Friday, July 19, 2024

Teva Touts First CGRP Success in Phase III Paediatric Migraine Prevention Study

(7/18, Anna Bratulic, FirstWord Pharma) ...Teva estimates that migraines affect about 7.7% of children, with prevalence rising from 5% in kids aged 5 to 10 to around 15% in teenagers. "The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them," said Chief Medical Officer Eric Hughes... Full

ASHP: Drug Shortages Slightly Down From All-Time High

(7/18, Jessica Karins, InsideHealthPolicy) ...The number of active drug shortages is down to 300 from an all-time high of 323, according to the most recent quarterly report released by the American Society of Health-System Pharmacists (ASHP) and the University of Utah...All categories of drugs have seen slight improvement since the last quarter, but many lifesaving and essential products are still in shortage, including drugs for chemotherapy, pain and sedation and ADHD... Sub. Req’d

Novartis Settles in to New Normal Two Years After Big Reorg, Even as Fine-Tuning Continues

(7/19, Amber Tong, Endpoints News) ...On looming generic competition for Entresto, the top-selling heart drug that brought in almost $1.9 billion in Q2: No Entresto generics are expected this year, but Novartis will face loss of exclusivity in the US in mid-2025. The patents in Europe, Japan and other countries will expire later. "This is not a cliff on a very large product," [CFO Harry] Kirsch said. "This is basically different geographies going off within a few years, and that allows our growth drivers to replace it."... Sub. Req’d

Novartis CEO: Trying to Crack Obesity Market with Another First-Gen Agent Is 'Not a Prudent Approach'

(7/18, Max Bayer, Endpoints News) ...On Thursday, CEO Vas Narasimhan said that trying to compete in the multibillion-dollar obesity market with an injectable or oral GLP-1 or GIP drug "is not a prudent approach for us as a company" and would instead look at new and different targets for the condition... Sub. Req’d

Centaur Launches Chronic Heart Failure Generic Drug in United States

(7/18, Financial Express) ...According to company's statement, Centaur received 180-day exclusivity on generic Ivabradine hydrochloride. The Mumbai-based company, through its marketing partner Ingenus Pharmaceuticals, launched Corlanor in a dosage of 5mg and 7.5mg tablets in the US... Full

J&J Confirms EU Stelara Biosimilars Are Imminent

(7/18, Dean Rudge, Generics Bulletin) ...Johnson & Johnson has confirmed that it continues to expect biosimilar competition to its multi-billion-dollar Stelara (ustekinumab) brand in Europe "later this month," with several approved biosimilar products waiting in the wings... Sub. Req’d

Approximately Half of Patients Demonstrated Poor Health Literacy Prior to Biosimilar Switch

(7/18, Lana Pine, The Center for Biosimilars) ...A real-world study showed patients with inflammatory bowel disease (IBD) or chronic inflammatory rheumatic disease treated with reference adalimumab who were switched to the biosimilar CT-P17 generally believed the switch was a treatment necessity. Higher satisfaction rates were observed among those who were convinced of the necessity compared with those with greater concerns about treatment... Full

Smaller Drugmakers Step up Hunt for Acquisitions; Midsize Companies Vie with Larger Players to Purchase Biotech Companies

(7/18, Brian Gormley, The Wall Street Journal) ...Large drugmakers buy biotechs to compensate for medicines coming off patent, and remain important consolidators. But the recent activity of smaller, publicly traded biotech companies signals a shift in the market, said Kevin Eisele, managing director, healthcare equity capital markets for William Blair... Sub. Req’d

Industry Speculates Biden Admin May Reveal Negotiated Drug Prices At DNC In August

(7/18, Maaisha Osman, InsideHealthPolicy) ...The White House deferred to CMS when asked whether officials might unveil the prices during the Aug. 19-22 convention, but industry experts say the possibility should be taken seriously. "I think there are a few ways the administration can spin this to their maximum benefit," Duane Wright, senior research analyst at Bloomberg LP, tells Inside Health Policy. "I wouldn't rule out the prices coming sooner rather than later for the Democratic candidate (Biden, Harris, or whomever) so they can take as much credit as possible for lowering drug prices, and when Democratic policies of the last four years will be center stage."... Sub. Req’d

Editorial: Prescription Drugs Cost Too Much. Medicare Negotiations Can Help

(7/19, Bloomberg) ...For too long, the fragmented US health-care system has inflated drug prices. A single government negotiator is a promising remedy. With the right incentives, lifesaving medications at reasonable prices should be an achievable goal... Sub. Req’d

PhRMA Doubles Down on Pricing Attack, Targeting Shared Ownership of Insurers and PBMs in New Ad

(7/18, Nick Paul Taylor, Fierce Pharma) ...PhRMA's smarmy avatar for the alleged avarice of pharmacy benefit managers (PBMs) is back in a fresh attack ad. And this time there's two of him, enabling the trade group to blast insurance companies and their PBMs at the same time... Full

Latest Big Pharma Ad Campaign A Potent Reminder Anti-PBM Policies Are Pharma-Backed, Would Increase Pharma Profits At Expense Of Patients, Taxpayers And Employers

(7/18, PCMA Blog) ...Pharma-backed proposals targeting PBMs, the only check against drug companies' pricing power, would do nothing to lower prescription drug prices. It's simple: If pharmacy benefit companies are weakened by restricting the tools used to lower drug costs, Big Pharma has more power to keep drug costs high... Full

Novartis CEO Sees IRA Impact ‘Manageable' in Short Run, Maintains Midterm Growth Goal

(7/18, Angus Liu, Fierce Pharma) ...As biopharma companies and the U.S. government near the deadline of their drug price talks under the Inflation Reduction Act (IRA), Novartis CEO said the cost cuts "might be manageable" in the short term for the firm's first few products to be included. That's because at least for the initial 10 drugs subject to IRA price negotiations, the products are already relatively close to their patent cliffs with generic entries expected not too far away, Narasimhan said... Full

Pharmacists Nervous but Optimistic as Gov. Shapiro Signs Pharmacy Benefit Manager Regulation Into Law

(7/18, Julia Maruca, TribLive) ...State Rep. Jessica Benham, D-South Side, who sponsored the bill, said she was proud to have introduced and shepherded the regulations across the finish line...She hopes to address spread pricing in the next legislative session and looks forward to receiving the data from the study... Full

Montana's Plan To Curb Opioid Overdoses Includes Vending Machines

(7/18, Mara Silvers, Montana Free Press) ...Montana health officials are considering a new strategy to make naloxone more accessible. Drawing on a pool of behavioral health funds set aside by lawmakers in 2023, health officials within Gov. Greg Gianforte's administration have proposed installing two dozen naloxone and fentanyl testing strip vending machines around the state at behavioral health drop-in centers and service locations for homeless people... Full

Re-Elected Von Der Leyen Sets Out EU Commission Plans For Critical Medicines Act

(7/18, David Wallace, Generics Bulletin) ...In her political guidelines for the next European Commission from 2024 to 2029, published today, [Ursula] von der Leyen underlined the need to "make our economy more resilient and less dependent." This was "notably important in the health and pharmaceutical sector," where "the EU has been confronted with severe shortages of medical devices and medicines, with antibiotics, insulin, painkillers and other products becoming particularly difficult to obtain."... Global Sub. Req’d

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