Thursday, October 3, 2024

Teva Leapfrogs Viatris With First US Sandostatin LAR Generic Launch

(10/2, Dean Rudge, Generics Bulletin) ...Teva says it has demonstrated "once again our ability to not only sustain a generics powerhouse, but also to bring value to patients and healthcare system," after launching the first-and-only US generic version of Novartis' Sandostatin LAR Depot (octreotide acetate) for injectable suspension...The company's complex generic and long-acting injectable rival, Viatris, has also spoken of its ambition to launch a generic Sandostatin LAR product this year... Global Sub. Full

Eli Lilly's Weight-Loss Drug No Longer in Shortage, FDA Says

(10/2, Hannah Ziegler, Daniel Gilbert, The Washington Post) ...Eli Lilly's supply of Mounjaro, which is used to treat Type 2 diabetes, and popular weight-loss drug Zepbound, can now meet present and projected national demand, the FDA said in a statement. Both medications, which trigger the hormone GLP-1 and curb hunger, have been in shortage since 2022 as demand for weight-loss drugs has skyrocketed... Sub. Req’d

Lilly Weight-Loss Drug Copycats Dealt Blow as Shortage Ends

(10/2, Ike Swetlitz and Madison Muller, Bloomberg) ...The drugmaker said Wednesday that while all doses of Zepbound and Mounjaro are available, the supply chain for refrigerated medicines is complex and patients' ability to find particular doses in pharmacies may still vary. "We know many people rely on our medicines, so we invested significantly to expand manufacturing and bring new options to the market," Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA, said in an emailed statement... Full

Eli Lilly to Build $4.5 Billion Research and Manufacturing Center to Propel Drug Pipeline

(10/2, Angelica Peebles, CNBC) ...Eli Lilly will invest $4.5 billion to construct the Lilly Medicine Foundry, a center aimed at finding better ways to make medicines. The investment seeks to build upon Lilly's success from Mounjaro and Zepbound, which are riding a wave of popularity in so-called GLP-1 drugs. Lilly has 11 obesity drugs in its pipeline and wants to develop more treatments for Alzheimer's disease, ALS and other brain diseases, Chief Executive Officer David Ricks told CNBC... Full

Weight-Loss Drugs Are Everywhere Now. How the GLP-1 Copycats Took Over.

(10/3, Josh Nathan-Kazis, Barron's) ...Late on Wednesday, the FDA declared the shortage of Lilly's drugs had been resolved. Novo's treatments are still on the list. The knockoff weight-loss drugs have been made possible by federal laws allowing compounding pharmacies to make copies of drugs that the FDA determines to be in shortage...Once the FDA determines that Novo and Lilly can meet demand for their drugs, the law requires larger compounders to stop making drugs within 60 days, and smaller ones to stop immediately... Full

Novo Nordisk Has Mitigation Plans to Minimize Disruption from Port Strikes

(10/2, Bhanvi Satija, Reuters) ...Danish drugmaker Novo Nordisk said on Tuesday it has mitigation plans in place to minimize or prevent any disruption to its production due to sea port strikes in the United States. The maker of popular drugs, Wegovy and Ozempic, plans to ship its products to and from the U.S. via air freight, a company spokesperson said... Full

How Blue Shield Closed a Big Drug Deal, and What it Means for Patients

(10/2, Ron Leuty, San Francisco Business Times) ...Blue Shield of California's deal with Fresenius Kabi is big for its 4.8 million members, who as of Jan. 1 will have no out-of-pocket cost for the biosimilar. Through the existing Blue Shield of California deal negotiated by Prime Therapeutics LLC, a PBM owned by several Blues plans, the insurer paid for about 40,000 Humira prescriptions a year, according to Bloomberg... Sub. Req’d

Biogen Once Again Accused Of US Tecfidera Skullduggery – This Time By Baltimore

(10/2, Dean Rudge, Generics Bulletin) ...Biogen resorted to using unlawful, anticompetitive agreements to block the distribution of generic Tecfidera, while it scrambled to switch the market to its follow-on brand, according to another class action lawsuit brought against the originator... Global Sub. Full

Amgen's Formulation of Eylea Biosimilar Saved It From Injunction

(10/2, Christopher Yasiejko, Bloomberg Law) ...Amgen Inc. avoided Regeneron Pharmaceuticals Inc.'s attempt to block its Eylea biosimilar because a federal judge in West Virginia found its version of the blockbuster eye-disease drug—unlike the four Regeneron successfully blocked—lacks a required separate buffer, according to a redacted order... Sub. Req’d

Alembic Pharma Shares Jump 5% On Final USFDA Nod to Seizure Treatment Drug

(10/3, CNBC TV 18) ...Shares of Alembic Pharmaceuticals rose nearly 5% on Thursday after the company received final approval from the US Food and Drug Administration for Lamotrigine Extended-Release tablets, which are primarily used in the management of certain types of seizures. This approval adds to Alembic Pharma's growing portfolio, which now includes 216 ANDA approvals from the USFDA, comprising 188 final approvals and 28 tentative approvals... Full

Gilead Licenses HIV Shot to Six Generic Manufacturers, But Falls Short of Access Sought by Advocates

(10/2, Lei Lei Wu, Endpoints News) ...The company is granting six drug manufacturers voluntary licenses to make and sell the drug for PrEP as well as treatment for certain adults with multi-drug resistant HIV, where it is already approved as Sunlenca. The manufacturers include Dr. Reddy's, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris subsidiary Mylan...Full

Gilead Signs Deal For Generic HIV Treatment, Prevention

(10/2, Luke Zarzecki, InsideHealthPolicy) ...Supporters of HIV drug access said they were disappointed the agreements do not include any guarantee of affordability within the United States, where the generic versions are not expected to be offered. One group said Gilead should have licensed the drug through a global organization like the United Nations' Medicines Patent Pool, which has worked with manufacturers to increase generics access for other HIV drugs around the world... Sub. Req’d

China's WuXi Explores Sale of Pharma Units as US Restrictions Loom

(10/3, Oliver Barnes, James Fontanella-Khan and Eleanor Olcott, Financial Times) ...WuXi AppTec has put its cell and gene therapy manufacturing arm WuXi Advanced Therapies, which operates four laboratories and manufacturing facilities in Philadelphia, up for sale, according to three people familiar with the matter. Discussions have been ongoing for months and rival contract manufacturers have been approached about buying all or some of the assets...WuXi Biologics told the FT it "continues to experience good business momentum. We are consistently securing new projects across all regions including the US, EU, China and the rest of Asia"... Full

A Promise Unfulfilled: The State of Biosimilars

(10/2, Mark Campbell, The Center For Biosimilars) ...Given the high cost of biologic drugs when the first biosimilars-highly similar, lower-cost alternatives-began to be developed, expectations for their cost-saving potential were high. Unfortunately, in the near decade since the first biosimilar was approved of filgrastim-sndz (Zarxio; Sandoz) in 2015, this promise has failed to materialize... Full

US Medicare Issues Updated Rules for Second Round of Drug Negotiations

(10/2, Ahmed Aboulenein, Reuters) ...The U.S. government will provide more time for negotiations and more chances for drugmakers to submit counter offers during the second round of talks over price cuts for its Medicare program, it said on Wednesday... Full

For Next Round of IRA Price Negotiations, US Says it Will Meet with Companies Sooner

(10/2, Nicole DeFeudis, Endpoints News) ...CMS said on Wednesday in a regulatory document that it listened to public feedback, and plans to engage companies earlier during the next cycle of negotiations. Next year's process will also allow additional opportunities for drugmakers and the agency to submit new offers and counteroffers, a CMS official said during a press call... Full

CMS To Allow More Counteroffers, Hike Patient Engagement, Use Transaction Facilitator In Next Negotiations

(10/2, Gabrielle Wanneh, InsideHealthPolicy) ...A CMS official told reporters Wednesday the aim is for CMS to engage with drug makers sooner and within the same number of meetings rather than waiting until after a written acceptance or counteroffer is received, which was the process for the inaugural negotiation period. Should CMS reject a drug maker's written counteroffer, the agency will offer up to two more optional negotiation meetings... Sub. Req’d

Patient/CMS Roundtables For Medicare-Negotiated Drugs Will Be Interactive, But Not Public Next Time

(10/2, Cathy Kelly, Pink Sheet) ...CMS plans to hold 15 roundtable sessions with patients, caregivers and patient advocates next spring to gather input on the next group of Medicare Part D drugs that will be selected for price negotiation, according to final guidance on the process. The closed-door roundtables are expected to be an improvement over the public listening sessions hosted by CMS for drugs negotiated in the first cycle of the program... Global Sub. Full

Lawmakers Want FTC to Probe Big PBMs Over Private-Label Biosimilar Deals

(10/2, Ed Silverman, STAT Plus) ..."The concern with these 'co-manufacturing' agreements is that they are a veiled attempt by pharmacy benefit managers to control additional parts of the supply chain, which has resulted in additional harm to consumers in the form of fewer drug choices and higher drug costs," U.S. Sen. Ron Wyden (D-Ore.) and U.S. Sen. Sherrod Brown (D-Ohio) wrote to FTC Chair Lina Khan in a Sept. 30 letter... Sub. Req’d

Editorial: Lina Khan Gets Punched Back

(10/2, The Wall Street Journal) ...More businesses are challenging the Biden Administration's regulatory overreaches. Now one is raising a novel question: Can government agencies smear businesses with legal impunity? That's the question posed by a defamation lawsuit against the Federal Trade Commission... Sub. Req’d

US Bill Recap: What Are The Latest Legislation Moves Covering Generics And Biosimilars?

(10/2, Urte Fultinaviciute, Generics Bulletin) ...The Association for Accessible Medicines and its Biosimilars Council division urged the Senate to pass "two important pieces of legislation" - the Biosimilar Red Tape Elimination Act (S.2305) and the Medication Affordability and Patent Integrity Act (S.2780)... Global Sub. Full

HHS Expecting ‘Limited' Impact On Drug Supply Chain from Port Strike

(10/2, Joseph Choi, The Hill) ...The Department of Health and Human Services (HHS) is not anticipating a major impact on the availability of health care products stemming from the port strike that began this week, with current assessments foreseeing a "limited" effect... Full

Warren, Rubio Renew Push to Investigate the Effects of Foreign Investment On U.S. Pharmaceutical Supply Chains

(10/2, Senator Elizabeth Warren) ...Senators Elizabeth Warren (D-Mass.) and Marco Rubio (R-Fla.) reintroduced the United States Pharmaceutical Supply Chain Review Act, legislation to require the Federal Trade Commission, in consultation with the Department of Commerce, to produce a report on the impacts of foreign investment in the United States' pharmaceutical industry... Full

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

(10/2, Sarah Karlin-Smith, Pink Sheet) ...FDA Commissioner Robert Califf stressed the US needs a more diversified drug supply chain that is less reliant on China, but cautioned against taking action that is too extreme given the two countries' interconnectedness. Califf said US pharma does not want to lose access to the Chinese market for exports. Califf also said his agency needs more staff with global expertise... Global Sub. Full

Improving Efficiency of Approval Process for New Medicines in the EU

(10/2, European Medicines Agency) ...EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and approval processes for new medicines in the European Union. The initiative aims to better manage the use of the network's expert resources, streamline assessment processes and encourage better and more comprehensive application dossiers from applicants at the time of initial submission. The overall objective of the initiative is to accelerate the availability of safe and effective treatments for patients... Full

EMA Looks to Make its Drug Approval Processes More Efficient

(10/2, Zachary Brennan, Endpoints News) ...Beginning in 2023, the EMA began monitoring every new marketing application to get a better understanding of delays. It found that only 35% of applications were submitted on the agreed-to time by the sponsor, and 21% were submitted with a delay... Full

European Regulator Seeks to Speed Up Approvals

(10/3, The Pharma Letter) ...The agency has said it wants to improve the use of expert resources and to streamline the assessment process, tackling long-standing inefficiencies. A key focus of the reforms is the need to improve the predictability of submissions for marketing authorisation applications... Sub. Req’d

Anvisa To Access US FDA-Reviewed Data For More Robust Evaluations In Brazil

(10/2, Francesca Bruce, Pink Sheet) ...The agreement was signed on September 30, by the heads of the agencies – Anvisa's Antoino Barra Torres and the FDA's Robert Callif. It means that Anvisa will have access to "strategic safety, efficacy and quality data" that has already been analyzed by the FDA, which will "contribute to more agile and robust evaluations in Brazil," said Anvisa. The agreement also marks a positive step in relations between the two regulators, which has been developing over the past ten years, commented Anvisa... Global Sub. Full

US Biosecure Act Offers No Visible Benefit To India In Near-Term, Says Quadria's Amit Varma

(10/3, NDTV Profit) ...The US Biosecure Act is unlikely to have an effect on Indian pharma companies in the near term, according to Quadria Capital's managing partner Amit Varma. Speaking to NDTV Profit, Varma said that the effects will only be visible after two to three years... Full

What is Up With The Drugs Manufactured, Sold and Marketed in India

(10/2, Zubeda Hamid, The Hindu) ...The questions of drugs, real and spurious, has come up in the healthcare sector this week, with reports of drugs not meeting quality standards, pharmaceutical companies claiming that these drugs were all counterfeits, one company issuing a ‘clarification' on the marketing of a new drug it has manufactured, and all of it together, casting doubts in the minds of those who need to use these drugs... Sub. Req’d

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