Monday, November 4, 2024

Teva Long-Acting Olanzapine Shows Improvements in Schizophrenia Patients

(11/1, Jonathan Block, Seeking Alpha) ...Data from a phase 3 trial of Teva Pharmaceutical Industries' TEV-'749 indicated that the long-acting, subcutaneous version of the antipsychotic olanzapine led to improvement in social functioning and quality of life through week...Separately, Teva released data from real-world analyses of Uzedy, its subcutaneous long-acting injectable of risperidone. Results showed high adherence rates in adults with high unmet social needs... Full

Attorney General Jackley Announces South Dakotans to See Benefit From Generic Drug Settlement

(11/1, Attorney General Marty Jackley) ...South Dakota Attorney General Marty Jackley announces the state will receive almost $300,000 as part of a settlement with global health company Apotex and Teva Pharmaceuticals to resolve allegations of generic drug price-fixing...A similar complaint was filed in 2019 against Teva Pharmaceuticals. South Dakota this year received $277,000 from that settlement. The money from those two settlements will go to the state's Anti-Trust Fund located in the Attorney General's Office... Full

Novartis CEO 'Very Confident' On Sales Target, Doesn't Fear Patent Cliff - Newspaper

(11/2, John Revill, Reuters) ...Novartis expects to increase its annual sales by least 5% per year in the coming years, CEO Vas Narasimhan said in an interview on Saturday, with the pharmaceuticals giant having nothing to fear from the end of patent protection on some drugs...Narasimhan said he was confident the company would reach its growth target despite the imminent expiry of patents on some medications including Entresto used to treat heart failure... Full

Samsung Biologics Breaks Record with Over $725M Quarterly Sales

(11/4, Sodam Park, HIT News) ...Samsung Biologics, led by CEO John Rim, reported Q3 2024 consolidated sales of $861 million and an operating profit of $245.5 million, showing respective year-over-year growth of 15% and 6%. The company credited the quarterly sales milestone of over $725 million to full-capacity operations at Plants 1 through 3 and the gradual ramp-up of Plant 4... Full

Biocon's Q2 Results Decoded. Exclusive Interview With Biocon's Management On Earnings & Plans Ahead

(11/4, Business Today TV) ...In this exclusive interview, Business Today TV's Sakshi Batra speaks with Siddharth Mittal, CEO & MD of Biocon Limited, about the company's Q2 FY25 earnings. Biocon reported total consolidated revenue of Rs 3,623 crore, which was flat year-on-year... Full

Sun Pharma Shares Fall 5% Post Leqselvi Injunction, But Analysts Say Opportunity 'Not Over'

(11/4, Meghna Sen, CNBC TV 18) ...According to Citi, the delay in the launch of Sun Pharma's alopecia areata drug, Leqselvi, could impact its near-term earnings by 3-6% of EPS and may also affect competitive positioning, as rival drugs will have longer-term clinical data by the time Sun's product reaches the market...Sun Pharma intends to appeal the district court's decision... Full

Celltrion Releases Stelara Biosimilar in Germany, Netherlands

(11/4, Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Monday that it has launched Steqeyma (ingredient: ustekinumab), its biosimilar to Stelara, in Germany, aiming to enhance its leadership in the biopharmaceutical sector by expanding its product portfolio for autoimmune disease treatment...On the same day, Celltrion also launched Steqeyma in the Netherlands, where its Dutch branch secured a bid from Inkoopcombinatie Ziekenhuis Apotheken Academische Ziekenhuizen (iZAAZ), a pharmaceutical procurement group. According to Celltrion, iZAAZ is recognized as a primary supply channel with significant influence across Dutch university hospitals... Full

EU Antitrust Regulators to Rule On Novo's Catalent Buy by Dec. 6

(11/4, Foo Yun Chee and Maggie Fick, Reuters) ...EU antitrust regulators will decide by Dec. 6 whether to clear Novo Holdings' acquisition of contract drug manufacturer Catalent, according to a filing on the European Commission website on Monday...Novo Holdings, Novo Nordisk and Catalent have all recently reiterated their expectations that the transaction will close towards the end of this year. The three companies did not immediately respond to a request for comment on Monday morning... Full

Baxter Pulls IV Products Out of China to Shift Supply to the US

(11/1, Anna Brown, Endpoints News) ..."The urgent need to support patient care in the US expedited our decision to suspend the promotion and selling of IV solutions in China," a spokesperson said. It had already been considering pulling back its business there for several months because of "numerous alternative" suppliers of IV fluids in China, the company added... Full

Dr Reddy's Recalls Over 3.3 Lakh Bottles of Generic Medication in US: USFDA

(11/3, Press Trust Of India) ...Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of Cinacalcet tablets in the US due to manufacturing issues. The recall is due to the presence of an impurity above FDA limits. The recall affects 30 mg, 60 mg, and 90 mg strengths, with the affected lot produced in India...The recall is due to the "presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit", it added... Full

Americans Hungry for Weight-Loss Drugs Grapple with Supply and Insurance Hurdles

(11/4, Patrick Wingrove and Bhanvi Satija, Reuters) ...In interviews with Reuters, eight U.S. obesity specialists at universities and large health systems described a different experience. All of them said they are still seeing intense demand for weight-loss medicines. Yet many of their patients cannot get health insurance coverage for the Lilly and Novo drugs, whose list prices top $1,000 per month. Four of the doctors told Reuters that patients are also still finding it hard to get various doses at times and are shopping around pharmacies to find supply... Full

5 Essential Drugs Currently Facing Shortages

(11/1, Brooke McCormick, AJMC) ...Key drugs in shortage include ADHD medications, pain treatments, chemotherapy drugs, insulin, and diabetes/weight loss medications...ADHD Medications...Teva reported a shortage in select doses due to increased demand for the drug, and Sandoz had most doses on intermittent backorders through October 2024...Conversely, methotrexate sodium injection is unavailable through Accord, Pfizer, and Teva... Full

Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

(11/1, Ashley Gallagher, Pharmacy Times) ...Although the number of active shortages decreased to 277 in the second quarter of 2024 from an all-time high of 323 in the second quarter of 2023, 50% of the active shortages in the United States persisted for 2 or more years, as reported by the American Society of Health-System Pharmacists. Furthermore, the report shows that 95 new drug shortages, 48% of which are injectables, were identified in 2024... Full

The Top 5 Hurdles Facing the Biosimilars Market Right Now

(11/1, Becker's Hospital Review) ...With high-cost specialty drugs making up an ever-greater percentage of new launches, and prices for existing brand biologics on an ongoing upward trajectory, biosimilars – lower cost alternatives to these expensive medications – brought with them the promise of lower costs for everyone. Yet, despite their potential, uptake has been slow and this promise has failed to materialize. Here's a look at the top five challenges facing the biosimilars market today... Full

CVS Entities Fail to Dump Proposed Drug-Price Fraud Class Action

(11/1, Mary Anne Pazanowski, Bloomberg Law) ...Pharmacy benefits managers, pharmacies, and drug manufacturers have been the focus of several cases alleging that they've colluded to drive up consumers' out-of-pocket costs. The lawsuits are being especially closely watched now that the US government has made efforts to lower prices for drugs... Sub. Req’d

Drug Pricing and the 2024 Presidential Election

(11/1, Ayla Ellison, Zoey Becker, Fierce Pharma) ...In this week's episode of "The Top Line," Fierce Pharma's Zoey Becker chats with John Barkett, managing director of BRG's healthcare transactions and strategy practice and former senior policy advisor for healthcare delivery system reform on the White House Domestic Policy Council, about what we can expect from each candidate's potential presidency and how the Inflation Reduction Act could play a pivotal role... Full

Video: What Really Happens to Drug Prices When Patents Expire

(11/4, Anna Yeo, STAT Plus) ...This video shows how exactly AbbVie used patents to protect Humira, and explores how all the topics this series has covered so far — including generic drug entry mechanisms and pharmacy benefit managers — interact to influence the price of drugs. And if you need a refresher on biologics and biosimilars, it covers that, too... Sub. Req’d

Product Or Class Guidances For Biosimilars? Industry Had Its Say

(11/1, Urte Fultinaviciute, Generics Bulletin) ...The responders used this opportunity to pitch other recommendations that may improve biosimilar development. Multiple stakeholders suggested the FDA should instead focus its limited resources on issuing or updating its foundational guidances. As an example, the Biosimilars Council took a biosimilarity demonstration guidance, which was finalized in April 2015, when only one biosimilar was approved... Global Sub. Full

FDA Revises More Than 800 PSGs in Line with ICH M13A

(11/1, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration on Thursday published revised draft product-specific guidances for immediate-release solid oral generic drugs deemed to be low risk that will no longer require two bioequivalence studies – one fed and one fasting – to demonstrate BE to a reference-listed drug. Instead, sponsors can choose to conduct either a fed or fasting bioequivalence study for the affected drugs... Full

US FDA Floats Communications Upgrade For ANDAs With Missed Goals

(11/1, Derrick Gingery, Generics Bulletin) ...Generic drug sponsors may no longer have to wonder why an ANDA had not received a US Food and Drug Administration action if it continues to linger more than two months after its goal date. A pilot program potentially launching in November will improve communications in those situations. When a complex regulatory issue forces the FDA to miss an ANDA goal date and not take action, agency officials will inform the sponsor of the situation, said FDA Office of Generic Drugs Director Iilun Murphy... Global Sub. Full

'It Was a Good Lesson': FDA Reconsiders CAR-T Boxed Warning On Secondary Cancers, Peter Marks Says

(11/1, Angus Liu, Fierce Pharma) ...An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. The probe led to classwide black boxed warnings on existing CAR-T products' labels... Full

Brief On Several FDA Actions and Topics of Interest

(11/1, Bob Pollock, Lachman Consultants) ...The FDA has also taken action to modify the risk evaluation and mitigation strategy (REMS) to the existing Opioid Analgesic REMS program. "[C]ompanies participating in the OA REMS Program have been notified that they will be required to begin providing pre-paid drug mail-back envelopes upon request to outpatient pharmacies and other dispensers of opioid analgesics by March 31, 2025."... Full

Danish Govt Rolls Out The ‘Red Carpet' for Pharma Production Companies

(11/4, The Pharma Letter) ...With new measures, the Danish government will make it easier to establish production facilities in Denmark. A total of 102.4 million Danish kroner ($14.9 million) is set aside for red carpets for production companies in the period 2024-2027. The measures are linked to the upcoming Danish Life science strategy. The Norwegian government must look to Denmark. They are now initiating measures that will make it more attractive to invest in Denmark and ensure continued growth in an important industry for the Danish economy, says Mr Skymoen... Sub. Req’d

Jan Aushadhi Kendras Report 43% Growth On Sales in September

(11/4, Pharmabiz.com) ...The Jan Aushadhi Kendras (JAKs), under the Department of Pharmaceuticals (DoP)'s flagship scheme of Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), has reported a growth of 43 per cent in sales of generic medicines at maximum retail price (MRP) value in the month of September, as compared to the sales in the same month a year ago... Full

In Letter to PM, Cong's Tagore Questions Logic Behind Decision to Hike Prices of 8 Essential Drugs

(11/2, Press Trust Of India) ...Congress MP Manickam Tagore writes to PM Modi, expressing concern over NPPA's decision to hike prices of eight essential drugs by 50%. Tagore urges for an independent review committee to assess the impact on patients and healthcare, emphasizing the need for transparency and balanced pricing policies... Full

[Reporter's Notebook] Ofev's Case Shows Why Multinational Pharmas Overlook Korean Market

(11/4, Kim Yun-mi, Korea Biomedical Review) ...Boehringer Ingelheim has made several attempts to bring Ofev into the reimbursement system but has been hampered by the drug's high price and comparisons with the alternative medicine pirfenidone. With Ofev's patent expiring in January 2025, Boehringer Ingelheim is taking on the reimbursement challenge again. In March, the company submitted economic evaluation data for Ofev. It is undergoing a reimbursement review at the Health Insurance Review and Assessment Service. It is expected to be an agenda item at the upcoming Pharmaceutical Reimbursement Evaluation Committee... Full

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