Friday, February 16, 2024

Please note: In observance of Presidents’ Day, the Teva Daily News will not be published Monday, February 19. Publication will resume Tuesday, February 20.

Headache as Hundreds of Thousands of Migraine Sufferers Face Medication Shortage

(2/16, 7NEWS) ...An effective chronic migraine and headache medication is facing a shortage in Australia, just months after it was listed under the Pharmaceutical Benefits Scheme. AJOVY — a prescription medication used for the treatment of migraines, has been available in Australia since September 2019...Therapeutic Goods Administration confirmed to 7NEWS.com.au it is aware of a shortage of the medication. "There is still stock available, but supply is limited and not expected to be enough to meet demand," it said. The government authority added the shortages are due to an "unexpected increase in demand relating to the shortage of another migraine medication known as Emgality". "In the meantime, the sponsor of AJOVY, Teva Pharma Australia, is closely controlling supply to support fair and equitable distribution of the limited stock," the TGA added... Full

How Sempre Health, Mark Cuban And More Are Leading The Charge To Disrupt Drug Pricing

(2/15, Seth Joseph, Forbes) ...From both a policy and industry partnership standpoint, the pressure exerted by Cuban and other disruptors stands to have a long-term effect of reconfiguring the supply chain. But these attention-grabbing names and partnerships aren't the only mechanisms for drug pricing transparency and change in healthcare at the moment... Full

Ozempic, Mounjaro and Hundreds of Other Drugs Become Even More Expensive in 2024

(2/15, Tami Luhby, CNN) ...Some drugmakers have curtailed their annual price hikes for certain medications amid increased scrutiny from the White House, Congress and patient advocacy groups. Another factor is the recent policies that penalize pharmaceutical manufacturers for raising list prices faster than inflation. "We've seen a deemphasis on increases over time," said Antonio Ciaccia, CEO of 46brooklyn. "Simultaneously, we've seen a greater emphasis on higher launch prices for products."... Full

Alvotech Clears A Path For 2024 Ustekinumab In Major Global Markets

(2/15, Dean Rudge, Generics Bulletin) ...Alvotech has reached settlement agreements with J&J in Japan, Canada and in the European Economic Area for its AVT04 biosimilar ustekinumab product. Regulatory approval for AVT04 in these markets has already been granted, the firm pointed out...Alvotech continues to anticipate approval for its ustekinumab biosimilar on April 16, 2024, two months after the expected approval for its proposed AVT02 adalimumab biosimilar. Alvotech and its US marketing partner Teva have for some time been seeking approval for their AVT02 100mg/ml adalimumab biosimilar, with the proposed high-concentration interchangeable product boasting a combination of attributes that the firms believe could make it a market leader... Global Sub. Full

Zydus Lifesciences Gets USFDA Nod for Generic Drug to Prevent Chest Pain

(2/16, Press Trust Of India) ...Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition... Full

Lupin Gains On USFDA Approval for Generic Anti-Pregnancy Drug

(2/16, CNBC TV 18) ...The leading global pharma company, in a filing to the stock exchanges, said that it has received approval from the US drug regulator for its Abbreviated New Drug Application for Minzoya tablets. The Minzoya tablets are used by women of reproductive potential to prevent pregnancy, the company informed the bourses...The new approval comes days after Lupin launched the Ganirelix Acetate Injection in the United States. The injection is used in fertility treatment in women... Full

Novartis Is Working on the Next Wave of Obesity Drugs, CEO Says

(2/16, Naomi Kresge, Bloomberg) ...Novartis AG Chief Executive Officer Vas Narasimhan says the drugmaker aims to compete in the growing obesity market by designing next-generation treatments. "We think there's opportunity to improve," Narasimhan said in an interview with David Rubenstein for Bloomberg TV. "It's very early stages within Novartis, but can we come up with drugs that better preserve muscle? Or may be easier to take, and more infrequently taken?"... Sub. Req'd

Aurobindo Pharma Shares Jump Over 3% as USFDA Completes Inspection at Telangana Unit with Zero Observations

(2/16, CNBC TV 18) ...Aurobindo Pharma shares jumped more than 3.5% on Friday, February 16, after the pharma company said the United States Food and Drug Administration completed the inspection at the manufacturing unit of its synthetic peptides active pharmaceutical pngredient business arm, Auro Peptides Ltd in Telangana. The USFDA's inspection had zero observations, Aurobindo Pharma said in a stock exchange filing... Full

Glenmark Pharma Zooms 10% On Positive Management Commentary

(2/16, Money Control) ...The company's Q3 earnings remained under pressure due to several one-off expenses on account of a one-time impact on Glenmark's India business, a forex loss of Rs 16.2 crore, hyper inflationary impact of Rs 48 crore in Argentina and an exceptional item related to remediation costs of Rs 76.7 crore for manufacturing sites in India and the US. The management comments hint towards better times for the drug manufacturer. The management expects its EBITDA to improve along with consistent improvement in margins in the coming quarter... Full

Pfizer Reaches $93M Deal On Decade-Old Lipitor Antitrust Suit

(2/16, Dean Rudge, Generics Bulletin) ...Pfizer has agreed provisionally to pay out $93m to a group of purchasers in the US of its former small-molecule powerhouse brand Lipitor (atorvastatin)...The Pink Sheet's Sue Sutter had observed back in November 2011 that approval and launch of Ranbaxy's generic atorvastatin had provided clarity on who would be selling the initial generic versions of Pfizer's Lipitor, "but the approval may have raised as many questions as it answered." "[There's] uncertainty [in] the role played by Teva in Ranbaxy's approval and launch. Under a deal with Ranbaxy, Teva is getting a cut of Ranbaxy's atorvastatin profits during the ANDA first-filer's 180-day marketing exclusivity period."... Global Sub. Full

‘Potent' Antibiotic Drug Boosts Fight Against Superbugs

(2/15, Michael Peel, Financial Times) ...The new antibiotic, known as cresomycin, is effective in mice against several bacteria that cause serious infections and are increasingly resistant to existing treatments, said a paper published in Science on Thursday...Cresomycin proved effective against a range of dangerous bacteria prominent in the spread of AMR, the paper said. These include: Staphylococcus aureus, which causes infections in the skin and other organs; Escherichia coli (E-coli), responsible for intestinal and urinary tract illnesses; and Pseudomonas aeruginosa, a trigger of blood and lung infections... Sub. Req'd

Biosimilars: Are They Delivering the Cost Savings Promised?

(2/15, Megan Holsopple, PharmD, BCPS, Pharmacy Times) ...When biosimilars initially hit the market, the hope was that providers and patients would switch to more affordable options when medically appropriate, and the industry would see lower overall health care costs and increased patient savings as a result. But the question remains: Does the simple availability of biosimilars for Humira and other medications drive adoption and anticipated impact on cost? To determine the answer, Arrive Health, which sees 11 million transactions per month pass through its Real-Time Prescription Benefit connection, conducted a review of historical prescribing data... Full

The Drug Discount Ecosystem Needs Clarity in 2024 and Beyond

(2/16, Adam J. Fein, Ph.D., Drug Channels) ...Today's guest post comes from Gavin Magaha, Senior Director of Value Delivery at Kalderos. Gavin discusses the problems manufacturers face in accessing and standardizing drug discount data. These data are necessary to avoid duplicate discounts and comply with regulatory requirements... Full

Democratic Lawmakers Call for Crack Down On Drug Companies Over System That Can Limit Affordable Options

(2/16, Riley Beggin, USA Today) ...Sen. Elizabeth Warren, D-Mass., and Rep. Pramila Jayapal, D-Wash., are pushing federal regulators to "crack down" on companies they say are preventing their competitors from producing lower-cost generic drugs for Americans. In a letter sent to the Food and Drug Administration Thursday night and seen exclusively by USA TODAY, the progressive lawmakers urged the agency to close loopholes that discourage competition among drug companies and keep prices high for crucial medication. That can include inhalers to help with chronic lung diseases... Full

Patients See First Savings From Biden's Drug Price Push, As Pharma Lines Up Its Lawyers

(2/16, Arthur Allen, KFF Health News) ...The IRA issues did not appear to be top of mind to most executives and investors as they gathered to make deals at the annual J.P. Morgan Healthcare Conference in San Francisco last month. "I think the industry is navigating its way beyond this," said Matthew Price, chief operating officer of Promontory Therapeutics, a cancer drug startup, in an interview there. The drugs up for negotiation "look to be assets that were already nearing the end of their patent life. So maybe the impact on revenues is less than feared. There's alarm around this, but it was probably inevitable that a negotiation mechanism of some kind would have to come in."... Full

US Cites PhRMA's Drug Price Suit Loss as Defense in Chamber Case

(2/15, Nyah Phengsitthy, Bloomberg Law) ...The US Department of Justice's response Wednesday to the US Chamber and affiliates in a case debating a federal price-setting program points to the government's victory against the Pharmaceutical Research and Manufacturers of America when a judge tossed the case due to lack of jurisdiction. The US District Court for the Western District of Texas ruled Feb. 12 it lacks jurisdiction to handle PhRMA's case, which also included plaintiffs the National Infusion Center Association and Global Colon Cancer Association... Sub. Req'd

The Real ‘Pill Penalty': US Biosimilar Law, Not The IRA

(2/15, Michael McCaughan, Pink Sheet) ...There is, however, a bigger problem. Eliminating the "pill penalty" in the Inflation Reduction Act will in no way undo the incentives for innovators to focus on large molecule biologics rather than small molecule drugs. To truly fix the "pill penalty," Congress would have to revisit all the differences between the generic drug system (governed by the 1984 Hatch-Waxman Act) and the biosimilar pathway... Sub. Req'd

The Long Read: CEOs Unplug At AAM Conference

(2/15, Dean Rudge, Generics Bulletin) ...The 80-minute ‘CEOs Unplugged' roundtable was introduced by the Association for Accessible Medicines' interim CEO David Gaugh as – typically – the most anticipated event at the AAM's two-day annual conference. So it showed, as seats filled quickly and other attendees stood or leaned at the back of the large conference hall in Tampa, eager to hear from the gathered panel of four esteemed US leaders, each boasting decades of experience across a wide range of backgrounds and geographies... Global Sub. Full

HHS Preps Guidelines for Medicare Drug Installment Payment Plan

(2/15, Tony Pugh, Bloomberg Law) ...The Biden administration issued additional draft guidance Thursday outlining requirements for Medicare prescription drug plans that participate in a program that will allow plan enrollees to pay out-of-pocket drug costs in monthly installments beginning in 2025. The new draft guidance outlines different plan requirements for the Medicare Prescription Payment Plan, including outreach and education requirements, pharmacy processes, and operational considerations for the program's first year... Sub. Req'd

'America First' Non-Profit Points To USPTO And FDA For Patent Abuse

(2/15, Urte Fultinaviciute, Generics Bulletin) ...In the run-up to the US presidential election, which is set to happen in November 2024, the right-wing non-profit America First Policy Institute has pointed to patent and drug approval systems as one of the reasons for drug unaffordability in the country...In its issue brief titled "Patent Abuses Keep Prescription Drugs Unaffordable", AFPI argued that while America's patent system and the US Food and Drug Administration's drug approval process have led to "enormous pharmaceutical breakthroughs", both systems have "numerous loopholes" that are exploited by brand-name drug developers, resulting in fewer generic drugs entering the market... Global Sub. Full

FDA Officials Discuss REMS Transparency Efforts

(2/15, Joanne S. Eglovitch, Regulatory Focus) ...In an effort to enhance the transparency of Risk Evaluation and Mitigation Strategies, the US Food and Drug Administration has launched a publish an interactive web-based dashboard that allows the public to analyze and visualize REMS data, said Yasmeen Abou-Sayed, a team leader in the division of risk management in the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research... Full

Why Lower Prescription Drug Prices May Come Later Rather Than Sooner

(2/16, Benjamin J. Hulac, NJ Spotlight News) ...More than a decade later, authorities in New Jersey and Washington, D.C., have new powers to scrutinize the byzantine and often murky ways drug companies set their prices and to negotiate for lower costs of prescription drugs, which are about 2.8 times more expensive in the U.S. than in other wealthy nations, according to the RAND Corporation, a nonpartisan research organization. But the public may not see some of the benefits of these new mechanisms for years to come, and Gov. Phil Murphy has yet to nominate members for a state health board on drug affordability, after he missed a January deadline... Full

EU Committee OKs More Pharma-Friendly Compulsory Licensing Plan

(2/15, Ian Schofield, Pink Sheet) ...The rapporteur for the draft EU legislation says it will help to balance the public health interests of European citizens with the need for the pharma industry to keep innovating. The European Parliament's legal affairs committee has approved a draft EU regulation that would allow the European Commission to issue compulsory licenses to improve access to crisis-relevant medicines in times of health emergencies... Sub. Req'd

Europa Perspectives—Pan-European Challenges and Solutions Post Brexit

(2/15, Chris Spivey, BioPharm) ...Steffen Thirstrup, chief medical officer, European Medicines Agency was interviewed by Chris Spivey, editorial director, Pharmaceutical Technology® and Biopharmaceutical International®, on Jan. 25, 2024 for the Europa Perspectives series. Thirstrup talks about major recent or ongoing challenges EMA is facing, such as drug shortages, COVID-19, Brexit, and ensuring sufficient skilled staff availability, alongside the solutions being implements to overcome them... Full

EU Regulators Make Finding & Using RWD Easier

(2/15, Neena Brizmohun, Pink Sheet) ...Two new electronic catalogs of real-world data sources and studies offer an improved and more efficient service to help drug companies, regulators and researchers find adequate data sources to generate real-world evidence for regulatory purposes, says the European Medicines Agency... Sub. Req'd

Limiting Competition in Medicines is Not An Option

(2/15, Monique Goyens, Euractiv) ...EU pharmaceutical legislation is undergoing a major reform which is an opportunity to increase people's access to medicines, but worryingly some right-leaning political groups want to give even more power to the pharma industry, writes Monique Goyens, Director General of the European Consumer Organisation... Full

India's Stand On IPRs, Pharma Help Promote Growth of Generic Industry: GTRI

(2/16, Press Trust Of India) ...India's stand on intellectual property rights and pharma issues in proposed trade agreements balances innovation with public health needs, ensures availability of affordable medicines and promotes growth of generic medicine industry, a GTRI report said on Friday. Think tank Global Trade Research Initiative said that by opposing demands of developed nations on issues like 'data exclusivity' and 'patent linkage' in free trade agreements, India ensures that generic drug manufacturers get greater market access and cost of life-saving medicines gets reduced significantly... Full

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