Friday, June 28, 2024

Teva Launches Victoza Rival In The US

(6/27, Adam Zamecnik, Generics Bulletin) ...Several years after securing a settlement with Novo Nordisk, Teva has launched its Victoza authorized generic in the US ahead of competition. Teva Pharmaceuticals has launched an authorized generic of the type 2 diabetes treatment Victoza (liraglutide) in the US, under the terms of its patent settlement with originator Novo Nordisk. Citing IQVIA data, Teva noted that Victoza had annual sales of $1.66bn as of April 2024... Global Sub. Full

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024

(6/28, European Medicines Agency) ...One application for an initial marketing authorisation was withdrawn. Dabigatran etexilate Teva (dabigatran etexilate) was intended for the prevention of venous thromboembolic events. A question-and-answer document on the withdrawal of Dabigatran Teva is available in the grid below... Full

Coherus All But Checks Out Of Biosimilars With Meitheal Adalimumab Deal

(6/27, Dean Rudge, Generics Bulletin) ...Meitheal Pharmaceuticals has ushered in what it believes is a "pivotal moment," picking up its fifth biosimilar product and the first one on the market after gaining the exclusive US commercial rights to Coherus BioSciences' Yusimry (adalimumab-aqvh) biosimilar to Humira. The US-based injectables specialist's parent company, Hong Kong King-Friend, has paid $40m upfront to Coherus for the worldwide rights to Yusimry, including "substantially all assets related to Yusimry, [as well as] any results of development and regulatory activities."... Global Sub. Full

What Coherus' $40M Sale of its Humira Biosimilar Says About the Crowded Market

(6/27, Zachary Brennan, Endpoints News) ...Coherus told Endpoints News in an emailed statement that the sale "reflects a strategic decision based on a comprehensive assessment of our current and future business priorities and allows Coherus to focus more resources and efforts on advancing our pipeline of novel cancer therapies."..."What this shows is just how hard it is to get even a small slice," Marta Wosinska, senior fellow at The Brookings Institution, told Endpoints. One of the few exceptions is Sandoz, which has made inroads through a CVS partnership... Full

Apotex Is Latest To Accuse Amarin Of ‘Freezing Out' Vascepa Competition

(6/28, Dean Rudge, Generics Bulletin) ...First Dr Reddy's, then Hikma, then Teva, now Apotex. The Canadian firm is the latest generics manufacturer to file an antitrust lawsuit against Amarin, accusing the originator of an anticompetitive scheme to "delay, hinder, and frustrate robust generic competition" to its Vascepa (icosapent ethyl) purified fish oil brand by "locking up" the supply of the brand's active pharmaceutical ingredient... Global Sub. Full

Lupin Loses Appeal in EU Court, Will Have to Pay €40 Mn Fine in Perindopril Case

(6/28, CNBC TV 18) ...The European Court of Justice has upheld the European Commission's decision to impose a fine of 40 million euros on Lupin Limited. This decision was in connection to a patent settlement agreement Lupin made with French drugmaker, Servier in January 2007, concerning the drug Perindopril. The commission had deemed the agreement anti-competitive...The Reuters report quoted the judges as saying, "The Court dismisses the appeals of Lupin, Niche Generics, Unichem Laboratories, Matrix, Teva and Biogaran," adding, "Those companies therefore remain liable for the fines imposed by the Commission."... Full

Alembic Pharmaceuticals Receives USFDA Approval for Doxycycline Capsules

(6/28, Business Standard) ...Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Doxycycline Capsules, 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Oracea Capsules, 40 mg, of Galderma Laboratories, L.P. (Galderma)... Full

Eisai and Biogen launch Alzheimer's drug Leqembi in China

(6/27, Surbhi Misra, Reuters) ...Eisai and Biogen have launched their Alzheimer's treatment Leqembi in China, the third country after the United States and Japan, the companies said on Friday...The drug will first be launched in the private market at 2,508 yuan ($345.04) for a 200 mg vial, the companies said in a statement. Eisai has also collaborated with a major Chinese medical insurance firm to plan partial coverage of the drug cost, the companies said without naming the insurer... Full

Biogen is Pursuing More Dealmaking This Year, With Plans to Spend Up to $8B

(6/27, Max Gelman, Endpoints News) ...In an exclusive interview with Endpoints News, Biogen head of corporate development Adam Keeney said the company is open to a "$5 billion to $8 billion" acquisition similar to last year's Reata Pharmaceuticals deal, should the right opportunity present itself...When asked about the change in direction, Keeney said Biogen is looking for acquisitions. Whether the company "pulls the trigger" depends on a combination of "our balance sheet but also our conviction" in a buyout, he added... Full

Pharmaceutical Manufacturer Addresses Ongoing Albuterol Shortage

(6/27, Medivant Healthcare) ...Medivant Healthcare, a pharmaceutical company and innovator in addressing drug shortages, recently announced that orders for its single-dose vials of critical respiratory drug Albuterol, specifically designed for use in nebulizers, are now being accepted. Medivant, which operates two fully automated CGMP FDA registered facilities in Arizona, is known for its consistent and high-quality single-dose injectable drugs and pre-filled syringes. The company is now bringing this powerful solution to Albuterol and began shipping the drug in mid-June... Full

The Supreme Court Rejects a Nationwide Opioid Settlement with OxyContin Maker Purdue Pharma

(6/27, Mark Sherman, Associated Press) ...The Supreme Court on Thursday rejected a nationwide settlement with OxyContin maker Purdue Pharma that would have shielded members of the Sackler family who own the company from civil lawsuits over the toll of opioids but also would have provided billions of dollars to combat the opioid epidemic... Full

UnitedHealth's Optum to Pay $20 Mln Over US Claims it Ignored Opioid 'Red Flags'

(6/27, Brendan Pierson, Reuters) ...UnitedHealth Group's OptumRx pharmacy benefit manager unit has agreed to pay $20 million to settle claims by U.S. authorities that it improperly filled certain opioid prescriptions, the U.S. Justice Department announced on Thursday. The settlement appeared to be the first reached by the government with a pharmacy benefit manager over allegedly illicit opioid prescriptions... Full

Community Health Systems Expands Purchasing Deal with Mark Cuban's Cost Plus Drugs

(6/27, Dave Muoio, Fierce Healthcare) ...Community Health Systems is expanding a previously announced partnership with Mark Cuban Cost Plus Drugs Company to all 71 of its affiliated hospitals, the for-profit system announced Thursday morning..."The benefits of this partnership are significant and include immediate savings on drugs frequently used in the hospital setting," Lynn Simon, M.D., CHS president of healthcare innovation and chief medical officer, said in a statement... Full

Lawmakers Seek Balance Between Lower Prescription Drug Prices, Drug Innovation Incentives

(6/27, Noah Tong, Fierce Healthcare) ...Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA). House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research. Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently... Full

Biden and Trump Spar Over Medicare and Abortion in a Presidential Debate Filled with Mistakes and Falsehoods

(6/27, Rachel Cohrs Zhang and Sarah Owermohle, STAT) ...For the most part, substantive debates on health policy between President Biden and former President Trump were overshadowed by mistakes, errors, and blatant falsehoods in Thursday night's presidential debate. Biden had difficulty articulating his accomplishments in office and points of contrast with Trump on health care...Trump did shed more light on his abortion policy stance, while Biden touted his support for abortion rights and efforts to lower drug prices. But an exchange on Medicare filled with flubbed lines and falsehoods proved to be more the norm... Full

W&M Passes Bill To Limit CMS CED Requirements To 10-Year Span, Rein In LCDs

(6/27, Maaisha Osman, InsideHealthPolicy) ...In the wake of controversy over CMS' controversial coverage limits for new Alzheimer's disease medications, the House Ways & Means Committee unanimously advanced a bill Thursday (June 27) that would limit the duration of CMS' coverage with evidence development requirements to a maximum of 10 years for new drugs and medical devices... Sub. Req'd

House Panel Advances Bill to Allow Medicare to Cover Obesity Drugs

(6/27, Lia DeGroot, Endpoints News) ...The committee voted 36-4 to pass an amended version of the Treat and Reduce Obesity Act, which directs Medicare to cover obesity treatments strictly for new enrollees whose insurance previously covered the medication for at least a year before they signed up for Medicare. The vote marks a step forward in expanding insurance coverage of obesity treatments, but falls short of an earlier version of the bill that would've ensured more widespread coverage of the drugs under Medicare... Full

Wyden To CMS: Step Up Enforcement Of Part D PBM Regulations

(6/27, Gabrielle Wanneh, InsideHealthPolicy) ...In a letter to CMS Administrator Chiquita Brooks-LaSure, Wyden urges the agency to use its authority to improve oversight and enforcement of the Part D requirements under the new rule, saying permitting PBMs to continue flouting the requirements may lead to hundreds of independent pharmacies closing their doors following the more than 300 net closures that took place in 2023... Sub. Req'd

Drug Prices Have Risen Almost 40% Over the Past Decade, According to a New Tracker

(6/27, Justin Fisher, CNBC) ...The cost of prescription medications in the U.S. has increased 37% since 2014, far surpassing the rate of inflation, according to data from drug savings company GoodRx. Though the price increases have slowed this year in comparison to the past decade, the average American spends $16.26 out of pocket per prescription, according to the data. On average, Americans pay two to three times more for prescription drugs than consumers in other developed countries, according to the White House... Full

GUEST COLUMN: How to Address America's Historic Drug Shortage Crisis

(6/27, Nick Iacovella, News and Tribune) ...The United States is facing an unprecedented drug shortage, with a record 323 active drug shortages at the start of 2024 — the highest number since 2001. Two major factors are driving this crisis: foreign government subsidies and regulatory failures by the U.S. Food and Drug Administration...America has become dangerously dependent on foreign manufacturers —particularly in China and India — for generic drugs that account for 91% of all U.S. prescriptions... Sub. Req'd

Decoding DSCSA: Ensuring Compliance in the Pharmaceutical Supply Chain

(6/27, Liz Updike, IQVIA) ...While implementation of the DSCSA will create a harmonization of licensing and electronic tracing standards nationwide, it will not be without its challenges. Supply chain entities need to pay close attention to implementation dates and requirements, with a focus on making sure their infrastructure and business procedures can meet the strict federal standards. The industry is in a state of anticipation as final rules on 3PL and wholesale distributor licensing from the FDA are pending, however some states have already begun the process of updating their requirements to comply with what has been proposed... Full

Stakeholders Urge FDA to Strengthen Guidance On Biosimilars Promotions, Stop Bad Actors

(6/27, Emily Hayes, Regulatory Focus) ...Biosimilars companies believe new draft guidance – Promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products: Questions and answers – could go further to prevent misinformation in the industry... Full

States Build Momentum to Protect 340B Drug Discounts - For Now

(6/26, Alex Kacik, Modern Healthcare) ...Missouri is the latest state to pass legislation requiring pharmaceutical manufacturers to distribute discounted drugs to pharmacies that contract with hospitals, federally qualified health centers and other 340B-covered providers. While the governor hasn't signed the bill, the Show-Me State would be the eighth one to enact a similar law. In addition, close to 30 states have implemented laws that prevent pharmacy benefit managers and insurers from reducing reimbursement rates for 340B drugs... Sub. Req'd

Script for Disaster: PBM Practices Widely Blamed As Pennsylvania 'Pharmacy Deserts' Grow

(6/28, Roger DuPuis, WVIA News) ...Pharmacy deserts continue to expand as independent and chain pharmacies close amid growing financial pressures, particularly low reimbursement rates from pharmacy benefit managers, or PBMs, which act as intermediaries between insurance providers, drug manufacturers and pharmacies...State Rep. Jessica Benham (D-Allegheny County) calls PBMs "shadowy middlemen" who shortchange independent pharmacies and look to steer customers to fill their prescriptions at corporate pharmacies they own or do business with... Full

EU Ministers Call For Tougher Shortage Notification Rules And Fines In Pharma Reform

(6/27, Ian Schofield, Pink Sheet) ...The Council of the EU says it has produced a "well balanced" text in response to the proposals on tackling medicine shortages in the pharma reform package, and has flagged up a number of areas where it wants more clarity...The council says that EU countries wanting to tackle drug shortages should be able to set up notification systems for products that move out of their markets, and that the European Commission should be able to fine companies for failing to notify decisions to stop marketing a medicine... Sub. Req'd

EMA Officials Discuss Expedited Approval Pathways, Scientific Advice Mechanisms

(6/27, Joanne S. Eglovtich, Regulatory Focus) ...Officials from the European Medicines Agency discussed the different types of expedited approval pathways available to sponsors of innovative drugs and advanced therapy medicinal products, as well as the various mechanisms for sponsors seeking scientific and regulatory advice at the DIA 2024 Global Annual Meeting on June 19... Full

India Plans Incentives for Diabetes, Obesity Drug Makers in 2026, Government Official Says

(6/28, Rishika Sadam, Reuters) ...Danish drugmaker Novo Nordisk's patent on semaglutide - a GLP-1 agonist and the key ingredient in its wildly popular obesity drug Wegovy and diabetes drug Ozempic - is set to expire in India in 2026, industry experts say. "The (Indian) companies (planning) manufacturing GLP-1 drugs have applied for the government's production-linked incentive scheme," Arunish Chawla, Secretary of Department of Pharmaceuticals, told Reuters. "Once they start manufacturing in 2026 after patent expiries, we will give them the incentive," said Chawla, without disclosing the names of these companies... Full

Indian Regulator Says 36% of Inspected Drug-Making Units Had to be Shut

(6/27, Rishika Sadam, Reuters) ...More than 36% of the 400 drug manufacturing units inspected since last year in India were ordered to be shut, the country's drug regulator said on Thursday, after deaths linked to sub-standard cough syrups prompted an increase in scrutiny. The country, regarded as the world's pharmacy given the volume of drugs it produces, is working to restore confidence after Indian-made cough syrups were linked to deaths of children in Gambia, Uzbekistan, and Cameroon... Full

Pharma Industry Should Focus On Value-Based Products to Tap Global Export Potential: Pharmexcil (6/28, DG Bhaskar, The Hindu BusinessLine) ...The Indian pharmaceutical industry should move up on the value chain to tap huge potential in the global pharma market for products like biosimilars, says R Uday Bhaskar, Director-General, Pharmaceuticals Export Promotion Council (Pharmexcil). Addressing a press conference here on Thursday, Bhaskar said the Government should also support industry to take up Research and Development in new and emerging areas such as biosimilars... Full

15 Blockbuster Drugs Worth $112 Billion To Go Off Patent By 2029, Says Pharmexcil Official

(6/27, NDTV) ...Patents of 15 blockbuster drugs worth $112 billion will expire by 2029, an official from the Pharmaceuticals Export Promotion Council of India, a department under the Union Ministry of Commerce, said. This could potentially result in a $10-billion growth opportunity for the Indian pharmaceutical sector, which can manufacture generic drugs, including intricate formulations... Full

German Vaccine Panel Endorses Astra-Sanofi's RSV Shot for Infants

(6/27, Patricia Weiss, Reuters) ...Germany's influential vaccine advisory panel said on Thursday all infants in the country should receive AstraZeneca and Sanofi's antibody therapy to protect them against the common respiratory infection RSV. The recommendation regardless of risk factors is another boost for the product, which has seen strong U.S. demand well above supplies during the first winter there... Full

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