Thursday, January 25, 2024

Teva Pharma (TEVA) PT Raised to $11 at JPMorgan

(1/25, StreetInsider.com) ...JPMorgan analyst Chris Schott raised the price target on Teva Pharma to $11.00 (from $9.00) while maintaining a Underweight rating... Full

Teva Price Target Raised to $11 from $9 at JPMorgan

(1/25, The Fly) ...On 2024, the analyst sees TEVA generating modest revenue growth with Austedo, generic Revlimid and Uzedy, offsetting headwinds for Bendeka/Treanda and Copaxone. Investor sentiment has become more positive on shares, the analyst tells investors in a research note... Full

Biosimilars Forum Welcomes Teva as Newest Member

(1/24, Biosimilars Forum) ...The Biosimilars Forum has announced Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., as its newest member. Teva rejoins the Biosimilars Forum during a watershed moment for the U.S. biosimilars industry – as the Forum leads the industry's effort to make lower-cost biosimilars accessible to all patients who need them. "Teva aspires to be a global leader in biologic medicines, and we are excited to rejoin the Biosimilars Forum and continue our work to deliver high quality, safe and effective biosimilar medicines to U.S. patients," said Pat McIntosh, Head of U.S. Commercial Generics and Biosimilars at Teva... Full

Biocon And Teva Sign Up To Biosimilars Forum

(1/25, David Wallace, Generics Bulletin) ...Biocon Biologics and Teva have become the latest firms to join the Biosimilars Forum industry association in the US, with Teva's membership representing a return to the group for the Israeli off-patent industry giant...[Julie Reed] Reed said that Teva's membership of the association and partnership in its activities would be "invaluable as the Forum spearheads advocacy efforts to ensure biosimilars are available to patients as lower-cost, safe and effective treatment options."... Global Sub. Full

AbbVie: Humira Competition Has Gone ‘Exceptionally Well' For Us

(1/24, David Wallace, Generics Bulletin) ...Speaking at the annual J.P. Morgan Healthcare Conference in January, AbbVie president and chief operating officer Robert Michael said the firm had been "managing the US Humira biosimilar erosion, which has gone exceptionally well." And in recent months, the firm had gained greater clarity on contracting for 2024, with Michael outlining that branded Humira was "going to have more parity access than we initially anticipated." This meant that branded Humira would capture volume in 2024 "that we initially did not anticipate we would," Michael said... Global Sub. Full

Glenmark Inks Licensing Pact with Jiangsu Alphamab, 3D Medicines for Cancer Drug

(1/25, Press Trust Of India) ...Glenmark Pharmaceuticals Ltd on Thursday said its arm Glenmark Specialty S A has signed a license agreement with Jiangsu Alphamab Biopharmaceuticals Co and 3D Medicines (Beijing) Co Ltd for KN035 (Envafolimab), used in cancer treatment. Under the agreement, Glenmark will get the license for KN035 (Envafolimab) in India, Asia Pacific, the Middle East, Africa, Russia, CIS, and Latin America, the company said in a statement... Full

Apotex, Heritage and Breckenridge Settle With Purchasers in Generics Price-Fixing Case

(1/24, Fraiser Kansteiner, Fierce Pharma) ...Apotex and two of its generics peers have agreed to settle with direct purchasers of their drugs in a price-fixing case that stretches all the way back to 2017. Apotex plans to settle with the group of direct purchaser plaintiffs for $30 million, while Heritage Pharmaceuticals and Breckenridge Pharmaceutical will hand over $10 million and $5 million, respectively, according to a trio of motions filed Tuesday in the multidistrict litigation in Pennsylvania federal court... Full

Pharma Companies to Remain Mum On CMS' Initial Offers Next Week for the First Year of IRA Negotiations

(1/24, Zachary Brennan, Endpoints News) ...Pharma companies are now saying they are not likely to go public with information on these initial offers from CMS come next Thursday, even though they are legally allowed to do so. Pharma companies had at first pushed back on CMS' requirements that the negotiations be kept secret...Novo Nordisk, which faces negotiations over some of its insulin products, told Endpoints, "Novo Nordisk intends to evaluate CMS's initial offer and will decide how to respond. The information provided by Novo Nordisk to CMS is confidential, and once the process has concluded, CMS will make public the maximum fair price it sets for the relevant products."... Full

US Pharmacy Benefit Lobby Group Ramps Up Spending As Lawmakers Close In

(1/25, Ahmed Aboulenein, Reuters) ...As U.S. pharmacy benefit companies face scrutiny from lawmakers and regulators, the main group representing them in Washington has nearly doubled its lobbying spend to over $15 million in 2023, a Reuters review of congressional disclosures shows..."The more people look under the hood at the broken PBM model, the clearer it is that the system needs to be fixed," said PhRMA spokesperson Nick McGee. "There's a growing bipartisan chorus of regulators, policymakers, patients, providers, pharmacists, smaller PBMs and others across the country calling for action," he said... Full

Senators Press FTC To Complete Probe Of PBM Business Practices

(1/24, Gabrielle Wanneh, InsideHealthPolicy) ...More than 18 months after the Federal Trade Commission first launched its inquiry into the effect common business tactics used by pharmacy benefit managers have on consumer drug costs, Senate Commerce Committee Chair Maria Cantwell (D-WA) and Sen. Chuck Grassley (R-ID), joined by 12 other lawmakers, are pressing the commission to provide an update on the study's progress and soon bring its investigation to a close... Sub. Req'd

When it Comes to Policing Pharma, The FTC Says it's On ‘An Incredible Winning Streak'

(1/24, Ed Silverman, STAT Plus) ...The agency is doing so as part of a wider effort by the Biden administration to address the controversy over prescription drug costs, which remains a pocketbook issue for many Americans. By tapping the FTC, the administration is hoping to send a message to drug companies that any moves to unfairly establish monopolies — and cost consumers money — will not be tolerated. To accomplish this goal, the FTC has approached this problem from different angles — rebates used by drug companies to win favorable health insurance coverage, mergers and deals that can help corner a market, and patents that keep generic rivals at bay. One FTC official maintained the agency has been on "an incredible winning streak." So here is an update on its progress... Sub. Req'd

How PBM Legislation Would Transform The Industry

(1/24, Lauren Berryman, Modern Healthcare) ...If Congress surmounts its protracted efforts to fund the federal government for the remainder of fiscal 2024 and to reauthorize key programs, a handful of PBM measures could see action in 2024. One bill, the Lower Costs, More Transparency Act of 2023, passed the House 320-71 last month..."The impact to all PBMs is that they're not going to get the same level of savings if their hands are tied and they're restricted from using the proven tools that they use today to lower costs," said Katie Payne, senior vice president of public affairs at PCMA... Sub. Req'd

Long-Term Market Sustainability for Infused Biosimilars in the U.S.

(1/24, IQVIA) ...Biosimilars in the U.S. have begun to fulfill their promise of generating savings for the healthcare system by reducing the cost of biologics. However, many studies and reports have highlighted issues within the current system that can lead to sub-optimal uptake of biosimilars and put the long-term sustainability of biosimilars at risk...This report intends to create a base of foundational analytics to better understand the dynamics of biosimilars. The focus of this report is on infused biosimilars that fall under the buy and bill program in Medicare Part B. In particular, the aim is to understand the key issues that can lead to the sub-optimal functioning of the biosimilars market in the U.S. by analyzing various case studies... Full

Central Planning On Drugs: Why Biden's Medicare Price Fixing Will Hurt Seniors

(1/24, Robert E. Moffit, RealClearHealth) ...While President Biden and his congressional allies promise that the law will reduce seniors' drug costs and "stabilize" their Medicare premiums, the reality is that these new changes could create serious obstacles for seniors attempting to access future life-saving medications. Why? Because the law sets in motion economic dynamics that will discourage investment in breakthrough medications for a large and growing Medicare population in a market environment already plagued by persistent prescription drug shortages and jeopardized by precarious drug supply chains. Let me be more specific. In the coming years, the Medicare bureaucracy will set the price of Medicare drugs through a progressive process of "negotiation" for an ever- larger number of prescription drugs... Full

APIIC Releases Recommendations to Combat Rising U.S. Drug Shortages and Ensure Access to Life-Saving Medications

(1/24, Active Pharmaceutical Ingredient Innovation) ...The rising rate of drug shortages demands immediate formation of a public supply-chain entity to drive the programs, policies and transparency required to protect our nation's health security, the Active Pharmaceutical Ingredient Innovation Center (APIIC), a consortium of biotechnology industry, policy and academic leaders, said today in a whitepaper, outlining recommendations for reshoring the manufacture of essential, life-saving pharmaceuticals... Full

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC's Report to The White House

(1/24, Kurt R. Karst, FDA Law Blog) ...APIIC report announced this week, titled "A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years." As discussed in the new report, producing 25% of all APIs for small molecule drugs within 5 years is an achievable goal...Ultimately, APIIC identifies several immediate, short-term, and long-term steps to meet the "Bold Goal," and concludes that "[a] comprehensive approach of the U.S. government, including the appointment of a coordinating entity, establishment of new funding lines, and rigorous review of regulatory authorities and policies, is imperative in implementing the incremental steps mentioned above. Improving our national health security requires significant mitigation of risk by creating a diversified manufacturing base and distributed buffer inventories that will guarantee Americans reliable access to essential medications."... Full

Florida's Plan to Import Cheaper Canadian Drugs Spotlights High Costs in U.S.

(1/25, Michael Scaturro, The Atlanta Journal-Constitution) ...Florida's decision to apply for permission to import drugs from Canada isn't likely to lower prices for most Georgians. But it could be a first step towards reigniting a debate around why Americans pay more than Canadians, Germans, and the French for the same drugs – and that debate could ultimately push the federal government and states to press pharmaceutical companies for lower prices. "The logical corollary of ‘We want to import cheaper drugs from Canada,' is for Americans to ask ‘Why are drugs cheaper in Canada?'" Eric Miller, a former senior Canadian official who is now a U.S.-Canada trade consultant, told The Atlanta Journal-Constitution... Full

Tennessee Lawmaker Files Bill to Import Medicine from Canada to Cut Taxpayers' Cost

(1/24, News Channel 9 ABC) ...A Tennessee lawmaker has filed legislation that would establish a Canadian drug importation program in Tennessee...According to Sen. Lamar, a recent study by the RAND Corporation found prescription drug prices in the United States were 218 percent higher than prices in Canada. By that metric, importing comparable medications through Canada could reduce the purchase price for the state by half... Full

Prescription Board Sets Tentative 2024 Cost Review Plan to Identify Expensive Drugs

(1/24, Danielle J. Brown, Maryland Matters) ...During a Tuesday Senate Finance Committee hearing, Andrew York, executive director of the Prescription Drug Affordability Board, outlined the upcoming year of board meetings. In meetings over the course of 2024, the board will gather data, manufacturer information and public testimonies that will inform its consideration of which drugs should undergo state cost reduction efforts. PDAB meets once every two months... Full

German Pharma Strategy Promises Drug Pricing Review & Stronger R&D Environment

(1/24, Francesca Bruce, Pink Sheet) ...The German government has published its much anticipated pharmaceutical strategy, which undertakes to reevaluate the Amnog drug pricing system, reduce bureaucracy and make Germany a better place to conduct clinical trials. "With the pharmaceutical strategy, we want to create reliable research and innovation-friendly framework conditions and reduce bureaucratic hurdles. This is the only way Germany can remain successful as a pharmaceutical location in the long term," said Bettina Stark-Watzinger, Germany's federal research minister... Sub. Req'd

Indian Firms Corner More of Growing Pharma Market as MNCs Go Niche

(1/25, Sonhini Das, Business Standard) ...Patent expiries, new brand launches, and better geo-grap-hical penetration have helped Indian pharma companies report better growth rates and a higher share of the domestic market in the last five years. Multinational companies, on the other hand, are focus-sing on niche therapies, going for licensing deals with Indian firms to get a wider reach, and bringing in more innovative global products... Sub. Req'd

Pharma Sector Can Be of $200 Bn by 2030 On Innovative Drugs: Biocon Chief

(1/25, Press Trust Of India) ...Research-based incentives to develop innovative drugs can help the domestic pharmaceutical sector to be worth $200 billion by 2030, Biocon Executive Chairperson Kiran Mazumdar-Shaw said on Wednesday..."India's pharma industry size is estimated at about $65 billion today. And by 2030, it is expected to increase to $165 billion. Now, I believe it has a potential to even be greater and touch $200 billion by 2030," Mazumdar-Shaw told PTI. But such a level of growth cannot just be driven by generics and biosimilars, it has to involve drug innovation, she noted... Full

Novartis Withdraws Medicines in Turkey in Response to Unfavourable Exchange Rate

(1/24, Akin Nazli, bne IntelliNews) ...Novartis has stopped selling some of its pharmaceutical products in Turkey, Nilufer Gurpinar Guner, a communications director at Novartis' Turkey unit, on January 23 confirmed in a statement to local daily Sozcu. The move is related to government exchange rate stipulations on payments made for pharmaceuticals amid the severe depreciation of the Turkish lira... Full

A PBM in Africa Flips the Industry's Script in a Bid to Make People Healthier

(1/25, Rachel Cohrs, STAT Plus) ...The organization, called Maisha Meds, plays the role of a middleman between international groups like USAID and the Gates Foundation and pharmacies. By definition, it's a PBM. But since it's a nonprofit company and it subsidizes medicines and tests aimed at promoting public health, it's hesitant to describe itself that way... Sub. Req'd

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