Monday, June 10, 2024

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book Patents

(6/10, David Wallace, Generics Bulletin) ...Generics Bulletin's editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA's Orange Book. This edition of the Generics Bulletin podcast sees editor Dave Wallace, deputy editor Dean Rudge and reporters Urte Fultinaviciute and Adam Zamecnik discuss recent strategic moves for Teva, Sandoz and Sawai as well as controversy over US patent listings in the US Food and Drug Administration's Orange Book... Global Sub. Full

Teva Pharmaceutical: Buy This Bargain Before It's Gone

(6/7, Seeking Alpha) ...I believe 2024 continues to be one of the key years in the company's history as Teva expects to publish the results of various clinical trials evaluating the efficacy of TEV-'574, which is developing for the treatment of ulcerative colitis and Crohn's disease, as well as olanzapine, which has the potential to become the "gold standard" in the treatment of schizophrenia. On the other hand, according to my assessment and analysts' expectations, thanks to the expansion of the portfolio of biosimilars and generics, as well as the growth in sales of Ajovy and Austedo/Austedo XR, the company's EPS in 2025 will reach 6.2x... Full

Medincell Publishes Its Consolidated Annual Financial Results

(6/10, Medincell) ...Christophe Douat, CEO of Medincell: "2023 has been a transformative year, marked by the FDA approval and successful commercial launch of UZEDY in the United States by our partner Teva. The anticipated rise in UZEDY royalties and the expected revenue from the olanzapine LAI will generate net profit to fuel Medincell's sustainable growth. We have entered a new era, demonstrating our ability to innovate and develop the enabling technologies to design innovative therapeutic solutions. We are now excited to welcome new partners, such as AbbVie, with whom we have recently signed a significant strategic agreement."... Full

Pharmacists Cite Highest Number of Drug Shortages Since 2001

(6/10, Ian McMahan, The Washington Post) ...In the first three months of 2024, there were 323 active drug shortages, the highest number since 2001, according to research by the University of Utah Drug Information Service. The drug shortage data, collected quarterly, is generated from reports from health-care professionals, most of them pharmacists at hospitals and health systems, said Erin Fox, the lead researcher and the Drug Information Service's director... Sub. Req'd

How Glenmark is Climbing the Pharma Ladder with Branded and Specialty Medicine

(6/10, Neetu Chandra Sharma, Business Today) ......"Our goal is to achieve two-thirds of our consolidated revenue from branded markets," says [Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd]. The company focusses on strategically expanding in key regions while strengthening its existing market presence. Saldanha says Glenmark uses advanced forecasting techniques, demand planning, and supply chain analytics to anticipate market needs accurately... Full

GSK Exec Lauds 'Great Start' to RSV Vaccine Uptake as Arexvy Nabs Label Expansion in Adults 50-59

(6/7, Fraiser Kansteiner, Fierce Pharma) ...June 7, the FDA approved Arexvy for RSV prevention in adults ages 50 to 59 who are at increased risk of developing RSV disease...According to GSK's research, there are about 13 million people between the ages of 50 and 59 in the U.S. with underlying conditions that place them at higher risk of RSV disease, Len Friedland, M.D., vice president and director, scientific affairs and public health, vaccines at GSK, said in an interview... Full

Lilly's Alzheimer's Drug Faces Delayed Reckoning

(6/10, Adriel Bettelheim, Axios) ...The outlook for the latest experimental drug shown to delay Alzheimer's disease will come into focus Monday, when Food and Drug Administration advisers review an application from Eli Lilly that's been held up by questions about the design of clinical trials and safety risks. Why it matters: Their conclusions could influence how the FDA treats future drugs that target proteins in the brain known as amyloid plaques that are believed to contribute to the development of the dreaded neurological condition that afflicts nearly 7 million people in the U.S... Full

Sun Pharmaceutical Prevails in Antitrust Suit Over Lipitor Drug

(6/7, Katie Arcieri, Bloomberg Law) ...Judge Peter G. Sheridan of the US District Court for the District of New Jersey in a Thursday order granted Sun's motion to end the case, saying the purchaser plaintiffs couldn't show an alleged anti-competitive settlement with Pfizer caused any generic delay. He also denied class certification to indirect and direct purchaser plaintiffs, including retailers, wholesalers, health insurance companies and consumers... Full

Federal Judge Dismisses Antitrust Claims Brought Against Bristol Myers by Insurers

(6/7, Nicole DeFeudis, Endpoints News) ...Several plaintiffs — including Humana, Blue Cross Blue Shield Association and Cigna Corporation — in the consolidated lawsuit made the case during oral arguments last summer that Celgene (now part of BMS) "unlawfully monopolized" the market for its cancer treatments Revlimid and Thalomid. But Judge Esther Salas determined Thursday that the plaintiffs' arguments rely on "insufficiently pled acts."... Full

Dr Reddy's Srikakulam Unit Gets 4 USFDA Observations

(6/10, Business Standard) ...The good manufacturing practices inspection was conducted from May 30, 2024 to June 7, 2024 at the API manufacturing facility and closed with an issuance of a form-483 with four observations. The pharma major stated that it will respond to the USFDA within the stipulated timeframe... Full

Lupin Recalls 51k Bottles of Generic Drug Due to Defective Containers in US

(6/9, Press Trust Of India) ...The US-based arm of the drug maker is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to "defective container: lack of seal integrity," US Food and Drug Administration said in its latest Enforcement Report... Full

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

(6/9, Ashley Gallagher and Skylar Jeremias, The Center For Biosimilars) ...Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, outlined educational resources on biosimilars that are already available to patients as well as how her organization ensures that patients are aware of biosimilars and are comfortable with switching products... Full

Pharma's R&D Gamble: Picking Pipeline Winners in a Risky Field

(6/7, Meagan Parrish, PharmaVoice) ...As companies face financial pressures, making strategic pipeline decisions is key to laying the groundwork for growth. But while so many drugs ultimately fail in development, how can company leaders know when they've got a pipeline winner on their hands? PharmaVoice asked leaders at BIO's annual international conference this week about the criteria they use to make these tough choices. Whether they're evaluating a potential new drug or weighing an investment into partnership, here's how leaders said they make the call... Full

Top Law Firms in US Opioid Lawsuits to Get Hundreds of Millions in Fees

(6/7, Brendan Pierson, Reuters) ...A court-appointed panel on Friday recommended how to divvy up a pool of $2.13 billion in legal fees from nationwide drug industry settlements over the U.S. opioid crisis, with top firms set to receive hundreds of millions of dollars...The fees stem from settlements with drugmakers Johnson & Johnson, AbbVie and Teva Pharmaceutical Industries; Distributors Cencora, McKesson and Cardinal Health; and pharmacies CVS, Walgreens Boots Alliance and Walmart... Full

Stakeholders Eye HHS' HSRM Rule As Possible Solution For Drug Shortages

(6/7, Maaisha Osman, InsideHealthPolicy) ...As HHS presses Congress to take legislative steps to avert drug shortages, industry stakeholders are eying HHS' upcoming proposed Healthcare System Resiliency and Modernization rule as a potential regulatory measure to address shortages through Medicare conditions of participation without action from lawmakers... Sub. Req'd

AHA Submits Comments On Draft Drug Shortage Legislation to Senate Finance Committee Leaders

(6/7, AHA) ...The AHA expressed concerns about impacts the bill would have on the 340B drug pricing program, such as the inability for a 340B payment-eligible provider participating in the Medicare Drug Shortage Prevention and Mitigation Program to access 340B pricing for units of a generic drug included in the program. Also, the bill would allow the secretary to reduce or waive the inflationary rebate for applicable drugs in shortage under the Medicaid Drug Rebate Program. AHA noted that this would likely result in increased drug prices and impact the determination of the 340B ceiling price, which would impact all 340B providers... Full

Supply Chain Shortage News

(6/7, Patrick Day, Lachman Consultants) ...The current state of drug shortages in the supply chain is under continued pressure, both outside of and within the U.S. According to the FDA, there are currently 105 products in shortage in the U.S. as of the drafting of this blog. Not only are the shortages continuing, but adherence to section 506C of the U.S. Food, Drug, and Cosmetic Act, which requires notification to the FDA in cases of temporary or permanent interruption to the U.S. market (Drug Shortages: Non-Compliance With Notification Requirement | FDA), is also coming under scrutiny... Full

Weight-Loss Drugs Are So Popular They're Headed for Medicare Negotiations

(6/7, Renuka Rayasam, McKenzie Beard, The Washington Post) ...Novo Nordisk's Ozempic and Wegovy could be eligible for negotiation as early as 2025, said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF. Lilly's Trulicity may follow the next year. Medicare shelled out $5.7 billion in 2022 for three popular GLP-1 drugs, up from $57 million in 2018, according to research by KFF. The "outrageously high" prices have "the potential to bankrupt Medicare, Medicaid, and our entire health care system," Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor and Pensions, wrote in a letter to Novo Nordisk in April... Full

Democrats Ramp Up Patent Fight with Drug Industry in Bid to Lower Prices

(6/7, Dan Diamond, The Washington Post) ...Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) this week wrote to eight pharmaceutical company CEOs, urging them to remove 130 patents from a key federal registry, according to letters shared with The Washington Post. The Democrats are targeting Novo Nordisk, including some of its patents related to expensive drug Ozempic; GlaxoSmithKline; and other companies that produce asthma and diabetes medications... Sub. Req'd

The U.S. is Fighting High Drug Prices. Big Pharma isn't Sweating — Yet

(6/10, Bruce Gil, Quartz) ...A key goal of the Biden administration has been to rein in healthcare costs. As the administration nears the end of its of its first term, Quartz talked to experts, industry analysts, and a government regulator to see how the industry has responded to federal policies to date — especially those aiming to drive down drug prices... Full

How a St. Paul Pharmacy's Fight for Survival is Tied to the 'Middle Men' of Drug Dricing

(6/7, Naasir Akailvi, KARE 11) ..."I'd venture to say 99% of people in America don't know what PBMs are, or who they are," says John Hoeshen, pharmacist and owner of St. Paul Corner Drug...As PBMs have grown, so too has their power. Hoeschen says he nor any other pharmacy can serve patients who are represented by a PBM that he hasn't signed a contract with. And he says those contracts have made it impossible to keep the shop up and running... Full

Would BIO Support a Biosecurity Bill Targeting Drug Developers? Hear CEO John Crowley's Response

(6/7, Angus Liu, Fierce Pharma) ..."I have expressed to Congress my view that any further companies that would be added as companies of concern have to have very clear and convincing evidence for why they would be added to the list," [BIO CEO John Crowley] said in an interview with Fierce Pharma on the sidelines of the BIO International Convention 2024 in San Diego...Crowley didn't directly answer whether BIO would support adding biotechs to the BIOSECURE Act target list. But he did note that the legislation features a mechanism to add new firms... Full

BIOSECURE Act Forces US Pharma to Re-Evaluate China Manufacturing Reliance

(6/10, The Pharma Letter) ...With heavy reliance on Chinese contract manufacturers, US companies are re-evaluating their partnerships amidst the proposed regulations aimed at safeguarding national security interests. While the Act remains a topic of debate, some anticipate potential onshoring benefits, while others foresee disruptions to the existing supply chains, finds pharma analytics company GlobalData... Sub. Req'd

Industry Experts Peel Back the Curtain On User Fee Negotiations

(6/7, Joanne S. Eglovitch, Regulatory Focus) ...What goes on behind the scenes in user-fee program negotiations? How are user fee agreements hammered out between the US Food and Drug Administration and industry representatives? Those were just two questions posed to an expert panel at the RAPS Regulatory Intelligence Conference on June 6... Full

State Drug Pricing Boards Forge Ahead With Eyes On Amgen Suit

(6/10, Celine Castronuovo, Bloomberg Law) ...The Colorado Prescription Drug Affordability Board is facing a lawsuit from Amgen Inc. over the five-member panel's February vote to pursue an upper payment limit, or UPL, for the autoimmune treatment Enbrel after members determined the injectable drug is "unaffordable" for Colorado patients. The Colorado board could soon face additional litigation after a vote Friday designating Johnson & Johnson‘s Stelara as unaffordable. The board has yet to decide on Novartis AG's Cosentyx. The PDABs in Maryland, Minnesota, and Washington also have the authority to set UPLs, and are watching the Colorado litigation as they move ahead with their own work... Sub. Req'd

Colorado Drug Price Board Says J&J's Stelara is Unaffordable

(6/7, Celine Castronuovo, Bloomberg Law) ...A blockbuster arthritis drug from Johnson & Johnson could soon see a limit on what Colorado health plans pay for the product after the state review board determined the treatment is "unaffordable" for patients. The five-member Colorado Prescription Drug Affordability Board voted Friday to grant this designation to Stelara, an injectable drug used to treat conditions like moderate to severe plaque psoriasis and Crohn's disease... Sub. Req'd

J&J's Stelara Deemed Unaffordable For Colorado Residents By PDAB

(6/7, Luke Zarzecki, Gabrielle Wanneh, InsideHealthPolicy) ...Johnson & Johnson strategic market director Lisa Pulver urged the board Friday against voting that Stelara is unaffordable based on findings of a draft report on the drug's affordability released in May, going as far as to ask the board to postpone its vote until after corrections are made to the draft report and an evidence review is completed. Janssen Biotech is a subsidiary of Johnson & Johnson... Sub. Req'd

It's Time We Stop Corporate Pharmaceutical Companies from Using Their Power to Rig the Rules

(6/10, Teresa Tanzi, The Boston Globe) ...Most Rhode Islanders agree that everyone, no matter where they come from or how much money they have, should get the medicine they need. Yet families across our state are forced to choose between paying for their prescriptions and paying for other necessities like housing, food or literally keeping the lights on. Thankfully, there's an option on the table that could dramatically decrease prescription drug costs for thousands of families: legislation to import these exact same medicines from our neighbor, Canada... Full

IGBA Celebrates ICH Re-Election And CEO Committee Progress

(6/7, David Wallace, Generics Bulletin) ..."The re-election of IGBA to the ICH assembly is a recognition of the important contribution of the generic and biosimilar medicine industries in supporting the ICH and accomplishing its global harmonization mission", commented Nick Cappuccino, chair of the IGBA's science committee and IGBA representative to the ICH management committee... Global Sub. Full

Blame Big Pharma, Not the NHS, for Drug Prices

(6/9, The Guardian) ...With the heavy encouragement of pharmaceutical companies, the blame for such shortfalls often falls on the National Institute for Health and Care Excellence (Nice), the public body that advises the NHS on whether medicines represent value for money. But high medicine prices, including that of Enhertu (average course of treatment: £117,857), are not some natural or necessarily occurring thing. While pharmaceutical companies are famously opaque when it comes to the real cost of producing drugs, it has been repeatedly shown that the NHS has been overcharged for similar cancer treatments... Full

Europe Debates Incentives to Combat Antimicrobial Resistance

(6/10, The Pharma Letter) ...Approving the new rules earlier in the year, lawmakers aim to increase competitiveness in the industry and simplify the drug application process. The law will also introduce a voucher system to encourage the development of new antibiotics. However, the EFPIA's Kristine Peers argued that key incentives required to stimulate this work need to be refined. Ms Peters argues that without these incentives, the commercial viability of developing new antimicrobials will remain low, perpetuating a cycle of inadequate treatment options and escalating healthcare costs... Sub. Req'd

Project Orbis, 'Cluster' Calls Validate Global Regulators' Drug Application Concerns

(6/7, Sue Sutter, Pink Sheet) ...Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting... Sub. Req'd

Nordic HTA Collaboration Expands To Boost Joint Assessments

(6/7, Ian Schofield, Pink Sheet) ...The five-country JNHB says that joint assessments mean HTA applications will be handled "efficiently and simultaneously" across the Nordic region, with one point of contact instead of multiple parallel processes...The JNHB will conduct joint assessments to support decision making processes in the five Nordic countries. It has entered into a collaboration with the Nordic Pharmaceutical Forum, which is made up of the drug price negotiation authorities in the five countries. It expects to continue its work beyond 2025 when EU-level joint clinical assessments kick in, initially for cancer drugs and ATMPs... Sub. Req'd

Global Bio-Pharmaceutical Alliance Launched to Strengthen Supply Chain Resilience

(6/9, Business Korea) ...South Korea, the United States, Japan, India, and the European Union convened in San Diego, USA, on June 5 (local time) to launch the inaugural meeting of the "Bio-Pharmaceutical Alliance." This significant event marks a collaborative effort to address the vulnerabilities in the global bio-pharmaceutical supply chain, which were starkly exposed during the COVID-19 pandemic... Full

A Success But Room For Improvement: Canada's Conditional Approval Pathway

(6/7, Neena Brizmohun, Pink Sheet) ...Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada's 26-year-old notice of compliance with conditions (NOC/c) pathway... Sub. Req'd

Homegrown Pharma Units Eye Double Digit Growth in Exports

(6/9, Times Of India) ...The first quarter of the 2024-25 fiscal has started on a positive note for homegrown pharmaceutical units eyeing double digit growth amid a rise in orders from African and South East Asian countries though payment woes may keep a lid on the upside. Drug manufacturers said the acute shortage of generic drugs in the United States is likely to give an edge to large pharmaceutical Indian companies and aid in surging exports... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.