Tuesday, November 5, 2024

Teva's TEV-‘749 Yields Positive Results in Phase 3 Schizophrenia Trial

(11/4, Manish Kumar, World Pharmaceutical Frontiers) ...Teva chief medical officer and global R&D executive vice president Eric Hughes said: "For people living with schizophrenia receiving treatment, outside of symptom control, potential improvements in social functioning and quality of life are of fundamental importance, so we are delighted to share these encouraging TEV-‘749 results." Additionally, Teva presented real-world data on Uzedy (risperidone), an extended-release injectable for treating schizophrenia in adults. Uzedy received approval from the US Food and Drug Administration in April 2023... Full

Teva's Long-Lasting Schizophrenia Injectable Shines in Phase III

(11/4, Jenna Philpott, Clinical Trails Arena) ...Teva Pharmaceuticals' TEV-479 (olanzapine) has shown statistical improvement in schizophrenia symptoms in a Phase III trial. The Phase III SOLARIS trial (NCT05693935) demonstrated improvements in social functioning and quality of life (QoL) over an eight-week treatment period... Full

India's Dr Reddy's Misses Q2 Profit View On Weak Pricing in North America

(11/5, Kashish Tandon and Rishika Sadam, Reuters) ...The company reported a 9.5% fall in its consolidated net profit after tax to 13.42 billion rupees ($159.6 million) for the quarter ended Sept. 30, missing analysts' estimate of 14.01 billion rupees, as per data compiled by LSEG...Dr Reddy's largely attributed the sales growth in the region to a rise in volumes but said it was partly offset by price erosion... Full

Sandoz Raises Guidance As Biosimilars Continue To Drive Growth

(11/4, Dave Wallace, Generics Bulletin) ...Sandoz has marked its first anniversary as an independent standalone company by raising its full-year guidance for 2024, predicting high-single-digit turnover growth in constant currencies – up from the previous forecast of mid-to-high-single-digit growth – and a core EBITDA margin of around 20%, as its portfolio continues to shift towards high-value biosimilars... Global Sub. Full

India's Mankind Pharma Tops Q2 Profit View On Higher Demand for Chronic Drugs

(11/5, Kashish Tandon, Reuters) ...The company, which also makes Manforce condoms and Prega News pregnancy kits, said its consolidated net profit rose to 6.53 billion rupees ($77.7 million) for the quarter ended Sept. 30, a 30% climb from last year. Analysts, on average, expected a profit of 5.90 billion rupees, as per data compiled by LSEG. Revenue contribution from its mainstay chronic illness drugs segment climbed to 35% from 34%, driving total revenue 14% higher... Full

Biocon Projects Accelerated Growth for H2 FY25 Fueled by Product Launches, Increased Volume

(11/4, Aishwarya Kumar and Venkatesha Babu, The Hindu BusinessLine) ...Pharma major Biocon Ltd announced its quarterly earnings reporting a loss of 16 crore for the quarter ending September 30. While the company missed analyst and market expectations, it is poised for growth in the second half of FY25. Siddharth Mittal, CEO and Managing Director of Biocon Ltd spoke to businessline about how the company is aligned with its growth strategy and the guidelines set for the year. He expects that new product launches and increased volumes will serve as key growth drivers in the latter half of the fiscal year... Full

India's Gland Pharma Posts Q2 Profit Drop Hurt by Europe Business

(11/4, Kashish Tandon and Anuran Sadhu, Reuters) ...The company said its overall revenue growth was hurt by temporary production issues at Cenexi. The unit has helped boost Gland's sales in Europe since its acquisition. Excluding Cenexi, Gland Pharma's revenue grew 5% during the quarter. Sales from the U.S., its biggest market, increased 3%, and sales from its other markets of Canada, Australia, and New Zealand rose 45%, the company said... Full

Cipla Signals Lanreotide Supply Strain, Eyes First Wave GLP-1 India Entry

(11/4, Anju Ghnagurde, Generics Bulletin) ...Lanreotide supply challenges could impact Cipla's US revenues in the coming quarter, while the firm hopes it can seize emerging opportunities in the GLP-I segment in India, where Novo Nordisk and Eli Lilly are progressing filings for their blockbuster products..."These issues are anticipated to be resolved by the end of Q3 and starting in Q4 FY25 we should be able to recover sharply in the lanreotide franchise. We're also working to increase the overall capacity of lanreotide through capex investment made by our partner," Vohra said in the earnings call for the second quarter of fiscal year 2025... Global Sub. Full

'We Play to Win': AstraZeneca Details First Results for Oral GLP-1 and Broader Obesity Ambitions

(11/4, Kyle LaHucik, Endpoints News) ..."When we think about how we're playing in this space, this is AstraZeneca — and we play to win," Sharon Barr, EVP of BioPharmaceuticals R&D, said Monday morning during a media call. "If we didn't think we had a highly competitive molecule, we would not be further investing in that molecule and moving it forward rapidly through clinical development."...The drugmaker on Monday revealed the first data for its once-daily oral GLP-1. It said the average weight loss was 5.8% at four weeks for patients with type 2 diabetes who were taking AZD5004 in a Phase 1 trial... Full

NICE Backs First Ophthalmic Bevacizumab for NHS Use

(11/5, Phil Taylor, Pharma Phorum) ...Outlook Therapeutics' Lytenava has become the first ophthalmic formulation of VEGF inhibitor bevacizumab to be cleared for use by the NHS in England and Wales for treating wet age-related macular degeneration...In its guidance, NICE said that clinical data suggests Lytenava is more effective than ranibizumab as a treatment for wet AMD, and offers similar efficacy to aflibercept and faricimab. It also notes that Lytenava's list price – at £470 for one vial of 7.5 mg per 0.3 ml solution – is "similar to the cost of aflibercept."... Full

Mark Cuban Cost Plus Among Compounders Facing FDA Inspection Issues

(11/4, Maaisha Osman, InsideHealthPolicy) ...FDA last week issued an inspection alert to Mark Cuban Cost Plus Company's 503b compounding facility, citing concerns its manufacturing processes may lead to microorganism contamination -- coming as the agency also finds problems with other compounders, including a California facility, and issues a broader warning to all compounders last week. The agency issued an alert reminding compounders "to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile."... Sub. Req’d

Kroger to Pay California Up to $122 Million for its Role in the Opioid Epidemic

(11/4, Matthew Rodriguez, CBS News) ...Kroger, the parent company of Ralphs, agreed to pay up to $122 to California to resolve allegations that it failed to adequately monitor opioids distributed by its pharmacies...The settlement also requires Kroger to monitor, report and share data about suspicious activity related to opioid prescriptions at its pharmacies... Full

Intensity of the IV Fluid Shortage at US Hospitals Remains Very High

(11/5, Brendan Murray, Bloomberg) ...Baxter is posting regular updates on its website as North Cove recovers gradually. The latest update, dated Oct. 31, says a key production line has restarted and that the earliest shipments from the facility will happen in late November - ahead of original estimates... Full

Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

(11/4, Adam J. Fein, Ph.D., Drug Channels) ...As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What's more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals' incentives to adopt biosimilars, while simultaneously raising costs for commercial plans... Full

Biosimilars Are Making Inroads In U.S., But It's Still A Bumpy Ride

(11/4, Joshua P. Cohen, Forbes) ...In a series of posts this month and next, beginning with this one focused on the role of patent disputes, I will assess what is holding back more robust biosimilar competition... Full

The Election is Tuesday. What's at Stake for the Pharma Industry?

(11/4, Nicole DeFeudis, Endpoints News) ...Drug pricing has been a focal point for the Biden White House, and the next administration will either continue with negotiations under the Inflation Reduction Act or seek to go their own direction. Vice President Kamala Harris has said she wants to "accelerate" Medicare negotiations. Meanwhile, former President Donald Trump has recently embraced Robert F. Kennedy Jr., saying at a Madison Square Garden campaign event that he will let Kennedy "go wild on health." But the candidates' stances on other issues pivotal to the pharmaceutical industry — such as march-in rights or FTC scrutiny — remain less clear... Full

IRA Litigation: Pharma's Exit Options Irk Third Circuit Judges

(11/4, Sarah Karlin-Smith, Pink Sheet) ...In oral arguments of their IRA case, Bristol Myers and Janssen appeared to have persuaded two of three judges that the Medicare drug price negotiation program did not have a reasonable exit option for manufacturers... Global Sub. Full

GoodRx, PBMs Accused of Suppressing Reimbursements to Independent Pharmacies

(11/4, Brendan Pierson, Reuters) ...Drug coupon aggregator GoodRx and pharmacy benefit managers including CVS Caremark and Express Scripts have been hit with at least three class action lawsuits accusing them of working together to suppress reimbursements to small pharmacies for generic prescription drugs... Full

Health Company Challenges Drug Discount Plan Purchasing Policy

(11/4, Nyah Phengsitthy, Bloomberg Law) ...The Health Resources and Services Administration acted unlawfully when it denied Premier's request to exempt it from a 2013 policy that limits when hospitals under the 340B Drug Discount Program can use their group purchasing arrangements to buy non-340B drugs, according to the health-care company's complaint filed Nov. 1 in the US District Court for the District of Columbia... Sub. Req’d

Walgreens Agrees to Pay $100 Mln to Resolve Lawsuit Over Generic Drug Pricing

(11/4, Brendan Pierson, Reuters) ...Walgreens has agreed to pay $100 million to settle a proposed class action lawsuit accusing it of fraudulently overcharging customers for a decade when they bought generic drugs through private insurance, Medicare or Medicaid... Full

FDA Expands Faster Drug Review Pilot from Supplemental to Full Applications

(11/4, Zachary Brennan, Endpoints News) ...The FDA on Dec. 2 will open up an expedited review pilot program that's meant to speed therapies that substantially improve upon what's currently available for serious conditions to full marketing applications and not just supplemental applications... Full

Arkansas Rejects Call for High Court Review of Drug Discount Law

(11/4, Nyah Phengsitthy, Bloomberg Law) ...An Eighth Circuit decision upholding an Arkansas law that prohibits drugmakers from imposing conditions on contract pharmacies under a federal drug discount program doesn't need Supreme Court intervention, the state told the justices Monday... Sub. Req’d

‘Unforeseen' Variations & ‘Super-Grouping' Addressed In New EU Guidance

(11/4, Ian Schofield, Pink Sheet) ...The European Medicines Agency has updated its guidance in line with the amended EU Variations Regulation, whose provisions will apply from January 1, 2025. Among issues addressed in the updated guidance are Type IA variations, the classification of "unforeseen" variations, grouping and "super-grouping" of variations, and work-sharing procedures. The European Commission is also updating its Variations Guidelines on categories and the operation of procedures, which should be ready sometime in 2025... Global Sub. Full

Foreign Pharma Calls for Suspending 50-Fold Hike in Korea's Drug Approval Fees

(11/5, Kim Yun-mi, Korea Biomedical Review) ...Global pharmaceutical companies operating in Korea have called for a moratorium on the government's "Innovation Plan for Drug Approval, which will be implemented next January. They said a moratorium is necessary to clarify the shortened approval period and work out concrete complementary measures... Full

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