Tuesday, March 12, 2024

Business Within a Business: The Evolving Role of CFO

(3/12, Sharon Barber-Lui, The CFO) ...Sharon Barber-Lui, CFO of Teva, shares her insight on what makes a CFO. Drawing on her personal experiences, she dispels the myth that they are limited to the finance functions and are more multifaceted strategist for businesses to utilise...The key to our success was embracing what I might call "fearless leadership" – being willing to step into new areas of the business and asking challenging questions while still trying to get to "yes" as often as possible. Today's CFO needs to have a solution-oriented mindset, which starts by asking the question, "How can we do this," instead of saying, "No, we can't."... Full

Teva Pharma (TEVA) PT Raised to $17 at Jefferies, 'Innovation Strategy Resonating'

(3/11, StreetInsider.com) ...Jefferies analyst Glen Santangelo raised the price target on Teva Pharma to $17.00 (from $16.00) while maintaining a Buy rating. The analyst comments "We hosted TEVA CEO, CFO, CMO and IR for mtgs and think that while the co is clearly executing on its growth strategy, many aspects of the story remain underappreciated incl 1) branded/gx strength, 2) biosimilars, 3) TAPI divestiture and 4) the innovation pipeline”... Sub. Req'd

FDA Rejects Mapi-Viatris Long-Acting Version of Teva's Copaxone

(3/11, Shiri Habib Valdhorn and Gali Weinreb, Globes) ...Positive news for Teva Pharmaceutical Industries Ltd., after the US Food and Drug Administration rejected Viatris and Israeli company Mapi Pharma's 40 mg dose of the long-acting version of Copaxone, which requires just one injection every four weeks for multiple sclerosis patients. The application for approval of a new drug was submitted to the FDA by the companies following outstanding results in clinical trials... Full

Viatris' Launch Plans Scuttled as FDA Rebuffs Long-Acting MS Drug from Partner Mapi

(3/11, Fraiser Kansteiner, Fierce Pharma) ...Copaxone earned Teva around $320 million in North America last year, a 17% decline from the $387 million it generated in 2022. The drug hauled in another $231 million in Europe and $39 million in other international markets in 2023. For 2024, Teva expects Copaxone to bring home around $400 million globally...As of late, Teva—now undergoing a revamp under new CEO Richard Francis—has largely been able to recover from its Copaxone revenue woes, thanks in large part to its steady roster of generics, plus newer brand-name medications like the Huntington's disease drug Austedo and migraine med Ajovy. The new drugs generated $1.2 billion and $435 million last year respectively... Full

FDA Rejects Viatris, Mapi's Long-Acting Multiple Sclerosis Injection

(3/11, Tristan Manalac, BioSpace) ...The FDA has rejected Viatris and Mapi Pharma's investigational formulation of glatiramer acetate, dubbed GA Depot 40, for the treatment of relapsing forms of multiple sclerosis, the companies announced on Monday. Details of the FDA's rejection were scant and the partners only said that they are currently reviewing the Complete Response Letter to better determine the "appropriate next steps" for GA Depot 40...Originally developed by Teva Pharmaceuticals, glatiramer acetate was first approved in the U.S. in 1996 for the treatment of relapsing forms of MS. It carries the brand name Copaxone. Viatris and Israel-based partner Mapi were proposing their investigational long-acting formulation of glatiramer acetate, which is designed to be given via an intramuscular injection every four weeks... Full

FDA Rejects Viatris/Mapi Long-Acting Version of Teva's Copaxone

(3/11, Val Brickates Kennedy, Seeking Alpha) ...Viatris said the FDA decision will not change its 2024 guidance or new product revenue range of $450M to $550M. GA Depot is a long-acting version of the MS drug GA, which is marketed under the brand name Copaxone by Teva Pharmaceutical Industries... Full

Who Wants to Buy Teva's API Business?

(3/11, Aayushi Pratap, Chemical & Engineering News) ...EuroAPI, a Sanofi spin-off, recently took drastic steps to cut down on its API business, announcing that it will discontinue 13 APIs with low or negative profit margins. It also plans to divest API sites in England and Italy and possibly close two workshops at its site in Frankfurt, Germany...There is little evidence to suggest that Teva has taken similar steps. Instead, Teva is placing its bets on its roster of innovative drugs for respiratory, neurodegenerative, and neuropsychiatric indications and on producing biosimilars of products like AbbVie's Humira. To make resources available, the company wants to complete the sale of its API business by 2025, but it is unclear who will buy it... Full

MM+M Unveils 2024 Classes of Women of Distinction, Women to Watch

(3/11, MM+M) ...In its ninth year, the MM+M Women of Distinction and Women to Watch programs are set to celebrate 55 healthcare marketing executives who have significantly impacted their organizations — and the industry writ large — during the past year...Women to Watch class of 2024...Nina DeLucia, director, consumer brand marketing, Austedo, Teva Pharmaceuticals... Full

Amneal ‘Very Excited' About Biosimilars Future, Looks To Expand Portfolio In 2024

(3/11, Urte Fultinaviciute, Generics Bulletin) ...."Given the market growth and importance of biosimilars, this is a key area of strategic focus and investment for Amneal. We look to further build out [our] biosimilars pipeline over time," said co-founder and co-CEO Chirag Patel during the firm's Q4 and full year 2023 earnings call..."We are very excited about the future of biosimilars and pleased with the commercial success of our first three products. This is a key area of growth for us," said the firm's other co-founder and co-CEO Chintu Patel... Global Sub. Full

AstraZeneca, Mankind Pharma Partner for Distribution of Asthma Medication

(3/11, Anjali Singh, Business Standard) ...In a move aimed at addressing the growing asthma burden in India, AstraZeneca Pharma India and Mankind Pharma on Monday announced that they are collaborating to exclusively distribute AstraZeneca's asthma medication, Symbicort (inhaler), in India. Under the agreement, AstraZeneca will maintain the intellectual property rights to budesonide and formoterol fumarate dihydrate, while Mankind Pharma will take on the exclusive distribution responsibilities. AstraZeneca will continue as the Marketing Authorization Holder and maintain the import licence for the medication... Full

Celltrion Leads Xolair Biosimilar Race With US FDA Application

(3/11, Urte Fultinaviciute, Generics Bulletin) ...Celltrion continues to establish its frontrunner position in the omalizumab biosimilar race as the firm submits a biologic license application to the US Food and Drug Administration for its CT-P39, an interchangeable biosimilar candidate to Genentech/Novartis' Xolair...Teva Pharmaceuticals also has an ongoing Phase III trial investigating its TEV-45779 compared to Xolair in adults with chronic idiopathic urticaria. According to ClinicalTrials.gov, the study is set to finish in June 2024... Global Sub. Full

AbbVie Loses Appeal to Keep Documents in AndroGel Suit Secret

(3/11, Bernie Pazanowski, Bloomberg Law) ...AbbVie Inc.‘s assertion that documents, created during a patent dispute involving the low testosterone drug AndroGel 1% were protected by attorney-client privilege, was rejected by the Third Circuit Monday...Judge D. Brooks Smith of the US Court of Appeals for the Third Circuit said that AbbVie didn't prove that the writ was "the only means available" to preserve confidentiality. When Perrigo Co. and Teva Pharmaceuticals USA, Inc. sought US Food and Drug Administration approval for the generic Androgel, Abbott sued for patent infringement... Sub. Req'd

No End in Sight for National ADHD Drug Shortage

(3/12, Alicia Ault, Medscape) ...Nearly 18 months after the US Food and Drug Administration first acknowledged a national shortage of Adderall, the most common drug used to treat attention-deficit/hyperactivity disorder, there is now a widespread scarcity of other stimulant medications — with no end in sight...Some manufacturers of generic versions of mixed amphetamine salts are only fulfilling orders for existing contracts, while others say new product won't be available until at least April or as late as September. All blame the delay on the shortage of active ingredients. Teva, which makes both the brand and generic of Adderall, reported on the FDA's site that its manufacturing and distribution is at record-high levels, but demand continues to rise... Full

Indivior Announces Publication Demonstrating that OPVEE® (Nalmefene) Nasal Spray Rapidly Reverses Effects of Opioid-Induced Respiratory Depression in Head-to-Head Study Against Intranasal Naloxone

(3/11, Indivior PLC) ...Indivior PLC today announced results from a pharmacodynamic study demonstrating that OPVEE® rapidly reverses opioid-induced respiratory depression, which is the major cause of deaths due to opioid overdose. The study, "Reversal of opioid-induced respiratory depression in healthy volunteers: comparison of intranasal nalmefene and intranasal naloxone", was published in the Journal of Clinical Pharmacology...and is the first head-to-head comparison examining the effects of 2.7 mg intranasal nalmefene (OPVEE) and 4 mg IN naloxone on opioid-induced respiratory depression... Full

Judge Trims US Justice Department Lawsuit Against Walmart Over Opioids

(3/11, Brendan Pierson, Reuters) ...A federal judge on Monday narrowed the U.S. government's lawsuit accusing Walmart of fueling the opioid epidemic, dismissing a claim that the retail giant failed to report suspicious prescription drug orders to the U.S. Drug Enforcement Administration...Walmart said in a statement that the ruling "reinforces what we have said all along: the government's lawsuit is misguided and misapplies the law."... Full

The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability

(3/11, Kashyap Patel, MD, The Center For Biosimilars) ...Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress... Full

Biden Pushes Expansion of Drug Pricing, Insurance Coverage Plans

(3/11, Alex Ruoff, Tony Pugh and Nyah Phengsitthy, Bloomberg Law) ...President Joe Biden's fiscal year 2025 budget request seeks to raise the Department of Health and Human Services' discretionary spending to $133.8 billion, a nearly $5 billion increase from fiscal year 2023, the White House announced Monday. The HHS budget plan is central to Biden's plan for reducing costs for Americans. A keystone of that plan is bolstering the drug price negotiation program: expanding the number of drugs subject to negotiation, speeding up the pace of the process, and extending the $2,000-per-year out-of-pocket cap on drug costs from Medicare to private plans... Sub. Req'd

Biosimilar Interchangeability Designation Would Be Nixed Under Biden Proposal

(3/11, Derrick Gingery, Pink Sheet) ...Eliminating the interchangeability distinction would bring the US in line with other major regulators and reflects the current science, Biden administration officials said. Changes to the legal framework are unlikely to happen soon, but FDA is increasingly willing to give biosimilars an interchangeable designation without additional data. The budget-neutral score for the interchangeability proposal reflects the major impact that PBM rebating has on biosimilar access as opposed to FDA approval status... Sub. Req'd

Biden Administration Proposes Funding Bump for FDA, Nixing Interchangeability Requirement

(3/11, Lia DeGroot, Endpoints News) ...Just days after Congress passed the FDA's fiscal year 2024 appropriations package at the 11th hour, the Biden administration is asking for a bump in FDA funding for fiscal year 2025...HHS Secretary Xavier Becerra went to bat for the FDA on a press call Monday, saying that the agency hasn't received sufficient funding as its responsibilities have grown. "We're not keeping up with funding for FDA to make sure that we keep pace with all the innovation that's out there," Becerra said... Full

President's Budget Calls For Unrestricted Biosimilar Switching

(3/11, Jessica Karins, InsideHealthPolicy) ...Experts on biosimilars have previously pointed out the interchangeable label is unique to the United States and is a legal distinction, not a medical one. Jacqueline Corigan-Curay, the principal deputy center director in FDA's Center for Drug Evaluation and Research, has said it would likely require congressional action to eliminate the distinction between biosimilar and interchangeable drugs, and said it would make most sense for biosimilar drugs to be treated as interchangeable unless there is a compelling reason they should not be... Sub. Req'd

Biden's Budget Hikes FDA Funding, But Becerra Says FDA Needs More

(3/11, Jessica Karins, InsideHealthPolicy) ...Following the budget's release Monday (March 11), HHS Secretary Xavier Becerra told reporters stakeholders should "talk to Congress" if they are disappointed FDA's funding isn't keeping up with the pace of innovation, saying the agency needs more money as new medical treatments and other responsibilities grow...[Xavier Becerra]"Could FDA use more money? Absolutely. Absolutely . . . We're not keeping up with funding for FDA to make sure that we keep pace with all the innovation that's out there. And so when industries complain that we're not moving fast enough, we're bogging down, bureaucracy's keeping innovation from getting to America's homes -- go talk to Congress."... Sub. Req'd

Other IRA Cases Could Be Influenced by New Jersey Judge's Decisions, Expert Says

(3/11, Nicole DeFeudis, Endpoints News) ...A New Jersey federal judge's skepticism of drugmakers' arguments against the Inflation Reduction Act's drug price negotiations could become influential in other courts as pharma's challenges to the law continue..."You see judges in different districts looking at decisions of other judges and either explaining why they agree with that analysis, or why they don't," Zachary Baron, director of the Health Policy and the Law Initiative at Georgetown University's O'Neill Institute, told Endpoints News on Monday... Full

Drugmaker Challenges Medicaid Alleging Rebate Misclassification

(3/11, Ganny Belloni, Bloomberg Law) ...In a complaint filed Friday in the US District Court for the District of Columbia, Illinois-based pharmaceutical firm Fresenius Kabi alleged that the Centers for Medicare & Medicaid Services misclassified a number of the company's generic medications, potentially leaving the company on the hook for higher payments to state Medicaid agencies. Under the Medicaid Drug Rebate Program, manufacturers are required to divvy out higher rebates to state Medicaid programs if a drug is classified as a name-brand or "innovator" medication; generic drugs, on the other hand, lead to fewer payments from manufacturers... Sub. Req'd

Research Considers Returns on "Maximum Fair Price" of Medicare Drugs

(3/12, Bentley University) ...A new working paper from the Center for Integration of Science and Industry at Bentley University shows that the National Institutes of Health spent $11.7 billion on basic or applied research leading to approval of the ten drugs selected for Medicare price negotiations in the first year of the Inflation Reduction Act. The study, titled "Considering Returns on Federal Investment in the Negotiated 'Maximum Fair Price' of Drugs Under the Inflation Reduction Act: an Analysis" published by the Institute for New Economic Thinking, argues that the negotiated "maximum fair price" for these drugs must provide the public sector with returns on this federal investment comparable to the returns on private sector investment by the pharmaceutical companies... Full

FAQs on Prescription Drug Importation

(3/11, Meredith Freed, Tricia Neuman, and Juliette Cubanski, KFF) ...The high cost of prescription drugs continues to be a top health care priority for the public. Policymakers from both parties at the federal and state level have been pursuing a range of options to lower drug prices for Americans, one of which would allow for the safe importation of prescription drugs from Canada. This idea is based on data showing that people in the U.S. often pay more for medications than people in other countries... Full

US FDA Neuroscience Office In Spotlight With Donanemab Delay, Relyvrio Trial Failure

(3/11, Sue Sutter, Pink Sheet) ...Lilly's surprise announcement that the Alzheimer's drug is going to an advisory committee, followed minutes later by Amylyx's disclosure that its ALS drug failed a Phase III study, marked a one-two punch of bad news for the Office of Neurosciences' recent use of regulatory flexibility... Sub. Req'd

FDA Updates Early Alzheimer's Drug Development Guidance to Add Support for Biomarkers, Surrogate Endpoints

(3/11, Jeff Craven, Regulatory Focus) ...The draft guidance, a revision of a previous draft guidance released by the agency in February 2018, is a document written for sponsors considering development of drugs for sporadic Alzheimer's disease stages prior to a patient developing overt dementia. FDA appears to have reorganized the latest version of the draft guidance in acknowledgment of the changing landscape of AD drug development... Full

Maryland's Prescription Drug Affordability Board is Not the Quick Fix for Lower Prices | GUEST COMMENTARY

(3/12, Christopher T. Adams, The Baltimore Sun) ...Four years and millions of dollars later, the PDAB has yet to set a single drug price and has not saved the state or patients a single dime, proving there is no easy answer to getting lower patient prices...It's not time to expand PDAB's workload. There are other policies that put patients before profits. I will continue to work with my colleagues in Annapolis to find ways to lower the cost of medicine for you and your family... Full

Drug Shortages Put Idahoans' Lives at Risk. Here's a Peek Inside Why They Happen | Opinion

(3/12, Mike Crapo, Idaho Statesman) ...For treatments targeting any number of conditions, from pediatric cancer to mental health ailments, our ability to prevent and resolve drug shortages can mean the difference between life and death. As ranking Republican member of the Senate Finance Committee, I have been working to develop meaningful policy improvements to reverse the current rise in drug shortages... Full

AMR Industry Alliance Calls Out UN For Urgent Steps

(3/12, Adam Zamecnik, Generics Bulletin) ...Ahead of a planned September UN meeting, the industry group and key companies demand concrete steps that could turn the tide in the fight against antimicrobial resistance. The AMR Industry Alliance and select companies such as Sandoz have called on the United Nations to include specific actions and steps in the organization's planned September High Level Meeting on AMR... Global Sub. Full

First ‘Critical Medicines' To Undergo EU Vulnerability Assessment

(3/11, Ian Schofield, Pink Sheet) ...The first set of medicines chosen from the EU's new "critical medicines list" are to undergo a "vulnerability analysis" that will be used as a pilot to test and refine the methodology for assessing weak points in the drug supply chain. The critical medicines list, which contains more than 200 products and was published last December, was drawn up by the European Commission, the European Medicines Agency and the Heads of Medicines Agencies, as part of a strategy to prevent shortages of vital medicines and ensure security of supply, particularly in health crises... Sub. Req'd

Pharma Experts Highlight How Innovative, Sustainable, Patient-Centric Supply Chains Are Reshaping The Future

(3/12, Rashmi Mabiyan, ETHealthWorld) ...Leading business executives, government regulators, and innovators in technology came together at ETPharma's Future-Ready Supply Chain Summit to collectively envision a transformative path for pharmaceutical supply chains of the future...The discussion highlighted that Pharmaceutical firms face a variety of difficulties, from unexpected shortages and disruptions to abrupt increases in demand... Full

Govt Revamps Pharma Scheme; Broadens Eligibility Criteria, Brings in Flexible Financing Options

(3/11, Press Trust Of India) ...The Indian government has revamped the Pharmaceuticals Technology Upgradation Assistance Scheme to support drug companies in upgrading their facilities to produce medicines conforming to global standards. The scheme now extends beyond MSMEs to pharmaceutical manufacturing units with a turnover of less than Rs 500 crore that require technology and quality upgradation. The scheme also introduces more flexible financing options, emphasizing subsidies on reimbursement basis... Full

New UAE Drug Agency Calls On Companies To Help Shape Mandate

(3/11, Neena Brizmohun, Pink Sheet) ...Companies are being encouraged to capitalize on opportunities to collaborate with the new medicines and medical devices regulatory agency that is being launched in the United Arab Emirates to shape the country's regulatory environment through public-private cooperation. The Emirates Drug Establishment was created last September to take over the regulation of drugs and devices from the Ministry of Health and Prevention. It is expected to start becoming operational by the end of April... Sub. Req'd

Formycon and MS Pharma Nab Saudi Nod for Lucentis Copy

(3/11, The Pharma Letter) ...German biosimilars company Formycon and Jordan-based MS Pharma have announced that FYB201, a biosimilar to Lucentis (ranibizumab), has received marketing authorization from the Saudi Food and Drug Authority. Following successful market launch in Jordan last year and with winning the National Unified Procurement Company tender in Saudi Arabia, FYB201 is expected to be available in another country in the Middle East and North Africa region from the second quarter of 2024... Sub. Req'd

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