Friday, January 3, 2025

Taking Stelara By Stealth? Amgen Stays Silent On US Ustekinumab Launch

(1/2, Dave Wallace, Generics Bulletin) ...Despite the firm having gained the first US Food and Drug Administration approval for its Wezlana (ustekinumab-auub) version in 2023 – along with a coveted interchangeability designation – and having agreed a settlement with originator Johnson & Johnson allowing a US launch from January 1, the firm has been silent on the subject since the start of 2025. Moreover, Amgen did not respond to Generics Bulletin enquiries seeking to confirm the US launch of Wezlana and asking for details of the firm's pricing strategy and its view of the competitive landscape for ustekinumab... Global Sub. Full

The Ten-Year Plan: How Sandoz Sees GLP-1s Shaping Up

(1/2, Dave Wallace, Generics Bulletin) ...Having kicked off his three-part interview with Generics Bulletin by talking about Sandoz's overall goals as a business before moving on to discuss the firm's generics and biosimilars strategy in more detail, CEO Richard Saynor now turns to the fresh opportunities on the horizon for the company – particularly when it comes to the current industry favorite, GLP-1s. Asked whether GLP-1s were the next biosimilars – in terms of a new frontier that off-patent industry leaders are becoming increasingly excited about conquering – Saynor said the comparison between GLP-1s and biosimilars "is an interesting one."... Global Sub. Full

After CagriSema, Eyes Are On Lilly's Oral GLP-1 as Next Key Obesity Play

(1/3, Elizabeth Cairns, Endpoints News) ...With Novo Nordisk's injected CagriSema having disappointed in obesity at the end of 2024, there are questions around how much more injected next-gen weight loss drugs can deliver above what's already in the market. Consequently, there is heightened anticipation around oral products. And Eli Lilly, Novo's main rival, has a major late-stage trial readout coming up. Lilly's orforglipron, a GLP-1 agonist, is in various Phase 3 trials in patients with type 2 diabetes, obesity and both... Full

Lilly Looks to 'Protect its Interests' by Moving to Join FDA Lawsuit Over Compounded Tirzepatide

(1/2, Fraiser Kansteiner, Fierce Pharma) ...After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking to protect its investment by wading into a lawsuit that seeks to allow compounding pharmacies to continue churning out knockoffs to the popular diabetes and obesity drugs... Full

Biocon Arm Biocon Pharma Receives Approval for Tacrolimus Capsules in China

(1/2, Jomy Jos Pullokaran, CNBC TV-18) ...Biotechnology firm BioconLtd on Thursday (January 2) announced that its wholly owned subsidiary, Biocon Pharma Ltd, has received approval from the National Medical Products Administration (NMPA) in China for its Tacrolimus capsules in 0.5mg, 1mg, and 5mg strengths... Full

Neumora Stumbles at Start of Phase 3 Depression Readout Run, Sending Stock Down 80%

(1/2, Nick Paul Taylor, Fierce Biotech) ...Neumora Therapeutics' big bet on a new era of neuroscience has delivered an age-old result. The first of three late-stage readouts on Neumora's lead drug candidate has ended in failure, wiping more than 80% off the value of the biotech... Full

Pfizer Sues Alkem to Block Copies of Blockbuster Xeljanz Drug

(1/2, Christopher Yasiejko, Bloomberg Law) ...Pfizer Inc. asked a federal court in Delaware to block copies of blockbuster arthritis drug Xeljanz proposed by Alkem Laboratories Ltd. that it said infringe a patent expiring this year. Alkem's generic versions of Xeljanz's 5- and 10-milligram tablets infringe US Patent No. RE41,783, according to a complaint filed Dec. 30 in the US District Court for the District of Delaware... Sub. Req’d

The "Amazon Effect" On Pharmacy Isn't About Medicine

(1/2, Erin Brodwin, Axios) ...CVS and Walgreens have long boosted their margins by selling products that customers find on their way to pharmacies at the back of their stores, but that model is no longer working...Both incumbents have reported declining retail sales, with Walgreens citing a "challenging" retail environment that reads like code for locked-up items and "Amazon." Amazon's retail business, meanwhile, continues to grow — even if its prescription pharmacy sales remain just a fraction of what CVS and Walgreens generate. "Pharmacies have an attachment factor — you go there for one product and buy another one on the way out," says Steven Wardell, managing partner at Wardell Advisors... Full

US FDA Forced To Rip Up, Start Biosimilar First Interchangeable Exclusivity Guidance Again

(1/2, Derrick Gingery, Pink Sheet) ...Uncertainty about first interchangeable biosimilar exclusivity remains a concern for industry. The FDA is writing guidance, but has been forced to start over based on new fact patterns. A new FDA position that all approved biosimilars should be deemed interchangeable likely will create more legal issues to resolve... Global Sub. Full

250 Brand Drugs To See Average Of 4.5% Price Hikes, Advocates Urge Congress To Act

(1/2, Gabrielle Wanneh, Inside Health Policy) ...At least 250 brand prescription drugs will have their prices hiked by an average increase of 4.5% at the top of the new year, a new data analysis by healthcare research firm 3 Axis Advisors shows. With the 119th Congress set to start on Friday, (Jan. 3), the Campaign for Sustainable Rx Pricing (CSRxP) is calling in lawmakers to refocus on stopping unsupported price hikes after pharmacy benefit manager and patent reforms were stripped from the December spending bill... Sub. Req’d

CSRXP: Big Pharma Back at it with Egregious Price Hikes Outpacing Inflation to Ring in 2025

(1/2, The Campaign for Sustainable Rx Pricing) ..."Big Pharma makes a tradition of ringing in each new year with egregious price hikes on hundreds of brand name prescription drugs," said CSRxP executive director Lauren Aronson. "Big Pharma's price hikes this January will continue to grow but already outpace the rate of inflation and include significant increases on drugs for serious conditions, like cancer."... Full

Schumer Taps New Dems For Finance, Health Committees

(1/2, Amy Lotven, Inside Health Policy) ...Medicare-for-All champion Sen. Bernie Sanders and four other Democrats will join the powerful Senate Finance Committee under now ranking Democrat Ron Wyden (OR), and the Vermont Independent will also serve as ranking Democrat of the Senate health committee that he chaired in the 118th Congress -- along with three new Democratic members on the health panel, according to the list of assignments released by Senate Democratic Leader Chuck Schumer (NY) on Thursday... Sub. Req’d

Guthrie Announces E&C Senior Staffers For Next Congress

(1/2, Jessica Karins, Inside Health Policy) ...Rep. Brett Guthrie (R-KY), the chairman-elect of the House Energy & Commerce Committee, on Thursday (Jan. 2) announced the committee's senior staffers for the upcoming 119th Congress, including experienced Capitol Hill staffers and veterans of President-elect Donald Trump's White House and previous campaigns... Sub. Req’d

Senators Introduce Bipartisan Legislation to Protect Skinny Labeling

(1/2, Skylar Jeremias, The Center For Biosimilars) ...If passed, the protections guaranteed under S 5573—also known as the Skinny Labels, Big Savings Act—would help shield biosimilar and generic drugmakers from timely and expensive lawsuits when they obtain skinny-label FDA approvals, ensuring faster access to affordable medications for patients. "Big pharma uses endless patent litigation to squeeze patients and stop competitors from coming into the market," said Senator John Hickenlooper (D, Colorado), the bill's main sponsor.3 "Our bill levels the playing field so generic drug manufacturers can help working people afford life-saving medication."... Full

Will Congress Get Another Shot at PBM Reform?

(1/2, Nathaniel Weixel and Joseph Choi, The Hill) ...Analysts expect congressional pressure on PBMs to continue. The spending bill that ultimately passed just before Christmas only funds the government through mid-March, so the next version could be a vehicle for those same policies that were jettisoned in December...A spokesman for incoming Senate Finance Committee Chairman Mike Crapo (R-Idaho) wouldn't speculate on what a path forward may look like for the health items not included in the most recent funding package. But he noted the senator is committed to passing his health priorities, which include those in the original bill that didn't make the cut... Full

The PBM Bill Failed. Americans Dodged A Bullet.

(1/2, Rita Numerof, Forbes) ...Lack of transparency in business operations, one of the criticisms leveled at PBMs today, is not addressed in the bill. Instead, the bill requires extensive reporting by PBMs at the patient transaction level separately by drug, dose, cost, where the drug is purchased etc. for every plan. Such extensive minutiae level reporting is likely to drive costs up and does not increase transparency. Pages upon pages of detailed reporting requirements are outlined without rationale and a defined outcome. The net result is overwhelming activity without benefit for patients... Full

Pennsylvania Blue Cross Insurer Restricts Coverage of Medicines Granted FDA Accelerated Approval

(1/2, Max Bayer, Endpoints News) ...A Blue Cross Blue Shield licensee serving parts of Pennsylvania says it will not cover some therapies granted accelerated approval for at least 18 months after the FDA signs off. The policy from Independence Blue Cross, which went into effect on Wednesday, says that drugs, biologics or gene therapies granted accelerated approval are considered "a benefit contract exclusion for most plans." The policy does not include cancer treatments or therapies that must be covered under state or federal mandates... Full

Advocates Hopeful to Expand Maryland Drug Affordability Board's Jurisdiction This Year

(1/2, WYPR) ...Lawmakers and health advocates are hoping to expand the jurisdiction of Maryland's Prescription Drug Affordability Board this year to allow the organization to negotiate pharmaceutical prices for private insurance plans in the state. Legislators tried to pass a similar bill last year, but it failed to make it to the governor's desk. Now, supporters are hopeful that 2025 will be the year... Full

New Idaho Law Targets Prescription Drug Costs Through Pharmacy Benefit Manager Regulation

(1/2, Jude Binkley, KTVB7) ...A new Idaho law aimed at lowering prescription drug costs by increasing the regulation of pharmacy benefit managers took effect Monday...Under the new regulations, PBMs must fully disclose drug costs and any fees or markups. They're also required to report to the state when drug prices increase and provide reasons for the changes... Full

California Lawmaker Aims to Reduce Drug Costs, Rein in PBMs With 2 New Bills

(1/2, Allison Bell, BenefitsPRO) ...State Sen. Scott Wiener, D-San Francisco, has introduced one bill that would create a new PBM regulation framework and a second bill that would limit what patients pay out-of-pocket for insulin to $35 per month. The PBM bill would require that PBMs be licensed by the California Department of Insurance... Sub. Req’d

PIC/S Sets Global Standards For Remote GMP Inspections

(1/3, Vibha Sharma, Pink Sheet) ...The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has issued harmonized recommendations to help good manufacturing practice inspectors plan, conduct and follow-up on remote and hybrid assessments. The recommendations are detailed in a guidance document and a related aide-mémoire that came into effect on January 1, 2025... Global Sub. Full

Korean Pharma Companies Launch New Year with Bold Global Ambitions

(1/3, Kim Chan-hyuk, Korea Biomedical Review) ...Major Korean pharmaceutical companies held ceremonies to kick off the new year, showing their strong commitment to attaining global status by developing innovative new drugs. However, despite the common goal of global expansion and new drug development, each company showed a differentiated approach... Full

South Korea to Streamline New Drug Approvals and Pharmaceutical Regulations in 2025

(1/2, M.H. Lee, The Korea Bizwire) ...The Ministry of Food and Drug Safety (MFDS) announced significant reforms to streamline drug approval processes in 2025, including reducing the time required for registering imported active pharmaceutical ingredients (APIs) and simplifying compliance procedures for low-risk manufacturers... Full

Indian Pharma: Realising the Viksit Bharat Vision'

(1/3, Samir Mehta, Fortune India) ...Today, the global healthcare landscape is undergoing a significant paradigm shift—a shift in disease patterns and population age, consumerisation of healthcare and increasing focus on holistic health. Indian pharma aims to grow to $120-130 billion by 2030 and $400-450 billion by 2047... Full

Wockhardt's 2 New Antibiotics In Global Spotlight: Chairman Khorakiwala Narrates Journey | Exclusive

(1/4, Manjiri Joshi, Himani Chandna, News18) ...Mumbai-based drugmaker Wockhardt has received the final approval from the country's drug regulatory authority to market its novel antibiotic, Nafithromycin, in India. The country's first indigenous Macrolide antibiotic, branded as Miqnaf, is touted to be "10 times" more effective than the existing treatments such as the popular azithromycin and the drug will hit the market in the next few months...On being asked about the pricing of the medicine, Khorakiwala said it was still under discussion; however, it is not going to be in the same range as the existing antibiotics... Full

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