Tuesday, February 13, 2024

Teva Upgraded to Overweight at Piper Sandler On Multiple Expansion

(2/12, Dulan Lokuwithana, Seeking Alpha) ...Teva Pharmaceutical traded higher in the morning hours Monday after Piper Sandler upgraded the generic drugmaker to Overweight from Neutral and raised its price target to $19 from $12 per share, citing a potential margin recovery/ expansion..."Upon further reflection and dialogue with management, we believe the shares are well-positioned for further multiple recovery/expansion," Amsellem wrote... Full

A Horrible, Perfect Storm': Frustrations Rise as Shortage of Adderall, Other ADHD Medication Continues

(2/12, Kate Armanini, Chicago Tribune) ...Over a year later, there's no end in sight, and a tangled network of causes has made for no clear solution. "It's the single biggest crisis right now in clinical mental health," said Greg Mattingly, president of the American Professional Society of ADHD and Related Disorders and an associate clinical professor at Washington University in St. Louis...The decreased production is likely also tied to the opioid crisis and the resulting backlash faced by manufacturers, Mattingly said. Many Big Pharma companies and some of the nation's largest pharmacy chains faced a slew of lawsuits in recent years related to the handling of drugs and their role in the epidemic... Full

Using AI to Solve Drug Shortage Issues

(2/12, Miranda Schmalfuhs, PharmExec.com) ...In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem...[Dr. Jo Varshney] I do believe that AI is not going to solve every problem in healthcare. But the challenges that are we seeing in drug shortage such as what do we do to create financial incentives for companies so that they help in manufacturing production, this is where AI can help improve the manufacturing efficiency. And there are several ways that certain companies are tackling this challenge... Full

Hikma Launches Combined Pain Relief Drug Combogesic IV In US

(2/12, Adam Zamecnik, Generics Bulletin) ...Hikma announced the launch of the pain relief solution in the US where it will be sold under the name Combogesic IV as part of a deal with Hyloris Pharmaceuticals. Hikma Pharmaceuticals has launched the solution Combogesic IV (paracetamol/ibuprofen) in the US following its long journey to approval in the country as an adjunct pain treatment to opioid analgesics at the end of last year... Global Sub. Full

In Stunning Reversal, Takeda Snags FDA Approval for Once-Snubbed Eohilia After ‘Significant Grassroots Support'

(2/12, Angus Liu, Fierce Pharma) ...Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug's developer, Takeda, had at one point abandoned the program following an FDA rejection. Monday, Takeda announced the FDA's approval for Eohilia for treating people 11 years and older with the inflammatory disease eosinophilic esophagitis. This makes Eohilia the first FDA-sanctioned oral med for the condition... Full

Celltrion Seeks Approval for Actemra Biosimilar in Europe

(2/13, Shim Woo-hyun, The Korea Herald) ...Celltrion announced Tuesday that the company has submitted its application for marketing authorization to the European Medicines Agency for CT-P47, a biosimilar referencing Roche's Actemra...Celltrion expects the biosimilar will be able to boost the company's sales in the future as well. The global market for Actemra was estimated at around $2.8 billion in 2022, according to IQVIA, a drug market research firm... Full

Gilead's Newest Acquisition: A Liver Disease Drug With $1B in Peak Sales Potential

(2/12, Katherine Lewin, Endpoints News) ...Gilead announced Monday that it will pay cash to buy CymaBay for $4.3 billion, at $32.50 a share. CymaBay is developing seladelpar as a second-line treatment for primary biliary cholangitis, a rare, chronic and progressive disease. The drug, which showed off positive Phase III results in September, has a PDUFA date in mid-August. Gilead is the latest drugmaker to spend billions of dollars on companies with late-stage assets as it aims to shore up its pipeline... Full

PTC's Emflaza to Face Generics This Month After Aurobindo's Final FDA Nod

(2/12, Eric Sagonowsky, Fierce Pharma) ...After a series of regulatory setbacks in Europe, PTC Therapeutics will soon find itself under a generic attack in the U.S. Monday, India's Aurobindo said it has received a final FDA approval for its generic form of PTC's Emflaza for the treatment of Duchenne muscular dystrophy in patients 5 and older. Aurobindo plans to launch generic deflazacort tablets at various dosage strengths this month, the company said in a release... Full

Fool Me Thrice: FDA Blasts Chinese API Maker for 'Misleading' Investigators, Making Up Testing Records

(2/12, Fraiser Kansteiner, Fierce Pharma) ...When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant's quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list. Now, China's Sichuan Deebio Pharmaceutical is learning that lesson the hard way in the aftermath of a U.S. regulatory inspection carried out in September...The Form 483 relays an especially troubling event during the inspection when Sichuan Deebio's quality control team leader provided "misleading information" about records on the results of a microbiology test... Full

Kentucky Attorney General Files Lawsuit Alleging Kroger Pharmacies Contributed to the Opioid Crisis

(2/12, Bruce Schreiner, Associated Press) ...Kentucky Attorney General Russell Coleman filed a lawsuit Monday against one of the nation's largest grocery chains, claiming its pharmacies helped fuel the state's deadly opioid addiction crisis. The lawsuit against the Kroger Co. says its more than 100 Kentucky pharmacies were responsible for over 11% of all opioid pills dispensed in the state between 2006 and 2019... Full

Pharmaceutical Group's Lawsuit Over Medicare Drug Price Program Dismissed

(2/13, Nate Raymond, Reuters) ...U.S. District Judge David Ezra in Austin, Texas, sided with President Joe Biden's administration in dismissing a lawsuit by the Pharmaceutical Research and Manufacturers of America and two other groups that argued the program was unconstitutional...The ruling marked another victory for the administration in its defense of the negotiation program, one of Biden's signature initiatives and part of the Inflation Reduction Act that the Democratic president signed into law in 2022... Full

Judge Tosses PhRMA Lawsuit Over Medicare Power to Negotiate Drug Prices

(2/12, Rachel Cohrs, STAT Plus) ...The move is an early but positive sign for the Biden administration in a legal fight that could stretch for years, as a host of major drugmakers, including Merck, Bristol Myers Squibb, and Johnson & Johnson, have also filed lawsuits over the constitutionality of Medicare's new powers. The first round of drug negotiations is ongoing, and a judge heard oral arguments in a challenge brought by AstraZeneca just last month...The lawsuit was a blow to the pharmaceutical industry and its allies, which are aiming to get conflicting rulings that draw the attention of the Supreme Court. Initial rulings in the other suits could come down in the next few months... Sub. Req'd

Federal Judge Tosses PhRMA's Suit On Medicare Drug Price Plan

(2/12, Celine Castronuovo, Ian Lopez and Nyah Phengsitthy, Bloomberg Law) ...The Biden administration secured a major win Monday in its fight to uphold Medicare's drug price negotiation program by persuading a federal judge to toss a lawsuit from the top group representing the brand-name prescription drug industry..."We are disappointed with the court's decision, which does not address the merits of our lawsuit, and we are weighing our next legal steps," said Nicole Longo, a PhRMA spokesperson... Full

Biden's Attempts to Lower Drug Costs Are Sabotaging Biosimilar Competition and Are Destined For Failure

(2/13, Dan Leonard, RealClearHealth) ...These biosimilar approvals could save patients tens of billions of dollars in the coming years. Unfortunately, policies passed into law by Congress and the Biden administration are deterring their development...Without meaning to, the IRA has discouraged the development of biosimilars. Unless they fix this mistake, the law may inadvertently inflate drug spending by tens of billions of dollars and decrease competition that could enable more patients access to these important treatments... Full

Generic Drug Makers Urged To Fund Suits Against Brands' PBM Policies

(2/12, Jessica Karins, InsideHealthPolicy) ...The drug manufacturer Johnson & Johnson is facing a lawsuit brought by one of its employees alleging it failed to secure reasonable prices for the drugs beneficiaries bought through its employee health plan, in a case that experts predict will lead to a flurry of additional suits against brand drug makers with self-funded insurance plans and could make a major difference in how employers contract with their pharmacy benefit managers. The suit against the drug maker's own PBM contract comes as the pharmaceutical industry lobbies hard for Congress to reform PBM practices in Medicare... Sub. Req'd

‘Sleeper Issue:' How Part B Drugs May Be Impacted By Medicare Part D Redesign

(2/12, Sarah Karlin-Smith, Pink Sheet) ...If changes to stand-alone Part D plans mandated by the IRA drive a switch to MA plans, the changing enrollment could drive more uptake of physician-administered drugs - but also more utilization management...Much time and energy has been focused on thinking about how drug pricing, rebating and Part D plan design may shift due to changes set to finish taking effect in 2025 including new caps on enrollee out-of-pocket spend and more liability falling on plans rather than taxpayers... Sub. Req'd

FTC Supports NIST Framework, Urges Further Action On Patent Reform

(2/12, Gabrielle Wanneh, InsideHealthPolicy) ...The Federal Trade Commission welcomes the Biden administration's efforts to implement a new guidance framework that would permit government agencies to consider the price of an invention when deciding whether to invoke their federal authority to override the privately-held patent of an invention, but is urging the administration to also take action against drug industry patent abuses to further ensure lower prescription drug costs for patients and the government... Sub. Req'd

The "Hows" of Drug Shortages

(2/12, Martin Shimer, Lachman Consultants) ...If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages. The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well. With different individuals providing their perspectives and presenting information on the subject, there was some divergence in the data that was presented and some eye-opening observations... Full

Is PhRMA Losing its Luster?

(2/12, Marc Iskowitz, MM+M) ...Medicare drug price negotiations began this month for the first 10 treatments, marking a major component of the Inflation Reduction Act of 2022...Asked to comment, a spokesperson for the Pharmaceutical Research and Manufacturers of America said the hearing was largely a distraction from the real issues. "None of this is surprising. We're in political season and people are looking for points to drive a political narrative," said PhRMA EVP of public affairs and strategic initiatives Robby Zirkelbach, pointing to the 2024 election year. While the political theater has been "disappointing," Zirkelbach said, "The real question is, Are we going to focus on the right solutions?"... Full

FDA Addresses Expanded Use of Data Monitoring Committees in Draft Guidance

(2/12, Lia DeGroot, Endpoints News) ...The FDA laid out considerations for how sponsors should leverage committees to help analyze clinical trial data in draft guidance published Monday. The draft arrives as the use of these data monitoring committees has increased over the past several years. The 29-page document, once finalized, will replace the FDA's 2006 guidance on the topic, titled Establishment and Operation of Clinical Trial Data Monitoring Committees. The updated guidance addresses an increased use of data monitoring committees over the past several years, as well as the expanded scope of what data monitoring committees are used for... Full

Four Years Later, Maryland Board Still Hasn't Delivered for Patients

(2/12, Stami Williams, PhRMA) ...Maryland may have been the first state in the country to establish a so-called prescription drug affordability board, but Marylanders will unfortunately continue to see the failures of government price setting as the board progresses...Since its inception, the PDAB has cost over $3.2 million and hasn't saved Maryland patients one cent. Maryland should focus on lowering costs for patients. That can't be accomplished without addressing the role pharmacy benefit managers play in increasing costs for patients... Full

Oregon Lawmakers Look for Ways to Curb Prescription Costs

(2/12, Ben Botkin, Oregon Capital Chronicle) ...Rep. Emerson Levy, D-Bend, is sponsoring a proposal that would allow Oregonians to put any financial assistance they receive from a pharmaceutical manufacturer towards their health insurance deductible. Pharmaceutical manufacturers sometimes offer discounts, also called co-pay assistance programs, as a tool to encourage people to use medications...The bill, heard Wednesday in the House Committee on Behavioral Health and Health Care, could be put to a committee vote on Monday. Patients advocates spoke in favor of the bill, saying patients stop taking life-saving medications when the costs grow beyond their means to pay for them... Full

More Than 100 Virginia Medical Professionals Voice Support for Prescription Drug Affordability Board

(2/12, Sarah Hammond, 13 News Now) ...More than 100 medical professionals signed a letter Monday saying they want to create a Prescription Drug Affordability Board to reign in high drug prices. A group of doctors said on Monday, that they've seen this scenario play out too many times — a patient needs a certain prescription to keep pain in check or cure an illness, but that drug is just too expensive... Full

FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake

(2/12, Urte Fultinaviciute, Generics Bulletin) ...A collaborative scheme between the US Food and Drug Administration and the European Medicines Agency is yet to be embraced by complex generic developers. According to the FDA's latest update on the parallel scientific advice scheme, only two applicants were granted PSA meetings and have completed the process more than two years after its launch... Global Sub. Full

‘A Maze Of Rules': EFPIA On EU's Proposed Health Data Sharing Law

(2/12, Eliza Slawther, Pink Sheet) ...The European Parliament and Council of the EU have made changes to the draft European Health Data Space text to ensure the legislation is aligned with the EU Clinical Trials Regulation, a move that has been praised by pharmaceutical R&D trade body EFPIA. Aneta Tyszkiewicz, director for digital data at EFPIA, told the Pink Sheet that the EHDS was an "unprecedented opportunity," but that there were "many aspects of the EHDS that need to be addressed," particularly around the protection of intellectual property, consistency with other EU data laws, and the use of an opt-out mechanism... Sub. Req'd

Czech Republic To Assess Impact Of National Drug Shortage Measures In The EU

(2/12, Ian Schofield, Pink Sheet) ...EU member states told the latest meeting of a European Commission advisory committee about steps they have taken to deal with drug shortages, including export bans, prescribing restrictions, the establishment of "national safety stocks," and specific requirements on marketing authorization holders. The health authorities in the Czech Republic are to carry out a survey of measures taken by individual EU countries to tackle medicines shortages in order to determine which measures might "potentially impact security and continuity of supply" in other countries of the EU, according to the European Commission... Sub. Req'd

Pharma Innovation Incentives, Medicines Shortages, Challenge Belgium's Option Paper Progress

(2/12, Nicole Verbeeck, Euractiv) ...Belgium's health Council presidency is focused on resolving two key challenges: the debate on incentives for pharmaceutical innovation and the pressing issue of medicine shortages. This commitment is reflected in the twenty-four planned, and three completed working groups dedicated to advancing the pharma package. The groups are adopting a cluster-based strategy, tackling the ‘shortages' and ‘incentives' clusters one after the other. This method involves addressing and clustering articles from both the directive and regulation perspectives... Full

Swissmedic Asks Sponsors For At Least Four Months' Notice Ahead Of New Drug Filings

(2/12, Eliza Slawther, Pink Sheet) ...Companies looking to file medicines containing new active substances in Switzerland should notify the regulator up to six months before their planned submission date to support early planning activities, Swissmedic says. Switzerland's medicines regulator, Swissmedic, has asked pharmaceutical companies to assist its resource planning processes by voluntarily notifying it of planned marketing authorization applications for new active substances several months in advance... Sub. Req'd

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