Friday, January 12, 2024

Please note: Teva Daily News will not publish Monday, January 15 in observance of Martin Luther King Jr. day. Publication will resume on Tuesday, January 16.

Teva Price Target Raised to $14 from $13 at BofA

(1/12, The Fly) ...BofA analyst Jason Gerberry raised the firm's price target on Teva to $14 from $13 and keeps a Buy rating on the shares. The firm e believes based on its review of Teva's U.S. generics segment that the company can achieve low single-digit growth, even excluding contributions from the "two wildcards" of Korlym and Humira-IC, the analyst tells investors... Full

Prescriptions for ADHD Drugs Jumped 14% During Pandemic: Study

(1/11, Youri Benadjaoud, ABC News) ...In a statement issued Thursday, an FDA spokesperson told ABC News that while some manufacturers of ADHD medications continue to have "supply issues," there are "nine manufacturers with availability" currently, and "there will be additional supply returning in the coming months."...Teva, the largest manufacturer of generic and brand name Adderall in the U.S, told ABC News last March that while the company was not experiencing manufacturing issues or shortages at that time... Full

Supply Issues With Certain Prescription Drugs Continue Into The New Year

(1/11, Colin Mayfiend, WCNC) ...Greg Deese, owner of Oakhurst Pharmacy told WCNC Charlotte that he's had to work harder than normal these last few months to stock the shelves. The abundance that people see in no way reflects his struggle to get some medications in the door. In some cases, it's been a full year being unable to find some ADHD medications. When generic drugs aren't available, that means higher prices are passed on to the patient because of insurance scrutiny. Many families are having to make decisions that impact their well-being with higher prices for medication... Full

Celltrion's Yuflyma, Remsima Win Multiple Bids in Europe

(1/12, Shim Woo-hyun, The Korea Herald) ...Celltrion said Friday that the company's biosimilar products for autoimmune diseases -- Yuflyma and Remsima -- are set for further expansion in key European markets following the multiple bids it has secured there. Celltrion said that Yuflyma, a copycat version to AbbVie's Humira, won state bids for adalimumab in Friuli-Venezia Giulia and Sicily, Italy, last year. Celltrion will supply Yuflyma for four and a half years in FVG and for two years in Sicily... Full

FDA Starts Review of Lantheus' Generic Lutathera

(1/12, Phil Taylor, PharmaPhorum) ...The FDA has started a review of the generic and – if approved – Lantheus could be in line for 180 days of market exclusivity as the first company to bring a copycat version of Lutathera (lutetium Lu 177 dotatate) to the US market. Novartis has already said it may consider legal action to try to block Lantheus' generic on the grounds of patent infringement, which could lead to a 30-month stay on launch under the US legal framework. That seems almost inevitable, given that there are US patents on the drug out to 2038... Full

Regeneron Asks US Court to Block Amgen's Eylea Biosimilar

(1/11, Blake Brittain, Reuters) ...New York-based biotech company Regeneron has sued rival Amgen (AMGN.O) in federal court in Los Angeles, alleging that Amgen's proposed biosimilar of Regeneron's blockbuster eye drug Eylea violates its patent rights. Regeneron said in its lawsuit filed on Wednesday that Amgen infringed dozens of its patents. It asked the court to block Amgen's version of Eylea, which earned Regeneron $6.26 billion in U.S. sales in 2022... Full

JPM24: Even After Seagen Buyout, Pfizer Oncology Chief Still Eyes ADC Deals

(1/11, Angus Liu, Fierce Pharma) ..."Building a world-class oncology organization, we obviously want to continue to make sure we not only compare the best opportunities internally but also externally," Pfizer's newly minted chief oncology officer, Chris Boshoff, Ph.D., said in an interview on the sidelines of the J.P. Morgan Healthcare Conference. The company is "looking at opportunities from companies in the Far East now, and certainly also companies in China, which is important in this whole area, especially ADC development," Boshoff added... Full

Sandoz Reveals European Natalizumab Launch Amid GLP-1 Ambitions

(1/11, Dean Rudge, Generics Bulletin) ...Sandoz's Polpharma Biologics-partnered Tyruko (natalizumab) biosimilar to Tysabri has begun shipping in Norway following a successful tender bid for the multiple sclerosis treatment, the company has disclosed at the J.P. Morgan Annual Healthcare Conference currently taking place in San Francisco, California. Launching into a space where "we don't see any competition in the short to medium term," Tyruko had been "well accepted," Sandoz's CEO Richard Saynor told attendees to the conference, "and now, we're looking then to roll that out as we go into the first half of 2024."... Global Sub. Full

Lilly InDirect? Telehealth Program Leans Into Third-Party Approach To Avoid Compliance Pitfalls

(1/11, Cathy Kelly, Pink Sheet) ...LillyDirect program for Zepbound, Emgality, insulins aims to ease points of friction for drug access, including delays in seeing physicians and inconsistent supply at pharmacies. Co-pay assistance tailored to skirt insurance plan tactics...The approach is a first for a major pharmaceutical company and analysts expect that other companies may follow suit. The fact that Lilly is sponsoring a direct-to-consumer program that engages prescribers raises questions about regulatory compliance, and telehealth is relatively new terrain for such issues... Sub. Req'd

Archimedes Announces Biosimilars First™, An Industry Leading Program to Drive Biosimilar Adoption in 2024

(1/11, Archimedes) ...Archimedes, a recognized leader in specialty drug management solutions, announced BiosimilarsFirst™, a program, which excludes Humira from formulary in favor of low cost, low WAC biosimilars. BiosimilarsFirst is projected to drive industry-leading adoption of biosimilars for autoimmune diseases, providing plan sponsor savings of 65% plus and more affordable treatment options for patients... Full

Editorial: Targeting Drug Middlemen Could Create More Loopholes

(1/11, Bloomberg) ...For years, Congress directed much of the blame toward drugmakers — they set the prices, after all. Increasingly, though, fingers have been pointing to the middlemen at the center of a labyrinthine drug supply chain: pharmacy benefit managers...Congress thus has good reason to examine PBMs' business practices. It's unclear, however, whether eliminating certain tactics will lower costs for patients or simply create new loopholes... Sub. Req'd

Readout of Latest White House Meeting with RSV Immunization Manufacturers

(1/11, The White House) ...Yesterday, senior Biden-Harris Administration officials convened a meeting with manufacturers of RSV immunizations for infants, including Sanofi and AstraZeneca, to receive an update on supply, and to underscore the need for manufacturers to continue efforts to meet current and projected demand through the commercial market. This meeting follows several in-person and virtual meetings, including last month when manufacturers announced the availability of hundreds of thousands of additional doses at the urging of the administration, including 230,000 additional doses, which providers and states will begin to be able to order starting next week... Full

Express Scripts Sued Over Alleged Reimbursement Fee Collusion

(1/11, Gabrielle Wanneh, InsideHealthPolicy) ...Express Scripts, one of the country's three largest PBMs that control more than 80% of the market, is under fire for allegedly entering price-fixing agreements with Prime Therapeutics, Benecard Services and Magellan Rx Management that enable the smaller PBMs to impose reimbursement rates and fees that are less favorable to pharmacies than they otherwise would be, and then have them share the revenue collected with Express Scripts, according to the suit filed in a Washington district court Tuesday (Jan. 9)... Sub. Req'd

JPM2024: IRA Favors Biologics Over Small Molecule Drugs and Hurts Innovation, Industry Analysts Say

(1/11, Greg Slabodkin, BioSpace) ...The potential impact of the Inflation Reduction Act's drug pricing provisions on small molecule drugs was on the minds of industry stakeholders in San Francisco this week for the J.P. Morgan Healthcare Conference. At the crux of the matter is a disparity in which biologics are spared from price negotiations under the Inflation Reduction Act for 13 years following approval, while the grace period for small molecules is only nine years... Full

FDA Updates Draft Guidance On Division-Level ANDA Disputes

(1/11, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a negative decision at the division level, detailing which issues are not fit for reconsideration and how many such disputes the agency will be able to handle... Full

Commenters Split On FDA's Off-Label Communication Guidance

(1/11, Mary Ellen Schneider, Regulatory Focus) ...Drugmaker AbbVie commented that the draft SIUU guidance does not go far enough to support clinical decision making by healthcare providers. AbbVie specifically objected to FDA's suggestion that communications related to early phase clinical trials are not clinically relevant. "We believe that such exclusions, if finalized, would be arbitrary and needlessly limit the communication of scientific information relevant to clinical practice decisions and the best interests of individual patient care and treatment," AbbVie wrote... Full

Florida Time: Sorting Out The Deadlines For Canadian Imports

(1/11, Michael McCaughan, Pink Sheet) ...The approval of Florida's plan to import drugs from Canada is an important symbolic milestone for FDA and the drug industry. But making sense of the timeline to actually begin the program is not an easy task...First, FDA notes, that the pre-import request must be submitted "at least 30 calendar days" before the scheduled date of arrival of the product for import. "Once the shipment arrives or is entered at the port of entry, it will be examined by a government agency. Be advised that this process may take longer than 30 calendar days." The letter notes that the only port of entry currently authorized by FDA for the program is Detroit... Sub. Req'd

Will Florida's Plan to Get Cheap Drugs From Canada Work?

(1/11, The Wall Street Journal) ...Florida recently became the first state to win approval from the Food and Drug Administration to import prescription drugs from Canada. As WSJ's Liz Essley Whyte explains, it's a milestone in efforts to reduce the cost of medications, but the plan faces opposition from pharmaceutical groups and Canadian officials...[Liz Essley Whyte] I think big picture, if you think about what this means for drug pricing generally, one response to this is the US could just negotiate drug prices on a grander scale just like Canada does. It could have the regulations on drug pricing that Canada does. We don't have to just buy drugs from Canada. We could just do their policy steps... Sub. Req'd

Florida Can Now Import Prescription Drugs from Canada. It's Great News to my Patients.

(1/12, Dr. Marc Siegel, USA Today) ...The U.S. prescription drug market is nearly 20 times that of Canada's market, so our northern neighbor certainly cannot supply all our drug needs. If nothing else, this move will help burst the Big Pharma myths once and for all. The prescription drugs in Canada are just as effective and just as safe, as are generic and biosimilar drugs that can be had for much lower costs and yet often face approval challenges here... Full

States' Big 2024 Health Plans: Workforce Support and Cheaper Drugs

(1/11, Maya Goldman, Axios) ...As state legislatures get back to work across the country, state policymakers are eying measures to bolster their burned-out health care workforces, make prescription drugs more affordable and reform their Medicaid programs...Seven states advanced legislation to create similar boards last year, per Stat, and could revisit the topic this year. The Food and Drug Administration's recent approval of Florida's plan to import some cheaper drugs from Canada could encourage states to take up similar measures, Tewarson said... Full

Nadler, Porter Introduce Bill to Independently Value Drug Prices and Scrutinize Accelerated Approvals

(1/11, Congressman Jerry Nadler New York's 12th District) ...Today, Congressman Jerrold Nadler (NY-12) and Congresswoman Katie Porter (CA-47) introduced a bill to ensure fair prices for prescription drugs by establishing an independent, evidence-based process for evaluating drug benefits and pricing. The legislation would advance much-needed oversight and robust analyses of drugs that are granted FDA approval. The Independent Drug Value Assessment Act would work in conjunction with the recently passed Inflation Reduction Act to ensure lower drug prices and greater transparency for patients and consumers... Full

Card Lowers Cost of Prescriptions in Connecticut

(1/11, Braley Dodson, News 8 WTNH) ...State and city leaders are encouraging more residents to sign up for ArryRx, Connecticut's first prescription drug discount card...People can save up to 80% on generic drugs and 20% on brand-named drugs by using the card. However, health insurance or Medicare can't be used at the same time as the discount card. Leaders said the program focuses on three types of people: those with high health care deductibles, the uninsured and seniors, where Medicare doesn't cover all drug costs... Full

WHO Proposes Guidance To Curb Antibiotic-Containing Discharges From Production Sites

(1/11, Ian Schofield, Pink Sheet) ...The World Health Organization says that all actors, including the pharmaceutical industry, waste management companies, regulators and reimbursement agencies, have a part to play in dealing with manufacturing waste containing antibiotics. Companies wanting to comment on proposed international guidance on managing and controlling the release of antibiotic-containing effluent from manufacturing plants have two weeks to do so... Sub. Req'd

India Sets Out Revised GMP Rules: Can It Weed Out Dodgy Players?

(1/11, Anju Ghangurde, Pink Sheet) ...India's revised GMP rules up the bar and lay out specifics for pharmaceutical quality systems, handling of product complaints and supplier audits, among other areas. While risk-based inspections are already being deployed, it will take unflinching enforcement to separate the wheat from the chaff across 10,000 manufacturing sites in the country... Sub. Req'd

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