Monday, July 29, 2024

Diabetes Patients Now Have Access to First Generic GLP-1 Medication: ‘More Accessible and Affordable'

(7/28, Melissa Rudy, FOX News) ...To help eliminate supply chain snafus, the first-ever generic GLP-1 — a duplicate of Victoza — launched on June 25. Manufactured by Novo Nordisk and distributed and sold by Israel-based Teva Pharmaceuticals, Victoza is an injectable medication intended to treat type 2 diabetes. It has also been shown to promote weight loss in certain patients, according to Teva..."This is a positive step forward to making GLP-1 agonist medications more accessible and affordable," [Alyssa Billingsley, PharmD, the senior director of Pharmacy Content at GoodRx in St. Louis, Missouri] told Fox News Digital via email... Full

Mark Cuban's Company Won't Fix Drug Costs, But it Can Still Help Rectify America's Drug Shortages

(7/29, Ezekiel J. Emanuel and John Connolly, STAT) ...Mark Cuban, the wildly successful entrepreneur and NBA owner, has committed himself to solving these two problems. Through the creation of the Mark Cuban Cost Plus Drug Company, Cuban aims to reduce drug prices and also drug shortages...Though Cuban is well-intentioned, his current approach will fail to significantly dent prices. But by expanding his production forays, Cuban could make real progress addressing America's drug shortage issues... Full

Big Pharma Rallies and Moves Past Obesity

(7/29, David Wainer, The Wall Street Journal) ...A market rotation is playing out across large pharmaceutical companies, with industry laggards such as Bristol Myers Squibb soaring in recent weeks and richly valued obesity plays Eli Lilly and Novo Nordisk sinking. But these moves are about more than just momentum: It is also helping that the industry seems to be weathering regulatory storms well. One of the biggest concerns for pharmaceutical companies in recent years has been drug-pricing pressure stemming from the Inflation Reduction Act, which for the first time empowered Medicare to directly negotiate how much it pays for some high-price therapies... Sub. Req'd

Samsung's Q2 Revenues Driven By Eylea And Stelara Biosimilar Milestone Payments

(7/29, Urte Fultinaviciute, Generics Bulletin) ...With blockbuster biosimilars under its belt, Samsung Bioepis marked triple-digit revenue growth in Q2, giving its parent company Samsung Biologics something to be proud of...Such growth was thanks to the "expansion of new product sales and the inflow of milestone revenues," particularly linked to biosimilar rivals to Bayer's Eylea (aflibercept) and Johnson & Johnson's Stelara (ustekinumab)... Global Sub. Full

Dr. Reddy's Lab Q1 Results: Profit Down 1% to Rs 1,392 Crore But Revenue Jumps 14%

(7/27, Nikhil Agarwal, The Economic Times) ..."We had a good start to the new fiscal year and our growth & profitability was mainly driven by our generics business. We continue to strengthen our core businesses and have made strategic investments in biologics, consumer healthcare and innovation to drive patient impact and value creation," said company Co-Chairman and MD GV Prasad. During the quarter, the global generics business recorded a growth of 155 YoY and was primarily volume led, aided by new launches and integration of recently in-licensed vaccine portfolio n India, partially offset by price erosion... Full

Germany's Merck Raises 2024 Forecast On Healthcare, Electronics Units' Performance

(7/26, Urvi Dugar, Reuters) ...The maker of pharmaceuticals, lab gear and specialty chemicals now expects net sales to be between 20.7 billion euros ($22.49 billion) and 22.1 billion euros for 2024. The healthcare unit's performance "more than offset the provision equal to a mid-double-digit million euro amount associated with xevinapant", the statement added... Full

Bristol Myers Squibb Beats Earnings Estimates, Raises Outlook as Drugmaker Slashes Costs

(7/26, Annika Kim Constantino, CNBC TV 18) ...Bristol Myers Squibb reported second-quarter earnings and revenue that topped expectations and raised its full-year guidance. Revenue growth was primarily driven by the company's blockbuster blood thinner Eliquis and a portfolio of drugs it expects to help it deliver long-term growth. The results come as Bristol Myers moves to cut $1.5 billion in costs by 2025 and reinvest that money into key drug brands and research and development programs... Full

Shares of Japan's Eisai Tumble After EU Rejects Alzheimer's Drug

(7/29, David Dolan, Reuters) ...Shares of Japan's Eisai tumbled 11% and were on track for their biggest one-day fall in three years on Monday, after the European Union's regulator rejected the drugmaker's Leqembi treatment for early Alzheimer's disease...Both Eisai and partner Biogen have said they will seek re-examination of the recommendation, but did not disclose what information they would provide the regulator. "Because EU approval was broadly expected, we consider this a very big negative surprise," Jefferies analyst Stephen Barker wrote in a note to clients... Full

Roche to Fast-Track Weight Loss Pill to Compete with Rivals

(7/29, Ian Johnston, Financial Times) ...Thomas Schinecker, chief executive of the Swiss pharmaceutical company, told the Financial Times that Roche's first obesity drugs would come to market "significantly faster than people are expecting", potentially by 2028. The treatments, acquired in an up to $3.1bn takeover of biotech Carmot last year, includes a weight-loss jab set to enter phase II trials and a pill that has given users 6.1 per cent reduction in weight compared with a placebo after four weeks. Schinecker said the company could have "around seven" drugs from the Carmot acquisition, with several in an earlier stage of development, although it has disclosed details for just three of the assets... Full

Dr. Reddy's Biosimilar of Roche's Cancer Drug Gets EMA Panel Nod

(7/29, N. Ravi Kumar, The Hindu) ...The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending launch of Dr. Reddy's Laboratories' proposed biosimilar Rituximab candidate DRL_RI (Ituxredi) in European markets... Full

EU Regulator Backs Use of GSK's RSV Shot in Adults Aged 50 to 59

(7/26, Prerna Bedi, Reuters) ...The European Union health regulator on Friday recommended expanded use of GSK's respiratory syncytial virus vaccine in adults aged between 50 and 59...The recommendation downsized GSK's U.S. market for the shot in 2024-25 from 93 million to about 55 million, according to analysts. GSK had forecast peak annual sales of more than 3 billion pounds for the vaccine... Full

RSV Vaccine Makers Vying for Market Share in Second Year of Shots

(7/29, Michael Erman, Reuters) ...Pfizer's, GSK's and Moderna's competition for arms for their new respiratory syncytial virus vaccines is on Wall Street's watch list for when the companies report earnings later this week. Investors and analysts said they are hoping for details on company negotiations with pharmacies for shelf space and the tactics they will use to gain share after U.S. regulators narrowed the recommendation for which older adults who should receive the shots this year... Full

Cipla Expects to Commence Supplies to US from China Plant Later This Year

(7/28, Press Trust Of India) ...Drug major Cipla expects to commence supplies to the US market from its China facility in the second half of the current fiscal after getting approval from the American health regulator, according to its MD and global CEO Umag Vohra..."Although we saw challenging phases with USFDA audits, I am glad to report that our China facility cleared the USFDA audit and is expected to supply to the US by the second half of FY 2024- 25," Vohra said... Full

Hyloris Follows On Transaction Scrutiny With Maxigesic IV Updates

(7/26, Adam Zamecnik, Generics Bulletin) ...Despite its recently announced leadership changes spurred by continued scrutiny over one of its acquisitions, Hyloris has managed to secure another agreement that will bring its combined pain relief drug Maxigesic IV (paracetamol/ibuprofen) into Brazil. Established through Hyloris' partner AFT Pharmaceuticals, the agreement granted exclusive licensing and distribution rights to Brazilian pharma Halex Istar... Global Sub. Full

US FDA Flags Dosing Risks from Compounded Versions of Novo's Weight-Loss Drug

(7/26, Mariam Sunny, Reuters) ...The U.S. Food and Drug Administration on Friday warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk's weight-loss and diabetes drugs...The FDA flagged the higher risk to patients from the use of compounded drugs, which may contain additional ingredients, and may contribute to potential medication errors. It urged healthcare providers and compounders to provide the appropriate syringe size and counsel patients on how to measure the dose... Full

GSK Settles Another Heartburn Drug Lawsuit in Illinois

(7/29, Yadarisa Shabong and Shanima A, Reuters) ...British drugmaker GSK said on Monday it has agreed to confidentially settle a lawsuit in Illinois that alleged its discontinued heartburn drug Zantac caused cancer, the latest in a series of settlements to end costly litigation...GSK did not admit any liability and said it would vigorously defend itself in any other Zantac cases... Full

PSG: Specialty Drug Trend Continues Upward

(7/26, Denise Myshko, Formulary Watch) ...Overall, specialty drug trend increased 14% in 2023, according to PSG's analysis of its clients specialty drug spend. Although claim utilization continues to be the leading driver of specialty drug trend, cost per claim is now playing a substantial role as well. "There are a lot of things happening in the market with specialty drugs," Renee Rayburg, RPh, vice president of Clinical Strategy at PSG, said in an interview. "There was hope for some cost savings from biosimilars, particularly the Humira biosimilars that were launched last year."... Full

Can AI Save Us From Superbugs?

(7/26, Akhila Kosaraju, RealClearHealth) ...Scientists predict that superbugs -- bacteria and fungi that have developed resistance to existing medicines -- could kill 10 million people per year by 2050. That would make drug resistance an even bigger killer than cancer. Fortunately, AI has the potential to usher in a new era of rapid treatment discovery to give humans a leg up on superbugs. But it'll take the best efforts of the public and private sectors to ensure these new drugs are developed, approved, and accessible to patients -- before it's too late... Full

Big Pharma Appears to Be Unfazed by IRA Drug Price Negotiations

(7/26, Greg Slabodkin, BioSpace) ...Despite their kicking and screaming, drugmakers seem to be faring well so far under the Medicare pricing talks. To date, all legal challenges to the program have failed and CMS will publish the maximum fair prices agreed upon with the participating companies by Sept. 1 for drugs selected for the first cycle of the program... Full

Among Pharma CEOs, The IRA Now and The IRA Later Get Very Different Reactions

(7/26, Max Bayer and Zachary Brennan, Endpoints News) ...Anna Kaltenboeck, a principal at ATI Advisory and former Senate staffer who helped draft the law, said that executives' outward confidence says little about the actual settled price. But she expects that the negotiated prices will "be significantly lower than current list prices." "In many cases, these drugs cost beneficiaries more in cost-sharing than plans ended up paying for the drugs," she said. "Negotiated prices will make these drugs significantly more affordable for these patients."... Full

Bristol Myers CEO 'Increasingly Confident' Company Can Handle IRA Pricing On Eliquis

(7/26, Kevin Dunleavy, Fierce Pharma) ...Friday, during a quarterly conference call, when asked about BMS' negotiations with Medicare over its blood thinner Eliquis, CEO Chris Boerner sounded nothing like a leader facing the apocalypse. "Now that we've seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on Eliquis," Boerner said...Boerner's comment sounds very similar to those from his large pharma peers: that at least the initial IRA-mandated prices are not that threatening to the companies' businesses... Full

Boehringer Appeals US Drug Price Battle Suit to Second Circuit

(7/26, Nyah Phengsitthy, Bloomberg Law) ...Boehringer Ingelheim is taking its challenge against the Medicare Drug Price Negotiation Program to the Second Circuit after a federal judge denied its claims that the plan is unconstitutional...Chief Judge Michael P. Shea of the US District Court for the District of Connecticut wrote that Boehringer's participation in Medicare and Medicaid is voluntary, even if the drugmaker "has a considerable economic incentive to participate."... Sub. Req'd

US Medicare To Codify Inflation Rebates, Adds Reconciliation Process

(7/26, Michael McCaughan, Pink Sheet) ...CMS said it would develop a formal reconciliation process for Part D rebates, and "consider" one for Part B, according to the guidances. But in the draft rule, the agency opted to create processes for both new programs. Part B and Part D will have 12-month reconciliation timelines, and the Part D program will have a second reconciliation process at 36 months, reflecting the timelines already in place for AMP restatements in Medicaid... Sub. Req'd

The Biden Administration is Wrapping Up Negotiations to Lower Prescription Drug Prices

(7/27, Sydney Lupkin and Scott Simon, NPR) ...[Sydney Lupkin] The government has said it won't announce them to the public for another month, but drug companies might do it sooner. Still, the drugmakers continue to oppose this and are in the middle of a bunch of lawsuits against the government to keep these negotiated prices from going into effect. They say this is all unconstitutional, that it's price setting, that it's going to hurt research and drug innovation and that companies won't bring as many drugs to market. But what they're telling their investors about the negotiations is actually less pessimistic... Full

A PBM Oligopoly: Three Companies Control 80% Of US Prescriptions – How Can We Fix It?

(7/26, Rita Numerof, Forbes) ...While rebates have long been the poster child of PBM profits, they're the tip of the iceberg in a complex web of financial maneuvers. These rebates create perverse incentives, encouraging drug companies to inflate prices with the knowledge that PBMs will negotiate them down—but it's the patients who end up footing the bill with high out-of-pocket expenses. However, PBMs make their money through more than rebates—and to curb these perverse incentives, the FTC needs to explore other practices too... Full

A Government Plan to Rule Out Innovation

(7/26, Laura Schoppe, RealClearHealth) ...The federal government may soon finalize guidance that could weaken ownership of intellectual property throughout the U.S. economy. This would affect a huge swathe of industries, among them biotechnology, clean energy, agriculture, and defense. More specifically, the new guidance would cause companies large and small, as well as their investors, to balk at licensing and developing promising new technologies -- with severe consequences for American innovation... Full

Interagency ‘Strike Force' To Hold First Meeting On Unlawful Pricing

(7/26, Gabrielle Wanneh, InsideHealthPolicy) ...The Strike Force on Unfair and Illegal Pricing, co-chaired by the Federal Trade Commission and Justice Department, will meet for the first time Aug. 1 for public and private discussions on enforcement actions that have been taken to combat anticompetitive, unfair, deceptive or fraudulent business practices used by corporations that raise prices across several key sectors of the economy, including the prices of prescription drugs... Sub. Req'd

Biosimilars Council Applauds FDA's Efforts To Hear From Industry About Biosimilar Development

(7/29, Urte Fultinaviciute, Generics Bulletin) ...The Biosimilars Council, a division of the Association for Accessible Medicines, told Generics Bulletin that it "appreciates the FDA taking an active role to engage industry and the public on the topic of biosimilar product development guidances." "At this time, we are working with our members to determine how impactful product-specific or product class-specific guidances may be when considering research and developing biosimilars," the organization added... Global Sub. Full

PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion

(7/26, Sue Sutter, Pink Sheet) ...The FDA wants sponsors to focus their questions for discussion at PDUFA meetings and recommends that patient advocate presentations be scheduled for the latter part of the meeting so pressing issues can be addressed first. Industry wants more explanation from the agency on why meetings are not granted or converted to written response-only format... Sub. Req'd

Some Asthma Inhalers Which Once Cost Nearly $100 Can Be Bought for $35 Today – But Philly Doctors Want More Help for Patients

(7/29, Aubrey Whelan, The Philadelphia Inquirer) ...Some asthma inhalers now cost as little as $35 a month. But Philadelphia-area doctors say new price caps are not enough to combat the rising cost of managing the chronic condition in a city where the childhood asthma rate is more than triple the national average..."The fact they made this stance is a movement in the right direction — but not the end game," said Tyra Bryant-Stephens, the medical director of the Community Asthma Prevention Program at Children's Hospital of Philadelphia... Full

For Mainers with ADHD, Getting Medication is a Full-Time Job

(7/26, Nick Song, Maine Public) ...The reason for the stimulant shortage is unclear: a mixture of supply chain issues for pharma manufacturers, and government medication quotas not keeping up with the surge in prescriptions created during the pandemic. Regardless, it's now on consumers to track down and locate their medication. Becca Kennedy of Freeport said she spent two hours tracking down a pharmacy that could refill her husband and teenage son's ADHD prescriptions last month. "Just the constantly having to call doctor's offices, pharmacies, and then the driving," said Kennedy. "It's just stressful to have to plan your life around that stuff."... Full

EFPIA Calls For Active Inclusion Of Pharma Industry In Roll Out Of European Health Data Space

(7/26, Eliza Slawther, Pink Sheet) ...The provisional political agreement on the European Health Data Space (EHDS) Regulation was a "pivotal moment" for patients across the EU which will require public and private health stakeholders to collaborate in "new and innovative" ways, according to the pharmaceutical R&D industry federation EFPIA... Sub. Req'd

EU Blow For Alzheimer's Drug Leqembi; Eisai To Appeal

(7/26, Neena Brizmohun, Pink Sheet) ...The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe is hoping that real-world findings from the US-mandated patient registry or from ongoing trials will help persuade the EU regulator to reconsider its position...Eisai and Biogen are to appeal against the European Medicines Agency's recommendation to refuse EU marketing approval for their Alzheimer's disease drug Leqembi (lecanemab), which is already approved in the US, Japan, China, South Korea, Hong Kong and Israel... Sub. Req'd

Europe's CHMP Endorses Clutch of New Medicines Including Astellas, J&J and Ipsen Offerings

(7/26, Eric Sagonowsky, Fierce Pharma) ...In a busy meeting this week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) signed off on seven new medicines, six biosimilars and 11 label expansions for existing drugs. In addition, Accord's generic to Pfizer's tyrosine kinase inhibitor Inlyta gained a CHMP thumbs-up, according to CHMP's meeting summary. Perhaps most notably, European regulators this week turned away Eisai and Biogen's Alzheimer's disease filing for Leqembi... Full

Higher PLI Budget to Promote Specialty Drugs and Gene Therapies

(7/27, Manu Kaushik, Financial Express) ...Experts believe that the higher incentives for the pharma sector is coming at a time when the volume growth has tapered down in the domestic market, and the sales growth has been largely driven by the price increases. But at the same time, there has been renewed focus by the pharma companies on complex therapies and life-saving drugs. "Bigger players like Sun Pharma or medium-sized companies like Zydus Lifesciences are focussing on advanced biosimilars and gene/cell therapies. It's clear that the government is keen to incentivise these companies who are launching complex products," said Unnati Jadhav, research analyst at KR Choksey... Full

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