Thursday, December 19, 2024

Antibody Drug Has Promise as "Next Frontier" in Inflammatory Bowel Disease

(12/18, Catherine Eckford, European Pharmaceutical Review) ...With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease, say Teva Pharmaceuticals and Sanofi...In the Phase IIb study, 36.2 percent (low-dose) and 47.8 percent (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission, Teva Pharmaceuticals and Sanofi shared. This is in comparison to 20.45 percent who were given placebo. In this cohort at week 14, clinical remission for low dose was reported to be 15.7 percent and 27.4 percent for high dose... Full

Teva Price Target Raised to $28 from $26 at UBS

(12/18, The Fly) ...UBS analyst Ashwani Verma raised the firm's price target on Teva to $28 from $26 and keeps a Buy rating on the shares. After Phase 2 duvakitug data surpassed expectations, the firm continues to see meaningful further upside on the stock despite the already strong performance, the analyst tells investors in a research note... Full

Teva Announces New Patient Access Program with Direct Relief to Provide Access to Inhalers for Uninsured Patients

(12/18, Direct Relief) ...Teva to provide two generic inhaler products to Direct Relief for its network of free and charitable clinics. The program, launching this month, will run for a minimum of three years..."Direct Relief is deeply grateful to Teva for this critical donation which will connect patients with respiratory treatments they otherwise would not have access to," said Katie Lewis, Regional Director, U.S. Programs for Direct Relief. "Free and charitable clinics offer quality care for underserved communities, and this donation will allow them to reach even more patients with these medications."... Full

Generics Industry Hungry For More After Showing Larger GLP-1 Appetite In 2024

(12/19, Dean Rudge, Generics Bulletin) ...Teva is, perhaps, an outlier in this current situation. The world's largest generics company broke new ground in 2024 when it launched the first generic GLP-1 drug in the US – an authorized generic version of Victoza, possible via a settlement agreement with Novo. In doing so, Teva leapfrogged its competitors Sandoz and Viatris, which had both earlier reached confidential settlement agreements over the type 2 diabetes treatment. However, Teva admits that, despite the massive opportunity in GLP-1s, it will not expend too many resources in this area, preferring instead to be more considerate of where it puts its money under the firm's ‘Pivot to Growth' strategic blueprint... Global Sub. Full

Torrent Picks Up Boehringer Diabetes Brands Ahead Of India Patent Expiry?

(12/19, Vibha Ravi, Generics Bulletin) ...A spokesperson for BI told Generics Bulletin sister publication Scrip that "we are transferring the trademark rights associated with these brands to Torrent Pharmaceuticals after March 2025. Boehringer Ingelheim India will continue to import, market and promote its empagliflozin in India under the brand names Jardiance, Jardiance Met (empagliflozin and metformin) and Glyxambi (empagliflozin and linagliptin)."... Global Sub. Full

Lupin Receives USFDA Nod for New HIV Drug

(12/19, Business Standard) ...Lupin announced that it has received an approval from the United States Food and Drug Administration for its abbreviated new drug application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets...The said drug is the generic equivalent of Descovy Tablets of Gilead Sciences, Inc. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity... Full

Zydus Gets USFDA Nod for Local Anesthetic Cream

(12/19, Anupama Ghosh, The Hindu BusinessLine) ...Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration to manufacture Lidocaine and Prilocaine Cream USP, 2.5 per cent/2.5 per cent, the company announced today. The cream, which is a generic version of EMLA Cream, will be produced at the company's topical manufacturing facility in Changodar, Ahmedabad... Full

Roche Reports Failure of Prothena-Partnered Parkinson's Prospect in Phase 2b, But Highlights Positives

(12/19, Nick Paul Taylor, Fierce Biotech) ...Roche's trial randomized 586 people with early-stage Parkinson's to receive monthly intravenous doses of the Prothena-partnered anti-alpha-synuclein antibody prasinezumab or placebo. Time to confirmed motor progression of Parkinson's was statistically no better on prasinezumab than placebo, causing the study to miss its primary endpoint...Roche said the drug candidate showed "potential clinical efficacy" on the primary endpoint, despite the lack of statistical significance, and shared further analyses to make the case that prasinezumab may have a future... Full

Merck's Long-Awaited Obesity Move is An Oral GLP-1 from China

(12/18, Kyle LaHucik, Endpoints News) ...The New Jersey pharma giant is now teaming up with Hansoh Pharma, one of the largest biopharma companies in China, for a candidate known as HS-10535. Merck will dish out $112 million upfront and up to $1.9 billion in biobucks, the companies said Wednesday. In China, Hansoh will co-promote or solely commercialize the drug. The move adds to a busy year of dealmaking for Merck in China... Full

Hikma Acquires Strategic MENA Portfolio Rights from Takeda Pharmaceuticals

(12/19, Petra) ...Hikma Pharmaceuticals PLC, a global pharmaceutical company, has entered into a definitive agreement with Takeda Pharmaceuticals International AG to acquire the rights to 17 established brands across the Middle East and North Africa (MENA) region. The acquisition encompasses a portfolio of market-leading products in key therapeutic areas including cardiovascular, diabetes, gastroenterology, and pain management... Full

India's ACG Kicks Off Operations at Mammoth Capsule Plant in Thailand

(12/18, Fraiser Kansteiner, Fierce Pharma) ...Looking to significantly bolster its presence across Asia, Indian solid dosage manufacturer ACG has kicked off operations at a massive plant in Thailand...Meanwhile, multiple other pharma outfits have flocked to Thailand in recent years. In June, for instance, Taiwan's Lotus Pharmaceuticals picked up Teva's Thailand operations for an undisclosed sum amid the Israeli drugmaker's ongoing restructuring initiative. Under the deal, Teva's Thailand outfit—which includes a team of about 80 workers—is set to become a wholly owned subsidiary of Lotus, which will take over the sales and marketing of existing Teva products in the region... Full

Trio of Indian Drugmakers Issue Recalls Tied to Impurity, Labeling Issues

(12/18, Joseph Keenan, Fierce Pharma) ...Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling... Full

Heron Beat Fresenius' Invalidity Claims to Block Cinvanti Copy

(12/18, Christopher Yasiejko, Bloomberg Law) ...Heron Therapeutics Inc. won a ruling blocking Fresenius SE & Co.'s copy of nausea-prevention drug Cinvanti for nearly 11 years because a federal judge rejected the generic-drug maker's arguments for invalidating two infringed patents, according to an unsealed opinion... Sub. Req’d

US Accuses CVS of Filling, Billing Government for Illegal Opioid Prescriptions

(12/18, Brendan Pierson, Reuters) ...The Justice Department said the violations were driven by company-mandated performance metrics that led to red flags being ignored, and that in some cases patients died of overdoses shortly after filling illegal prescriptions... Full

PharmPix Corp. Joins Forces With Mark Cuban Cost Plus Drug Company to Revolutionize Pharmacy Benefits

(12/18, PharmPix Corp.) ...Millions of patients nationwide will soon benefit from unprecedented cost transparency in their medications, thanks to a new alliance between PharmPix and Mark Cuban Cost Plus Drug Company (Cost Plus Drugs). With over 90% of prescribed drugs in the U.S. being generics, PharmPix and Cost Plus Drugs are taking bold steps to ensure transparency and affordability within the pharmacy benefits arena... Full

With CR In Flux -- PBM, Generic Drug Transparency, Drug Patent Reforms Uncertain

(12/18, Gabrielle Wanneh, Inside Health Policy) ...A long-sought deal unveiled by lawmakers Tuesday to reform pharmacy benefit managers' practices in Medicare, Medicaid and the commercial market -- as well as streamline the generic drug approval process and rein in brand drug makers' use of so-called patent thickets to delay generic competition -- may now be in flux given President-elect Donald Trump's call Wednesday for Republicans to rewrite their massive lame-duck spending bill... Sub. Req’d

Trump and Vance Stall Congressional Spending Deal, Leaving Healthcare Provisions in Jeopardy

(12/18, Noah Tong, Emma Beavins, Fierce Healthcare) ...Congress' end-of-year healthcare deal may be falling apart, lobbyists told Fierce Healthcare. The bill text for the deal to extend expiring healthcare programs like Medicare telehealth flexibilities was finally finished Wednesday evening. By Thursday morning, there was blowback from Elon Musk, an incoming watchdog on federal spending, about the cost of the bill and the rush to pass it in the days before the government runs out of funding... Full

AAM Comments On End of Year Funding Bill

(12/18, AAM) ..."The healthcare provisions in the year-end funding bill are a double win—streamlining patient access to affordable generic and biosimilar medicines and saving the government money," said John Murphy III, President and CEO of AAM... Full

Chink In PBM Armor? ‘Delinking' Policy In Spending Bill But Passage Unclear

(12/19, Cathy Kelly, Pink Sheet) ...The policy's impact would be blunted by the reality that the major PBMs are vertically integrated with the leading Part D plan sponsors. Compensation between a PBM and its plan sponsor client circulates in the same overall corporate entity... Global Sub. Full

Steps to Rein in Pharmacy Benefit Managers in US Bill "Manageable" for Firms

(12/18, Christy Santhosh, Reuters) ...Healthcare provisions in a stopgap bill unveiled by top Republicans and Democrats are likely manageable for companies that own pharmacy benefit managers such as CVS Health and UnitedHealth, Wall Street analysts said on Wednesday..."Overall, the PBM provisions are a win for big pharma, but may not accomplish the primary goal of lowering drug costs," Oppenheimer analyst Michael Wiederhorn said... Full

CMS: Health Spending Grew by 7.5% in 2023 Amid Increase in Insurance Coverage, Care Utilization

(12/18, Paige Minemyer, Fierce Healthcare) ...The Centers for Medicare & Medicaid Services Office of the Actuary released its annual National Health Expenditure report on Wednesday, where it found that total health spending in 2023 was $4.9 trillion, accounting for 17.6% of the total U.S. economy. The study found that spending in the private insurance sector as well as Medicare grew at a faster rate than in 2022, while spending and enrollment growth in Medicaid slowed with the end of the COVID-19 public health emergency... Full

Post-Hoc: Biosecure is Dead. Long Live Biosecure? 

(12/18, Jared Whitlock, Endpoints News) ...The biggest question from readers: Would the bill, called the Biosecure Act, really become law? For now, the answer seems like no. As of yesterday, it was left out of an end-of-the-year legislative package that seemed like its last, best hope of passage — at least in the short term. Sources have told me that China hawks will try to reboot Biosecure next year despite past opposition from Rep. Jim McGovern (D-MA) and Sen. Rand Paul (R-KY), who believe a national security case hasn't been made for targeting WuXi companies... Full

Biosimilar Year In Review: Regulatory Achievements And Future Aspirations

(12/18, Urte Fultinaviciute, Generics Bulletin) ...Indeed, the industry saw many new or revised guidances from major regulators such as the European Medicines Agency and the US Food and Drug Administration, which, if enacted, could lower the development costs of biosimilars...As such, Generics Bulletin asked industry stakeholders to share, in their opinion, what were the biggest regulatory developments in 2024 and what to expect next year... Global Sub. Full

The Generic Drug Cluster Third Anniversary Reflection

(12/18, U.S. Food & Drug Administration) ...The Generic Drug Cluster has become an essential forum for international regulatory collaboration, bringing together agencies from around the world to share knowledge, address common challenges, and align on best practices in the oversight of generic drugs. This manuscript outlines the contributions, challenges, and outcomes of the Cluster's activities since its inception in 2021, highlighting the tangible benefits for participating agencies... Full

Novartis, AbbVie and PhRMA Secure 340B Court Win in West Virginia

(12/18, Zachary Brennan, Endpoints News) ...Novartis, AbbVie and industry group PhRMA on Tuesday notched a victory over a West Virginia law that would have required the companies to distribute drugs at reduced prices to an unlimited number of pharmacies under a federal drug discount program known as 340B... Full

EU Adopts New Procedural Rules To Guide Joint Scientific Consultations For HTA

(12/18, Francesca Bruce, Pink Sheet) ...The European Commission has adopted an implementing act that explains how companies can request joint scientific consultations (JSCs), through which they can get advice from health technology assessment bodies on their development plans for a medicinal product. Such consultations will allow companies to obtain guidance on the information, data, analyses and other evidence that are likely to be required for the joint clinical assessment (JCA) of their medicinal products... Global Sub. Full

EU Regulators Gear Up for Alzheimer's Treatment Challenges

(12/18, Anabel Costa-Ferreira, Pink Sheet) ...Efforts are underway to enhance the ability of EU medicines regulators to review new treatments for Alzheimer's disease (AD) that may be heading their way in the near future. Many of the recommendations listed in a new horizon scanning report, which aims to help the EU medicines regulatory network (EMRN) proactively address upcoming challenges and opportunities in relation to AD, will be implemented, the European Medicines Agency told the Pink Sheet... Global Sub. Full

Making Affordable Generics More Reliable

(12/19, Aditya Sinha, The Hindu) ...Generic drugs are crucial for addressing healthcare affordability in a population marked by significant income disparities. Bioequivalent to branded drugs, generics offer cost-effective alternatives. India leverages economies of scale and low production costs to supply affordable medication domestically and internationally... Full

NPPA Ropes in Patent Office to Decide On Pleas for Price Cap Exemption

(12/19, Teena Thacker, The Economic Times) ...India's drug pricing regulator, NPPA, is increasing scrutiny of pharmaceutical companies seeking price exemptions. The NPPA is collaborating with the Indian Patent Office to evaluate applications, including those from Intas Pharmaceuticals and Biological E, under DPCO, 2013. These companies claim their new drugs, developed through indigenous research and patented in India, qualify for a five-year exemption from price controls... Full

India Becomes Third Largest Pharma Market Globally

(12/19, Sheezan Naseer, International Business Times) ...India's pharmaceutical industry, the third largest globally by volume, has been valued at $50 billion in FY 2023-24, according to Union Minister of State for Chemicals and Fertilizers Anupriya Patel. The domestic consumption value of the pharmaceutical market was $23.5 billion, while exports were valued at $26.5 billion. The industry's strong global presence is further highlighted by its 14th position in terms of production value, with a diversified product base that includes generic drugs, bulk drugs, over-the-counter drugs, vaccines, biosimilars, and biologics... Full

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