Monday, January 29, 2024

Teva Price Target Raised to $15 from $14 at BofA

(1/29, The Fly) ...BofA raised the firm's price target on Teva to $15 from $14 and keeps a Buy rating on the shares. The firm, which forecasts Q4 sales and EBITDA that are slightly higher and roughly in-line versus consensus, respectively, cites a valuation multiple re-rate for its higher target... Full

Teva Price Target Raised to $15 from $14 at Barclays

(1/29, The Fly) ...Barclays analyst Balaji Prasad raised the firm's price target on Teva to $15 from $14 and keeps an Overweight rating on the shares. The analyst sees the generics and biosimilars outlook as the "healthiest in years," with easing generic deflation and rising loss of exclusivity opportunities. The firm upgraded the specialty pharmaceuticals industry to Positive... Full

Records Show Publix Opioid Sales Grew Even as Addiction Crisis Prompted Other Chains' Pullback

(1/29, KFF Health News/Tampa Bay Times) ...The share of high-strength oxycodone orders was well above normal for a chain of grocery store pharmacies, and the total number of pills sent to Publix stores was "significantly above their peers," Teva's head of federal compliance wrote in the email to his supervisors, according to court records in a federal lawsuit pending in Ohio against Publix and other companies... Full

Apotex, Heritage, Breckenridge US Price-Fixing Settlements Could Top $50m

(1/26, Dean Rudge, Generics Bulletin) ...A trio of generics manufacturers, including Canadian giant Apotex, have agreed to multi-million-dollar settlements with direct purchasers to resolve allegations of collusion and generic price fixing, in the latest episode from sprawling antitrust multi-district litigation...After years rumbling through the US legal system, many more price fixing allegations involving other manufacturers have also resulted in settlements. Teva, one of the largest providers of generic medicines in the US, announced last August that it had struck a deal with the US Department of Justice to settle longstanding criminal charges over generic price-fixing... Global Sub. Full

Big Pharma Is at a Crossroads, as J&J, Merck and Others Prepare to Lose Heaps of Revenue From Blockbuster Drugs

(1/28, Annika Kim Constantino, CNBC) ...JPMorgan sees the upcoming patent cliffs in the mid-2020s as "largely manageable" as drug pipelines improve, and expects the biopharmaceutical industry's sales to be "roughly stable" through 2030, analyst Chris Schott said in a note in December... Sub. Req’d

Byooviz Or Beovu? Canadian Court Halts Samsung, Biogen Biosimilar Trademark

(1/26, Dean Rudge, Generics Bulletin) ...In a 57-page judgment, Federal justice Christine Palotta ordered that the biosimilars partners be permanently enjoined from using the Byooviz trademark in association with "pharmaceutical preparations for use in ophthalmology or pharmaceutical preparations for prevention and treatment of ocular disorders and diseases, or any other trademark or trade name that is confusingly similar to the registered Beovu trademark."... Global Sub. Full

Celltrion Seeks FDA Approval for Actemra Biosimilar

(1/29, Shim Woo-hyun, The Korea Herald) ...Celltrion has completed its submission of a biologics license application (BLA) to the US Food and Drug Administration for CT-P47, a biosimilar candidate mimicking Roche's rheumatoid arthritis treatment Actemra (tocilizumab), the company said Monday... Full

Alvotech Reports Positive Top-Line Results from a Pharmacokinetic Study for AVT03

(1/29, StreetInsider.com) ...Alvotech...announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab... Sub. Req’d

Boan Biotech Nears Denosumab Registration After Phase III Enrollment Completion

(1/26, Urte Fultinaviciute, Generics Bulletin) ...Boan Biotech has completed participant enrollment in its international Phase III trial investigating its proposed denosumab biosimilars, BA6101 and BA1102. While the China-based biotech did not disclose when it expects to finish the study, the trial completion may lead to license applications for both injections in Europe, the US, and Japan... Global Sub. Full

Pfizer's First-Launched Vyndamax Patent Case Is Down to Validity

(1/26, Christopher Yasiejko, Bloomberg Law) ...Dexcel Pharma Technologies Ltd.'s proposed generic will infringe US Patent Nos. 7,214,695, 7,214,696, and 9,770,441 if the asserted patent claims aren't proven invalid, according to a stipulation and proposed order of infringement that Magistrate Judge Christopher J. Burke approved in the US District Court for the District of Delaware... Sub. Req’d

AstraZeneca to Import Critical Drugs to India, Focus on Cancer Therapies

(1/29, Anjali Singh, Business Standard) ...The pharma company is aiming to import Palivizumab for respiratory infections, Tremelimumab for cancer, and a Fixed Dose Combination (FDC) of Budesonide, Formoterol fumarate, Glycopyrronium for asthma combination. However, these plans depend on receiving all necessary statutory regulatory permissions, the company said... Full

Biosimilar Insulins Promise Patients New Choices, But Competition Is Still Lacking

(1/28, Frank Vinluan, MedCity News) ...Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it's also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022... Full

Sanders Pressures Pharma CEOs on Drug Prices Amidst Lawsuits

(1/26, Jalen Brown, Ian Lopez, and Nyah Phengsitthy, Bloomberg Law) ...The CEOs of Johnson & Johnson and Merck & Co. Inc. agreed on Friday to testify before the Senate Health, Education, Labor and Pensions Committee, following Bristol-Myers Squibb Co.‘s CEO who agreed a week earlier to appear. Sanders threatening to subpoena the executives after they originally declined to appear before the panel. The committee, chaired by Sanders, is now set to hold a hearing on Feb. 8, where lawmakers will question these executives about how they price their products... Sub. Req’d

Democrats Urge Government to Rein in Medicare Advantage Overpayments and Denials

(1/26, Bob Herman, STAT Plus) ...Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) sent a letter Friday to Medicare's top leader, Chiquita Brooks-LaSure, outlining steps they say would drastically reduce the estimated $100 billion in annual overpayments and questionable quality bonuses Medicare Advantage insurers receive. All of the proposed actions — which include terminating more contracts with insurers that violate the program's coverage rules — fall within Medicare's existing powers... Sub. Req’d

Bipartisan Reform Required to Turn Back the Clock on Outcomes of Federal Drug Discount Program

(1/26, William S. Smith & Robert Popovian, RealClear Health) ...Here lies the root of the problem. The original statute does not define which patients are eligible for drug discounts, require covered entities to be located in areas that serve a high percentage of uninsured and low-income patients, nor ensure that revenue generated from the program be used to provide charity care for these populations. Due to these gaps in the program guidance, covered entities are incentivized to serve wealthier, insured populations to turn a profit, while the patients the program was designed to serve continue to struggle to access care... Full

Pharma Just Increased the Price of Hundreds of Drugs. PBMs are Minimizing the Impact for Health Plans, Employers and Patients

(1/28, Adam Kautzner, MedCity News) ...The bottom line: regardless of what pharma companies say and do, we will work relentlessly to protect patients and clients from their greedy, price-gouging tactics by countering these increases with competition while improving health outcomes in the process... Full

Demand-Side Reforms To Prevent Drug Shortages: Medicare's Role In A Successful National Strategy

(1/26, Stephen Colvill, Thomas Roades, Gerrit Hamre, Marianne Hamilton Lopez, Mark B. McClellan, Health Affairs) ...Despite many efforts to reduce drug shortages, the root causes persist and until addressed are very likely to cause more shortages. Increased concentration of manufacturing, including geographic concentration, has created vulnerabilities. Limited supply chain visibility complicates efforts to assess and address shortage risks, but the largest driver of drug shortages is quality issues in manufacturing which too frequently lead to a lack of availability of critical medications... Full

FDA Offers Guidance To Generics On Label Updates, Tentative Approvals

(1/26, Jessica Karins, InsideHealthPolicy) ...The agency issued final guidance on revisions to labeling for abbreviated new drug applications (ANDAs) for generic drugs following updates to the labeling of the reference listed drug. FDA provides information on how to monitor reference drug labeling updates and submit updates to labels for ANDAs. The agency also released a revised final guidance on amendments and requests for final approval to tentatively approved ANDAs. The revision updates a guidance from 2020 and incorporates performance goals outlined in the most recent commitment letter for the Generic Drug User Fee Amendments (GDUFA)... Sub. Req’d

Janet Woodcock Retires From US FDA: ‘I'm Trying To Tie Up All The Loose Ends'

(1/26, Derrick Gingery, Pink Sheet) ...Janet Woodcock did not mince words when asked if she was ready to retire from the US Food and Drug Administration after one of the most distinguished careers in its history. Her answer was a resounding yes. And she seemed excited to have only a handful of days left. "I'm feeling ready," the FDA principal deputy commissioner said during a 25 January interview with the Pink Sheet. "I was ready like several years ago."..."I'm 75. ... I should have like boy scouts helping me across streets instead of having to do all the stuff I do," Woodcock added. "I have other things I want to do."... Sub. Req’d

Regulators Tout ICMRA Pilots, Adoption of ICH Guidelines as Major Steps Toward Convergence

(1/26, Joanne S. Eglovitch, Regulatory Focus) ...Regulators from around the globe touted some of the progress made to increase their collaborations through the joint review pilots sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the adoption of the International Council for Harmonisation's (ICH) guidelines on viral safety evaluation and analytical method development as major accomplishments in 2023... Full

Joint Statement Association for Accessible Medicines - Medicines for Europe Ahead of 5th

EU-U.S. Trade and Technology Council Ministerial Meeting

(1/26, Medicines for Europe) ...Ahead of the 5th TTC Ministerial meeting on 30th January, we call on the EU and the U.S. to allow faster patient access through a regulatory framework enabling a Single Development Programme for complex generic medicines... Full

EMA Clamps Down On ‘Unpronounceable' Trade Names For Medicines

(1/26, Vibha Sharma, Pink Sheet) ...The revised guideline, which came into effect on 1 January, has a stronger focus on preventing name-related medication errors. It introduces new concepts (eg, cognitive error, umbrella branding, 'in use' status) and further clarifies the assessment methods and criteria applied by the EMA's Name Review Group (NRG) when reviewing the acceptability of "invented" names proposed by drug sponsors... Sub. Req’d

Competition Enforcement Led to Fairer Prices, Innovative Products — EC Report

(1/26, Lia DeGroot, Endpoints News) ...The 58-page report, which analyzed enforcement actions by the EC and member states' national competition authorities between 2018 and 2022, found that enforcement actions ultimately led to a stronger pharmaceutical market and enhanced access to medications. The report comes as US regulators have taken a closer look at anticompetitive practices by pharma in recent years, with the FTC having a heavier hand in mergers, and lawmakers taking a closer look at the misuse of the patent system... Full

Imports of Bulk Drugs and Drug Intermediates Decline 12% in First Nine Months of Fy24

(1/29, Gireesh Babu, Pharmabiz.com) ...Imports of bulk drugs and drug intermediates to India have reported a decline of 12 per cent during the first three quarters of the fiscal year 2023-24, even as in terms of quantity there was a marginal growth of one per cent. Imports from China have registered a decline of 9.45 per cent during the period, as compared to the corresponding period of previous fiscal year... Full

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