. Bradley White, Nathaniel Lipkus and Leah McGurn, Osler) ...In light of the recent decisions upholding the effectiveness of dosage regimen patents, the Supreme Court of Canada's forthcoming decision will have a significant impact on the balance between patent enforcement and access to affordable generic and biosimilar alternatives. Although not yet scheduled, the hearing of this case is likely to occur toward late 2025...The outcome will determine whether drug costs are likely to become more of a pain point over the coming years or whether the pain is likely to subside. Either way, the decision has the potential for a dramatic impact on pharmaceutical policy, including the planned national pharmacare program... Full

Korea's Biopharma Policies Put To Test Amid Political Turmoil

(12/5, Jung Won Shin, Pink Sheet) ...Prolonged political instability in South Korea from a failed martial law declaration could hurt foreign pharma investor sentiment, setting back government attempts to attract such investment as part of effort to build a global biopharma cluster. Merck KGaA, which is building a major production site in Korea, said the country is a good fit for potential investments, but noted political stability, policy and the regulatory environment are also critical factors... Global Sub. Full

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