Wednesday, December 4, 2024

Teva Presents Data from SPACE Study

(12/4, The Fly) ...Teva presented data from its Phase 3 SPACE study evaluating the efficacy and safety of Ajovy for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favorable safety profile consistent with that observed in the adult population... Full

Teva Pharmaceutical Says Migraine Prevention Drug Shows Efficacy in Younger Patients

(12/4, MT Newswires) ...Teva Pharmaceutical Industries said Wednesday a phase 3 study of its fremanezumab drug to prevent episodic migraine in patients aged 6 to 17 years showed "statistically significant superior efficacy" compared with placebo...Teva said it continues to study the impact of fremanezumab on pediatric patients with chronic migraines and its long-term safety... Full

Coherus Sells its Last Biosimilar Udenyca to Intas for Up to $558M as Company Homes in On Novel Cancer Meds

(12/3, Fraiser Kansteiner, Fierce Pharma) ...Coherus has agreed to sell its biosimilar Udenyca—which references Amgen's febrile neutropenia drug Neulasta—to Intas Pharmaceuticals for up to $558.4 million. The deal, which is expected to close by the end of 2025's first quarter, will see Coherus receive $483.4 million upfront, plus $75 million in potential sales milestones, the company said Tuesday... Full

Sandoz to Invest $80M to Boost Capacity at Turkey Plant

(12/4, Ercan Ersoy, Bloomberg) ...Capacity of plant at Gebze, near Istanbul, will be raised by 50% to 15b tablets a year, Sandoz's Turkish unit says in emailed statement. Gebze plant is among the biggest 3 Sandoz manufacturing facilities around the world; its $115m of exports to 60 countries in 2023 made up 10% of Turkey's total drug sales abroad... Sub. Req’d

Lupin Takes A Step Closer To $1Bn US Janumet Opportunity

(12/3, Dean Rudge, Generics Bulletin) ...Lupin has welcomed tentative generic approval for one of the most sought-after small molecule opportunities in the US – Merck & Co's Janumet (metformin/sitagliptin) to treat type 2 diabetes, which has attracted dozens of abbreviation new drug application sponsors. The Indian firm said that it would look to manufacture its generic metformin/sitagliptin 50mg/500mg and 50mg/1,000mg tablets at its Pithampur facility in India... Global Sub. Full

Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

(12/3, Alaric DeArment, Generics Bulletin) ...Outlook said the NORSE EIGHT trial did not meet its primary endpoint of showing that ONS-5010 was noninferior to ranibizumab at eight weeks, but it will file for US FDA approval anyway. Despite the primary endpoint miss, the company remains hopeful about FDA approval, though one analyst said the results cloud its prospects. The drug nevertheless remains approved and in the process of launching in Europe. Also, Outlook has addressed FDA concerns that led to a complete response letter last year... Global Sub. Full

Alembic Pharma Gets USFDA Nod for Olopatadine Hydrochloride Eye Drops

(12/4, Business Standard) ...Alembic Pharmaceuticals announced that it has received tentative approval from the US Food & Drug Administration for its abbreviated new drug application, Olopatadine Hydrochloride Ophthalmic Solution USP. The approved ANDA is therapeutically equivalent to the reference listed drug product, Pataday Once Daily Relief Ophthalmic Solution, of Alcon Laboratories, Inc... Full

Biogen Expects Steady Growth for Alzheimer's Drug Leqembi in Near Term

(12/3, Mariam Sunny, Reuters) ...Biogen expects growth of its keenly watched Alzheimer's disease drug, Leqembi, to see a "linear trend" in the United States in the near term, a company executive said at a healthcare conference on Tuesday..."I would expect a linear trend...at this point, until some things sort of change in the market," Alisha Alaimo, Biogen's head of North America, said at the Evercore HealthCONx Conference... Full

Eli Lilly's Zepbound Defeats Novo Nordisk's Wegovy in Head-to-Head Weight Loss Trial

(12/4, Kevin Dunleavy, Fierce Pharma) ...Wednesday, the answer finally arrived as Lilly revealed results from a study that showed that its obesity drug Zepbound was 47% more effective than Novo's Wegovy in helping patients lose weight. In the SURMOUNT-5 study, while participants taking Zepbound lost an average of 20.2% of their weight after 72 weeks, those on Wegovy lost 13.7% of their weight. The results translated to an average weight loss of 50.3 pounds (22.8 kg) for patients on Zepbound and 33.1 pounds (15 kg) for those taking Wegovy... Full

Takeda Puts Up to $1.3B On The Line for Keros' Blood Cancer Anemia Drug

(12/3, Tristan Manalac, BioSpace) ...Keros' elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a formidable challenge to Bristol Myers Squibb's Reblozyl. Takeda Pharmaceuticals on Tuesday inked an exclusive licensing deal with Massachusetts-based biotech Keros Therapeutics to advance a potential competitor to Bristol Myers Squibb's blockbuster injection Reblozyl (luspatercept)... Full

Granules India's Loss is Which Pharma Company's Gain?

(12/4, Hormaz Fatakia, CNBC TV-18) ...Granules India Ltd.'s shares fell 10% on Tuesday after the USFDA granted an Official Action Indicated (OAI) status to its crucial Gagillapur facility, which had earlier received a form 483 with six observations...Investec analysed Granules' on-market US product portfolio and saw companies that have product overlap with Granules...Investec believes that Aurobindo Pharma has the most products overlapping with granules, including acetaminophen, ER metformin, ibuprofen, fexofenadine, and guaifenesin ER... Full

Nearly 30% of US Drugstores Closed in One Decade, Study Shows

(12/3, Tom Murphy, Associated Press) ...Drugstores have been dealing with shrinking reimbursement for prescriptions, rising costs and changing customer shopping habits. The chains have been closing money-losing stores and transferring prescription files to more profitable locations... Full

Concerns Over PREVAIL Act Persist, Even With Amendment To Shield Off-Patent Drugs

(12/3, Urte Fultinaviciute, Generics Bulletin) ...Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs... Sub. Req’d

Bloomberg, Gottlieb Intensify Push To Sink RFK Jr.'s HHS Nomination

(12/3, Maaisha Osman, InsideHealthPolicy) ...Businessman and former New York City Mayor Mike Bloomberg slammed Robert F. Kennedy Jr.'s nomination to lead HHS as "medical malpractice on a mass scale," joining former FDA Commissioner Scott Gottlieb in urging Senate Republicans to reject the president-elect's controversial pick. Their remarks signal an effort to derail Kennedy's nomination ahead of the Senate's return from its Thanksgiving break, when Kennedy is expected to begin meeting with senators to lobby for his confirmation... Sub. Req’d

How Republican 'Red Wave' in Washington Could Shake Up Healthcare, Pharma Policy: S&P

(12/3, Heather Landi, Fierce Healthcare) ...With the incoming Trump administration and a Republican-controlled Congress, significant policy shifts are expected for the healthcare industry, from changes to the Affordable Care Act (ACA), the tone at the Federal Trade Commission (FTC) on M&A and tariffs and the priorities of the new head of Department of Health and Human Services (HHS)...Analysts with S&P Global Ratings don't expect a major ratings impact for healthcare companies over the near to intermediate term, but anticipate changes will be a net negative for the industry from a credit perspective... Full

Impact of the Inflation Reduction Act On Biosimilar Pricing, Dispensing

(12/3, Brian Nowosielski, Drug Topics) ...On the most recent episode of Over the Counter, Steve Callahan, Senior Director of Advisory & Insights at MMIT, talked with us about biosimilars and the Inflation Reduction Act... Full

Medicare Talks Lowered Drug Prices Up to 42%, Study Finds

(12/3, Peter Sullivan, Axios Pro) ...Negotiated prices were 8% to 42% lower than the previous net prices before negotiation, the study found. That ranges from 8% for the diabetes drug Farxiga to 42% for another diabetes treatment, Januvia..."All products remained more expensive in the U.S. than in other countries," the study found, apart from insulin, whose price was reduced by manufacturers... Sub. Req’d

Podcast: How Mark Cuban is Disrupting Big Pharma and Taking On Politics

(12/3, Chris Cuomo, WGN Radio 720) ...Mark Cuban (entrepreneur, investor, and founder, Cost Plus Drugs) joins Chris Cuomo to discuss disrupting Big Pharma, lowering healthcare costs, and how transparency can fix the system. Cuban also responds to Megyn Kelly's criticism of his political views and shares his thoughts on polarization, ranked choice voting, and why innovation is key to solving America's biggest challenges... Full

Mark Cuban Explains His Battle Against Pharmacy Benefit Managers

(12/4, Hoag Levins, Penn LDI) ...In January, Forbes profiled Cuban and spotlighted how, in an incredibly short period of time, he has achieved a dramatic disruption of the U.S. prescription drug distribution market: "Two years in, Mark Cuban's company keeps shaking up the generic pharmaceutical space. It added another 1,000 medicines in December to the list of now 2,200 drugs it sells directly to patients. The firm now offers prescription drugs—mostly generics—to over 2 million members."..."This industry is the easiest industry I've ever disrupted," Cuban told Emanuel. "And all it took was transparency and just telling the truth."... Full

Bristol Myers Squibb Latest Drug Company to Sue HHS Over 340B Rebate Model

(12/3, Heather Landi, Fierce Healthcare) ...Bristol Myers Squibb became the latest large drugmaker to sue the federal government over a plan to change how it doles out drug discounts to hospitals...To start, BMS said it intended to implement the model exclusively as to its Eliquis blood thinner product starting in the spring of 2025. HHS rejected BMS's intended 340B rebate model in early November saying the proposal would be inconsistent with the statutory requirements for the 340B Program, which requires approval of a rebate model such as BMS has proposed... Full

340B Plan B: Pharma Pivots To Rebate Pricing Model After Pharmacy Restrictions Fall Short

(12/3, Cathy Kelly, Pink Sheet) ...Drug manufacturers are shifting 340B price concessions for some products upfront counts to back-end rebates, despite HRSA opposition. Some companies are limiting their new rebate models only to products with Medicare negotiated prices for now. Regulatory consultant Bill Sarraille predicted more rebate-model announcements and litigation are coming in 2025... Global Sub. Full

ACR Urges Congressional Leaders to Reform ‘Underwater' Biosimilar Reimbursement

(12/3, Healio) ...The group, which also includes the Arthritis Foundation and dozens of state and local rheumatology organizations, have dubbed themselves the Underwater Biosimilars Coalition. On Nov. 30, the coalition sent a letter to leaders in both the U.S. House of Representatives and the Senate expressing "grave concerns" about providers being reimbursed for less than they spend to administer some biosimilars in outpatient facilities under Medicare Part B, leaving them "underwater."... Full

"If You've Got Legitimate Suspenders, Don't Have an Unconstitutional Belt:" Federalist Society Panel's Take On Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act

(12/4, Kurt R. Karst, FDA Law Blog) ...The heightened discussion concerning Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act has even caught the attention of a Federalist Society panel. Indeed, in a recent Federalist Society-sponsored webinar, titled "Does Jarkesy Doom the Preserve Access to Affordable Generics and Biosimilars Act?," moderator Brian Pandya (Duane Morris LLP) hashes out the interplay between Jarkesy and The Preserve Access to Affordable Generics and Biosimilars Act with Matthew S. Hellman (Jenner & Block), William M. Jay (Goodwin Procter LLP), and Prof. Emily Michiko Morris (The University of Akron School of Law)... Full

California Voters Deliver Accountability to Health Care Providers Exploiting Drug Program

(12/3, Julie Gill Shuffield, Desert Sun) ...While the official vote won't be certified until next month, the results were clear enough to declare a victory for a California ballot initiative on health care, namely Proposition 34, an effort to make sure that drug sale revenue is used solely on health care. Prop. 34 confronts the longtime abuse of the federal 340B prescription drug program and will hold bad actors accountable if providers don't spend 98% of their revenue on patients. California voters got it right... Full

As ‘Carveout' Debate Continues, States Try Hybrid Approach to Medicaid Rx Benefits

(12/3, Leslie Small, Pink Sheet) ...Some states are implementing hybrid approaches to pharmacy benefits management, where managed care organizations are paid to provide pharmacy benefits, but must contract with a single pharmacy benefit manager. Kentucky touted the savings produced by the move and now eight states have implemented similar systems. But finding proof that the program is beneficial can be difficult... Global Sub. Full

English NHS Failing to Meet Targets For Availability Of NICE-Approved Cancer Drugs

(12/3, Leela Barham, Pink Sheet) ...An analysis of the time to first treatment for anticancer drugs made available under the UK Early Access to Medicine Scheme (EAMS) and OK'd by England's health technology assessment body NICE has found that the National Health Service has only rarely been able to achieve the aim of availability in 30 days. There is reason for optimism though, according to the analysis conducted by the Pink Sheet: availability has been getting faster over time for both EAMS and non-EAMS treatments... Global Sub. Full

EMA PRIME Scheme: Two New Entries, 10 Rejections & One Withdrawal

(12/3, Neena Birzmohun, Pink Sheet) ...A total of 141 products have made it onto the European Medicines Agency's PRIME (priority medicines) scheme since 2016 and over 370 applications have been denied entry...The fact that a medicine is not accepted in PRIME does not mean that its development should not be pursued. As previously noted by the agency, "medicines that are not granted PRIME access can still benefit patients by providing alternative treatment options for a disease."... Global Sub. Full

UK MHRA Reminds Industry Of Looming Deadline For New Packaging Requirements

(12/3, Eliza Slawther, Pink Sheet) ...More than 90% of companies have submitted new medicines packaging artwork to the UK's drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its December 31, deadline to comply with the new Windsor Framework arrangements... Global Sub. Full

MHRA's Stature Undermined by Lack of Resources Says Pharma

(12/4, Phil Taylor, PharmaPhorum) ...The Association of British Pharmaceutical Industry (ABPI) warns in the document that lack of resources, and the knock-on effect of struggling to attract and retain top talent, have undermined the MHRA's standing as a global regulator and – as a consequence – threatens the UK's competitiveness in life sciences. It has urged the MHRA's new chair Professor Anthony Harnden and its new chief executive – when appointed – to take steps to restore the agency's standing after a difficult few years navigating the changes forced by Brexit, the COVID-19 pandemic, and an ongoing restructuring drive... Full

India Regulatory Reform: ‘Redeliberation' At SECs Tightened, ‘Unnecessary Load' Reduced

(12/3, Anju Ghangurde, Pink Sheet) ...Addressing the annual summit of the Organisation of Pharmaceutical Producers of India (OPPI), Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), outlined certain initiatives that the regulator is implementing to ensure optimal use of resources, while also seemingly tightening some processes around areas like clinical trial clearances. The OPPI essentially represents the interests of foreign firms in India... Global Sub. Full

Japanese Drug Market Prices 5.2% Lower Than Official Prices

(12/4, The Japan Times) ...Market prices of drugs purchased by medical institutions from wholesalers in Japan were 5.2% lower than the state-set official prices on average as of September, a health ministry survey showed Wednesday. Based on the survey results, presented to a relevant panel advising the health minister, the government plans to lower official drug prices for fiscal 2025 while carefully considering the scope of items subject to the planned cuts in light of the impacts on drugmakers... Full

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