Tuesday, October 22, 2024

Teva, Alvotech Announce U.S. FDA Approval of Presentation of SELARSDI

(10/22, The Fly) ...Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced that the U.S. Food and Drug Administration, FDA, has approved SELARSDI in a new presentation, 130 mg/26 mL solution in a single-dose vial for intravenous infusion. This approval paves the way for SELARSDI to further align its label with the indications of the reference product Stelara in the U.S. at launch, which is expected in the first quarter of 2025... Full

Celltrion Inks $72.4Mn CDMO Deal for Migraine Drug with Teva Pharm

(10/22, Pulse) ...South Korea's Celltrion Inc. announced on Tuesday that it has signed a contract development and manufacturing organization (CDMO) agreement for its migraine drug, Ajovy, with global pharmaceutical company Teva Pharmaceuticals International GmbH... Full

Celltrion Signs $72.8 Million Deal for Migraine Drug Ajovy

(10/22, Lee Jae-Lim, Korea JoongAng Daily) ...Celltrion secured a 100.4 billion won ($72.8 million) deal for contract development and manufacturing (CDMO) with TEVA Pharmaceuticals International for the migraine treatment Ajovy. The contract runs through July 30 of next year, the pharmaceutical firm said Tuesday through an electronic disclosure... Full

A Sign Of Things To Come? Teva Bows To Galafold IP With 2037 US Settlement Agreement

(10/21, Dean Rudge, Generics Bulletin) ...Under the terms of a deal that terminates all ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold patents pending in the US District Court for the District of Delaware, Teva will be able to launch its generic version of the Fabry disease treatment beginning on January 30, 2037...To date, no generic versions of either Galafold or Fabrazyme have received a final approval from the FDA, meaning that with Teva's settlement, a small but vastly expensive market can open up to cheaper generic competition... Global Sub. Full

Teva Pharma (TEVA) PT Raised to $18 at JPMorgan

(10/21, StreetInsider.com) ...JPMorgan analyst Chris Schott raised the price target on Teva Pharma to $18.00 (from $16.00) while maintaining a Neutral rating... Sub. Req’d

Stelara ‘At The End Of Its Life' As Biosimilars Put Pressure On J&J

(10/21, Urte Fultinaviciute, Generics Bulletin) ..."We know that Stelara is near or at its end of life," said the firm's executive vice president and worldwide chairman of innovative medicine, Jennifer Taubert, who did not hide the imminent reality during the recent Q3 2024 earnings call. Stelara sales declined by 6.6% to $2.68bn in the third quarter compared to the same period last year, with ex-US sales dropping by 4.8% to $906m, particularly in the EMEA region due to biosimilar competition, Taubert said...Now, J&J is putting its efforts into a different immunology drug – Tremfya (guselkumab), which, according to Taubert, "is definitely an asset that is Stelara-size or bigger and better," with hopes that it will fill the shoes of Stelara... Global Sub. Full

Fresenius Offers First And Only Canadian Tocilizumab Biosimilar

(10/21, Dave Wallace, Generics Bulletin) ...Fresenius Kabi has once again blazed a trail for competitors to Actemra (tocilizumab) by becoming the first company to launch a rival version of the inflammatory and immune diseases treatment in Canada in the form of its Tyenne biosimilar. Other than Roche's Actemra reference brand, Fresenius holds the only Health Canada approval for a tocilizumab product... Global Sub. Full

Amneal Pharmaceuticals Gets FDA Approval for Pyridostigmine Bromide

(10/21, Sabela Ojea, Dow Jones) ...Amneal Pharmaceuticals said the U.S. Food and Drug Administration has approved its new drug application for its medication pyridostigmine bromide extended-release tablets. The pharmaceutical company on Monday said the treatment has been developed for the U.S. armed services and U.S. allies... Full

Sanofi in 'Exclusive Negotiations' to Sell 50% Stake in €16B Consumer Health Unit Opella

(10/21, Kevin Dunleavy, Fierce Pharma) ...With the proposed transaction, which could close in the second quarter of next year "at the earliest," Sanofi will double down on its innovative medicines and vaccines. In doing so, the French drugmaker joins other biopharma giants that have made similar moves, including Johnson & Johnson, Pfizer and GSK. In making this move, "Sanofi can focus even more in bringing innovative solutions to patients suffering from debilitating or life-threatening diseases or viruses such as RSV, COPD, or multiple sclerosis," Paul Hudson, the CEO of Sanofi, said in a release... Full

Roche, Genentech End Anti-Tau Alzheimer's Drug Collaboration with UCB

(10/22, Ayisha Sharma, Endpoints News) ...UCB will advance its anti-tau antibody for Alzheimer's disease solo after Roche and Genentech walked away from the asset known as bepranemab...As for Roche, the deal termination comes as part of a broader strategy shift that focuses on cardiometabolic, oncology and neurology drugs. The company has notably made investments in next-generation weight loss approaches... Full

ICER Raises Cost-Effective Price for Pfizer's ATTR Drug in Final Analysis But Still Calls for Hefty Discount

(10/21, Angus Liu , Fierce Pharma) ...Pfizer's tafamidis drugs, Vyndaqel and Vyndamax, need a minimum 85% discount from annual list prices of nearly $268,000 to meet commonly accepted cost-effectiveness thresholds, the Institute for Clinical and Economic Review (ICER) found in an updated ATTR-CM report published Monday... Full

Baxter Aims to Take More New Dialysis Patients After Storm Halt

(10/21, Rthvika Suvarna, Bloomberg) ...Baxter International Inc. will begin accepting more new home dialysis patients after hurricane damage to a plant forced it to limit enrollment to children and emergency cases. The company, a major provider of fluids used for home dialysis, is aiming to "restore the number of new patient starts to pre-Hurricane Helene levels by the end of the year," according to a statement Monday... Sub. Req’d

Biden, Sanders to Highlight Savings from Medicare Price Caps

(10/22, Joseph Choi, The Hill) ...According to a senior administration official, Biden and Sanders will go to Concord, N.H. to discuss the details of a new HHS report that shows almost 1.5 million Medicare beneficiaries saved roughly $1 billion thanks to the price caps on prescription drugs during the first half of 2024.... Full

Biden to Highlight Drug Price Reductions with New Hampshire Visit

(10/22, Paulina Smolinski, CBS News) ..."Congress has talked a lot about this, but just never got much done. And partly it had to do with the fact that Pharma is such a big lobbyist," Leighton Ku, a professor in the department of health policy and management at George Washington University, said in an interview with CBS News. "So the fact that the Biden administration could work with Congress to get even these marginal things done is impressive."... Full

Biden, Harris Propose Free OTC Contraception Under ACA

(10/21, Seeking Alpha) ...The Biden-Harris administration on Monday unveiled a proposal that would expand the Affordable Care Act's coverage of contraceptives to include over-the-counter contraception with no cost sharing...Teva Pharmaceutical Industries and Bayer are major players in the branded oral contraceptive space... Full

Blumenthal Urges House to Pass Bill Supporting Prescription Drug Competition

(10/21, Molly Ingram, WSHU) ...U.S. Sen. Richard Blumenthal (D-CT) wants the House of Representatives to vote on legislation he co-sponsored that he said will reduce prescription drug prices..."When a new drug applies for a patent, these companies throw a thicket of patent applications at the system, in effect, to block competitors with lower prices," Blumenthal said on Monday. "Consumers need and deserve choices for generics or biosimilars that have lower prices; drugs with lower prices that have the same effect."... Full

Novartis Appeals US Drug Price Negotiation Loss to Third Circuit

(10/21, Nyah Phengsitthy, Bloomberg Law) ...Novartis AG appealed its challenge against the Biden administration's drug price negotiation plan to the Third Circuit after a lower court rejected its claims that the program violates speech and takes property...The manufacturer alleged the Centers for Medicare & Medicaid Services' program violates the First Amendment compelled speech doctrine, the Fifth Amendment takings clause, and the Eighth Amendment excessive fines clause... Sub. Req’d

Pharmacy Benefit Managers Are Crucial to Competitive Drug Pricing

(10/22, Anthony LoSasso, Bloomberg Law) ...Rather than dismantle mechanisms that counterbalance high drug costs, we should focus on enhancing market competition throughout the pharmaceutical supply chain. Preserving PBMs' ability to negotiate lower prices—which has saved patients and governments billions of dollars—remains the most effective way to lower costs and improve patient access to care... Full

Medicare Part D Cost Sharing Relief Driving Surge In Specialty Drug Prescribing – UnitedHealth

(10/21, Cathy Kelly, Pink Sheet) ...UnitedHealth Group saw "rapid acceleration in the prescribing of certain high-cost specialty medications" in its Medicare Advantage prescription drug plans in the third quarter. Prescribing increased primarily for drugs used to treat cardiovascular disease, autoimmune disorders, and cancer, UnitedHealth Group president and chief financial officer John Rex said during the firm's earning call on October 15... Global Sub. Full

Senators Demand Answers On Telehealth Platforms from Pfizer and Eli Lilly

(10/22, Katie Palmer, STAT Plus) ...Senators led by Sen. Dick Durbin (D-Ill.) on Monday demanded answers from Pfizer and Eli Lilly about their relationship with the telehealth prescribers they point patients to from their websites, seeking to determine whether the pharma giants are violating the federal anti-kickback statute... Sub. Req’d

Pharma Execs Donated More to Democrats in Campaign's Final Stretch

(10/21, Rachel Cohrs Zhang, STAT Plus) ...A STAT review of contributions by CEOs of member companies and board members of the brand drug lobby PhRMA showed most executives just gave to their companies' political action committees, if they gave at all. But of the six executives who donated to individual candidates between July 1 and Sept. 30, five gave to Democratic candidates, even though Democratic lawmakers passed the most aggressive drug pricing reform in decades in 2022... Sub. Req’d

PCMA Statement On The Truth About Independent Pharmacies

(10/21, PCMA) ...The Pharmaceutical Care Management Association (PCMA) released the following statement today responding to another incomplete and unbalanced article from The New York Times, that again made sweeping assertions about pharmacy benefit managers, this time distorting the relationship between independent pharmacies and PBMs by relying on anecdotes instead of data... Full

Déjà Vu: Revived Mifepristone Case Puts FDA And Pharma At Risk Again

(10/21, Sarah Karlin-Smith, Pink Sheet) ...Three US states are attempting to intervene in a lawsuit that seeks to roll back changes the Food and Drug Administration made to the abortion pill mifepristone's Risk Evaluation and Mitigation Strategy, a move that puts the entire agency's drug approval process – and the pharmaceutical industry that relies upon the certainty of the status quo – in jeopardy, again... Sub. Req’d

AAM's GRx-Biosims Conference – Highlights from Day One

(10/21, Bob Pollock, Lachman Consultants) ...While I can't remember how many of these meetings I have attended over my 40 years, so far this rates with the best of them for a couple of reasons. AAM's new President and CEO, John A. Murphy III, and we got to meet him for the first time...The second reason that I was so happy, was that Janet Woodcock, MD who has worked tirelessly at the FDA for over four decades, was recognized by AAM and presented with the Association's highest award, the Lifetime Achievement Award. Dr. Woodcock thanked AAM and then did a sit- down with the association's David Gaugh, Executive Vice President for a lively Q & A session... Full

FDA to Launch Pilot Project for More Transparency On Generic Drug Delays

(10/21, Zachary Brennan, Endpoints News) ...The FDA is rolling out a new six-month pilot program to provide more transparency to generic drug applicants on complicated regulatory issues, Office of Generic Drugs Director Iilun Murphy told an industry conference on Monday. The pilot, set to roll out sometime in the next month, is in response to feedback from industry and will "provide more clarity to applicants, where possible, about the nature of the issues delaying action" on generic drug applications, Murphy said at the Association for Accessible Medicines' GRx+Biosims conference... Full

FDA Drug Center Officials Defend Biosimilar Switching Policy Change

(0/21, Jessica Karins, InsideHealthPolicy) ...Accumulated scientific evidence has led FDA to conclude clinical studies are mostly unnecessary to determine whether a biosimilar drug should be interchangeable with its reference product, according to top agency officials Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, and Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars... Sub. Req’d

Make Sure EU SPC Applications Cite The ‘First' Marketing Authorization, Firms Told

(10/21, Ian Schofield, Pink Sheet) ...Pharmaceutical companies seeking a supplementary protection certificate in Europe have been advised to make sure that their application is based on the first EU marketing authorization (MA) granted for the product concerned, even if that MA was subsequently withdrawn. The advice is aimed at companies that may be planning to apply for an SPC based on a new MA for a product containing the same active substance as a product whose original MA is no longer in force... Global Sub. Full

EU Extends Pilot On Using Raw Data In Medicines Reviews ‘Until Further Notice'

(10/21, Eliza Slawther, Pink Sheet) ...The European Medicines Agency and EU Heads of Medicines Agencies have published interim results from a proof-of-concept pilot investigating the benefits of using raw data from clinical trials in regulatory procedures. In the October 18, report, the EMA and HMA said that a survey of pilot participants revealed the value of performing a statistical analysis of clinical study data was "greatest for more complex dossiers and products with a contentious risk-benefit balance."... Global Sub. Full

Spend More On Medicines to Fix NHS, Says ABPI

(10/21, The Pharma Letter) ...Trade group the Association of the British Pharmaceutical Industry has had its say on UK government plans to overhaul the National Health Service. The government says it wants to transform the NHS by shifting from hospital to community, analogue to digital, and sickness to prevention. To inform these plans, it has launched a national conversation about the future of the NHS, said Health Secretary Wes Streeting... Sub. Req’d

The Pharmacy Business Gets a New Prescription

(10/22, Chris Hannay, The Globe and Mail) ...Provinces are giving pharmacists a more prominent place in the health system, helping patients get access to more care and changing the nature of pharmacies as a business. And analysts see pharmacists' new powers as a revenue driver for major chains. But this has also sparked confrontation with some doctors' groups, who agree that pharmacists have an important role in health teams – but only as long as physicians are still in the lead... Sub. Req’d

Prozac to Be Replaced with Generic Equivalent in Taiwan

(10/22, Taiwan News) ...Local Prozac manufacturer Eli Lilly recently announced it will stop producing the drug that is used to treat depression, bulimia, and obsessive compulsive disorder at the end of 2024, per CNA. The company said it ceased supplying 20-milligram tablets of the drug in September. In response, a consultant for the health ministry's insurance department Tai Hsueh-yung said 11 other drugs with the same content and ingredients as Prozac are available to the public under the National Health Insurance. He said the 20 mg Prozac tablets only account for 15.3% of the drug's market share, and that clinicians are generally accepting of generic drugs... Full

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