Friday, May 3, 2024

Who's Hired? Teva Brings New Legal Head Onboard

(5/2, Dean Rudge, Generics Bulletin) ...Teva has announced a new overseer for all legal matters, bringing in the former long-serving Eli Lily exec David McAvoy to serve as the company's executive vice president and chief legal officer. McAvoy – who spent almost three decades with Lily before his departure at the end of 2019 – replaces in the role David Stark, who himself spent more than 20 years with Teva... Global Sub. Full

Lupin Enters Canadian Biosimilars Market With Etanercept

(5/3, David Wallace, Generics Bulletin) ...Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen's Enbrel. The launch is taking place via Lupin's local partner Sandoz..."Data show a high patient acceptance of the easy-to-handle pre-filled pen," Lupin said, suggesting that "patients favored this latex-free device for self-injection, which can lead to improvement in compliance."... Global Sub. Full

Dr. Reddy's Laboratories Announces the Launch of Doxycycline Capsules, 40 mg* in the U.S.

(5/3, Dr. Reddy's Laboratories Ltd.) ...Dr. Reddy's Laboratories Ltd., today announced its launch of Doxycycline Capsules, 40 mg* in the U.S. market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the U.S. Food and Drug Administration... Full

Amgen Kicks Off Pembrolizumab Program As It Delivers Q1 Results

(5/3, David Wallace, Generics Bulletin) ...Amgen has revealed a development program for a biosimilar rival to Keytruda (pembrolizumab), as it revealed first-quarter results for 2024 that saw its biosimilars business grow sales by 12%...Sales of Amgen's Amjevita (adalimumab-atto) rival to Humira – sold as Amgevita outside the US – rose by 2% in total to $168m, with US sales bringing in $30m and the rest of the world accounting for the remaining $138m... Global Sub. Full

Amgen Goes All in On Injectable Obesity Drug As it Scraps Early-Stage Pill

(5/2, Elaine Chen, STAT Plus) ...Amgen said Thursday that it will no longer develop an early-stage obesity pill, and will instead focus on a more advanced injectable candidate that's seen as a potential competitor to Novo Nordisk's Wegovy and Eli Lilly's Zepbound. The injectable drug, called MariTide, is in a Phase 2 trial for obesity, and Chief Executive Bob Bradway said on an earnings call that "we are very encouraged with the results" from an interim analysis of that trial. Topline data are expected late this year... Sub. Req'd

Amgen Shares Jump After Teasing Weight-Loss Drug Data, Rivals Slip

(5/3, Manas Mishra and Christy Santhosh, Reuters) ...Amgen, which is conducting mid-stage studies of its injectable drug MariTide, said, based on interim data, that it was "confident in MariTide's differentiated profile and believe it will address important unmet medical needs." "The fact that ... the delivery dosing schedule is likely to be monthly or less frequent implies far fewer injection devices than competitors who, for example, are administering a weekly therapy," Amgen's CEO Robert Bradway told investors late on Thursday... Full

Regeneron Reveals Potential Delay for Dupixent in COPD, Stagnant Sales for Eylea

(5/2, Kevin Dunleavy, Fierce Pharma) ...Sanofi and Regeneron's highly anticipated approval of Dupixent to treat chronic obstructive pulmonary disease could be delayed, Regeneron CEO Len Schleifer said on Thursday. Earlier this week, the FDA requested additional efficacy analyses from two trials that have set Dupixent up for the potential label expansion. In February, the regulator accepted the application and designated it for priority review with a decision date of June 27... Full

Are Jubilant Pharmova's US Plant Closure, FDA Observations At Canada Unit A Concern?

(5/3, Vibha Ravi, Generics Bulletin) ...The US FDA's observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits. The US Food and Drug Administration has had a significant influence on the direction Indian pharma companies' revenues could head in a financial year given the dependence of these companies on North America and the role played by the agency as the geography's gatekeeper... Global Sub. Full

Cardinal Health Lifts 2024 Profit View On Demand for Costly Specialty Drugs

(5/2, Mariam Sunny, Reuters) ...Cardinal Health raised its annual profit forecast on Thursday, betting on strength in its pharmaceutical unit selling costly specialty drugs used to treat complex conditions such as cancer. Drug distributors, including rival Cencora, have been benefiting from growing sales of specialty medicines at a time when prices of generic, or copycat, versions have been falling due to intense competition... Full

Moderna Expects CDC to View its RSV Vaccine As Equal to Rival Shots

(5/2, Patrick Wingrove and Leroy Leo, Reuters) ...Moderna said on Thursday it expects U.S. Center for Disease Control and Prevention advisers to recommend the company's respiratory syncytial virus vaccine be considered equal to rival shots launched last year...Moderna shares jumped more than 7% in early trading after the company said it expects "a parity recommendation" to Pfizer's and GSK's RSV shots based on the data it has submitted and plans to provide. "We certainly think the data supports that," Moderna President Stephen Hoge said during a conference call with investors and analysts... Full

As Imbruvica Bows Out, AstraZeneca Clinches Early Calquence Win in Newly Diagnosed MCL

(5/2, Angus Liu, Fierce Pharma) ...As AbbVie and Johnson & Johnson's Imbruvica retreated, AstraZeneca's Calquence has become the first BTK inhibitor to claim a unique win in previously untreated mantle cell lymphoma...The result came from an interim analysis of a phase 3 trial called ECHO, for which AZ most recently projected a readout in 2025. Data from ECHO could potentially help Calquence convert its existing accelerated approval in previously treated MCL into a full nod... Full

Biologics for Severe Asthma Present Opportunities for Pharmacists

(5/2, Brian Gaul, PharmD, Pharmacy Times) ...Over the past 2 decades, the FDA has approved 6 biologic agents to treat severe, uncontrolled asthma. These agents provide new treatment options for providers whose patients experience severe exacerbations, decreased lung function, and increased oral corticosteroid use...The 6 available options are all humanized monoclonal antibodies but differ in several important ways...Reslizumab (Cinqair; Teva) is an interleukin-5 (IL-5) receptor blocker that interrupts the inflammatory cascade, preventing the release of eosinophils... Full

Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars

(5/2, Skylar Jeremias, The Center For Biosimilars) ...According to a study by Cencora, there is a discrepancy in payer coverage for granulocyte colony-stimulating factor (G-CSF) biosimilars. Although filgrastim biosimilars are frequently preferred over the originator (Neupogen), reference pegfilgrastim (Neulasta) continues to hold a dominant position over its biosimilar counterparts... Full

Senate Finance Committee Introduces Legislation Aimed at Fixing Drug Shortages

(5/3, Joseph Choi, The Hill) ...The Senate Finance Committee on Friday introduced bipartisan legislation aimed at preventing and reducing generic drug shortages by leveraging Medicare and Medicaid programs. The draft legislation proposes the creation of a "Medicare Drug Shortage Prevention and Mitigation Program" that would encourage improved contracting and purchasing practices in the drug supply chain. The program would begin in 2027, according to the committee... Full

Senate Finance Leaders Want Medicare to Combat Drug Shortages

(5/3, Alex Ruoff, Bloomberg Law) ...The long-awaited draft bill from Ron Wyden (D-Ore.) and Mike Crapo (R-Idaho), the Democratic and Republican heads of the Finance panel, would offer health-care providers between 5% and 25% of the drug's price plus the opportunity to get more add-on payments as part of the new program. The goal is to encourage more reliable and resilient purchasing of generic drugs to avoid them going into shortage... Sub. Req'd

Senate Drug Shortage Bill Would Pay Hospitals Bonuses for Good Contracting Practices

(5/3, John Wilkerson, STAT Plus) ...The Senate Finance Committee has drafted a bipartisan bill to mitigate drug shortages by rewarding hospitals for business practices that ensure an adequate supply of drugs...At first, Medicare would target drugs at highest risk, beginning with generic sterile injectables and infused medications, such as chemotherapies. The program eventually could be expanded to multiple-source drugs... Sub. Req'd

Warren, Experts Say DOD Could Help Produce Drugs In Shortage

(5/2, Jessica Karins, InsideHealthPolicy) ...The Department of Defense (DOD) should be involved in the production of pharmaceuticals to help combat drug shortages that impact members of the military, the chair of the Senate Armed Services subcommittee on personnel suggested at a hearing, hinting that senators may pursue legislation that would allow DOD to make its own drugs... Sub. Req'd

Novo Nordisk Defends Ozempic's Price in Face of Senate Scrutiny

(5/2, Elaine Chen, STAT Plus) ...Novo Nordisk defended the prices of its blockbuster diabetes and obesity drugs Ozempic and Wegovy amid a Senate probe into what the company charges. Speaking on an earnings call Thursday, CEO Lars Fruergaard Jørgensen said the company launched the treatments at similar prices to earlier generations in the drug class, despite their having greater efficacy, making them "an attractive value proposition."... Sub. Req'd

Pharma Companies Soften Tone On Full IRA Impact

(5/2, Nicole DeFeudis, Endpoints News) ...Despite the pharmaceutical industry's heavy criticism of the Inflation Reduction Act, Johnson & Johnson, Pfizer and Bristol Myers Squibb recently downplayed the legislation's overall impact on business in first-quarter earnings calls. All three companies voiced early opposition to the IRA, likening Medicare negotiations to price setting and arguing that the law is a threat to innovation. J&J's executive VP Jennifer Taubert reinforced that stance in an April call with investors. But she also noted that J&J's products currently under negotiation — Xarelto, Stelara and Imbruvica — "are not our growth drivers for the future."... Full

PhRMA, Providers Insist On Standing In IRA Appeals Case; Judge Briefly Touches On Merits

(5/2, Gabrielle Wanneh, InsideHealthPolicy) ...As the brand drug lobby and other groups asked the conservative 5th Circuit appeals court Wednesday (May 1) to revive their case against Medicare drug price negotiation after a Texas district court said the infusion industry plaintiffs had to appeal to Medicare first, a judge briefly veered off the standing issue and signaled she was sympathetic to an industry argument against the negotiation program... Sub. Req'd

Bracing for Impact: The Future of Hub, PAP, and Affordability Programs Under the Inflation Reduction Act

(5/3, Adam J. Fein, Ph.D., Drug Channels) ...Today's guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx. Chris explains how the Inflation Reduction Act of 2022 will impact hub, patient assistance programs, and affordability programs. He discusses steps manufacturers can take to accommodate the anticipated budget reductions while maintaining access and affordability for patients... Full

At Finance Hearing, Brown Blasts Healthcare CEO Over PBM Practices That Put Local Ohio Pharmacies Out Of Business

(5/2, U.S. Senator for Ohio Sherrod Brown) ...At a Senate Finance Committee hearing yesterday, U.S. Senator Sherrod Brown (D-OH) blasted UnitedHealth Group CEO Andrew Witty over the role that Pharmacy Benefit Managers play in driving up costs for families, imposing punitive direct and indirect renumeration fees on pharmacies, and the significant role PBMs play in the closure of local pharmacies across Ohio. UnitedHealth Group owns OptumRx, a massive corporate middleman PBM that accounts for nearly a quarter of all prescription drug claims in the U.S... Full

PBM Rebate Schemes to Suppress Biosimilar Humira Cost U.S. Patients $6 Billion

(5/2, Biosimilar Council) ...Today, the Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, released a new analysis of IQVIA data revealing health plans and patients missed out on savings up to $6 billion as a result of rebate schemes by pharmacy benefit managers. The report highlights the strategy created by pharmacy benefit managers to protect $2 billion in profits by suppressing adoption of lower-cost versions of the brand drug Humira®, once the best-selling drug in the world... Full

Senate Finance Draft Aims To Change Hospital, GPO Drug Procurement

(5/3, Maaisha Osman, InsideHealthPolicy) ...The Senate Finance Committee released a draft bill that would create a new program within Medicare aimed at incentivizing hospitals, group purchasing organizations and other drug supply chain stakeholders to help create stable pricing for generic drug manufacturers by rewarding quality, reliability and long-term sustainable contracts... Sub. Req'd

FDA-EMA Advice Pilot For Complex Generics: What Does Industry Have To Say?

(5/3, Urte Fultinaviciute, Generics Bulletin) ...Scientific convergence between the US Food and Drug Administration and the European Medicines Agency has been ongoing for several decades. First, it started with programs for new drugs, then both agencies set up a cluster to discuss topics of mutual interest on biosimilars, an off-patent version of a biologic product. However, complex generics and hybrid medicines had not been part of the transatlantic discussion, said Beata Stepniewska, head of regulatory affairs at off-patent association Medicines for Europe... Global Sub. Full

US FDA Wants Advice About Advisory Committees: Try Having Some?

(5/2, Michael McCaughan, Pink Sheet) ...The US Food and Drug Administration is eager to correct the "persistent misconception" that recommendations by its public advisory committees amount to final decisions or are somehow binding on the agency. The agency says so, at some length, in its recent announcement of a June 13, "listening session" for stakeholders to seek advice, as the notice of the meeting puts it, on "optimizing FDA's use of and process for advisory committees." Here's the thing: it is something of a wonder that the public has any perception of what advisory committee votes mean, given the paucity of them in recent months... Sub. Req'd

ORA Chief Says Funding Needed to Keep Pace with Growing Inspectional Inventory

(5/2, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration will not be able to keep up with its growing inspection inventory if it does get additional funding from Congress in its FY 2025 budget, said Michael Rogers, associate commissioner for regulatory affairs at the US Food and Drug Administration's Office of Regulatory Affairs... Full

Hawaii Drug Price Suit Against PBMs to Be Heard in Federal Court

(5/2, Celine Castronuovo, Bloomberg Law) ...Judge Leslie E. Kobayashi of the US District Court for the District of Hawaii said in an order Wednesday that CVS Caremark successfully met all requirements under the US federal officer removal statute in requesting that Hawaii Attorney General Anne E. Lopez's lawsuit against the company, as well as Express Scripts and OptumRx, should be transferred from the Hawaii Circuit Court, First Circuit... Sub. Req'd

Draft Rule Requiring Pharmacy Payments Hits Roadblock

(5/2, Steve Brawner, TB&P) ...A draft Arkansas Insurance Department rule that would have required pharmacy benefit managers to reimburse pharmacists for 110% of their drug acquisition costs plus a $10.50 dispensing fee has hit a roadblock. The Insurance Department is studying the impact of the proposed rule based on a measure passed in Kentucky that included the dispensing fee. It has asked insurance providers to provide data about the costs by May 24... Full

Industry Calls For Caution Over EMA Supply Chain Recommendations

(5/2, Francesca Bruce, Pink Sheet) ...Some of the European Medicines Agency's recommendations on how to address supply chain vulnerabilities affecting medicines on the EU critical medicines list should be treated with caution, says EFPIA, the federation representing the innovative pharmaceutical industry in Europe. Certain measures, for example on stockpiling and joint procurement, could prove counterproductive and cause problems for manufacturers, the federation told the Pink Sheet... Sub. Req'd

Industry Slates Decision To Exempt Parallel Importers From New Danish Stockpile Rules

(5/2, Ian Schofield, Pink Sheet) ...The bill on new rules on companies holding minimum stock levels for "critical medicines" has been amended but is still likely to take effect at the beginning of July. A revised version of the Danish bill introducing new stockpiling and reporting requirements for "critical medicines" is due to come before parliament on May 3...However, "in a move widely opposed by the remainder of the pharmaceutical industry, the revised language will make parallel importers and parallel distributors exempt from the stockpiling and reporting obligations imposed by the draft bill," Bech-Bruun said... Sub. Req'd

Shionogi: Other Countries Must Follow UK's Lead On Antimicrobial Incentives

(5/2, Eliza Slawther, Pink Sheet) ...Shionogi's UK general manager praised NHS England's novel subscription model for antibiotics, but warned the country would be "wasting money" unless other global regulators introduced similar incentives for antimicrobial development...Keiko Tone, UK general manager at Shionogi, said during a conference on April 23, that England's pilot scheme had "proven" that the concept of delinking antimicrobial sales volume from funding worked, and it had also demonstrated a way to "practically implement" this type of model... Sub. Req'd

Panel to Reform Drug Pricing Authority Packed with Industry Representatives

(5/3, Rema Nagarajan, The Times Of India) ...A committee constituted for "institutional reforms" of the National Pharmaceutical Pricing Authority is filled with representatives of the industry that the Authority is supposed to regulate. Public health activists have pointed out the absurdity and the conflict of interest in the Department of Pharmaceuticals constituting the committee with 14 pharma associations' representatives included as "special invitees"... Full

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