Wednesday, October 30, 2024

Pharma Giant Novartis Raises Forecast On Strong Drugs Demand

(10/29, Doloresz Katanich, Euronews) ...Total net sales at Novartis AG grew by 10% to $12.8bn (€11.9bn) at constant exchange rates in the three months to September 30,, and the core operating income was also up by 20% at $5.15bn (€4.78bn). The highest-selling medicines of the company, included the cardiac drug Entresto and psoriasis drug Cosentyx which showed 26% and 28% growth in sales respectively, compared to the previous year, according to the report published on the website of the Swiss pharmaceutical giant... Full

Sandoz Reports Third-Quarter and Nine-Month 2024 Sales

(10/30, Sandoz) ...Sandoz, the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year... Full

Biogen Lifts Annual Profit Forecast as Cost Cuts Help

(10/30, Mariam Sunny, Reuters) ...Biogen raised annual profit forecast and beat third-quarter profit expectations on Wednesday, as its cost-cutting measures helped make up for falling sales of its multiple sclerosis medicines...U.S. sales of Leqembi, which the company sells with Eisai, were $39 million for the third quarter ended Sept. 30. The Wall Street consensus was at $45 million, according to brokerage Jefferies. Biogen now expects annual adjusted per-share profit of between $16.10 and $16.60 compared with previous forecast in the range of $15.75 to $16.25... Full

Eli Lilly Misses Third-Quarter Profit Amid Soaring Demand for Weight-Loss Drug

(10/30, Bhanvi Satija and Christy Santhosh, Reuters) ...Eli Lilly missed Wall Street estimates for its popular weight-loss and diabetes drugs on Wednesday, hit by a decrease in U.S. wholesale inventory and sending its shares down 9% premarket...The company also missed third-quarter profit estimates due to higher manufacturing costs and a previously disclosed $2.8 billion acquisition-related charge... Full

GSK Warns of Lower 2024 Vaccine Sales After Weaker RSV, Shingles Demand

(10/30, Yadarisa Shabong, Maggie Fick, Reuters) ...GSK on Wednesday said its vaccine sales would fall this year, after a weaker-than-expected performance for its respiratory syncytial virus and shingles vaccines in the third quarter, sending its shares 4% lower in early trade..."We are on track to deliver our 2024 guidance, and we are even more confident in our 2026 and 2031 outlooks," Walmsley said in a statement... Full

British Pharma Giant GSK Reports a Q3 Loss Due to Zantac Cancer Lawsuits

(10/30, AFP) ...GSK earlier this month agreed to pay $2.3 billion to end lawsuits alleging that Zantac caused cancer, despite the group not admitting liability. Stripping out the litigation costs, GSK said Wednesday that core operating profit increased five percent in the third quarter. "Strong growth in specialty medicines helped to offset lower vaccine sales and reflected successful new product launches in oncology and HIV," chief executive Emma Walmsley said in the earnings statement... Full

Pfizer CEO Defends Turnaround Strategy as Activist Pressures Management

(10/29, Michael Erman, Bhanvi Satija, Reuters) ...Pfizer CEO Albert Bourla, under pressure from activist hedge fund Starboard Value, made his case to Wall Street on Tuesday that the drugmaker's turnaround is succeeding after it reported a higher-than-expected profit due to strong sales of COVID-19 treatment Paxlovid...He said Pfizer has been taking steps for some time to cut costs and has made changes to its corporate structure, including top management of its commercial operations and a new chief strategy officer... Full

Sun Pharma Seeing Efforts To Speed Up Development For Complex Generics

(10/29, Dean Rudge, Generics Bulletin) ...Sun Pharma is pleased with ongoing efforts by the US Food and Drug Administration to facilitate and speed up development for complex generics, but feels more can still be done to guide generics manufacturers...Sun Pharma enjoyed solid growth in its financial Q2 ended September 30, including top-line growth of 21.9% to INR43.3bn ($515m) for its US Formulations business, which now also comprises the US portion of Taro... Global Sub. Full

Strides To Arm GLP-1 Generics Ahead Of LoEs, As Novo Spars Over Semaglutide Capacity

(10/29, Vibha Ravi, Generics Bulletin) ...Strides is to supply semaglutide and liraglutide to generics companies amid global capacity constraints and drug shortages, ahead of loss of exclusivity. An ability to make drug-device combinations has meant it has contracts for seven of the eight GLP-1 agonists, and counting...Strides Pharma's CDMO OneSource stands to benefit from seven of the eight GLP-1 products launched globally. Its ability to make drug-device combinations (DDCs) gives OneSource and edge... Global Sub. Full

‘What We're Really Focused On Is Internationalization' – Aspire CEO Sets Out Strategy

(10/29, Dave Wallace, Generics Bulletin) ...In the wake of its recent acquisition of dermatology assets from Canute Pharma, UK-based Aspire Pharma is looking to new frontiers of expansion in Europe and beyond. Chief executive Richard Condon talks to Generics Bulletin about the next steps on the niche generics and value added medicines firm's journey... Global Sub. Full

Sage, Biogen Won't Pursue Major Depression Approval for Postpartum Pill

(10/29, Max Gelman, Endpoints News) ...Sage and Biogen will not attempt to get their postpartum depression pill Zurzuvae approved in the broader population of people with major depressive disorder. Sage, which has recently gone through waves of layoffs and scientific setbacks, cited the cost of running and recruiting additional trials for MDD as the reason, and said it would focus solely on postpartum depression. In addition, the company will stop selling its infused PPD drug Zulresso at the end of this year... Full

US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (Denosumab)

(10/30, Organon and Shanghai Henlius Biotech, Inc.) ...In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China... Full

Novo's Main Ozempic Plant Cited for Quality Lapses by FDA

(10/29, Madison Muller, Bloomberg) ...Novo Nordisk A/S was cited for quality lapses at a drug production plant in Denmark that makes the hit medicines Ozempic and Wegovy. The plant in Kalundborg, Denmark lacked information intended to show that water used in drug production was adequately controlled for certain microorganisms, according to a US Food and Drug Administration inspection report from March. The manufacturing process was being used at the plant to make a once-weekly form of insulin, a Novo spokesperson said... Sub. Req’d

IV Fluid Maker Says Expiration Date Extensions Approved

(10/29, Alejandra O'Connell-Domenech, The Hill) ...The Food and Drug Administration approved changing the expiration date on multiple types of intravenous and sterile fluids made by Baxter International earlier this week, the company said in a statement Monday. Now, the fluids can be used up to two years after manufacturing instead of the previous one year, Baxter International said in a statement... Full

9 Drugs Now in Shortage

(10/29, Alexandra Murphy, Becker's Hospital Review) ...Here are nine new drug shortages to know, according to databases compiled by the FDA and the American Society of Health-System Pharmacists... Full

#HLTH24: GLP-1 Compounding Pharmacies Took Center Stage at Digital Health's Biggest Conference

(10/29, Shelby Livingston, Endpoints News) ...The GLP-1 craze "drastically changed the footprint of compounding pharmacies, in my mind," Matthew Montes de Oca, chief clinical officer at the Gilbert, Arizona-based Strive Pharmacy, said during a HLTH panel discussion...Meanwhile, Houston-based Empower Pharmacy, which claims to be the largest compounding pharmacy, historically grew revenue at a 40% clip. With GLP-1s, its revenue has doubled in a year, CEO Shaun Noorian told Endpoints... Full

Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry

(10/29, Skylar Jeremias, The Center For Biosimilars) ...Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector... Full

Leveraging US Prescription Market Insights to Drive Pharmacy Innovation

(10/29, Brian Nowosielski, Drug Topics) ...At the Fall 2024 Total Pharmacy Solutions Summit, held virtually on October 19, Scott Biggs, Director of Supplier Services at IQVIA, discussed various pharmacy trends including the US Use of Medicine Report, retail pharmacy performance, booming medications like GLP-1s, and much more. Keeping their hand on the pulse of pharmacy, the team at IQVIA and InterLink AI put together this presentation to also help independent pharmacists stay ahead of the curve... Full

Discontinuation of Popular Asthma Medication, Flovent, Linked with Increased Hospitalization

(10/29, Dr. Sejal Parekh and Sara Avery, ABC News) ...ICU admissions for asthma in those previously using Flovent increased 17.4% three months after discontinuation, and 23.1% three to six months after discontinuation. The data included children and adults. It was analyzed by two teams at EPIC Research, who came to similar conclusions. These findings have not gone through the usual peer-review process... Full

PBMs, FTC and IRA: Experts Tackle Pharma's Tough Acronyms At BioFuture Conference

(10/29, Jessica Merrill, Pink Sheet) ...A BioFuture panel of pharmaceutical executives, a Democratic lawmaker and a health economist debated some of complicated issues facing industry. Rep. Jake Auchincloss, D-MA, said he is sympathetic to industry's lobbying efforts to change parts of the IRA and seek PBM reform. Industry representatives said pharma also needs to take responsibility for high drug prices... Global Sub. Full

Mark Cuban On Prescription Drug Costs and PBM Reform

(10/29, Jessica Hagen, MobiHealthNews) ...Mark Cuban says it is vital for government officials to consider and understand the hierarchy when it comes to the prescription drug market and evaluating and setting laws around drug pricing..."The drug industry should be very simple. Someone gets a drug approved. Doctors prescribe it. The pharmacy, which has purchased the drug from a wholesaler, sells it to the patient, who either pays directly or has their insurer or employer pay for it. It should be that simple. There is absolutely nothing hard about this industry," Cuban told MobiHealthNews... Full

$35 Insulin: Who in the US Benefits?

(10/30, Ahmed Aboulenein, Reuters) ...Patient advocates say some people who are not on Medicare still pay well above $35. Their medicines originally had monthly list prices set at hundreds of dollars. Even after dramatic price cuts, a month's supply of injector pens may still cost more than $150. Many diabetes patients also need to use a combination of insulins... Full

Time for Congress To Act for Affordable Prescriptions for Patients

(10/28, Patricia Kelmer, DC Journal) ...We oppose the Patent Eligibility Restoration Act (PERA), which would allow patents on natural phenomena, laws of nature, and abstract ideas...The other bill we oppose would make it harder than ever to strike down a patent that should never have been granted in the first place. S.2220 is aptly named the PREVAIL Act, because it would help companies defeat challenges to their patents by eliminating the public's ability to challenge wrongly granted patents... Full

Demand for Obesity Drug Copycats Pressures FDA's Shortage Review

(10/30, Nyah Phengsitthy, Bloomberg Law) ...The Food and Drug Administration's methodology for monitoring drug shortages wasn't heavily scrutinized before weight-loss drugs arrived, attorneys say, but the agency is now facing calls to increase its transparency around how it determines whether compounding pharmacies are free to make copycat versions of Eli Lilly & Co.‘s popular diabetes and obesity treatment, which are branded as Mounjaro and Zepbound... Full

US FDA Floats Communications Upgrade For ANDAs With Missed Goals

(10/29, Derrick Gingery, Pink Sheet) ...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

Virginia's Adderall Shortage: ADHD Patients Struggle to Access Medication

(10/30, Sabrina Moreno, Axios) ...Increasing demand, greater awareness of ADHD leading to more diagnoses, manufacturer delays and drug quota limits are all factors for the shortage, but widespread solutions are currently at an impasse...Earlier this month, in a letter obtained by Axios, Virginia Rep. Abigail Spanberger pressed the heads of the FDA and DEA — the agencies responsible for addressing drug shortages and regulating supply, respectively — about the two-year limbo ADHD patients have been facing... Full

Illinois Lawmakers Scrutinize Prescription Drug Pricing at Hearing

(10/29, Lourdes Duarte, WGN Chicago) ...Illinois lawmakers questioned the price of prescription drugs in a rare Senate Judiciary Committee hearing on Tuesday at the Dirksen Federal Courthouse in Chicago...Among the issues tackled was the role PBM's or "pharmacy benefit managers" play in manipulating the cost of drugs by acting as middlemen. Lawmakers were upset over the effect they're also having on small independent pharmacies... Full

EMA Should Lead AI Oversight In Pharma & Align With Global Regulators, Says EFPIA

(10/29, Eliza Slawther, Pink Sheet) ...EFPIA, which represents the R&D-based pharma industry in Europe, has said the EMA should be responsible for overseeing the safe use of AI in drug development. The organization also called for global alignment in terms of vocabulary and policy around AI in the medicines lifecycle. While EFPIA agrees with most of the EMA's current positions on AI, it has requested more clarity around the "risk-based" approach that the agency has opted for... Global Sub. Full

India's Pharma and Meditech Industry Set to Double by 2030: Pharma Secretary

(10/29, Shereen Bhan, CNBC TV 18) ...In an interview with CNBC-TV18, Pharma Secretary Arunish Chawla highlighted that this growth is driven by India's expanding CRDMO (Contract Research Development Manufacturing Organisation) ecosystem, which is developing rapidly and is set to contribute significantly to the country's economic and employment landscape... Full

Govt Asks Manufacturers to Cut Price of 3 Anti-Cancer Drugs

(10/29, Press Trust Of India) ...The government has asked the companies to reduce prices of three anti-cancer drugs to pass on the benefit of customs duty exemption and GST reduction to the consumers. In line with the government's commitment to ensure the availability of drugs at affordable prices, the National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum directing the concerned manufacturers to reduce the MRP on three anti-cancer drugs, Trastuzumab, Osimertinib and Durvalumab... Full

Exploring the Costs of Asthma Medication

(10/29, Cambridge Network) ...In the world of healthcare, the cost of treatments remains a critical concern, particularly for chronic conditions like asthma. Dr. Potter, GP lead at Wadden Medical Center, recently shed light on the complexities of asthma management, including the financial implications of various inhalers. This blog explores the pharmaceutical landscape, the issue of price fixing, and its impact on asthma care... Full

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