Tuesday, March 5, 2024
Top News
UBS Confident in Teva's Continued Growth Trajectory
(3/4, The Fly) ...UBS made no change to the firm's Buy rating or $16 price target on shares of Teva. Following meetings with the company's management, UBS has increased confidence in its fiscal 2024 estimates and continued growth trajectory, the analyst tells investors in a research note... Full
Industry News
Mark Cuban Says Cost Plus Drugs Targeting Generic Meds in Short Supply as it Opens Manufacturing Facility
(3/4, Heather Landi, Fierce Healthcare) ...The billionaire entrepreneur and "Shark Tank" star told CNBC reporter Morgan Brennan during an interview Monday that the company's biggest challenge was keeping up with volume..."We're about to open up our manufacturing plant this week, where we will be releasing sterile injectables for generics that are in short supply. We're going to start shipping sterile injectables and pediatric cancer drugs in about two months," he said. Standing up the production line was a hefty investment, Cuban noted, but has been part of Cost Plus Drug's vision to address drug shortages... Full
SmithRx and Mark Cuban Cost Plus Drug Company Announce $9.5 Million in Client Savings Through Innovative Autoimmune Drug Sourcing
(3/4, SmithRx) ...SmithRx, a transparent and 100% pass-through PBM, and Mark Cuban Cost Plus Drug Company, PBC, announced today that in 6 months, they have saved SmithRx clients more than $9.5 million in the autoimmune category alone. This milestone has been achieved by strategically sourcing the lowest net cost autoimmune medications, including impactful transitions to cost-effective alternatives through Cost Plus Drugs. This successful alliance combines SmithRx's patient-first approach with Cost Plus Drugs' revolutionary drug pricing strategy to tackle the highest cost drug category for many employers... Full
Viatris: Customer Dialogue Has Changed From Price, Price, Price To Availability
(3/4, Dean Rudge, Generics Bulletin) ...Viatris has weighed in on the FTC's continued investigations into US healthcare middlemen, arguing that it can be a good thing for an industry battling shortages, even as the firm continues to rationalize products that do not make sense economically. Viatris believes that the US Federal Trade Commission's sustained investigations into pharmaceutical middlemen, including its recent efforts to look into the contracting practices of large healthcare group purchasing organizations and drug wholesalers, "is going to be good for the overall health of the generics industry."... Global Sub. Full
Veteran Affairs Formulary Exclusively Includes Hadlima, Biosimilar to Humira
(3/4, Pharmacy Times) ...Jon Martin, US commercial lead of biosimilars at Organon, discusses how making their biosimilar Hadlima the preferred product on the Veteran Affairs formulary will help lower treatment costs. Martin emphasizes the VA's long-standing support for biosimilar adoption and discuss pharmacists' important role in educating veterans about biosimilars... Full
Sanofi's CEO On the Consumer Divestiture, A Future in Weight Loss, Antitrust and AI's Secrecy Wave: Q&A
(3/4, Drew Armstrong, Endpoints News) ...Last week, Endpoints News executive editor Drew Armstrong sat down with Sanofi CEO Paul Hudson in Boston at the company's expansive complex. They spoke about how the company is using AI across its business, Sanofi's plans for the consumer unit it announced last year that it plans to divest, a hint about the company's very early pipeline, and much more... Full
Strides Pharma Gains On USFDA Nod for Gabapentin Tablets
(3/5, Business Standard) ...Strides Pharma Science advanced 2.68% to Rs 817.90 after its step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore received approval from the United States Food & Drug Administration for Gabapentin tablets. The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug, Neurontin tablets of Viatris Specialty LLC...The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which over 235 ANDAs have been approved. The firm said that it has set a target to launch around 60 new products over three years in the US... Full
After Multiple Wrist-Slaps, Aurobindo Unit Eugia Receives Another Manufacturing Write-Up
(3/4, Fraiser Kansteiner, Fierce Pharma) ...Aurobindo subsidiary Eugia is back in hot water with the FDA after a recent plant inspection yielded yet another Form 483—this time in India. Following an inspection of an Eugia injectables facility in Telangana, India, the FDA issued a formal rebuke laying out seven manufacturing observations, parent company Aurobindo said in a recent filing... Full
The War on Recovery: How the U.S. is Sabotaging its Best Tools to Prevent Deaths in the Opioid Epidemic
(3/5, Lev Facher, STAT) ...By beating back the cravings and agonizing withdrawal symptoms that result from trying to quit opioids "cold turkey," methadone and buprenorphine can help people addicted to opioids escape an existence defined by drugs and achieve stable, healthy lives. But a year long investigation by STAT shows that virtually every sector of American society is obstructing the use of medications that could prevent tens of thousands of deaths each year. Increasingly, public health experts and even government officials cast the country's singular failure to prevent overdose deaths not as an unavoidable tragedy but as a conscious choice... Full
U.S. Policy & Regulatory News
Biden Admin Urged To Cut Ties With Top PBMs To Achieve Lower Drug Costs
(3/4, Gabrielle Wanneh, InsideHealthPolicy) ...Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, pitched to White House officials Monday (March 4) a complete cutting of ties with the nation's top three pharmacy benefit managers by federal and state health programs and employers, in favor of pursuing a transparent business model that translates to lower prescription drug costs for patients and payers... Sub. Req'd
White House is Told The Big Three PBMs Are ‘Everything Wrong With This Industry'
(3/4, Ed Silverman, STAT Plus) ..."The big three [pharmacy benefit managers] are everything wrong with this industry," said Mark Cuban, who co-founded the Cost Plus Drug Company and is trying to cut out the middlemen with a website that sells mostly generic medicines directly to consumers...Along with Cuban, the session also featured remarks from Kentucky Gov. Andy Beshear who, as the state's attorney general, investigated pharmacy benefit managers; Federal Trade Commission Chair Lina Khan, who is currently probing these companies; and Sandra Clarke, executive vice president and chief operating officer at Blue Shield of California, which is pursuing a new pharmacy model... Sub. Req'd
Mark Cuban: Pharma's Secret Weapon In The Fight Against PBMs
(3/5, Sarah Karlin-Smith, Pink Sheet) ...The big three PBMs, as they were called during the discussion titled to "bring transparency to prescription drug middlemen," weren't invited to take part in the event either. But unlike the PBMs, who lacked the ability to defend themselves due to the exclusion, pharma appears to have come out a silent winner. That's in large part thanks to Mark Cuban, the co-founder of Cost-Plus Drugs, who appeared at the roundtable along with co-founder and CEO Alex Oshmyansky...Despite the public relations victory for pharma with the March 4, Washington event, there's no clear policy victory coming soon as Congress is having trouble getting PBM reform done despite large bipartisan majorities in favor of the idea... Sub. Req'd
Mark Cuban Backs Biden in 2024, Urging More Action on Drug Costs
(3/4, Josh Wingrove, Bloomberg) ...Mark Cuban urged President Joe Biden to go further to rein in prescription drug costs, a key element of his reelection pitch, as he backed the incumbent ahead of a likely November rematch against Donald Trump...Cuban said Biden's reforms to allow Medicare to negotiate the prices of some drugs was a "good start" and that "for Medicare patients, they've been off-the-charts amazing, perfect."... Sub. Req'd
FTC's Lina Khan and Mark Cuban Headline White House Listening Session to Rail Against PBMs
(3/4, Zachary Brennan, Endpoints News) ...The White House on Monday held a roundtable on pharmacy benefit managers featuring FTC Chair Lina Khan, billionaire entrepreneur Mark Cuban and Kentucky Gov. Andy Beshear, as the Biden administration looks to keep up pressure on patients' drug costs and PBMs...Khan's FTC, meanwhile, is running its own investigation into PBMs and said that some have not yet complied with FTC orders to turn over documents and data, and that the agency will use its authority to make sure they do so. The PBMs, which were not at Monday's session, criticized the event through their lobbying group, the Pharmaceutical Care Management Association... Full
PCMA Releases Statement On White House PBM Listening Session
(3/4, PCMA) ..."Today's White House listening session on PBMs, where policymakers only hear from people and groups with vocal anti-PBM agendas, will make for a biased and unproductive discussion. The PBM market is diverse and competitive, giving employers and plan sponsors choice and flexibility in managing prescription drug costs. Unfortunately, today's event serves to promote only one model and one perspective. We share the Administration's goal of lowering prescription drug costs and would welcome the opportunity to work together to make prescription drugs more affordable for patients and employers.”... Full
Hospitals and PBMs Seem to Have Dodged Big Federal Reforms — for Now
(3/5, Peter Sullivan, Axios) ...Hospitals and pharmacy benefit managers who've repeatedly been targeted in congressional debates over health spending appear to have ducked major federal reforms that could have upended how they do business..."The combination of industry lobbying and dysfunction in Congress have conspired to stop anything from happening" on proposals to change how Medicare pays the providers or impose new price transparency requirements, said Larry Levitt, executive vice president of health policy at KFF... Full
Government Funding Bills Leave Out PBM Changes As White House Mulls Reforms
(3/4, Nathaniel Weixel, The Hill) ...The congressional funding bills unveiled Sunday do not include bipartisan reforms to the pharmacy benefit manager industry, as lawmakers and the Biden administration look for a path forward...PBM reforms cleared two Senate committees on a bipartisan basis, but major policy disagreements between House and Senate Republicans in terms of the scope of the changes led to them being sidelined, likely until a lame duck session after the November elections... Full
Drugmakers Send Counter Offers for U.S. Medicare Price Negotiations, Biden Says
(3/4, Manas Mishra, Reuters) ...The manufacturers of 10 high-cost drugs selected for the U.S. Medicare program's first-ever pricing negotiations have submitted counter offers to the U.S. government's initial proposal, U.S. President Joe Biden said on Monday... Full
As Medicare Price Negotiations Roll On, Drugmakers Counter HHS' Initial Offers
(3/4, Zoey Becker, Fierce Pharma) ...Every drugmaker with a product on the list has responded to the government's Feb. 1 pricing offer with a counteroffer, the Department of Health and Human Services said in a Monday press release. The agency is pleased with the "good-faith, up front negotiations," HHS Secretary Xavier Becerra said in the release. "We are committed to constructive dialogue and are glad the drug companies are coming to the table."... Full
All Drugmakers Send in Counteroffers in Medicare Price Negotiations
(3/4, Joseph Choi, The Hill) ...President Biden confirmed in a statement Monday that all companies are continuing to engage in the negotiation process, despite the host of legal battles to block the program...Biden indicated he would have more to say on this issue in his State of the Union address Thursday. Talks are expected to go through Aug. 1, when negotiations officially end, per CMS guidance. The maximum fair prices are scheduled to be published Sept. 1 and are set to go into effect at the start of 2026... Full
White House Announces ‘Strike Force' On Unfair and Illegal Prices Ahead of State of the Union
(3/5, Josh Sisco, Politico) ...The White House is launching a multi-agency "strike force" on Tuesday in an effort to curb unfair and illegal pricing across the economy, according to Lael Brainard, chair of the National Economic Council. Brainard will make the announcement at a meeting Tuesday of the White House competition council, a group stacked with Cabinet officials, and other agency heads. The move comes as President Joe Biden seeks new ways to show voters he's cracking down on the so-called corporate greed that he has increasingly blamed for high prices... Full
Sen. Warren Accuses GSK of Price Gouging Over Pediatric Asthma Drug
(3/4, Val Brickates Kennedy, Seeking Alpha) ...U.S. Sen. Elizabeth Warren has slammed GSK for alleged price-gouging over the marketing of its pediatric asthma drug Flovent HFA and its authorized generic. In a statement released Monday, Warren accused GSK of discontinuing the branded version of the product "in order to evade new rebates it would have owed because of years of outrageous price hikes."... Full
Republican Senators Join Attack On Biden's Proposal to Seize Drug Patents Based On Price
(3/4, Zachary Brennan, Endpoints News) ...As President Joe Biden continues to tout his administration's efforts to lower drug prices, 16 Republican senators on Monday raised concerns with NIH director Monica Bertagnolli over plans to "march-in" and seize pharma company patents if the price of a drug is too high... Full
Romney, Colleagues Oppose Biden Proposal to Illegally Seize Drug Patents
(3/4, U.S. Senator for Utah Mitt Romney) ...U.S. Senator Mitt Romney (R-UT), member of the Senate Health, Education, Labor, and Pensions Committee, today joined HELP Ranking Member Bill Cassidy, M.D. (R-LA) and 15 Republican colleagues in sending a letter to National Institutes of Health (NIH) Director Monica Bertagnolli, M.D. raising serious concerns with the Biden Administration's proposal that attempts to allow agencies to seize drug patents from companies under the Bayh-Dole Act if the Administration views that the price the company is charging is too high... Full
HDA Issues Policy Platform Addressing Drug Shortages
(3/4, The Healthcare Distribution Alliance) ...The Healthcare Distribution Alliance (HDA) and its pharmaceutical distributor members today released a policy agenda to combat drug shortages. HDA's recommendations center around three core themes: federal coordination, strategic investment and end-to-end stabilization of the generic drug supply chain...HDA's "Policy Agenda on Drug Shortages" recommends developing solutions that bolster resilience and protect the integrity of the supply chain... Full
Narrow Therapeutic Index Drugs, Generics, and Better Education
(3/4, Bob Pollock, Lachman Consultants) ...FDA published a conversation piece on narrow therapeutic index drugs entitled, "Setting and Implementing Standards for Narrow Therapeutic Index Drugs" to better inform health care professionals, patients, and other consumers regarding the use of and how the FDA treats narrow therapeutic index drugs. Let's look at what an NTI drug is and some of the issues surrounding the public's and HCP's perception of NTI drugs and substitution... Full
Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing
(3/5, Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese, FDA Law Blog) ...On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients, and outlines information FDA would like to receive in addition to the requirements... Full
FDA Stakeholders Focus On 2025 After Flat-Funding In Approps Deal
(3/4, Jessica Karins, InsideHealthPolicy) ...Following the release of a package of spending bills that includes roughly flat funding for FDA and new demands on the agency's allocation of resources, the Alliance for a Stronger FDA is expressing disappointment while already looking forward to the fiscal year 2025 to boost the agency's funding... Sub. Req'd
International News
EMA ‘Trying Its Best' To Offer More Early Scientific Support For Sponsors
(3/5, Eliza Slawther, Pink Sheet) ...The European Medicines Agency is aware that its US counterpart, the Food and Drug Administration, offers a "much higher variety" of early support mechanisms for sponsors, but it is aiming to support companies as much as it can, according to the head of the agency's scientific advisory office, Iordanis Gravanis. During an interactive EMA event, Gravanis noted that while the EMA does not have as many mechanisms in place to facilitate these early dialogs as the FDA has, it is "trying [its] best."... Sub. Req'd
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
(3/4, Sarfaraz K. Niazi, PhD, The Center For Biosimilars) ...Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval. It did not take long for the European Medicines Agency to act after the FDA held a conference on "Increasing the efficiency of biosimilar development" in September 2023, which was participated by several regulatory agencies and other stakeholders, debating issues relating to removing hurdles in the approval of biosimilars... Full
Trade Pact With EFTA May Be the First For India With Committed Investments, Jobs, Says Official
(3/4, Amiti Sen, The Hindu) ...The proposed free trade agreement between India and the European Free Trade Association countries, with a commitment of $100-billion investments from the four-country bloc into India over the next 15 years generating an estimated 1 million jobs, may be formalised soon as the pact "is ready" and going through legal scrutiny, sources have said... Full
French Shortages Bill Would Impose ‘Dissuasive' Penalties On Firms That Fail To Meet Tougher Obligations
(3/5, Ian Schofield, Pink Sheet) ...The French lower house of parliament (Assemblée Nationale) has approved a bill that will introduce new requirements on medicine suppliers to hold "security stocks" of certain products, with the threat of tougher penalties if they fail to meet their obligations. The bill, which now goes to the Senate, is the latest in a series of actions intended to address the continuing problem of medicine shortages. According to the bill, in 2023, 37% of French people were affected by a product being unavailable... Sub. Req'd
Alvotech And Jamp Launch First Stelara Biosimilar In Canada
(3/4, David Wallace, Generics Bulletin) ...Canada's first Stelara (ustekinumab) biosimilar has been introduced to the market by Alvotech and marketing partner Jamp Pharma through the latter's BioJamp unit. The launch comes after the firms received approval from Health Canada towards the end of 2023... Global Sub. Full
WEZLANA™ (Ustekinumab), A Biosimilar to STELARA®, Now Available in Canada for Certain Chronic Inflammatory Diseases
(3/4, Amgen Canada) ...Amgen Canada today announced that WEZLANA (ustekinumab injection) and WEZLANA I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to STELARA, is now available in Canada. WEZLANA is the first biosimilar to STELARA to be approved by Health Canada for all indications. WEZLANA is indicated for adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis... Full
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