Thursday, November 21, 2024

Reddy's Looks To Be Its Own Boss As It Gears Up For GLP-1 Opportunities

(11/20, Dean Rudge, Generics Bulletin) ...Dr Reddy's Laboratories says it will rely primarily on its in-house capabilities as it looks to break into off-patent GLP-1 agonists in the coming years, with up to 15 targets identified in what it terms a "very important segment for us." Erez Israeli, the Indian firm's CEO, told investors during Reddy's second-quarter financial earnings call that the company would be able to use its expertise in peptides to achieve success, "especially on the active pharmaceutical ingredient side."... Global Sub. Full

Novartis Lifts Midterm Sales Guidance Amid U.S. Expansion

(11/21, Helena Smolak, The Wall Street Journal) ...The Swiss pharmaceutical company will look at potential mergers and acquisitions as it continues to pursue its goal of becoming one of the top five pharma companies in the U.S. in the coming years, Chief Executive Vas Narasimhan said Thursday in a call with reporters. The company said it ranked tenth in the U.S. by sales as of the second quarter... Sub. Req’d

Novartis: Launch of Morphosys Drug by Could Be 2027 or Later

(11/21, Ludwig Burger, Reuters) ...Novartis' CEO said on Thursday that the delayed launch of blood-cancer drug pelabresib from the takeover of Morphosys could be achieved in 2027 or later, but any approval would depend on further safety data... Full

Updated: Sage Reports Phase 2 Failure in Huntington's Disease, Ends Drug's Development

(11/20, Max Gelman, Endpoints News) ...The company announced Wednesday morning that a Phase 2 study for dalzanemdor, previously known as SAGE-718, failed in Huntington's disease, saying it missed the primary and all secondary endpoints. As a result, Sage will stop all further dalzanemdor development and suspend an ongoing open-label safety study in Huntington's. With the failure, Sage has no other programs in an advanced stage of development... Full

Tris Pharma Receives Ex-US Approvals for ADHD Treatments

(11/20, Pharmaceutical Technology) ...The Saudi Food and Drug Authority approved Quillivant XR Suspension and Quillivant XR prolonged-release tablets, in October 2024, to treat patients aged six years and above. China's National Medical Products Administration has also approved the usage of Quillivant XR as methylphenidate hydrochloride for sustained-release suspension and QuilliChew ER as methylphenidate hydrochloride extended-release chewable tablets to treat ADHD, and Israel's Ministry of Health Pharmaceutical Division approved Quillivant XR in early 2024. The company is actively pursuing distribution partnerships to increase its accessibility in Israel... Full

Lupin Launches Bumetanide Injection USP in the United States

(11/21, Express Pharma) ...On November 19, 2024, Lupin announced the launch of Bumetanide Injection USP in the United States following approval from the United States Food and Drug Administration (FDA). The product is available in two formulations: 1 mg/4 mL (0.25 mg/mL) single-dose vials and 2.5 mg/10 mL (0.25 mg/mL) multiple-dose vials... Full

Wall Street Awaits Amgen Weight-Loss Drug Data Expected to Move Shares

(11/21, Deena Beasley, Reuters) ...Encouraging comments from Amgen about the 52-week Phase 2 trial helped fuel an 8% rise in the company's shares over the past year. That rally lost steam in recent weeks as investors sought details on the injected drug's safety profile. "We are thinking of the stock as being a double-edged sword highly dependent on late 2024 MariTide's data," Mizuhu analyst Salim Syed said in a recent note. Amgen has said its drug could offer quicker weight loss and possibly better weight maintenance, as well as fewer shots, than once-weekly GLP-1s such as Novo's Wegovy and Lilly's Zepbound... Full

Roche Files Patent Suit to Fend Off Potential Evrysdi Generics from Zydus, Natco

(11/20, Zoey Becker, Fierce Pharma) ...In a new patent lawsuit in New Jersey federal court, the Swiss drugmaker claims Natco's generic infringes five patents while Zydus' infringes three. The patents in question, which are owned by Roche and Evrysdi's original maker PTC Therapeutics, cover chemical compounds, methods for treating SMA and formulations of pharmaceutical compositions, according to Roche's lawsuit. They're all expected to expire in the 2030s... Full

Supreme Court Denies Norwich Bid For US Xifaxan Reprieve

(11/20, Dave Wallace, Generics Bulletin) ...The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label...Teva, Sandoz and Sun Pharma have all previously settled Xifaxan litigation over with Bausch, picking up US rifaximin launch dates of January 1, 2028, while litigation between the originator and other ANDA filers continues... Global Sub. Full

FDA Updates Label of 33-Year-Old Cancer Drug with New Dose and Warning

(11/20, Zachary Brennan, Endpoints News) ...Fludarabine phosphate, which first won approval in 1991, is now authorized for use as part of a combination regimen for adults with B cell chronic lymphocytic leukemia (CLL) and for adults with B cell CLL whose disease got worse after treatment with one alkylating-agent containing regimen, or who didn't respond to that treatment. The FDA also updated the dosage regimen for the injection and removed the boxed warning, incorporating that information into the "Warnings and Precautions" part of the label... Full

Cipla Recalls Over 1.8k Boxes of Generic Drug in US Due to Broken Tablets

(11/20, Press Trust Of India) ...As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), US-based arm of Cipla is recalling 1,875 boxes of Lanthanum Carbonate chewable tablets (1000 mg, 10-count bottle) in the American market...As per the USFDA, New Jersey-based Cipla USA, Inc is recalling the affected lot due to "complaints received of crushed and broken tablets"... Full

Harm Reduction Agencies Look to More Opioid Overdose Reversal Drugs as Additional Tools. Is Narcan the Only Answer?

(11/20, Spencer Wilson, CBS News) ...Due to the current Colorado standing order for Naloxone, Narcan is the only reversal drug distributed free of charge to organizations, but it's not the only reversal drug that's FDA approved for the same purpose, and other brands or even other compounds could have different, possibly better success rates. Maggie Seldeen, founder of High Rockies Harm Reduction (HRHR), said it's about having the opportunity to make that choice, instead of being constrained to one brand... Full

Weight-Loss Drug Coverage Rises Among Largest US Employers, Mercer Survey Finds

(11/20, Amina Niasse, Reuters) ...About 44% of U.S. employers with 500 or more employees cover drugs for weight loss in 2024, up from 41% in 2023, according to a survey from consulting firm Mercer released on Wednesday. Mercer also said 64% of U.S. employers with over 20,000 employees covered weight-loss drugs in 2024, compared with 56% last year... Full

The Health Care Industry is Girding for Trump's Tariffs —and Pushing Hard for Carveouts

(11/21, Tara Bannow and Ed Silverman, STAT Plus) ...President-elect Trump campaigned on imposing broad, steep tariffs to create more jobs in the U.S. and combat China. If enacted, these taxes would send the U.S. health care industry scrambling and could eventually force patients and insurers to shell out more for medical care. But no one in the industry is in a tizzy just yet, at least not publicly. There are two reasons for that. One: No one knows what Trump is actually going to do. Two: They're pushing hard for carve-outs behind the scenes... Sub. Req’d

RFK Jr. as Health Secretary? Not So Fast, Says a Broad, Bipartisan Coalition.

(11/20, Sam Brodey, Boston Globe) ...In one important sense, President-elect Donald Trump's provocative decision to nominate Robert F. Kennedy Jr. as his health secretary has been unifying: a broad collection of people and interests have found at least one reason to lose sleep over the prospect of Kennedy becoming the nation's top health official. That's because of Kennedy's eccentric and contrarian worldview, which mixes deep distrust in the regulations and practices of government, science, and big business with a desire to enforce his crusading views with stringent new rules... Full

Cassidy Brings PBM, Drug Patent, Site-Neutral Reform Focus To Committee Helm

(11/20, Sigi Ris, InsideHealthPolicy) ...Sen. Bill Cassidy (R-LA) will take the helm of the powerful health committee next Congress focused on lowering health care costs through bipartisan reforms to pharmacy benefit manager, drug patent and site-neutral policies, but he also brings extensive research on more politically charged topics like the government's role in overseeing laboratory-developed tests, data privacy, Orange Book patent listings, 340B drug discounts and transgender care... Sub. Req’d

Oz Raised Concerns With PBMs, Insulin Costs, But His IRA Views Unclear

(11/20, Gabrielle Wanneh, InsideHealthPolicy) ...President-elect Donald Trump's nominee for CMS administrator, Mehmet Oz, previously raised concerns with high insulin prices and the role pharmacy benefit managers play in the supply chain, but he hasn't weighed in on the politically charged Medicare drug price negotiation process he will need to quickly take charge of if confirmed to lead the agency... Sub. Req’d

PBMs Strike Back at FTC, Claim Administrative Process is Unconstitutional

(11/20, Noah Tong, Fierce Healthcare) ...Express Scripts, Caremark and Optum Rx—owned by Cigna, CVS Health and UnitedHealth Group, respectively—are arguing in a new lawsuit the FTC's recent actions and administrative process subvert the U.S. Constitution by reforming an industry by "regulatory fiat." This is in response to a September lawsuit filed by the FTC against PBMs and group purchasing organizations, also vertically integrated with insurers... Full

CSRxP Analysis Finds Pharmaceutical Industry's Profit Margins Ten Times Greater Than Other Sectors of Drug Supply Chain

(11/20, The Campaign for Sustainable Rx Pricing) ...CSRxP's analysis found the pharmaceutical industry's average annual net income margin was nearly 23 percent, while the average for other sectors of the U.S. prescription drug supply chain, including distributors, retail pharmacies, pharmacy benefit managers and health insurers, was just 2.3 percent. Pharmaceutical Manufacturers' Profit Margins are 10 Times Larger than Other Drug Supply Chain Sectors... Full

The BIOSECURE Act: What Does It Mean For The Off-Patent Industry?

(11/20, Urte Fultinaviciute, Generics Bulletin) ...According to a white paper by the National Institute for Pharmaceutical Technology and Education, India and China produced 62.1% and 22%, respectively, of API for all generic drugs in 2021...Moreover, the US grew more and more reliant on the import of widely used generics, with China importing 95% of ibuprofen, 91% of hydrocortisone, 70% of acetaminophen, 40%-45% of penicillin, and 40% of heparin, the organization said. This begs the question – how will the BIOSECURE Act affect the off-patent industry?... Global Sub. Full

US FDA Biosimilar Standards Likely Sealed Interchangeability Designation's Fate

(11/20, Derrick Gingery, Pink Sheet) ...Agency officials proposed earlier this year that the interchangeability designation, which requires additional studies to show no efficacy or safety concerns when switching between the reference and biosimilar product, should be eliminated...Sarah Yim, director of the FDA Office of Therapeutic Biologics and Biosimilars, said in an interview with the Pink Sheet that the transition, if it occurs, could have been different if the standards for biosimilarity and interchangeability were different... Global Sub. Full

When Generative AI Meets the FDA: First Digital Health Adcomm Kicks Off Discussion

(11/20, Zachary Brennan, Endpoints News) ...FDA Commissioner Rob Califf opened the meeting, explaining how the agency since 1995 has received more than 1,000 submissions for AI-enabled medical devices, more than 300 submissions for drugs and biologics with AI components, and that almost every drug application uses AI somewhere in the development process. But he also warned that without proper safeguards, AI may not make the US healthier in the end... Full

Representative Doggett and Senator Warren Urge Biden Administration to Lower Prices for Prescription Drugs

(11/20, Representative Lloyd Doggett) ...Before Donald Trump assumes the White House and a Republican-led Congress attempts to obstruct progress on reigning in pharmaceutical companies, Representative Lloyd Doggett (D-Texas) and Senator Elizabeth Warren (D-Mass.) are urging the Biden Administration to fulfill its promise and finalize a strengthened framework to lower prescription drug prices and ensure increased transparency, oversight and accessibility of taxpayer-funded medical products... Full

New York Aims to Lower Drug Prices by Targeting Pharmacy Plans

(11/20, John Tozzi, Bloomberg) ...New York state regulators are setting new rules to rein in the behavior of prescription drug middlemen — including units of CVS Health Corp., Cigna Group and UnitedHealth Group Inc. — in a step the state's top financial regulator said will boost competition and transparency... Sub. Req’d

Canada's New Pharmacare Committee "Excludes" Industry

(11/20, Francesca Bruce, Pink Sheet) ...A new Expert Committee will make recommendations on what Canada's single-payer pharmacare program should look like. The R&D-based industry says the committee should include an industry representative and that its voice has been overlooked during pharmacare discussions. The recent Pharmacare Act provides access to contraceptives and diabetes medicines a the first stage of the pharmacare program... Global Sub. Full

Court Of Appeal Offers Fresh Hope For Patentees That Opted Out Of Europe's UPC

(11/20, Neena Brizmohun, Pink Sheet) ...A new ruling by the Court of Appeal (CoA) of Europe's Unified Patent Court has introduced new possibilities for patentees who believed that the UPC was unavailable to them due to having opted out patents that were subject to national litigation before the UPC became effective on June 1, 2023... Global Sub. Full

EMA to Consult On Biosimilars Regulatory Requirements in 2025

(11/21, Tracey Roberts, Out-Law News) ...The European Medicines Agency could table proposals next year to relax requirements around the need for comparative efficacy trials in the development of biosimilar medicines, Out-Law has learned. Experts at Pinsent Masons said the move could be a "game-changer" and help address the so-called ‘biosimilars void' – an expected shortfall in the number of biosimilars that will be ready to be sold to rival originator biologics when protections providing market exclusivity to originator products end. This, in turn, could improve patient access to medicines and lower healthcare system costs across Europe... Full

Bruce Warner: ‘Medicines Shortages Will Never Go Away, But The Situation Can Be Improved'

(11/20, Sophie Willis, The Pharmaceutical Journal) ...During his nine-year tenure as deputy chief pharmaceutical officer for England from 2014 to 2023, Bruce Warner saw two events that had major implications for the supply of medicines to the UK: Brexit and the COVID-19 pandemic...The Pharmaceutical Journal spoke to Warner from his home in Sheffield to find out more about his work on medicines shortages and whether he thinks the problem is getting worse... Full

South Korean Biotech Firms Boost CDMO, Biosimilar Efforts Ahead of Trump Return

(11/21, Park Ji-min, Park Su-hyeon, The Chosun Daily) ...South Korean biosimilar manufacturers are positioned to benefit from Trump's return to office, with his administration likely to continue promoting biosimilars as a cost-saving alternative to pricier original drugs. South Korea has developed 14 of the 61 biosimilars approved by the U.S. Food and Drug Administration, the second-highest number after the U.S...Celltrion said, "The industrial environment is expected to shift toward encouraging biosimilar use, creating opportunities for expanded sales during Trump's second term."... Full

Financial Incentives Drive Biosimilar Adoption in Japan

(11/20, Cameron Santoro, AJMC) ...Increased prescriptions of biosimilar products were associated with financial incentives provided to hospitals that utilized biosimilars in Japan, according to an analysis published in PLoS One. Across the US, Europe, and Japan, regulatory approvals for bevacizumab, trastuzumab, and rituximab, all oncology drugs, have been granted. The 3 countries have expressed cost-saving expectations of over US$110 billion by 2029, mainly due to the substitution of oncology biosimilars for reference biologics... Full

Japan's Generic Drug Shortage Continues as Flu Season Kicks Off

(11/21, Francis Tang, The Japan Times) ...Out of over 16,000 pharmaceutical products, 3,103 — or 18.5% — were either in limited or suspended supply as of the end of October, according to a survey conducted by the Federation of Pharmaceutical Manufacturers' Associations of Japan. Over 60% of these are generic drugs, which include treatments for fever, cough and other flu-like symptoms. With the health ministry declaring the start of this year's flu season on Nov. 8, demand for such medicine is rising... Full

Andhra Pradesh to Promote Generic Medicines to Ease Financial Burden, Says Health Minister

(11/20, The New Indian Express) ...The State government is aiming to reduce the financial burden on the poor by increasing access to generic medicines and promoting their usage, said Health Minister Y Satya Kumar Yadav. Accusing the previous YSRC government of neglecting generic medicines, the minister revealed that, of the total sale of medicines worth Rs 10,000 crore in the State, generic medicines account for only 7%... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.